Afatinib – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 44 min read
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Afatinib - Uses, Dosage, Side Effects, Interaction
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Afatinib is an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. Afatinib is a maleate salt obtained by combining afatinib with two molar equivalents of maleic acid. Upon administration, afatinib selectively and irreversibly binds...

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Article Summary

Afatinib is an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. Afatinib is a maleate salt obtained by combining afatinib with two molar equivalents of maleic acid. Upon administration, afatinib selectively and irreversibly binds to and inhibits the epidermal growth factor receptors 1 (ErbB1; EGFR), 2 (ErbB2; HER2), and 4 (ErbB4; HER4), and certain...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
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Afatinib is an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. Afatinib is a maleate salt obtained by combining afatinib with two molar equivalents of maleic acid. Upon administration, afatinib selectively and irreversibly binds to and inhibits the epidermal growth factor receptors 1 (ErbB1; EGFR), 2 (ErbB2; HER2), and 4 (ErbB4; HER4), and certain EGFR mutants, including those caused by EGFR exon 19 deletion mutations or exon 21 (L858R) mutations. This may result in the inhibition of tumor growth and angiogenesis in tumor cells overexpressing these RTKs. Additionally, afatinib inhibits the EGFR T790M gatekeeper mutation which is resistant to treatment with first-generation EGFR inhibitors. EGFR, HER2, and HER4 are RTKs that belong to the EGFR superfamily; they play major roles in both tumor cell proliferation and tumor vascularization and are overexpressed in many cancer cell types.

Afatinib is a tyrosine kinase receptor inhibitor that is used in the therapy of selected forms of metastatic non-small cell lung cancer. Afatinib is associated with transient elevations in serum aminotransferase levels during therapy and has been reported to cause clinically apparent acute liver injury and rare instances of death.

Afatinib dimaleate is the dimaleate salt form of afatinib, an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. Upon administration, afatinib selectively and irreversibly binds to and inhibits the epidermal growth factor receptors 1 (ErbB1; EGFR), 2 (ErbB2; HER2), and 4 (ErbB4; HER4), and certain EGFR mutants, including those caused by EGFR exon 19 deletion mutations or exon 21 (L858R) mutations. This may result in the inhibition of tumor growth and angiogenesis in tumor cells overexpressing these RTKs. Additionally, afatinib inhibits the EGFR T790M gatekeeper mutation which is resistant to treatment with first-generation EGFR inhibitors. EGFR, HER2, and HER4 are RTKs that belong to the EGFR superfamily; they play major roles in both tumor cell proliferation and tumor vascularization and are overexpressed in many cancer cell types.

Afatinib is a quinazoline compound having a 3-chloro-4-fluoroanilino group at the 4-position, a 4-dimethylamino-trans-but-2-enamido group at the 6-position, and an (S)-tetrahydrofuran-3-aryloxy group at the 7-position. Used (as its dimaleate salt) for the first-line treatment of patients with metastatic non-small cell lung cancer. It has a role as a tyrosine kinase inhibitor and an antineoplastic agent. It is a member of quinazolines, a member of furans, an organofluorine compound, an enamide, an aromatic ether, a tertiary amine compound, a member of monochlorobenzenes and a secondary carboxamide.

Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim’s Gilotrif (afatinib) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [rx]. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I rx].

Mechanism of Action

Afatinib is a potent and selective, irreversible ErbB family blocker. Afatinib covalently binds to and irreversibly blocks signaling from all homo and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. In particular, afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling. Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC. Non-resistant mutations are defined as those occurring in exons constituting the kinase domain of EGFR that lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib sustainable at the recommended dosage according to validated methods. The most commonly found of these mutations are exon 21 L858R substitutions and exon 19 deletions. Moreover, afatinib demonstrated inhibition of autophosphorylation and/or in vitro proliferation of cell lines expressing wild-type EGFR and in those expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at afatinib concentrations achieved in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2.

or

Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in the downregulation of ErbB signaling. Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC. Non-resistant mutations are defined as those occurring in exons constituting the kinase domain of EGFR that lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib sustainable at the recommended dosage according to validated methods. The most commonly found of these mutations are exon 21 L858R substitutions and exon 19 deletions. Afatinib demonstrated inhibition of autophosphorylation and/or in vitro proliferation of cell lines expressing wild-type EGFR and in those expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at afatinib concentrations achieved in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2. Treatment with afatinib resulted in the inhibition of tumor growth in nude mice implanted with tumors either overexpressing wild-type EGFR or HER2 or in an EGFR L858R/T790M double mutant model.

Indications

  • Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant EGFR mutations as detected by an FDA-approved test, and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim’s Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I.
  • Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
  • Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, hematopoietic and lymphoid tissue neoplasms), Treatment of malignant neoplasms of the central nervous system.
  • Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy [rx].
  • EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an approved test.
  • Previously Treated, Metastatic Squamous NSCLC: For the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
  • Metastatic Non-Small Cell Lung Cancer
  • Refractory, metastatic squamous cell Non-small cell lung cancer

Use in Cancer

Afatinib dimaleate is approved to treat:

Afatinib dimaleate is also being studied in the treatment of other types of cancer.

Contraindications

  • Any life-threatening bullous, blistering, or exfoliative skin lesions.
  • Confirmed interstitial lung disease (ILD)
  • Severe drug-induced hepatic impairment.
  • Persistent ulcerative keratitis.
  • Symptomatic left ventricle dysfunction.
  • Severe or intolerable adverse reaction occurring at a dose of 20 mg per day.
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the cornea of the eye
  • left ventricular heart failure
  • stomach or intestinal ulcer
  • diverticulitis
  • damage to the liver and infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation
  • excessive diarrhea
  • pregnancy
  • a patient who is producing milk and breastfeeding
  • lung tissue problem
  • chronic kidney disease stage 4 (severe)

Dosage

Strengths: 30 mg; 40 mg; 20 mg

Non-Small Cell Lung Cancer

  • 40 mg orally once a day until disease progression or intolerance by the patient
  • Take on an empty stomach at least 1 hour before or 2 hours after a meal.
  • Epidermal growth factor receptor (EGFR) mutation status should be established prior to therapy initiation.
  • Do not take a missed dose within 12 hours of the next dose.

