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MEKTOVI®(binimetinib)
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MEKTOVI® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
MEKTOVI® is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating MEKTOVI...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- Cardiomyopathy [see Warnings and Precautions (5.1)] ...
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Drug Interactions
7 DRUG INTERACTIONS
No clinically important drug interactions have been observed with MEKTOVI.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
Since binimetinib is 97% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with MEKTOVI.
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Description
11 DESCRIPTION
Binimetinib is a kinase inhibitor. The chemical name is 5-[(4-bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide. The molecular formula is C17...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with binimetinib have not been conducted. Binimetinib was...
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Clinical Studies
14 CLINICAL STUDIES
MEKTOVI in combination with encorafenib was evaluated in a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453). Eligible patients were required to have BRAF V600E or V600K...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
MEKTOVI (binimetinib) is supplied as 15 mg yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side, available in...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the following:
...
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