Encorafenib (Braftovi) is an oral targeted therapy that belongs to the class of kinase inhibitors. It is primarily used in combination with specific regimens for the treatment of advanced cancers harboring certain gene mutations.

What Are the Indications for Encorafenib (Braftovi)?

Combined with Binimetinib for Melanoma

Population Indicated: For the treatment of patients with unresectable or metastatic (advanced) melanoma that has been detected to be positive for the BRAF V600E or V600K mutation.

Combined with Cetuximab ± Chemotherapy for Colorectal Cancer

Regimen A (First-line Therapy): Combined with cetuximab and the mFOLFOX6 chemotherapy regimen, for the treatment of metastatic colorectal cancer positive for the BRAF V600E mutation.

Regimen B (Later-line Therapy): Combined with cetuximab, for the treatment of adult patients with metastatic colorectal cancer positive for the BRAF V600E mutation that has progressed after receiving at least one prior treatment regimen.

Combined with Binimetinib for Non-small Cell Lung Cancer (NSCLC)

Population Indicated: For the treatment of adult patients with metastatic non-small cell lung cancer that has been detected to be positive for the BRAF V600E mutation.

Precautions

Encorafenib is not intended for monotherapy use. Its efficacy is entirely dependent on combination with different drug regimens, and it is only indicated for patients confirmed to have the specific BRAF V600E or V600K gene mutation via FDA-approved testing methods.

Important Limitation: This product is not indicated for patients with cancers harboring the wild-type BRAF gene.

Dosage Form, Strength and Appearance of Encorafenib (Braftovi)

Dosage Form and Strength

Dosage Form and Strength: Encorafenib is available as oral hard capsules. The only commercially available strength contains 75 mg of encorafenib as the active ingredient per capsule.

Appearance Description

Appearance: The capsule features specific markings for easy identification. Its beige cap is printed with a stylized letter "A", while the white capsule body is imprinted with the text "LGX75mg".

Packaging

Packaging: The medicinal product is usually supplied in bottles, which are further packaged in outer cartons. Common packaging specifications include 2 bottles per carton, with each bottle containing 90 or 60 capsules.

Composition

Active Ingredient: Encorafenib.

Inactive Ingredients: The capsule contents consist of copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, and vegetable-sourced magnesium stearate, among other components.

Capsule Shell: Composed of gelatin, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, etc., and printed with pharmaceutical-grade ink.

Storage Instructions for Encorafenib (Braftovi)

Temperature Requirement: Store at room temperature between 20°C and 25°C (68°F and 77°F). Short-term excursions between 15°C and 30°C (59°F and 86°F) are permitted for carrying purposes. Do not freeze.

Storage in Original Packaging: Always keep the medicinal product in its original bottle. The desiccant (moisture-proof packet) inside the bottle is crucial for protecting the drug from moisture damage; do not remove or discard it.

Seal Tightly Against Moisture: Immediately tighten the bottle cap securely after each dose to ensure airtight sealing. Store the bottle in a dry place, and avoid humid environments such as bathrooms.

Safety Check: Inspect the bottle before use. Do not use the medicinal product if the safety seal under the bottle cap is damaged or missing.