Renal Dose Adjustments

  • Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended.
  • Severe renal impairment (CrCl 15 to 29 mL/min): 30 mg orally once a day
  • End stage renal disease (CrCl less than 15 mL/min) or dialysis: Data not available

Liver Dose Adjustments

  • Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
  • Severe (Child-Pugh C) hepatic impairment: Closely monitor the patient and adjust the dose if not tolerated.

Dose Adjustments

Dose Modifications for Adverse Reactions:
WITHHOLD THERAPY FOR:

  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or higher.
  • Diarrhea Grade 2 or higher persisting for 2 or more consecutive days while taking antidiarrheal medication.
  • Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable.
  • Renal impairment Grade 2 or higher

Resume therapy when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute therapy at a reduced dose (e.g., 10 mg per day less than the dose at which the adverse reaction occurred).

PERMANENTLY DISCONTINUE THERAPY FOR:

  • Life-threatening bullous, blistering, or exfoliative skin lesions
  • Confirmed interstitial lung disease (ILD)
  • Severe drug-induced hepatic impairment
  • Persistent ulcerative keratitis
  • Symptomatic left ventricular dysfunction
  • The severe or intolerable adverse reactions occurring at a dose of 20 mg per day

Dose Modifications for Drug Interactions:

  • P-gp Inhibitors: Reduce the daily dose by 10 mg if not tolerated for patients who require therapy with a P-glycoprotein (P-gp) inhibitor. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated.
  • P-gp Inducers: Increase the daily dose by 10 mg as tolerated for patients who require chronic therapy with a P-gp inducer. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer.

Administration advice:

  • Swallow tablets whole with water.
  • In case of swallowing difficulties, the tablets may be dispersed (not crushed) in approximately 100 mL of noncarbonated water. The dispersion may also be given via a gastric tube.
  • Take on an empty stomach.
  • Do not take a missed dose within 12 hours of the next dose.

Side Effects

The Most Common

  • cracking or swelling of the lips or sores in the corners of the mouth
  • dry skin or itching
  • loss of appetite
  • nail infection
  • acne
  • nose bleeds
  • diarrhea
  • dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration
  • decreased urination
  • swelling of the arms, hands, feet, ankles, or lower legs
  • rash
  • pain, redness, peeling, or blistering of skin
  • difficulty breathing
  • shortness of breath
  • rapid, irregular, or pounding heartbeat
  • sudden weight gain
  • cough
  • fever
  • excessive tiredness
  • pain in the right upper part of the stomach
  • unusual bruising or bleeding
  • nausea
  • vomiting
  • yellowing of the skin or eyes
  • dark urine
  • red, swollen, painful, or teary eyes
  • sudden changes in vision, including blurred vision
  • sensitivity to light

More common

  • Bloody or cloudy urine
  • burning, dry, or itching eyes
  • diarrhea
  • difficult, burning, or painful urination
  • discharge or excessive tearing
  • fever
  • frequent urge to urinate
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • tingling of the hands and feet
  • ulceration of the skin
  • Cough
  • difficult breathing
  • Blemishes on the skin
  • canker sores
  • chapped, red, or swollen lips
  • decreased appetite
  • decreased weight
  • dry skin
  • itching skin or rash
  • loosening of the fingernails
  • nosebleeds
  • pimples
  • redness or soreness around the fingernails
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

Rare

  • Bloody, black, or tarry stools
  • heartburn
  • indigestion
  • nausea
  • severe abdominal pain, cramping, or burning
  • vomiting of material that looks like coffee grounds, severe and continuing
  • Dizziness
  • headache
  • lack or loss of strength
  • stomach pain
  • vomiting

Drug Interactions

Pregnancy and Lactation

US FDA pregnancy category: Not assigned. 

Pregnancy

Based on findings from animal studies and its mechanism of action, GILOTRIF can cause fetal harm when administered to a pregnant woman. There are no available data on the use of GILOTRIF in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the
potential risk to a fetus.

Lactation

No information is available on the clinical use of afatinib during breastfeeding. Because afatinib is about 95% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 37 hours and it might accumulate in the infant. the manufacturer recommends that breastfeeding be discontinued during afatinib therapy and for 2 weeks after the last dose.

How should this medicine be used?

Afatinib comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after eating a meal or snack. Take afatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take afatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may temporarily or permanently stop your treatment or decrease the dose if you experience serious side effects of afatinib. Talk to your doctor about how you are feeling during your treatment. Continue to take afatinib even if you feel well. Do not stop taking afatinib without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

What special precautions should I follow?

Before taking afatinib,

  • tell your doctor and pharmacist if you are allergic to afatinib, any other medications, or any of the ingredients in afatinib tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., Erythrocin, others); certain medications for human immunodeficiency virus (HIV) such as nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin); quinidine (in Nuedexta); rifampin (Rimactane, Rifadin, in Rifater); tacrolimus (Prograf); and verapamil (Calan, Covera, Isoptin, Verelan). Many other medications may also interact with afatinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John’s wort.
  • tell your doctor if you are of Asian descent or have or have ever had lung or breathing problems (other than lung cancer); eye problems, including dry eyes; heart problems; liver or kidney disease; or any other medical condition. Also, tell your doctor if you wear contact lenses.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking afatinib and for at least 2 weeks after your treatment. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking afatinib, call your doctor immediately. Afatinib may harm the fetus.
  • tell your doctor if you are breastfeeding. You should not breastfeed while you are taking afatinib.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Afatinib may make your skin sensitive to sunlight. Exposure to sunlight increases the risk that you will develop a rash or acne during your treatment with afatinib.

Monitoring

Afatinib has several monitoring requirements. These include:

  • Given that dermatology adverse reactions are the most commonly reported adverse reactions during treatment, patients should be advised to avoid sun exposure if possible or utilize adequate sun protection.
  • Monitor for signs and symptoms of volume depletion in patients with diarrhea
  • Hepatic impairment was commonly observed in clinical trials; it is advised to monitor liver function periodically during treatment.
  • The patient’s renal function requires periodic monitoring.
  • Keratitis is one of the rare adverse effects but reported in clinical trials – therapy should be interrupted with any suspected keratitis.
  • Recommended to reduce the dose in case of paronychia
  • Monitor patients for any signs and symptoms that raise concern for pulmonary toxicity – interstitial lung disease occurred in a small percentage of patients.
  • Assess left ventricle function before and during treatment in high-risk cardiac patients. This drug should be used with caution in patients with cardiac risk factors and/or decreased left ventricle heart failure as patients with significant cardiac history met exclusion criteria for clinical trials.

