Avelumab – Uses, Dosage, Side Effects, Interactions

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 27 min read
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Avelumab - Uses, Dosage, Side Effects, Interactions
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Avelumab is a monoclonal antibody used to treat metastatic Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell...

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Article Summary

Avelumab is a monoclonal antibody used to treat metastatic Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). It is a fully human anti-PD immunoglobulin G1 (IgG1) lambda monoclonal antibody with antineoplastic actions. It was granted...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindication in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Avelumab is a monoclonal antibody used to treat metastatic Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). It is a fully human anti-PD immunoglobulin G1 (IgG1) lambda monoclonal antibody with antineoplastic actions. It was granted accelerated approval in March 2017 under the name Bavencio.

Avelumab is a human monoclonal antibody to programmed cell death ligand 1 (PD-L1), which acts as a checkpoint inhibitor and is used in the immunotherapy of several forms of advanced or metastatic cancer. Avelumab therapy has major side effects and particularly immune-related conditions, including acute hepatocellular and cholestatic liver injury which can be serious and even life-threatening

Mechanism of action

PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. The binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 through the FG loops 7 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.

Avelumab is a whole antibody that binds the immunosuppressive programmed death-ligand 1 and inhibits the interaction between PD-1 and PD-L1. It prevents the formation of a PD-1/PD-L1 receptor/ligand complex that normally leads to the inhibition of CD8+ T cells, and therefore inhibition of an immune reaction. Alevumab is an immunotherapeutic and antineoplastic agent that belongs to the group of immune checkpoint blockade cancer therapies. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and may induce antibody-dependent cell-mediated cytotoxicity (ADCC).

Indications

  • Avelumab is indicated for the treatment of adult and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma (MCC).[rx]
  • It is also indicated as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC) which has not progressed with first-line platinum-containing chemotherapy. In addition, it is indicated in patients with locally advanced or metastatic UC who experience disease progression on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.[rx]
  • Avelumab is additionally indicated as a first-line treatment, in combination with axitinib, in the treatment of advanced renal cell carcinoma (RCC).[rx]
  • Advanced Renal Cell Carcinoma (aRCC)
  • Metastatic Urothelial Cancer
  • Locally advanced Urothelial Carcinoma
  • Metastatic Merkel Cell Carcinoma (MCC)

Use in Cancer

Avelumab is approved to treat:

  • Merkel cell carcinoma (a type of skin cancer) has spread. It is used in adults and in children aged 12 years and older.
  • Renal cell carcinoma (a type of kidney cancer) has spread or cannot be removed by surgery. It is used with axitinib as the first treatment.
  • Urothelial cancer (a type of cancer in the bladder or urinary tract) that has spread or cannot be removed by surgery. It is used:
    • As maintenance therapy in patients whose cancer did not get worse after first-line platinum chemotherapy.
    • In patients whose cancer got worse during or after treatment with platinum chemotherapy.

¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that avelumab provides a clinical benefit in these patients.

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

Contraindication

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

  • overactive thyroid gland
  • a condition with low thyroid hormone levels
  • low blood sugar
  • decreased function of the adrenal gland
  • a type of 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 lung called interstitial pneumonitis
  • 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 large intestine
  • kidney 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
  • abnormal liver function tests
  • pregnancy
  • a patient who is producing milk and breastfeeding

Dosage

Strengths: 20 mg/mL

Merkel Cell Carcinoma

  • 800 mg IV over 60 minutes every 2 weeks
  • Duration of therapy: Until disease progression or unacceptable toxicity

 

Urothelial Carcinoma

  • 800 mg IV over 60 minutes every 2 weeks
  • Duration of therapy: Until disease progression or unacceptable toxicity

Renal Cell Carcinoma

  • 800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food
    Duration of therapy: Until disease progression or unacceptable toxicity

Pediatric Dose for Merkel Cell Carcinoma

12 years and older:

  • 800 mg IV over 60 minutes every 2 weeks
  • Duration of therapy: Until disease progression or unacceptable toxicity

Renal Dose Adjustments

  • Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
  • Serum creatinine more than 6 x ULN: Permanently discontinue therapy.

