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MEKTOVI® (binimetinib)
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MEKTOVI® Quick Finder
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...
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...
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.
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in...
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- Cardiomyopathy [see Warnings and Precautions (5.1)] ...
7 DRUG INTERACTIONS
No clinically important drug interactions have been observed with MEKTOVI.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
10 OVERDOSAGE
Since binimetinib is 97% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with MEKTOVI.
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with binimetinib have not been conducted. Binimetinib was...
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...
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...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
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