Encorafenib (Braftovi) is an oral kinase inhibitor that first received approval for marketing from the U.S. Food and Drug Administration (FDA) in 2018. Specifically designed to treat malignant tumors harboring specific BRAF gene mutations, this drug exerts its effects through a precise molecular targeting mechanism.

Indications of Encorafenib (Braftovi)

Application in Melanoma Treatment

Unresectable or metastatic melanoma with positive BRAF V600E or V600K mutation.

Encorafenib in combination with binimetinib is indicated for the treatment of patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations.

Application in Colorectal Cancer Treatment

Metastatic colorectal cancer with positive BRAF V600E mutation.

In combination with cetuximab and the mFOLFOX6 regimen, it is used for the treatment of patients with metastatic colorectal cancer harboring BRAF V600E mutation.

In combination with cetuximab, it is used for adult patients with metastatic colorectal cancer who have received prior treatment.

Application in Non-Small Cell Lung Cancer (NSCLC) Treatment

Metastatic non-small cell lung cancer with positive BRAF V600E mutation.

Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer harboring BRAF V600E mutation.

Usage Limitations

Encorafenib is not indicated for the treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.

Dosage Specifications and Properties of Encorafenib (Braftovi)

Dosage Specifications

Capsule strength: 75 mg.

Packaging form: Each carton contains two bottles of 90 capsules or two bottles of 60 capsules.

Physical Characteristics Description

The capsules are made of hard gelatin, with the letter "A" printed on the beige cap and "LGX 75mg" marked on the white body.

Drug Composition

Active ingredient: 75 mg of encorafenib.

Inactive ingredients: Copovidone, Poloxamer 188, Microcrystalline Cellulose, Succinic Acid, Crospovidone, Colloidal Silicon Dioxide, and Magnesium Stearate (of vegetable origin).

Chemical Properties

Molecular formula: C₂₂H₂₇ClFN₇O₄S

Molecular weight: 540 Daltons

Encorafenib is a white to off-white powder. It is slightly soluble in aqueous media at pH 1, very slightly soluble at pH 2, and insoluble at pH 3 and above.

Storage Methods for Encorafenib (Braftovi)

Temperature Control

Store at room temperature between 20°C and 25°C (68°F and 77°F). Short-term storage within a temperature fluctuation range of 15°C to 30°C (59°F to 86°F) is permitted.

Moisture-Proof Measures

Store in the original bottle, which contains a desiccant packet.

Keep the bottle cap tightly closed to prevent moisture ingress.

Do not remove the desiccant packet.

Storage After Opening

Do not use the product if the safety seal under the bottle cap is damaged or missing.

Repackaging into other containers for storage is strictly prohibited.

Transportation Conditions

Ensure that appropriate storage conditions are maintained during transportation to prevent temperature fluctuations and moisture exposure.