Liver Dose Adjustments

  • Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।" data-rx-term="bilirubin" data-rx-definition="Bilirubin is a yellow pigment that can build up in jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।">bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper
  • AST or ALT more than 5 x ULN or total jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।" data-rx-term="bilirubin" data-rx-definition="Bilirubin is a yellow pigment that can build up in jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।">bilirubin more than 3 X ULN: Permanently discontinue therapy.

Dose Adjustments

DOSE ADJUSTMENTS FOR ADVERSE REACTIONS:
PNEUMONITIS:

  • Grade 2: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper
  • Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy

HEPATITIS:

  • Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।" data-rx-term="bilirubin" data-rx-definition="Bilirubin is a yellow pigment that can build up in jaundice. সহজ বাংলা: জন্ডিসে বাড়তে পারে এমন হলুদ রঞ্জক।">bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper
  • AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy

COLITIS:

  • Grade 2 or 3 diarrhea or colitis: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
  • Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis: Permanently discontinue therapy

ENDOCRINOPATHIES:
Endocrinopathies (including but not limited to hypothyroidism, hyperthyroidism, adrenal insufficiency, and hyperglycemia):

  • Grade 3 or 4: Withhold therapy; administer corticosteroids as appropriate for adrenal insufficiency; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper

NEPHRITIS AND RENAL DYSFUNCTION:

  • Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
  • Serum creatinine more than 6 x ULN: Permanently discontinue therapy.

OTHER IMMUNE-MEDIATED ADVERSE REACTIONS

(e.g., myocarditis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barre syndrome, bullous dermatitis, Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis, rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis, demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, encephalitis):

  • For moderate or severe signs of an immune-mediated adverse reaction not previously described: Withhold therapy; administer high dose corticosteroids, and if appropriate, initiate hormone replacement; resume therapy in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper
  • For any of the following: Life-threatening adverse reaction (excluding endocrinopathies); recurrent severe immune-mediated adverse reactions; requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks; persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy

INFUSION-RELATED REACTIONS:

  • Grade 1 or 2: Interrupt or slow the rate of infusion
  • Grade 3 or 4: Permanently discontinue therapy

COMBINATION THERAPY:
In patients with RCC being treated with this drug in combination with axitinib:

  • If ALT or AST is 3 times the upper limit of normal (ULN) or greater but less than 5 x ULN or total bilirubin is 1.5 x ULN or greater but less than 3 x ULN: Withhold both this drug and axitinib until adverse reactions recover to Grade 0 or 1. If persistent (greater than 5 days), consider corticosteroid therapy (initial dose of 0.5 to 1 mg/kg/day) prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. Dose reduction per the axitinib Full Prescribing Information if rechallenging with axitinib.
  • If ALT or AST is 5 x ULN or greater or greater than 3 x ULN with concurrent total bilirubin 2 x ULN or greater or total bilirubin is 3 x ULN or greater, permanently discontinue both this drug and axitinib and consider corticosteroid therapy (initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
  • When this drug is administered in combination with axitinib, review the axitinib Full Prescribing Information for recommended dose modifications for axitinib.

Side Effects

The Most Common

  • muscle, bone, or joint pain
  • headache
  • constipation
  • nausea
  • vomiting
  • weight loss
  • tiredness
  • new or worsening cough; shortness of breath; or chest pain
  • yellowing of the skin or eyes; nausea; vomiting; pain in upper right side of stomach; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding
  • headaches that won’t go away or unusual headaches; rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more hungry or thirsty than usual; dizziness or fainting; hair loss; vomiting; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; stomach pain; or feeling cold
  • diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness
  • persistent muscle pain, weakness, or muscle cramps
  • feeling dizzy or faint
  • neck stiffness
  • swelling of hands, feet, ankles, or legs

More Common

  • irregular heartbeat; chest pain and tightness; pain in the arms, back, neck, or jaw; breaking out in cold sweat
  • fever or other flu-like symptoms
  • blurry or double vision, sensitivity to light, or other vision problems
  • rash, blistering or peeling skin
  • sores in mouth, nose, throat, or genital area
  • swollen glands
  • decreased urination; blood in urine; swelling in ankles; or loss of appetite
  • unusual bleeding or bruising
  • frequent, painful, or urgent urination

