Encorafenib is a BRAF kinase inhibitor targeting mutated BRAF – BRAF V600E, wild-type BRAF, and CRAF, inhibiting tumor growth via the suppression of RAF/MEK/ERK pathway.
Encorafenib
Generic Name/API:Encorafenib
Packaging:75 mg capsules available in cartons containing two bottles of 90 capsules each and cartons containing two bottles of 60 capsules each.
Storage:Store at 20°C to 25°C (68°F to 77°F).
Dosage:For dosage information, please visit the General Information section.
Strength:Each capsule contains 75 mg encorafenib.
Indication:BRAFTOVI (encorafenib) is a targeted therapy designed for adults with melanoma, NSCLC, and colorectal cancer with a BRAF mutation that have spread or cannot be surgically removed. BRAFTOVI helps improve tumor response and duration of benefit. When paired with binimetinib or cetuximab-based regimens, it offers powerful, personalized treatment designed to enhance anti-tumor response and extend control. It is not suitable for cancers without the BRAF mutation.
BRAFTOVI (Encorafenib) is a prescription medication used to treat certain cancers that have spread (metastasized), cannot be removed with surgery, and have specific mutations in the BRAF gene. It is used in the following ways:
- Melanoma and Non-Small Cell Lung Cancer (NSCLC): In combination with MEKTOVI (binimetinib), BRAFTOVI is used to treat adults with melanoma or NSCLC that has a BRAF mutation.
- Colorectal Cancer (CRC): In combination with cetuximab and mFOLFOX6 (a chemotherapy regimen including fluorouracil, leucovorin, and oxaliplatin) to treat colorectal cancer.
The approval for this combination was based on tumor response and the duration of that response. Ongoing studies are evaluating the clinical benefit of this regimen.
Encorafenib may also be used in combination with cetuximab alone for adults with colorectal cancer who have previously received treatment.
Important Note:
Encorafenib should not be used in people whose melanoma, colorectal cancer, or NSCLC has wild-type BRAF (no mutation). Your healthcare provider will perform a test to confirm if Encorafenib or the combination with binimetinib is appropriate for your condition.
It is currently not known whether encorafenib or binimetinib is safe or effective in children.
Encorafenib is a BRAF kinase inhibitor targeting mutated BRAF – BRAF V600E, wild-type BRAF, and CRAF, inhibiting tumor growth via the suppression of RAF/MEK/ERK pathway. It also binds other kinases at clinically relevant levels. In combination with binimetinib or cetuximab, it showed enhanced anti-tumor effects and delayed resistance in BRAF-mutant models. Resistance in BRAF-mutant CRC due to EGFR activation can be overcome with EGFR-targeted combination therapy.
STRENGTH:
Each capsule contains 75 mg encorafenib.
DOSAGE:
Recommended Dosage for:
BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma: 450 mg (six 75 mg capsules) orally once daily in combination with binimetinib until disease progression or unacceptable toxicity. Recommended binimetinib prescribing information for dosage to be referred separately.
Dose reductions:
- 1st dose reduction: 300 mg (four 75 mg capsules) orally once daily
- 2nd dose reduction: 225 mg (three 75 mg capsules) orally once daily
- Subsequent Modification: Permanently discontinue if unable to tolerate encorafenib 225 mg (three 75 mg capsules) once daily
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC): 300 mg (four 75 mg capsules) orally once daily in combination with cetuximab until disease progression or unacceptable toxicity. Recommended cetuximab prescribing information for dosage to be referred separately.
Dose reductions:
- 1st dose reduction: 225 mg (three 75 mg capsules) orally once daily
- 2nd dose reduction: 150mg (two 75 mg capsules) orally once daily
- Subsequent Modification: Permanently discontinue if unable to tolerate encorafenib 150mg (two 75 mg capsules) once daily
Encorafenib may be taken with or without food. Do not take a missed dose of encorafenib within 12 hours of the next dose of the same. Do not take an additional dose if vomiting occurs post administration, but continue with the next scheduled dose.
- New Primary Malignancies: Cutaneous malignancies like cutaneous squamous cell carcinoma (including keratoacanthoma) and basal cell carcinoma; and non-cutaneous malignancies have occurred with encorafenib treatment. Regular dermatologic exams are recommended. Manage skin lesions by excision; no dose change is required for cutaneous malignancies. Discontinue for RAS-mutant non-cutaneous cancers.
- Tumor Promotion in BRAF Wild-Type Tumors: Encorafenib may paradoxically activate MAPK signaling in BRAF wild-type cells. Confirm BRAF V600E/K mutation before initiating treatment.
- Hemorrhage: Hemorrhage (Grade ≥3 in ~3% of cases) reported with encorafenib + binimetinib or cetuximab. Common sites include GI tract and nasal passages. Withhold, reduce, or discontinue based on severity.
- Uveitis: Uveitis (4% incidence) may occur with encorafenib + binimetinib. Monitor for visual symptoms and perform ophthalmologic exams as needed. Withhold treatment if necessary.
- QTc Prolongation: QTc prolongation has been observed; 0.5% had QTcF >500 ms. Monitor high-risk patients. Correct electrolytes and modify dose for significant prolongation.
- Fetal Harm and Contraception: Encorafenib can harm a fetus and reduce hormonal contraceptive effectiveness. Use effective non-hormonal contraception during and for 2 weeks post-treatment.
- Monotherapy vs Combination Use: Single-agent encorafenib has higher risk of severe skin reactions (21%) vs combination (2%). Reduce encorafenib dose if binimetinib is interrupted or discontinued.
FAQ
What is encorafenib used for?
Encorafenib is a therapy for adults with melanoma, NSCLC, and colorectal cancer with a BRAF mutation that have spread or cannot be surgically removed. When used in combination with binimetinib or cetuximab-based regimens, it enhances antitumor response. It is not suitable for cancers without the BRAF mutation.
What are the common side effects of encorafenib use?
New primary malignancies, hemorrhage, uveitis and QT prolongation are the common side effects of encorafenib treatment.
Can encorafenib be used in specific populations i.e. for pregnant, breastfeeding , pediatric and geriatric use?
Presence of encorafenib in breast milk and effects on infants are unknown; breastfeeding is not recommended during treatment and for 2 weeks after. Encorafenib may impair male fertility and reduce the effectiveness of hormonal contraceptives; non-hormonal contraception is advised. Pregnancy status should be confirmed before treatment, and effective contraception used during and for 2 weeks after therapy. In clinical trials, no differences in safety or effectiveness were seen in elderly patients compared to younger ones. Encorafenib is not approved for pediatric use. No dose adjustment is needed for mild to moderate renal or hepatic impairment, and use in severe impairment lacks dosing recommendations.
What is the cost of Encorafenib 75mg Capsules in India?
The cost of Encorafenib 75 mg may vary, as it is not approved in India and must be imported. Pricing depends on currency rates and import duties. For details, contact 247 QualityMeds.
How to buy Encorafenib 75mg Capsules Online in India?
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While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution Practice (GDP) certificate and possesses a valid operating license. These credentials confirm that the suppliers adherence to International standards for the proper distribution of medicinal product
