BRAFTOVI 75 MG CAPSULE ( ENCORAFENIB )

🏥 Indications

• Braftovi is a medicine used in adults for treating certain cancers when their cells have a mutation (change) in their genes called ‘BRAF V600’.
• Braftovi is used in combination with another medicine, binimetinib to treat: a type of lung cancer called non-small cell lung cancer (NSCLC).

        Braftovi is indicated in adults for use in combination therapy with:

• Binimetinib for BRAFV600E/K-mutated unresectable or metastatic melanoma

• Cetuximab for metastatic colorectal cancer with BRAFV600E mutation who have received prior systemic therapy

📌 Brand & Composition

• Brand Name: Braftovi

• Generic (Salt): Encorafenib

• Dosage Form: Hard gelatin oral capsules

• Strength: 75 mg each (marked “LGX 75 mg”)

💊 Dosage & Administration

• Melanoma: 450 mg once daily (six 75 mg capsules), in combination with binimetinib

• Colorectal Cancer: 300 mg once daily with cetuximab (four capsules)

• Administration: Swallow capsules whole, with or without food

• Missed dose: Take as soon as possible unless within 12 h of the next dose; do not double; skip if vomiting happens

⚠️ Major Warnings & Precautions

• New Primary Malignancies: Increased risk of cutaneous & non-cutaneous cancers; conduct regular skin checks

• Tumor Promotion in BRAF Wild‑Type Tumors: Confirm BRAFV600 mutation before initiating therapy

• Cardiomyopathy: Monitor for heart failure symptoms; adjust therapy as needed

• Hepatotoxicity: Regular monitoring of liver enzymes (ALT, AST, bilirubin); report signs of liver injury

• Hemorrhage: Assess for bleeding risk; educate patients to report unusual bleeding

• Ocular Toxicity (Uveitis): Advise patients to report vision changes immediately

🔢 Common Adverse Reactions

(≥25% incidence): Fatigue, nausea, diarrhea, vomiting, abdominal pain, arthralgia

Other frequently reported side effects include rash, headache, myalgia, and photosensitivity .

🔁 Drug Interactions

• CYP3A4 inhibitors (strong/moderate): Avoid co-administration or reduce dose; e.g., with ketoconazole or clarithromycin

• CYP3A4 inducers: Avoid (e.g., rifampin, phenytoin, St John’s wort) due to reduced efficacy

• Other substrates: Encorafenib induces CYP3A4 and inhibits UGT1A1—use caution with medications like hormonal contraceptives, atorvastatin, raltegravir

ℹ️ Additional Patient Counseling

• Maintain hydration to prevent kidney issues, and remain vigilant for signs of tumor lysis syndrome

• Avoid grapefruit juice to prevent drug toxicity

• Effective contraception is required during treatment and for at least one month after ending therapy; hormonal methods may be less effective

✅ Conclusion

Braftovi (encorafenib) is a targeted oral BRAF inhibitor available in 75 mg capsules. It’s used in combination regimens for BRAFV600-mutated melanoma and colorectal cancer. While effective, it carries risks such as secondary cancers, heart problems, liver injury, ocular events, bleeding, and significant drug interactions—requiring careful patient monitoring and education.