Encorafenib – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 48 min read
Encorafenib - Uses, Dosage, Side Effects, Interaction
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Article Summary

Encorafenib is an orally available Raf kinase inhibitor with potential antineoplastic activity. Encorafenib specifically inhibits Raf kinase, a serine/threonine enzyme in the RAF/mitogen-activated protein kinase kinase (MEK)/extracellular signal-related kinase (ERK) signaling pathway. By inhibiting the activation of the RAF/MEK/ERK signaling pathway, the administration of LGX818 may result in a decrease in the proliferation of tumor cells. The Raf mutation BRAF V600E is frequently upregulated in a variety...

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.
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Definition

Encorafenib is an orally available Raf kinase inhibitor with potential antineoplastic activity. Encorafenib specifically inhibits Raf kinase, a serine/threonine enzyme in the RAF/mitogen-activated protein kinase kinase (MEK)/extracellular signal-related kinase (ERK) signaling pathway. By inhibiting the activation of the RAF/MEK/ERK signaling pathway, the administration of LGX818 may result in a decrease in the proliferation of cells. The Raf mutation BRAF V600E is frequently upregulated in a variety of human tumors and results in the constitutive activation of the RAF/MEK/ERK signaling pathway that regulates cellular proliferation and survival.

Encorafenib, also known as BRAFTOVI, is a kinase inhibitor. Encorafenib inhibits the BRAF gene, which encodes for the B-RAF protein, which is a proto- involved in various mutations. This protein plays a role in regulating the MAP kinase/ERK signaling pathway, which impacts cell division, differentiation, and secretion. Mutations in this gene, most frequently the V600E mutation, are the most commonly identified cancer-causing mutations in and have been isolated in various other cancers as well, including non-Hodgkin , colorectal cancer, , non-small cell lung carcinoma, hairy cell and adenocarcinoma of the lung. On June 27, 2018, the Food and Drug Administration approved encorafenib and [Binimetinib] (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Mechanism of Action

Encorafenib is a kinase inhibitor that specifically targets BRAF V600E, as well as wild-type BRAF and CRAF while tested with in vitro cell-free assays with IC50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, including BRAF V600E, result in activated BRAF kinases that may stimulate tumor cell growth. Encorafenib is able to bind to other kinases in vitro including JNK1, JNK2, JNK3, LIMK1, LIMK2, MEK4, and STK36, and significantly reduce ligand binding to these kinases at clinically achievable concentrations (≤ 0.9 μM). In efficacy studies, sorafenib inhibited the in vitro cell growth of tumor cell lines that express BRAF V600 E, D, and K mutations. In mice implanted with tumor cells expressing the BRAF V600E mutation, sorafenib-induced tumor regressions were associated with RAF/MEK/ERK pathway suppression. Encorafenib and binimetinib target two different kinases in the RAS/RAF/MEK/ERK pathway. Compared with either drug alone, co-administration of encorafenib and binimetinib results in greater anti-proliferative activity in vitro in BRAF mutation-positive cell lines and greater anti-tumor activity with respect to tumor growth inhibition in BRAF V600E mutant human melanoma xenograft studies in mice. In addition to the above, the combination of encorafenib and binimetinib acted to delay the emergence of resistance in BRAF V600E mutant human melanoma xenografts in mice compared with the administration of either drug alone.

Encorafenib has shown improved efficacy in the treatment of metastatic melanoma. Encorafenib, a selective BRAF inhibitor (BRAFi), has a pharmacologic profile that is distinct from that of other clinically active BRAFis. Once-daily dosing of single-agent encorafenib has a distinct tolerability profile and shows varying antitumor activity across BRAFi-pretreated and BRAFi-naïve patients with advanced/metastatic stage melanoma.

Indications

  • Used in combination with [Binimetinib] in metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
  • Encorafenib indicated in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior therapy
  • Treatment of colorectal carcinoma
  • Treatment of melanoma
  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Melanoma
  • Unresectable Melanoma

Use in Cancer

Encorafenib is approved to be used with other drugs to treat patients whose cancer has a certain mutation in the BRAF gene, including:

  • Colorectal cancer has spread to other parts of the body. It is used with cetuximab in adults who have received previous treatment.
  • Melanoma. It is used with binimetinib in patients whose cancer cannot be removed by surgery or has spread to other parts of the body.

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

Contraindications

  • have untreated low potassium or low magnesium in your blood
  • decreased blood platelets
  • low levels of a type of white blood cell called neutrophils
  • fluid in the covering of the heart or
  • escape of fluid into the lungs
  • fluid in the lungs
  • problems
  • fluid retention in the legs, feet, arms or hands
  • high amount of in the blood
  • excessive
  • abnormal liver function tests
  • pregnancy

Strengths: 50 mg; 75 mg

Melanoma – Metastatic

  • 450 mg orally once a day in combination with binimetinib until or unacceptable toxicity
  • If binimetinib is withheld, reduce encorafenib to a maximum dose of 300 mg once a day until binimetinib is resumed.
  • Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating therapy
  • Refer to the binimetinib prescribing information for recommended dosing information.