Rare

  • fatigue,
  • lack of energy,
  • back pain,
  • neck pain,
  • pain in your arms or legs,
  • diarrhea,
  • nausea,
  • chills,
  • fever,
  • hypersensitivity reactions,
  • low blood pressure,
  • rash,
  • skin redness,
  • decreased appetite,
  • swelling of your arms or legs,
  • joint pain,
  • constipation,
  • abdominal pain,
  • vomiting,
  • itching,
  • weight loss,
  • cough,
  • shortness of breath,
  • dizziness,

Drug Interaction

Pregnancy and Lactation

FDA pregnancy category: Not assigned

Pregnancy

Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of BAVENCIO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG1 immunoglobulins (IgG1) are known to cross the placenta. Therefore, BAVENCIO has the potential to be transmitted from the mother to the developing fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Lactation

There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. Since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

Before receiving avelumab injection,

  • tell your doctor and pharmacist if you are allergic to avelumab, any other medications, or any of the ingredients in avelumab injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had an organ or bone marrow transplant; radiation therapy to your chest area. diabetes; thyroid problems; high blood pressure; high cholesterol; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or liver, heart, or kidney disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
  • tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 1 month after your final dose of avelumab. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving avelumab, call your doctor immediately. Avelumab may harm the fetus.
  • tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving avelumab and for 1 month after your final dose.

How should this medicine be used?

Avelumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given once every 2 weeks. Your doctor will decide how often you are to receive avelumab based on your body’s response to this medication.

Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other medications to treat or help prevent reactions to avelumab. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during the infusion: chills or shaking, hives, fever, flushing, back pain, shortness of breath, wheezing, dizziness, feeling faint, or stomach pain. Your doctor may need to slow down your infusion or delay or permanently stop your treatment if you experience these side effects.

Your doctor may also permanently or temporarily stop your treatment, or treat you with other medications if you experience other side effects. Be sure to tell your doctor how you are feeling during your treatment with avelumab injection.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with avelumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

References

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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: Orthopedic / spine specialist, physical medicine doctor, or qualified clinician
Tests to discuss with doctor
  • Neurological examination for leg power, sensation, reflexes, and straight leg raise
  • X-ray only if injury, deformity, long-lasting pain, or doctor suspects bone problem
  • MRI discussion if severe nerve symptoms, weakness, bladder/bowel problem, or persistent symptoms
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?
  • Is physiotherapy, posture correction, or activity modification needed?

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: Avelumab – Uses, Dosage, Side Effects, Interactions

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.

