Brand Name

Braftovi

Generic Name
Encorafenib
View Brand Information
FDA approval date: March 07, 2017
Form: Capsule

What is Braftovi (Encorafenib)?

BRAFTOVI is a kinase inhibitor indicated: Melanoma in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
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Brand Information

BRAFTOVI (Encorafenib)
1DOSAGE FORMS AND STRENGTHS
Capsules: 75 mg, hard gelatin, stylized "A" on beige cap and "LGX 75mg" on white body.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
  • New Primary Malignancies
  • Tumor Promotion in BRAF Wild-Type Tumors
  • Cardiomyopathy
  • Hepatotoxicity
  • Hemorrhage
  • Uveitis
  • QT Prolongation
  • Embryo-Fetal Toxicity
  • Risks Associated with BRAFTOVI as a Single Agent
  • Risks Associated with Combination Treatment
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4OVERDOSAGE
Since encorafenib is 86% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with BRAFTOVI.
5DESCRIPTION
Encorafenib is a kinase inhibitor. The chemical name is methyl
Chemical Structure
Encorafenib is a white to almost white powder. In aqueous media, encorafenib is slightly soluble at pH 1, very slightly soluble at pH 2, and insoluble at pH 3 and higher.
BRAFTOVI (encorafenib) capsules for oral use contain 75 mg of encorafenib with the following inactive ingredients: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, magnesium stearate (vegetable origin). The capsule shell contains gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol).
6HOW SUPPLIED/STORAGE AND HANDLING
BRAFTOVI (encorafenib) is supplied as 75 mg hard gelatin capsules.
75 mg: stylized "A" on beige cap and "LGX 75mg" on white body, available in cartons (NDC 70255-025-01) containing two bottles of 90 capsules each (NDC 70255-025-02) and cartons (NDC 70255-025-03) containing two bottles of 60 capsules each (NDC 70255-025-04).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the following:
8PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-02
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
NDC 70255-025-02
BRAFTOVI
75 mg
Rx only
PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-02
9PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Carton
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
NDC 70255-025-01
BRAFTOVI
75 mg
Rx only
PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Carton
10PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-06
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
NDC 70255-025-06
BRAFTOVI
75 mg
Rx only
Sample–
PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-06
11PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-05
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
NDC 70255-025-05
BRAFTOVI
75 mg
Rx only
Sample–
PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label - 025-05