Colorectal Cancer

  • 300 mg orally once a day in combination with cetuximab until disease or unacceptable toxicity
  • Confirm the presence of a BRAF V600E mutation in tumor specimens prior to initiating therapy.
  • Refer to the cetuximab prescribing information for recommended dosing information.

Dose Adjustments

BRAF V600E OR V600K MUTATION-POSITIVE UNRESECTABLE OR METASTATIC MELANOMA:

  • If binimetinib is withheld, reduce encorafenib to a maximum dose of 300 orally mg once a day until binimetinib is resumed.
  • If cetuximab is discontinued, discontinue binimetinib.

RECOMMENDED DOSE REDUCTIONS FOR ADVERSE REACTIONS for BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma:

  • First dose reduction: 300 mg orally once a day
  • Second dose reduction: 225 mg orally once a day
  • Subsequent modification: Permanently discontinue this drug if unable tolerate 225 mg once a day.

BRAF V600E MUTATION-POSITIVE METASTATIC COLORECTAL CANCER (CRC):

  • If cetuximab is discontinued, discontinue binimetinib.

RECOMMENDED DOSE REDUCTIONS FOR ADVERSE REACTIONS for BRAF V600E MUTATION-POSITIVE METASTATIC CRC:

  • First dose reduction: 225 mg orally once a day
  • Second dose reduction: 150 mg orally once a day
  • Subsequent modification: Permanently discontinue this drug if unable tolerate 150 mg once a day.

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma and BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC):
NEW PRIMARY MALIGNANCIES:

  • Non-cutaneous RAS mutation-positive malignancies: Discontinue this drug.

UVEITIS:

  • Grade 1 through 3: If Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold this drug for up to 6 weeks; if improved, resume at same or reduced dose; if not improved, permanently discontinue this drug.
  • Grade 4: Permanently discontinue therapy.

QTc PROLONGATION:

  • QTcF greater than 500 milliseconds (ms) and less than or equal to 60 ms increase from : Withhold this drug until QTcF is less than or equal to 500 ms; resume at reduced dose; if more than one , permanently discontinue this drug.
  • QTcF greater than 500 ms and greater than 60 ms increase from baseline: Permanently discontinue this drug.

HEPATOTOXICITY:

  • Grade 2 AST or ALT increased: Maintain the dose; if no improvement within 4 weeks, withhold this drug until improvement to Grade 0 or 1 or to pretreatment/baseline levels and then resume at same dose.
  • Grade 2 or first occurrence of any Grade 3 AST or ALT increased: Withhold this drug for up to 4 weeks; if improvement to Grade 0 or 1 or to pretreatment/baseline level, resume at reduced dose; if no improvement, permanently discontinue this drug.
  • First occurrence of any Grade 4 AST or ALT increase: Permanently discontinue this drug OR withhold this drug for up to 4 weeks; if improves to Grade 0 or 1 or to pretreatment/baseline level, then resume at reduced dose; if no improvement, permanently discontinue this drug.
  • Recurrent Grade 3 AST or ALT increased: Consider permanently discontinuing this drug.
  • Recurrent Grade 4 AST or ALT increased: Permanently discontinue this drug.

DERMATOLOGIC:

  • Grade 2: If no improvement within 2 weeks, withhold this drug until Grade 0 or 1; resume at same dose.
  • Grade 3: Withhold this drug until Grade 0 or 1; resume at same dose if first occurrence or reduce dose if recurrent.
  • Grade 4: Permanently discontinue this drug.

OTHER ADVERSE REACTIONS (INCLUDING HEMORRHAGE):

  • Recurrent Grade 2 or first occurrence of any Grade 3: Withhold this drug for up to 4 weeks; if improves to Grade 0 or 1 or to pretreatment/baseline level, then resume at reduced dose; if no improvement, permanently discontinue this drug.
  • First occurrence of any Grade 4: Permanently discontinue this drug OR withhold for up to 4 weeks; if improves to Grade 0 or 1 or to pretreatment/baseline level, then resume at reduced dose; if no improvement, permanently discontinue this drug.
  • Recurrent Grade 3: Consider permanently discontinuing this drug.
  • Recurrent Grade 4: Permanently discontinue this drug.

DOSE MODIFICATIONS FOR COADMINISTRATION OF STRONG OR CYP450 3A4 INHIBITORS:
Avoid concurrent use of strong or moderate CYP450 3A4 inhibitors during therapy with this drug. If concomitant use of a strong or moderate CYP450 3A4 inhibitor is unavoidable, reduce the dose of this drug as follows:
Current daily dose 450 mg:

  • Dose for coadministration with moderate CYP450 3A4 inhibitor: 225 mg
  • Dose for coadministration with strong CYP450 3A4 inhibitor: 150 mg

Current daily dose 300 mg:

  • Dose for coadministration with moderate CYP450 3A4 inhibitor: 150 mg
  • Dose for coadministration with strong CYP450 3A4 inhibitor: 75 mg

Current daily dose 225 mg:

  • Dose for coadministration with moderate CYP450 3A4 inhibitor: 75 mg
  • Dose for coadministration with strong CYP450 3A4 inhibitor: 75 mg

Current daily dose 150 mg:

  • Dose for coadministration with moderate CYP450 3A4 inhibitor: 75 mg
  • Dose for coadministration with strong CYP450 3A4 inhibitor: 75 mg

*NOTE: Encorafenib exposure at the 75 mg daily dose when coadministered with a strong CYP450 3A4 inhibitor is expected to be higher than at the 150 mg daily dose in the absence of a CYP450 3A4 inhibitor and similar to exposure at the 225 mg daily dose in the absence of a CYP450 3A4 inhibitor. Monitor patients closely for adverse reactions and use judgement when using encorafenib with strong CYP450 3A4 inhibitors at the 150 mg dose level.

