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BRAFTOVI®(encorafenib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.