Takahashi T. et al. studied using afatinib trough plasma concentrations in patients with non-small-cell lung cancer to improve the safety and efficacy of afatinib therapy.

References

Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Afatinib – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Mechanism of Action Afatinib is a potent and selective, irreversible ErbB family blocker. Afatinib covalently binds to and irreversibly blocks signaling from all homo and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. In particular, afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling. Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC. Non-resistant mutations are defined as those occurring in exons constituting the kinase domain of EGFR that lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib sustainable at the recommended dosage according to validated methods. The most commonly found of these mutations are exon 21 L858R substitutions and exon 19 deletions. Moreover, afatinib demonstrated inhibition of autophosphorylation and/or in vitro proliferation of cell lines expressing wild-type EGFR and in those expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at afatinib concentrations achieved in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2. or Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in the downregulation of ErbB signaling. Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC. Non-resistant mutations are defined as those occurring in exons constituting the kinase domain of EGFR that lead to increased receptor activation and where efficacy is predicted by 1) clinically meaningful tumor shrinkage with the recommended dose of afatinib and/or 2) inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation at concentrations of afatinib sustainable at the recommended dosage according to validated methods. The most commonly found of these mutations are exon 21 L858R substitutions and exon 19 deletions. Afatinib demonstrated inhibition of autophosphorylation and/or in vitro proliferation of cell lines expressing wild-type EGFR and in those expressing selected EGFR exon 19 deletion mutations, exon 21 L858R mutations, or other less common non-resistant mutations, at afatinib concentrations achieved in patients. In addition, afatinib inhibited in vitro proliferation of cell lines overexpressing HER2. Treatment with afatinib resulted in the inhibition of tumor growth in nude mice implanted with tumors either overexpressing wild-type EGFR or HER2 or in an EGFR L858R/T790M double mutant model. Indications Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant EGFR mutations as detected by an FDA-approved test, and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim's Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I. Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, hematopoietic and lymphoid tissue neoplasms), Treatment of malignant neoplasms of the central nervous system. Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy [rx]. EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer: For the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an approved test. Previously Treated, Metastatic Squamous NSCLC: For the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy. Metastatic Non-Small Cell Lung Cancer Refractory, metastatic squamous cell Non-small cell lung cancer Use in Cancer Afatinib dimaleate is approved to treat: Non-small cell lung cancer (NSCLC) that has metastasized (spread to other parts of the body). It is used: As first-line treatment in patients with tumors that have certain EGFR gene mutations. In patients with squamous NSCLC that got worse after treatment with platinum chemotherapy. Afatinib dimaleate is also being studied in the treatment of other types of cancer. Contraindications Any life-threatening bullous, blistering, or exfoliative skin lesions. Confirmed interstitial lung disease (ILD) Severe drug-induced hepatic impairment. Persistent ulcerative keratitis. Symptomatic left ventricle dysfunction. Severe or intolerable adverse reaction occurring at a dose of 20 mg per day. inflammation of the cornea of the eye left ventricular heart failure stomach or intestinal ulcer diverticulitis damage to the liver and inflammation excessive diarrhea pregnancy a patient who is producing milk and breastfeeding lung tissue problem chronic kidney disease stage 4 (severe) Dosage Strengths: 30 mg; 40 mg; 20 mg Non-Small Cell Lung Cancer 40 mg orally once a day until disease progression or intolerance by the patient Take on an empty stomach at least 1 hour before or 2 hours after a meal. Epidermal growth factor receptor (EGFR) mutation status should be established prior to therapy initiation. Do not take a missed dose within 12 hours of the next dose. Renal Dose Adjustments Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended. Severe renal impairment (CrCl 15 to 29 mL/min): 30 mg orally once a day End stage renal disease (CrCl less than 15 mL/min) or dialysis: Data not available Liver Dose Adjustments Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended. Severe (Child-Pugh C) hepatic impairment: Closely monitor the patient and adjust the dose if not tolerated. Dose Adjustments Dose Modifications for Adverse Reactions: WITHHOLD THERAPY FOR: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or higher. Diarrhea Grade 2 or higher persisting for 2 or more consecutive days while taking antidiarrheal medication. Cutaneous reactions of Grade 2 that are prolonged (lasting more than 7 days) or intolerable. Renal impairment Grade 2 or higher Resume therapy when the adverse reaction fully resolves, returns to baseline, or improves to Grade 1. Reinstitute therapy at a reduced dose (e.g., 10 mg per day less than the dose at which the adverse reaction occurred). PERMANENTLY DISCONTINUE THERAPY FOR: Life-threatening bullous, blistering, or exfoliative skin lesions Confirmed interstitial lung disease (ILD) Severe drug-induced hepatic impairment Persistent ulcerative keratitis Symptomatic left ventricular dysfunction The severe or intolerable adverse reactions occurring at a dose of 20 mg per day Dose Modifications for Drug Interactions: P-gp Inhibitors: Reduce the daily dose by 10 mg if not tolerated for patients who require therapy with a P-glycoprotein (P-gp) inhibitor. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated. P-gp Inducers: Increase the daily dose by 10 mg as tolerated for patients who require chronic therapy with a P-gp inducer. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer. Administration advice: Swallow tablets whole with water. In case of swallowing difficulties, the tablets may be dispersed (not crushed) in approximately 100 mL of noncarbonated water. The dispersion may also be given via a gastric tube. Take on an empty stomach. Do not take a missed dose within 12 hours of the next dose. Side Effects The Most Common cracking or swelling of the lips or sores in the corners of the mouth dry skin or itching loss of appetite nail infection acne nose bleeds diarrhea dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration decreased urination swelling of the arms, hands, feet, ankles, or lower legs rash pain, redness, peeling, or blistering of skin difficulty breathing shortness of breath rapid, irregular, or pounding heartbeat sudden weight gain cough fever excessive tiredness pain in the right upper part of the stomach unusual bruising or bleeding nausea vomiting yellowing of the skin or eyes dark urine red, swollen, painful, or teary eyes sudden changes in vision, including blurred vision sensitivity to light More common Bloody or cloudy urine burning, dry, or itching eyes diarrhea difficult, burning, or painful urination discharge or excessive tearing fever frequent urge to urinate redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid redness, swelling, or pain of the skin scaling of the skin on the hands and feet tingling of the hands and feet ulceration of the skin Cough difficult breathing Blemishes on the skin canker sores chapped, red, or swollen lips decreased appetite decreased weight dry skin itching skin or rash loosening of the fingernails nosebleeds pimples redness or soreness around the fingernails runny nose scaling, redness, burning, pain, or other signs of inflammation of the lips sores, ulcers, or white spots on the lips or tongue or inside the mouth Rare Bloody, black, or tarry stools heartburn indigestion nausea severe abdominal pain, cramping, or burning vomiting of material that looks like coffee grounds, severe and continuing Dizziness headache lack or loss of strength stomach pain vomiting Drug Interactions DRUG INTERACTION Abaloparatide The therapeutic efficacy of Abaloparatide can be decreased when used in combination with Afatinib. Abemaciclib The serum concentration of Abemaciclib can be increased when it is combined with Afatinib. Abrocitinib The serum concentration of Afatinib can be increased when it is combined with Abrocitinib. Acetaminophen The serum concentration of Acetaminophen can be increased when it is combined with Afatinib. Alectinib Alectinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Allopurinol Afatinib may decrease the excretion rate of Allopurinol which could result in a higher serum level. Alpelisib The serum concentration of Alpelisib can be increased when it is combined with Afatinib. Ambrisentan The serum concentration of Ambrisentan can be increased when it is combined with Afatinib. Amiodarone The serum concentration of Afatinib can be increased when it is combined with Amiodarone. Apalutamide The serum concentration of Afatinib can be decreased when it is combined with Apalutamide. Apixaban Afatinib may decrease the excretion rate of Apixaban which could result in a higher serum level. Arsenic trioxide The serum concentration of Afatinib can be increased when it is combined with Arsenic trioxide. Articaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Articaine. Asciminib The serum concentration of Afatinib can be increased when it is combined with Asciminib. Asunaprevir The serum concentration of Afatinib can be increased when it is combined with Asunaprevir. Avanafil Avanafil may decrease the excretion rate of Afatinib which could result in a higher serum level. Avatrombopag Avatrombopag may decrease the excretion rate of Afatinib which could result in a higher serum level. Axitinib The serum concentration of Axitinib can be increased when it is combined with Afatinib. Beclomethasone Beclomethasone dipropionate may decrease the excretion rate of Afatinib which could result in a higher serum level. Belantamab The serum concentration of Belantamab mafodotin can be increased when it is combined with Afatinib. Belinostat The serum concentration of Belinostat can be increased when it is combined with Afatinib. Belumosudil The serum concentration of Afatinib can be increased when it is combined with Belumosudil. Bendamustine The serum concentration of Bendamustine can be increased when it is combined with Afatinib. Benzocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Benzyl alcohol. Berotralstat The serum concentration of Berotralstat can be increased when it is combined with Afatinib. Betrixaban The serum concentration of Betrixaban can be increased when it is combined with Afatinib. Binimetinib The serum concentration of Binimetinib can be increased when it is combined with Afatinib. Bisoprolol The serum concentration of Bisoprolol can be increased when it is combined with Afatinib. Bortezomib The serum concentration of Bortezomib can be increased when it is combined with Afatinib. Bosutinib The serum concentration of Bosutinib can be increased when it is combined with Afatinib. Brentuximab The serum concentration of Brentuximab vedotin can be increased when it is combined with Afatinib. Brigatinib Afatinib may decrease the excretion rate of Brigatinib which could result in a higher serum level. Bupivacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Bupivacaine. Buprenorphine Buprenorphine may decrease the excretion rate of Afatinib which could result in a higher serum level. Butacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Butamben. Cabazitaxel The serum concentration of Cabazitaxel can be increased when it is combined with Afatinib. Cabergoline The serum concentration of Cabergoline can be increased when it is combined with Afatinib. Caffeine Caffeine may decrease the excretion rate of Afatinib which could result in a higher serum level. Canagliflozin The serum concentration of Afatinib can be increased when it is combined with Canagliflozin. Cannabidiol Cannabidiol may decrease the excretion rate of Afatinib which could result in a higher serum level. Capmatinib The serum concentration of Afatinib can be increased when it is combined with Capmatinib. Capsaicin The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Capsaicin. Carbimazole The therapeutic efficacy of Carbimazole can be decreased when used in combination with Afatinib. Carfilzomib The serum concentration of Afatinib can be increased when it is combined with Carfilzomib. Carvedilol The serum concentration of Afatinib can be increased when it is combined with Carvedilol. Celecoxib Afatinib may decrease the excretion rate of Celecoxib which could result in a higher serum level. Ceritinib The serum concentration of Ceritinib can be increased when it is combined with Afatinib. Cerivastatin Afatinib may decrease the excretion rate of Cerivastatin which could result in a higher serum level. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Chloroprocaine. Cholesterol Cholesterol may increase the excretion rate of Afatinib which could result in a lower serum level and potentially a reduction in efficacy. Cinchocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Cinchocaine. Cladribine Afatinib may decrease the excretion rate of Cladribine which could result in a higher serum level. Clarithromycin The serum concentration of Afatinib can be increased when it is combined with Clarithromycin. Clobazam The serum concentration of Clobazam can be increased when it is combined with Afatinib. Clofarabine Afatinib may decrease the excretion rate of Clofarabine which could result in a higher serum level. Clofazimine The serum concentration of Afatinib can be increased when it is combined with Clofazimine. Clomifene The serum concentration of Clomifene can be increased when it is combined with Afatinib. Cobicistat The serum concentration of Afatinib can be increased when it is combined with Cobicistat. Cobimetinib The serum concentration of Cobimetinib can be increased when it is combined with Afatinib. Cocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Cocaine. Colchicine The serum concentration of Colchicine can be increased when it is combined with Afatinib. Conivaptan The serum concentration of Afatinib can be increased when it is combined with Conivaptan. C. estrogens Afatinib may decrease the excretion rate of Conjugated estrogens which could result in a higher serum level. Copanlisib The serum concentration of Copanlisib can be increased when it is combined with Afatinib. Crizotinib The serum concentration of Afatinib can be increased when it is combined with Crizotinib. Curcumin The serum concentration of Afatinib can be increased when it is combined with Curcumin. Cyclosporine The serum concentration of Afatinib can be increased when it is combined with Cyclosporine. Dabigatran The serum concentration of Dabigatran etexilate can be increased when it is combined with Afatinib. Dabrafenib The serum concentration of Dabrafenib can be increased when it is combined with Afatinib. Daclatasvir The serum concentration of Afatinib can be increased when it is combined with Daclatasvir. Dacomitinib The serum concentration of Afatinib can be increased when it is combined with Dacomitinib. Dactinomycin The serum concentration of Dactinomycin can be increased when it is combined with Afatinib. Daptomycin The serum concentration of Daptomycin can be increased when it is combined with Afatinib. