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BRAFTOVI®(encorafenib)
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BRAFTOVI® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma
BRAFTOVI® is indicated, in combination...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
BRAF V600E or V600K Mutation-Positive...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Capsules: 75 mg, hard gelatin, stylized "A" on beige cap and "LGX 75mg" on white body.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 New Primary Malignancies
New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- New Primary Malignancies [see Warnings and Precautions (5.1)]...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on BRAFTOVI
Strong or Moderate CYP3A4...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism...
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Overdosage
10 OVERDOSAGE
Since encorafenib is 86% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with BRAFTOVI.
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Description
11 DESCRIPTION
Encorafenib is a kinase inhibitor. The chemical name is methyl N-{(2S)-1-[(4-{3-[5-chloro-2-fluoro-3-(methanesulfonamido)phenyl]-1-(propan-2-yl)-1...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Encorafenib is a kinase inhibitor that targets BRAF V600E, as well as wild-type BRAF and CRAF in in vitro cell-free...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with encorafenib have not been conducted. Encorafenib was...
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Clinical Studies
14 CLINICAL STUDIES
14.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma
BRAFTOVI in combination with binimetinib was evaluated in a...
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How Supplied/Storage and Handling
16 HOW 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...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration... |
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