Side Effects

The Most Common

  • stomach pain
  • constipation
  • decreased appetite
  • headache
  • dizziness
  • skin thickening
  • rash
  • dry or itchy skin
  • hair loss
  • joint or muscle pain
  • change in taste
  • back, arm, or leg pain
  • acne
  • numbness, burning or tingling in the arms, hands, feet, or legs
  • difficulty falling asleep or staying asleep
  • dizziness, fainting or feeling faint
  • vision changes
  • skin changes such as a new wart, a sore or reddish bump that does not heal, a change in the size or color of a mole
  • unusual bleeding or bruising
  • black, tarry, or bloody stools
  • coughing up blood
  • nose bleeding
  • redness, swelling, numbness, and skin peeling of hands and soles of feet

More Common

  • eye pain or swelling, vision changes, seeing halos around lights, seeing color “dots” in your vision;
  • severe skin rash, skin pain or swelling, redness, and peeling skin on your hands or feet;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
  • signs of bleeding–weakness, dizziness, headache, nosebleeds, rectal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
  • nausea, vomiting, stomach pain;
  • tiredness; or
  • joint pain or swelling.

Rare

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • eye pain,
  • swelling of the eye,
  • vision changes,
  • seeing halos around lights,
  • seeing color “dots” in your vision,
  • severe skin rash,
  • skin pain or swelling,
  • redness and peeling skin on your hands or feet,
  • fast or pounding heartbeats,
  • fluttering in your chest,
  • shortness of breath,
  • sudden dizziness,
  • weakness,
  • dizziness,
  • headache,
  • nosebleeds,
  • rectal bleeding,
  • bloody or tarry stools,
  • coughing up blood, and
  • vomit that looks like coffee grounds

Drug Interaction

Pregnancy and Lactation

TGA pregnancy category D:

US FDA pregnancy category Not Assigned

Pregnancy

Drugs that have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

Lactation

The effects in the nursing infant are unknown. Women should be advised not to breastfeed during therapy with this drug and for 2 weeks after the final dose.

How should this medicine be used?

Encorafenib comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take encorafenib 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 encorafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking the medication, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease or temporarily or permanently stop your treatment depending on if you experience any side effects. Be sure to tell your doctor how you are feeling during your treatment with encorafenib.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

What special precautions should I follow?

Before taking encorafenib,

  • tell your doctor and pharmacist if you are allergic to encorafenib, any other medications, or any of the ingredients in encorafenib capsules. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements 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 what herbal products you are taking, especially St John’s wort.
  • tell your doctor if you have or have ever had a QT interval prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), low levels of potassium or magnesium in your blood, heart failure, or liver disease.
  • tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should use a nonhormonal birth control to prevent pregnancy during your treatment with encorafenib and for 2 weeks after your final dose. Encorafenib may decrease the effectiveness of oral contraceptives (birth control pills), so it is especially important to use a nonhormonal form of birth control. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while taking encorafenib, call your doctor immediately. Encorafenib may harm the fetus.
  • tell your doctor if you are breastfeeding. Do not breastfeed while you are taking encorafenib and for 2 weeks after your final dose.
  • you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking encorafenib.

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    LICENSE
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RX Clinical Pathway Engine

Continue through a complete learning pathway

Move from understanding the topic to symptoms, tests, treatment, medicines, monitoring, and prevention.

Search the complete library
  1. Understand the condition Begin with the essential facts and a clear explanation of the topic.
  2. Recognize symptoms Learn common symptoms, signs, and patterns of presentation.
  3. Know when to seek help Review urgent warning signs and when professional assessment may be needed.
  4. Understand causes and risks Explore causes, risk factors, mechanisms, and contributing conditions.
  5. Explore tests and diagnosis Learn how clinicians assess the condition and which investigations may be discussed.
  6. Learn treatment approaches Review general treatment categories and management principles.
  7. Understand medicines safely Continue to medicine education, uses, precautions, and monitoring.
  8. Plan monitoring and follow-up Understand monitoring, complications, rehabilitation, and follow-up learning.
  9. Review prevention and self-care Explore prevention, healthy routines, and questions to discuss with a clinician.

Conditions & Diseases

Background, symptoms, causes, diagnosis, and care.

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Tests & Investigations

Laboratory, imaging, screening, and diagnostic education.

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Medicines

Uses, safety, monitoring, and related medicine knowledge.

Explore this library

Cancer Knowledge

Cancer types, screening, oncology, and treatment education.

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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: Encorafenib – 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.