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Afatinib. Darolutamide The serum concentration of Afatinib can be increased when it is combined with Darolutamide. Darunavir The serum concentration of Darunavir can be increased when it is combined with Afatinib. Dasabuvir Dasabuvir may decrease the excretion rate of Afatinib which could result in a higher serum level. Dasatinib The serum concentration of Dasatinib can be increased when it is combined with Afatinib. Daunorubicin Afatinib may decrease the excretion rate of Daunorubicin which could result in a higher serum level. Delafloxacin Afatinib may decrease the excretion rate of Delafloxacin which could result in a higher serum level. Dexamethasone Dexamethasone may decrease the excretion rate of Afatinib which could result in a higher serum level. Dexamethasone The serum concentration of Afatinib can be decreased when it is combined with Dexamethasone acetate. Diethylstilbestrol Diethylstilbestrol may decrease the excretion rate of Afatinib which could result in a higher serum level. Digitoxin The serum concentration of Digitoxin can be increased when it is combined with Afatinib. Digoxin Afatinib may decrease the excretion rate of Digoxin which could result in a higher serum level. Diosmin The serum concentration of Afatinib can be increased when it is combined with Diosmin. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Diphenhydramine. Dolutegravir Afatinib may decrease the excretion rate of Dolutegravir which could result in a higher serum level. Donepezil Afatinib may decrease the excretion rate of Donepezil which could result in a higher serum level. Doxorubicin The serum concentration of Doxorubicin can be increased when it is combined with Afatinib. Dronedarone The serum concentration of Afatinib can be increased when it is combined with Dronedarone. Duvelisib Afatinib may decrease the excretion rate of Duvelisib which could result in a higher serum level. Dyclonine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Dyclonine. Edoxaban The serum concentration of Edoxaban can be increased when it is combined with Afatinib. Elagolix The serum concentration of Afatinib can be increased when it is combined with Elagolix. Elbasvir Elbasvir may decrease the excretion rate of Afatinib which could result in a higher serum level. Eliglustat The serum concentration of Afatinib can be increased when it is combined with Eliglustat. Eltrombopag Eltrombopag may decrease the excretion rate of Afatinib which could result in a higher serum level. Enasidenib The serum concentration of Afatinib can be increased when it is combined with Enasidenib. Enfortumab The serum concentration of Enfortumab vedotin can be increased when it is combined with Afatinib. Entrectinib The serum concentration of Afatinib can be increased when it is combined with Entrectinib. Erdafitinib The serum concentration of Afatinib can be increased when it is combined with Erdafitinib. Erlotinib Erlotinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Ertugliflozin Afatinib may decrease the excretion rate of Ertugliflozin which could result in a higher serum level. Erythromycin The serum concentration of Afatinib can be increased when it is combined with Erythromycin. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Afatinib. Estradiol Estradiol may decrease the excretion rate of Afatinib which could result in a higher serum level. Estradiol acetate Estradiol acetate may decrease the excretion rate of Afatinib which could result in a higher serum level. Estradiol benzoate Estradiol benzoate may decrease the excretion rate of Afatinib which could result in a higher serum level. Estradiol cypionate Estradiol cypionate may decrease the excretion rate of Afatinib which could result in a higher serum level. Estradiol Estradiol dienanthate may decrease the excretion rate of Afatinib which could result in a higher serum level. Estradiol valerate Estradiol valerate may decrease the excretion rate of Afatinib which could result in a higher serum level. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Etidocaine. Etoposide The serum concentration of Etoposide can be increased when it is combined with Afatinib. Everolimus The serum concentration of Afatinib can be increased when it is combined with Everolimus. Ezetimibe Afatinib may decrease the excretion rate of Ezetimibe which could result in a higher serum level. Favipiravir The serum concentration of Afatinib can be increased when it is combined with Favipiravir. Febuxostat The excretion of Afatinib can be decreased when combined with Febuxostat. Fedratinib The serum concentration of Afatinib can be increased when it is combined with Fedratinib. Fexofenadine The serum concentration of Fexofenadine can be increased when it is combined with Afatinib. Flibanserin The serum concentration of Afatinib can be increased when it is combined with Flibanserin. Fluconazole The serum concentration of Afatinib can be increased when it is combined with Fluconazole. Fluorouracil Afatinib may decrease the excretion rate of Fluorouracil which could result in a higher serum level. Folic acid Afatinib may decrease the excretion rate of Folic acid which could result in a higher serum level. Follitropin The therapeutic efficacy of Follitropin can be decreased when used in combination with Afatinib. Fostamatinib Fostamatinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Fostemsavir Afatinib may decrease the excretion rate of Fostemsavir which could result in a higher serum level. Fusidic acid Fusidic acid may decrease the excretion rate of Afatinib which could result in a higher serum level. Futibatinib The serum concentration of Futibatinib can be increased when it is combined with Afatinib. Gefitinib Gefitinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Gemcitabine The serum concentration of Gemcitabine can be increased when it is combined with Afatinib. Gilteritinib Gilteritinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Glasdegib The serum concentration of Afatinib can be increased when it is combined with Glasdegib. Glecaprevir The serum concentration of Afatinib can be increased when it is combined with Glecaprevir. Glyburide Afatinib may decrease the excretion rate of Glyburide which could result in a higher serum level. Grazoprevir Grazoprevir may decrease the excretion rate of Afatinib which could result in a higher serum level. Idelalisib Afatinib may decrease the excretion rate of Idelalisib which could result in a higher