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Frequently Asked Questions

Mechanism of action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. The binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 through the FG loops 7 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth. Avelumab is a whole antibody that binds the immunosuppressive programmed death-ligand 1 and inhibits the interaction between PD-1 and PD-L1. It prevents the formation of a PD-1/PD-L1 receptor/ligand complex that normally leads to the inhibition of CD8+ T cells, and therefore inhibition of an immune reaction. Alevumab is an immunotherapeutic and antineoplastic agent that belongs to the group of immune checkpoint blockade cancer therapies. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and may induce antibody-dependent cell-mediated cytotoxicity (ADCC). Indications Avelumab is indicated for the treatment of adult and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma (MCC).[rx] It is also indicated as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC) which has not progressed with first-line platinum-containing chemotherapy. In addition, it is indicated in patients with locally advanced or metastatic UC who experience disease progression on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.[rx] Avelumab is additionally indicated as a first-line treatment, in combination with axitinib, in the treatment of advanced renal cell carcinoma (RCC).[rx] Advanced Renal Cell Carcinoma (aRCC) Metastatic Urothelial Cancer Locally advanced Urothelial Carcinoma Metastatic Merkel Cell Carcinoma (MCC) Use in Cancer Avelumab is approved to treat: Merkel cell carcinoma (a type of skin cancer) has spread. It is used in adults and in children aged 12 years and older. Renal cell carcinoma (a type of kidney cancer) has spread or cannot be removed by surgery. It is used with axitinib as the first treatment. Urothelial cancer (a type of cancer in the bladder or urinary tract) that has spread or cannot be removed by surgery. It is used: As maintenance therapy in patients whose cancer did not get worse after first-line platinum chemotherapy. In patients whose cancer got worse during or after treatment with platinum chemotherapy. ¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that avelumab provides a clinical benefit in these patients. Avelumab is also being studied in the treatment of other types of cancer. Contraindication The following conditions are contraindicated with this drug. Check with your physician if you have any of the following: overactive thyroid gland a condition with low thyroid hormone levels low blood sugar decreased function of the adrenal gland a type of inflammation of the lung called interstitial pneumonitis inflammation of the large intestine kidney inflammation abnormal liver function tests pregnancy a patient who is producing milk and breastfeeding Dosage Strengths: 20 mg/mL Merkel Cell Carcinoma 800 mg IV over 60 minutes every 2 weeks Duration of therapy: Until disease progression or unacceptable toxicity   Urothelial Carcinoma 800 mg IV over 60 minutes every 2 weeks Duration of therapy: Until disease progression or unacceptable toxicity Renal Cell Carcinoma 800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food Duration of therapy: Until disease progression or unacceptable toxicity Pediatric Dose for Merkel Cell Carcinoma 12 years and older: 800 mg IV over 60 minutes every 2 weeks Duration of therapy: Until disease progression or unacceptable toxicity Renal Dose Adjustments Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper Serum creatinine more than 6 x ULN: Permanently discontinue therapy. Liver Dose Adjustments Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy. Dose Adjustments DOSE ADJUSTMENTS FOR ADVERSE REACTIONS: PNEUMONITIS: Grade 2: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy HEPATITIS: Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy COLITIS: Grade 2 or 3 diarrhea or colitis: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis: Permanently discontinue therapy ENDOCRINOPATHIES: Endocrinopathies (including but not limited to hypothyroidism, hyperthyroidism, adrenal insufficiency, and hyperglycemia): Grade 3 or 4: Withhold therapy; administer corticosteroids as appropriate for adrenal insufficiency; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper NEPHRITIS AND RENAL DYSFUNCTION: Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper Serum creatinine more than 6 x ULN: Permanently discontinue therapy. OTHER IMMUNE-MEDIATED ADVERSE REACTIONS (e.g., myocarditis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barre syndrome, bullous dermatitis, Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis, rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis, demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, encephalitis): For moderate or severe signs of an immune-mediated adverse reaction not previously described: Withhold therapy; administer high dose corticosteroids, and if appropriate, initiate hormone replacement; resume therapy in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper For any of the following: Life-threatening adverse reaction (excluding endocrinopathies); recurrent severe immune-mediated adverse reactions; requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks; persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy INFUSION-RELATED REACTIONS: Grade 1 or 2: Interrupt or slow the rate of infusion Grade 3 or 4: Permanently discontinue therapy COMBINATION THERAPY: In patients with RCC being treated with this drug in combination with axitinib: If ALT or AST is 3 times the upper limit of normal (ULN) or greater but less than 5 x ULN or total bilirubin is 1.5 x ULN or greater but less than 3 x ULN: Withhold both this drug and axitinib until adverse reactions recover to Grade 0 or 1. If persistent (greater than 5 days), consider corticosteroid therapy (initial dose of 0.5 to 1 mg/kg/day) prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. Dose reduction per the axitinib Full Prescribing Information if rechallenging with axitinib. If ALT or AST is 5 x ULN or greater or greater than 3 x ULN with concurrent total bilirubin 2 x ULN or greater or total bilirubin is 3 x ULN or greater, permanently discontinue both this drug and axitinib and consider corticosteroid therapy (initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper). When this drug is administered in combination with axitinib, review the axitinib Full Prescribing Information for recommended dose modifications for axitinib. Side Effects The Most Common muscle, bone, or joint pain headache constipation nausea vomiting weight loss tiredness new or worsening cough; shortness of breath; or chest pain yellowing of the skin or eyes; nausea; vomiting; pain in upper right side of stomach; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding headaches that won't go away or unusual headaches; rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more hungry or thirsty than usual; dizziness or fainting; hair loss; vomiting; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; stomach pain; or feeling cold diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness persistent muscle pain, weakness, or muscle cramps feeling dizzy or faint neck stiffness swelling of hands, feet, ankles, or legs More Common irregular heartbeat; chest pain and tightness; pain in the arms, back, neck, or jaw; breaking out in cold sweat fever or other flu-like symptoms blurry or double vision, sensitivity to light, or other vision problems rash, blistering or peeling skin sores in mouth, nose, throat, or genital area swollen glands decreased urination; blood in urine; swelling in ankles; or loss of appetite unusual bleeding or bruising frequent, painful, or urgent urination Rare fatigue, lack of energy, back pain, neck pain, pain in your arms or legs, diarrhea, nausea, chills, fever, hypersensitivity reactions, low blood pressure, rash, skin redness, decreased appetite, swelling of your arms or legs, joint pain, constipation, abdominal pain, vomiting, itching, weight loss, cough, shortness of breath, dizziness, Drug Interaction DRUG INTERACTION Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Avelumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Avelumab. Aducanumab The risk or severity of adverse effects can be increased when Avelumab is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Avelumab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Avelumab. Amivantamab The risk or severity of adverse effects can be increased when Avelumab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Avelumab is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Avelumab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Avelumab. Antilymphocyte immunoglobulin (horse) The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Avelumab. Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Avelumab. Articaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Articaine. Asfotase alfa The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Avelumab. Atezolizumab The risk or severity of adverse effects can be increased when Atezolizumab is combined with Avelumab. Atoltivimab The risk or severity of adverse effects can be increased when Avelumab is combined with Atoltivimab. Bamlanivimab The risk or severity of adverse effects can be increased when Avelumab is combined with Bamlanivimab. Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Avelumab. Bebtelovimab The risk or severity of adverse effects can be increased when Avelumab is combined with Bebtelovimab. Belantamab mafodotin The risk or severity of adverse effects can be increased when Avelumab is combined with Belantamab mafodotin. Belimumab The risk or severity of adverse effects can be increased when Belimumab is combined with Avelumab. Benralizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Benralizumab. Benzocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Benzyl alcohol. Besilesomab The risk or severity of adverse effects can be increased when Avelumab is combined with Besilesomab. Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Avelumab. Bezlotoxumab The risk or severity of adverse effects can be increased when Avelumab is combined with Bezlotoxumab. Bimekizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Bimekizumab. Blinatumomab The risk or severity of adverse effects can be increased when Blinatumomab is combined with Avelumab. Brentuximab vedotin The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Avelumab. Brodalumab The risk or severity of adverse effects can be increased when Brodalumab is combined with Avelumab. Brolucizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Brolucizumab. Bupivacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Bupivacaine. Burosumab The risk or severity of adverse effects can be increased when Avelumab is combined with Burosumab. Butacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Butamben. Canakinumab The risk or severity of adverse effects can be increased when Canakinumab is combined with Avelumab. Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Avelumab. Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Avelumab. Capsaicin The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Capsaicin. Casirivimab The risk or severity of adverse effects can be increased when Avelumab is combined with Casirivimab. Catumaxomab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Avelumab. Cemiplimab The risk or severity of adverse effects can be increased when Avelumab is combined with Cemiplimab. Certolizumab pegol The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Avelumab. Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Avelumab. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Chloroprocaine. Cilgavimab The risk or severity of adverse effects can be increased when Avelumab is combined with Cilgavimab. Cinchocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Cinchocaine. Cocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Cocaine. Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Avelumab. Daratumumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Avelumab. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Avelumab. Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Avelumab. Dienestrol Dienestrol may increase the thrombogenic activities of Avelumab. Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Avelumab. Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Avelumab. Dinutuximab The risk or severity of adverse effects can be increased when Dinutuximab is combined with Avelumab. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Diphenhydramine. Dostarlimab The risk or severity of adverse effects can be increased when Avelumab is combined with Dostarlimab. Dulaglutide The risk or severity of adverse effects can be increased when Dulaglutide is combined with Avelumab. Dupilumab The risk or severity of adverse effects can be increased when Avelumab is combined with Dupilumab. Durvalumab The risk or severity of adverse effects can be increased when Durvalumab is combined with Avelumab. Dyclonine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Dyclonine. Ebola Zaire vaccine (live, attenuated) The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Avelumab. Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Avelumab. Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Avelumab. Eflapegrastim The risk or severity of adverse effects can be increased when Avelumab is combined with Eflapegrastim. Eftrenonacog alfa The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Avelumab. Elotuzumab The risk or severity of adverse effects can be increased when Elotuzumab is combined with Avelumab. Emapalumab The risk or severity of adverse effects can be increased when Avelumab is combined with Emapalumab. Emicizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Emicizumab. Eptinezumab The risk or severity of adverse effects can be increased when Avelumab is combined with Eptinezumab. Erenumab The risk or severity of adverse effects can be increased when Avelumab is combined with Erenumab. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Avelumab. Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Avelumab. Estetrol Estetrol may increase the thrombogenic activities of Avelumab. Estradiol Estradiol may increase the thrombogenic activities of Avelumab. Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Avelumab. Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Avelumab. Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Avelumab. Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Avelumab. Estriol Estriol may increase the thrombogenic activities of Avelumab. Estrone Estrone may increase the thrombogenic activities of Avelumab. Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Avelumab. Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Avelumab. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Etidocaine. Evolocumab The risk or severity of adverse effects can be increased when Evolocumab is combined with Avelumab. Fanolesomab The risk or severity of adverse effects can be increased when Avelumab is combined with Fanolesomab. Fremanezumab The risk or severity of adverse effects can be increased when Avelumab is combined with Fremanezumab. Galcanezumab The risk or severity of adverse effects can be increased when Avelumab is combined with Galcanezumab. Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Avelumab. Golimumab The risk or severity of adverse effects can be increased when Golimumab is combined with Avelumab. Guselkumab The risk or severity of adverse effects can be increased when Guselkumab is combined with Avelumab. Hepatitis B immune globulin The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Avelumab. Human cytomegalovirus immune globulin The risk or severity of adverse effects can be increased when Avelumab is combined with Human cytomegalovirus immune globulin. Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Avelumab. Human Rho(D) immune globulin The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Avelumab. Human varicella-zoster immune globulin The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Avelumab. Ibalizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Ibalizumab. Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Avelumab. Idarucizumab The risk or severity of adverse effects can be increased when Idarucizumab is combined with Avelumab. Imdevimab The risk or severity of adverse effects can be increased when Avelumab is combined with Imdevimab. Imlifidase The therapeutic efficacy of Avelumab can be decreased when used in combination with Imlifidase. Inebilizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Inebilizumab. Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Avelumab. Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Avelumab. Ipilimumab The risk or severity of adverse effects can be increased when Ipilimumab is combined with Avelumab. Isatuximab The risk or severity of adverse effects can be increased when Avelumab is combined with Isatuximab. Ixekizumab The risk or severity of adverse effects can be increased when Ixekizumab is combined with Avelumab. Lanadelumab The risk or severity of adverse effects can be increased when Avelumab is combined with Lanadelumab. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Levobupivacaine. Lidocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Lidocaine. Loncastuximab tesirine The risk or severity of adverse effects can be increased when Avelumab is combined with Loncastuximab tesirine. Maftivimab The risk or severity of adverse effects can be increased when Avelumab is combined with Maftivimab. Margetuximab The risk or severity of adverse effects can be increased when Avelumab is combined with Margetuximab. Meloxicam The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Mepivacaine. Mepolizumab The risk or severity of adverse effects can be increased when Mepolizumab is combined with Avelumab. Mestranol Mestranol may increase the thrombogenic activities of Avelumab. Methoxy polyethylene glycol-epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Avelumab. Mogamulizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Mogamulizumab. Mosunetuzumab The risk or severity of adverse effects can be increased when Avelumab is combined with Mosunetuzumab. Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Avelumab. Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Avelumab. Necitumumab The risk or severity of adverse effects can be increased when Necitumumab is combined with Avelumab. Nivolumab The risk or severity of adverse effects can be increased when Nivolumab is combined with Avelumab. Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Avelumab. Obinutuzumab The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Avelumab. Ocrelizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Ocrelizumab. Odesivimab The risk or severity of adverse effects can be increased when Avelumab is combined with Odesivimab. Ofatumumab The risk or severity of adverse effects can be increased when Ofatumumab is combined with Avelumab. Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Avelumab. Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Avelumab. Oxetacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Oxybuprocaine. Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Avelumab. Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Avelumab. Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Avelumab. Pembrolizumab The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Avelumab. Pertuzumab The risk or severity of adverse effects can be increased when Pertuzumab is combined with Avelumab. Phenol The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Phenol. Polatuzumab vedotin The risk or severity of adverse effects can be increased when Avelumab is combined with Polatuzumab vedotin. Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Avelumab. Pramocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Pramocaine. Prilocaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Prilocaine. Procaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Procaine. Proparacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Propoxycaine. Quinestrol Quinestrol may increase the thrombogenic activities of Avelumab. Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Avelumab. Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Avelumab. Ravulizumab The risk or severity of adverse effects can be increased when Ravulizumab is combined with Avelumab. Raxibacumab The risk or severity of adverse effects can be increased when Raxibacumab is combined with Avelumab. Reslizumab The risk or severity of adverse effects can be increased when Reslizumab is combined with Avelumab. Risankizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Risankizumab. Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Avelumab. Romosozumab The risk or severity of adverse effects can be increased when Romosozumab is combined with Avelumab. Ropivacaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Ropivacaine. Sacituzumab govitecan The risk or severity of adverse effects can be increased when Avelumab is combined with Sacituzumab govitecan. Sarilumab The risk or severity of adverse effects can be increased when Sarilumab is combined with Avelumab. Secukinumab The risk or severity of adverse effects can be increased when Secukinumab is combined with Avelumab. Siltuximab The risk or severity of adverse effects can be increased when Siltuximab is combined with Avelumab. Sotrovimab The risk or severity of adverse effects can be increased when Avelumab is combined with Sotrovimab. Spesolimab The risk or severity of adverse effects can be increased when Avelumab is combined with Spesolimab. Sulesomab The risk or severity of adverse effects can be increased when Avelumab is combined with Sulesomab. Sutimlimab The risk or severity of adverse effects can be increased when Avelumab is combined with Sutimlimab. Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Avelumab. Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Avelumab. Tafasitamab The risk or severity of adverse effects can be increased when Avelumab is combined with Tafasitamab. Tetanus immune globulin, human The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Avelumab. Tetracaine The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Tetracaine. Tezepelumab The risk or severity of adverse effects can be increased when Avelumab is combined with Tezepelumab. Tibolone Tibolone may increase the thrombogenic activities of Avelumab. Tildrakizumab The risk or severity of adverse effects can be increased when Avelumab is combined with Tildrakizumab. Tisotumab vedotin The risk or severity of adverse effects can be increased when Avelumab is combined with Tisotumab vedotin. Tixagevimab The risk or severity of adverse effects can be increased when Avelumab is combined with Tixagevimab. Tocilizumab The risk or severity of adverse effects can be increased when Tocilizumab is combined with Avelumab. Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Avelumab. Tralokinumab The risk or severity of adverse effects can be increased when Avelumab is combined with Tralokinumab. Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Avelumab. Trastuzumab deruxtecan The risk or severity of adverse effects can be increased when Avelumab is combined with Trastuzumab deruxtecan. Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Avelumab. Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Avelumab. Vedolizumab The risk or severity of adverse effects can be increased when Vedolizumab is combined with Avelumab. Pregnancy and Lactation FDA pregnancy category: Not assigned Pregnancy Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of BAVENCIO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG1 immunoglobulins (IgG1) are known to cross the placenta. Therefore, BAVENCIO has the potential to be transmitted from the mother to the developing fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Lactation There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. Since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants. Before receiving avelumab injection, tell your doctor and pharmacist if you are allergic to avelumab, any other medications, or any of the ingredients in avelumab injection. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had an organ or bone marrow transplant; radiation therapy to your chest area. diabetes; thyroid problems; high blood pressure; high cholesterol; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or liver, heart, or kidney disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems). tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 1 month after your final dose of avelumab. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving avelumab, call your doctor immediately. Avelumab may harm the fetus. tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving avelumab and for 1 month after your final dose. How should this medicine be used?

Avelumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given once every 2 weeks. Your doctor will decide how often you are to receive avelumab based on your body's response to this medication. Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other medications to treat or help prevent reactions…

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