serum level. Imatinib Imatinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Imipramine The serum concentration of Imipramine can be increased when it is combined with Afatinib. Indacaterol The serum concentration of Indacaterol can be increased when it is combined with Afatinib. Inotuzumab The serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Afatinib. Irinotecan Afatinib may decrease the excretion rate of Irinotecan which could result in a higher serum level. Isavuconazole The serum concentration of Afatinib can be increased when it is combined with Isavuconazole. Isavuconazonium The serum concentration of Afatinib can be increased when it is combined with Isavuconazonium. Istradefylline The serum concentration of Afatinib can be increased when it is combined with Istradefylline. Itraconazole The serum concentration of Afatinib can be increased when it is combined with Itraconazole. Ivacaftor The serum concentration of Afatinib can be increased when it is combined with Ivacaftor. Ivermectin Afatinib may decrease the excretion rate of Ivermectin which could result in a higher serum level. Ixabepilone The serum concentration of Afatinib can be increased when it is combined with Ixabepilone. Ketoconazole The serum concentration of Afatinib can be increased when it is combined with Ketoconazole. Lamivudine Afatinib may decrease the excretion rate of Lamivudine which could result in a higher serum level. Lansoprazole Lansoprazole may decrease the excretion rate of Afatinib which could result in a higher serum level. Lapatinib The serum concentration of Afatinib can be increased when it is combined with Lapatinib. Larotrectinib The serum concentration of Larotrectinib can be increased when it is combined with Afatinib. Lasmiditan The serum concentration of Afatinib can be increased when it is combined with Lasmiditan. Ledipasvir The serum concentration of Ledipasvir can be increased when it is combined with Afatinib. Lefamulin Afatinib may decrease the excretion rate of Lefamulin which could result in a higher serum level. Leflunomide Afatinib may decrease the excretion rate of Leflunomide which could result in a higher serum level. Lemborexant The serum concentration of Lemborexant can be increased when it is combined with Afatinib. Lenvatinib Afatinib may decrease the excretion rate of Lenvatinib which could result in a higher serum level. Letermovir Letermovir may decrease the excretion rate of Afatinib which could result in a higher serum level. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Levobupivacaine. Levoketoconazole The serum concentration of Afatinib can be increased when it is combined with Levoketoconazole. Levothyroxine The serum concentration of Afatinib can be decreased when it is combined with Levothyroxine. Lidocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Lidocaine. Linagliptin The serum concentration of Afatinib can be increased when it is combined with Linagliptin. Liothyronine The therapeutic efficacy of Liothyronine can be decreased when used in combination with Afatinib. Liotrix The therapeutic efficacy of Liotrix can be decreased when used in combination with Afatinib. Lomitapide The serum concentration of Afatinib can be increased when it is combined with Lomitapide. Lonafarnib The serum concentration of Afatinib can be increased when it is combined with Lonafarnib. Loncastuximab The serum concentration of Loncastuximab tesirine can be increased when it is combined with Afatinib. Loperamide The excretion of Loperamide can be decreased when combined with Afatinib. Lopinavir The serum concentration of Afatinib can be increased when it is combined with Lopinavir. Lorlatinib The serum concentration of Afatinib can be decreased when it is combined with Lorlatinib. Loxapine The serum concentration of Afatinib can be increased when it is combined with Loxapine. Lumacaftor The serum concentration of Afatinib can be increased when it is combined with Lumacaftor. Lusutrombopag Afatinib may decrease the excretion rate of Lusutrombopag which could result in a higher serum level. Mannitol The serum concentration of Mannitol can be increased when it is combined with Afatinib. Maribavir The serum concentration of Afatinib can be increased when it is combined with Maribavir. Mefloquine The serum concentration of Afatinib can be increased when it is combined with Mefloquine. Meloxicam The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Mepivacaine. Methimazole The therapeutic efficacy of Methimazole can be decreased when used in combination with Afatinib. Methotrexate Afatinib may decrease the excretion rate of Methotrexate which could result in a higher serum level. Methoxy The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Afatinib. Methylene blue The serum concentration of Afatinib can be increased when it is combined with Methylene blue. Mifepristone The serum concentration of Afatinib can be increased when it is combined with Mifepristone. Mirabegron The serum concentration of Afatinib can be increased when it is combined with Mirabegron. Mitapivat The serum concentration of Afatinib can be increased when it is combined with Mitapivat. Mitoxantrone Afatinib may decrease the excretion rate of Mitoxantrone which could result in a higher serum level. Morphine The serum concentration of Morphine can be increased when it is combined with Afatinib. Mycophenolate Afatinib may decrease the excretion rate of Mycophenolate mofetil which could result in a higher serum level. Naloxegol The serum concentration of Naloxegol can be increased when it is combined with Afatinib. Nelfinavir Nelfinavir may decrease the excretion rate of Afatinib which could result in a higher serum level. Neratinib The serum concentration of Afatinib can be increased when it is combined with Neratinib. Netupitant The serum concentration of Afatinib can be increased when it is combined with Netupitant. Nilotinib The serum concentration of Afatinib can be increased when it is combined with Nilotinib. Nintedanib The serum concentration of Nintedanib can be increased when it is combined with Afatinib. Nitrofurantoin Afatinib may decrease the excretion rate of Nitrofurantoin which could result in a higher serum level. Norgestimate The serum concentration of Afatinib can be increased when it is combined with Norgestimate. Nortriptyline The serum concentration of Nortriptyline can be increased when it is combined with Afatinib. Novobiocin Novobiocin may decrease the excretion rate of Afatinib which could result in a higher serum level. Omadacycline The serum concentration of Omadacycline can be increased when it is combined with Afatinib. Ombitasvir Afatinib may decrease the excretion rate of Ombitasvir which could result in a higher serum level. Omeprazole Omeprazole may decrease the excretion rate of Afatinib which could result in a higher serum level. Osimertinib The serum concentration of Osimertinib can be increased when it is combined with Afatinib. Oteseconazole The serum concentration of Afatinib can be increased when it is combined with Oteseconazole. Oxaliplatin Afatinib may decrease the excretion rate of Oxaliplatin which could result in a higher serum level. Oxetacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Oxybuprocaine. Ozanimod Afatinib may decrease the excretion rate of Ozanimod which could result in a higher serum level. Pacritinib The serum concentration of Afatinib can be increased when it is combined with Pacritinib. Palbociclib The serum concentration of Afatinib can be increased when it is combined with Palbociclib. Paliperidone The serum concentration of Afatinib can be increased when it is combined with Paliperidone. Panobinostat The serum concentration of Panobinostat can be increased when it is combined with Afatinib. Pantoprazole Pantoprazole may decrease the excretion rate of Afatinib which could result in a higher serum level. Parathyroid The therapeutic efficacy of Parathyroid hormone can be decreased when used in combination with Afatinib. Paritaprevir Paritaprevir may decrease the excretion rate of Afatinib which could result in a higher serum level. Pazopanib The serum concentration of Pazopanib can be increased when it is combined with Afatinib. Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Afatinib. Phenol The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Phenol. Pibrentasvir The serum concentration of Afatinib can be increased when it is combined with Pibrentasvir. Pitavastatin Afatinib may decrease the excretion rate of Pitavastatin which could result in a higher serum level. Pitolisant The serum concentration of Afatinib can be increased when it is combined with Pitolisant. Pomalidomide The serum concentration of Pomalidomide can be increased when it is combined with Afatinib. Ponatinib The serum concentration of Afatinib can be increased when it is combined with Ponatinib. Posaconazole The serum concentration of Posaconazole can be increased when it is combined with Afatinib. Potassium Iodide The therapeutic efficacy of Potassium Iodide can be decreased when used in combination with Afatinib. Potassium The therapeutic efficacy of Potassium perchlorate can be decreased when used in combination with Afatinib. Pralatrexate Afatinib may decrease the excretion rate of Pralatrexate which could result in a higher serum level. Pralsetinib The serum concentration of Pralsetinib can be increased when it is combined with Afatinib. Pramocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Pramocaine. Pravastatin Pravastatin may decrease the excretion rate of Afatinib which could result in a higher serum level. Prazosin Afatinib may decrease the excretion rate of Prazosin which could result in a higher serum level. Prednisolone The serum concentration of Afatinib can be decreased when it is combined with Prednisolone phosphate. Prilocaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Prilocaine. Procaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Procaine. Progesterone Progesterone may decrease the excretion rate of Afatinib which could result in a higher serum level. Propafenone The serum concentration of Afatinib can be increased when it is combined with Propafenone. Proparacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Propoxycaine. Propylthiouracil The therapeutic efficacy of Propylthiouracil can be decreased when used in combination with Afatinib. Protirelin The therapeutic efficacy of Protirelin can be decreased when used in combination with Afatinib. Prucalopride The serum concentration of Prucalopride can be increased when it is combined with Afatinib. Quinidine The serum concentration of Afatinib can be increased when it is combined with Quinidine. Quinine The serum concentration of Afatinib can be increased when it is combined with Quinine. Rabeprazole Rabeprazole may decrease the excretion rate of Afatinib which could result in a higher serum level. Raloxifene Afatinib may decrease the excretion rate of Raloxifene which could result in a higher serum level. Ranolazine The serum concentration of Ranolazine can be increased when it is combined with Afatinib. Regorafenib The serum concentration of Afatinib can be increased when it is combined with Regorafenib. Relugolix The serum concentration of Relugolix can be increased when it is combined with Afatinib. Reserpine The serum concentration of Afatinib can be increased when it is combined with Reserpine. Revefenacin Afatinib may decrease the excretion rate of Revefenacin which could result in a higher serum level. Rifampicin The serum concentration of Afatinib can be decreased when it is combined with Rifampicin. Rifamycin The serum concentration of Afatinib can be increased when it is combined with Rifamycin. Rifaximin The serum concentration of Rifaximin can be increased when it is combined with Afatinib. Rilpivirine Rilpivirine may decrease the excretion rate of Afatinib which could result in a higher serum level. Riluzole Afatinib may decrease the excretion rate of Riluzole which could result in a higher serum level. Rimegepant The serum concentration of Rimegepant can be increased when it is combined with Afatinib. Riociguat Afatinib may decrease the excretion rate of Riociguat which could result in a higher serum level. Ripretinib The serum concentration of Afatinib can be increased when it is combined with Ripretinib. Ritonavir The serum concentration of Afatinib can be increased when it is combined with Ritonavir. Rivaroxaban Afatinib may decrease the excretion rate of Rivaroxaban which could result in a higher serum level. Rolapitant The serum concentration of Afatinib can be increased when it is combined with Rolapitant. Romidepsin The serum concentration of Romidepsin can be increased when it is combined with Afatinib. Ropivacaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Ropivacaine. Rosuvastatin Afatinib may decrease the excretion rate of Rosuvastatin which could result in a higher serum level. Roxadustat The serum concentration of Afatinib can be increased when it is combined with Roxadustat. Rucaparib Afatinib may decrease the excretion rate of Rucaparib which could result in a higher serum level. Safinamide Safinamide may decrease the excretion rate of Afatinib which could result in a higher serum level. Salmon calciton The therapeutic efficacy of Salmon calcitonin can be decreased when used in combination with Afatinib. Sapropterin The serum concentration of Afatinib can be increased when it is combined with Sapropterin. Saquinavir The serum concentration of Afatinib can be increased when it is combined with Saquinavir. Sarecycline The serum concentration of Afatinib can be increased when it is combined with Sarecycline. Selexipag The serum concentration of Selexipag can be increased when it is combined with Afatinib. Selumetinib Afatinib may decrease the excretion rate of Selumetinib which could result in a higher serum level. Sildenafil The serum concentration of Afatinib can be increased when it is combined with Sildenafil. Silodosin The excretion of Silodosin can be decreased when combined with Afatinib. Simeprevir The serum concentration of Afatinib can be increased when it is combined with Simeprevir. Simvastatin The serum concentration of Afatinib can be increased when it is combined with Simvastatin. Sirolimus The serum concentration of Sirolimus can be increased when it is combined with Afatinib. Sitagliptin The serum concentration of Sitagliptin can be increased when it is combined with Afatinib. Sofosbuvir Afatinib may decrease the excretion rate of Sofosbuvir which could result in a higher serum level. Sorafenib The serum concentration of Afatinib can be increased when it is combined with Sorafenib. Sotagliflozin The serum concentration of Afatinib can be increased when it is combined with Sotagliflozin. Sotorasib The serum concentration of Afatinib can be increased when it is combined with Sotorasib. St. John's Wort The serum concentration of Afatinib can be decreased when it is combined with St. John's Wort. Stiripentol The excretion of Afatinib can be decreased when combined with Stiripentol. Sulfasalazine Sulfasalazine may decrease the excretion rate of Afatinib which could result in a higher serum level. Sumatriptan Afatinib may decrease the excretion rate of Sumatriptan which could result in a higher serum level. Sunitinib Sunitinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Suvorexant The serum concentration of Afatinib can be increased when it is combined with Suvorexant. Tacrolimus The serum concentration of Afatinib can be increased when it is combined with Tacrolimus. Tafamidis The serum concentration of Afatinib can be increased when it is combined with Tafamidis. Talazoparib The serum concentration of Talazoparib can be increased when it is combined with Afatinib. Tamoxifen The serum concentration of Afatinib can be increased when it is combined with Tamoxifen. Taurocholic acid Taurocholic acid may decrease the excretion rate of Afatinib which could result in a higher serum level. Tazemetostat Afatinib may decrease the excretion rate of Tazemetostat which could result in a higher serum level. Technetium The serum concentration of Technetium Tc-99m sestamibi can be increased when it is combined with Afatinib. Tegaserod Afatinib may decrease the excretion rate of Tegaserod which could result in a higher serum level. Telaprevir The serum concentration of Afatinib can be increased when it is combined with Telaprevir. Telmisartan Telmisartan may decrease the excretion rate of Afatinib which could result in a higher serum level. Temsirolimus The serum concentration of Afatinib can be increased when it is combined with Temsirolimus. Teniposide Afatinib may decrease the excretion rate of Teniposide which could result in a higher serum level. Tenofovir The serum concentration of Tenofovir alafenamide can be increased when it is combined with Afatinib. Tenofovir The serum concentration of Tenofovir disoproxil can be increased when it is combined with Afatinib. Tepotinib The serum concentration of Tepotinib can be increased when it is combined with Afatinib. Teriflunomide Teriflunomide may decrease the excretion rate of Afatinib which could result in a higher serum level. Teriparatide The therapeutic efficacy of Teriparatide can be decreased when used in combination with Afatinib. Testosterone Afatinib may decrease the excretion rate of Testosterone which could result in a higher serum level. Testosterone Afatinib may decrease the excretion rate of Testosterone cypionate which could result in a higher serum level. Testosterone Afatinib may decrease the excretion rate of Testosterone enanthate which could result in a higher serum level. Tetracaine The risk or severity of methemoglobinemia can be increased when Afatinib is combined with Tetracaine. Tezacaftor The serum concentration of Tezacaftor can be increased when it is combined with Afatinib. Thyroid, porcine The therapeutic efficacy of Thyroid, porcine can be decreased when used in combination with Afatinib. Thyrotropin alfa The therapeutic efficacy of Thyrotropin alfa can be decreased when used in combination with Afatinib. Ticagrelor The serum concentration of Afatinib can be increased when it is combined with Ticagrelor. Tipranavir The serum concentration of Afatinib can be increased when it is combined with Tipranavir. Tivozanib Tivozanib may decrease the excretion rate of Afatinib which could result in a higher serum level. Tolvaptan The serum concentration of Tolvaptan can be increased when it is combined with Afatinib. Topotecan The serum concentration of Topotecan can be increased when it is combined with Afatinib. Toremifene The serum concentration of Afatinib can be increased when it is combined with Toremifene. Trastuzumab The serum concentration of Trastuzumab emtansine can be increased when it is combined with Afatinib. Trazodone The serum concentration of Afatinib can be decreased when it is combined with Trazodone. Trilaciclib Afatinib may decrease the excretion rate of Trilaciclib which could result in a higher serum level. Trimipramine The serum concentration of Trimipramine can be increased when it is combined with Afatinib. Tucatinib Tucatinib may decrease the excretion rate of Afatinib which could result in a higher serum level. Ubrogepant The serum concentration of Ubrogepant can be increased when it is combined with Afatinib. Umbralisib The serum concentration of Afatinib can be increased when it is combined with Umbralisib. Umeclidinium The serum concentration of Umeclidinium can be increased when it is combined with Afatinib. Vandetanib The serum concentration of Afatinib can be increased when it is combined with Vandetanib. Vardenafil The serum concentration of Afatinib can be increased when it is combined with Vardenafil. Velpatasvir The serum concentration of Afatinib can be increased when it is combined with Velpatasvir. Vemurafenib The serum concentration of Afatinib can be increased when it is combined with Vemurafenib. Venetoclax The serum concentration of Afatinib can be increased when it is combined with Venetoclax. Venlafaxine Venlafaxine may increase the excretion rate of Afatinib which could result in a lower serum level and potentially a reduction in efficacy. Verapamil The serum concentration of Afatinib can be increased when it is combined with Verapamil. Vinblastine The serum concentration of Vinblastine can be increased when it is combined with Afatinib. Vincristine The excretion of Vincristine can be decreased when combined with Afatinib. Vinflunine The serum concentration of Vinflunine can be increased when it is combined with Afatinib. Vismodegib Vismodegib may decrease the excretion rate of Afatinib which could result in a higher serum level. Voclosporin The serum concentration of Afatinib can be increased when it is combined with Voclosporin. Vorapaxar The serum concentration of Afatinib can be increased when it is combined with Vorapaxar. Voriconazole The serum concentration of Afatinib can be increased when it is combined with Voriconazole. Voxilaprevir The serum concentration of Afatinib can be increased when it is combined with Voxilaprevir. Zidovudine Afatinib may decrease the excretion rate of Zidovudine which could result in a higher serum level. Zonisamide The serum concentration of Afatinib can be increased when it is combined with Zonisamide. Pregnancy and Lactation US FDA pregnancy category: Not assigned.  Pregnancy Based on findings from animal studies and its mechanism of action, GILOTRIF can cause fetal harm when administered to a pregnant woman. There are no available data on the use of GILOTRIF in pregnant women. Administration of afatinib to pregnant rabbits during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and, in rabbits showing maternal toxicity, increased abortions at late gestational stages [see Data]. Advise a pregnant woman of the potential risk to a fetus. Lactation No information is available on the clinical use of afatinib during breastfeeding. Because afatinib is about 95% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 37 hours and it might accumulate in the infant. the manufacturer recommends that breastfeeding be discontinued during afatinib therapy and for 2 weeks after the last dose. How should this medicine be used?

Afatinib comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after eating a meal or snack. Take afatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take afatinib exactly as directed. Do not take more or less of it or take…

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