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MEKTOVI®(binimetinib)

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MEKTOVI® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Cardiomyopathy

Cardiomyopathy, manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in...

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

  • Cardiomyopathy [see

    6.1 Clinical Trials Experience

    Because...

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7 DRUG INTERACTIONS

No clinically important drug interactions have been observed with MEKTOVI.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with binimetinib have not been conducted. Binimetinib was...

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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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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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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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Distributed by:
Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc.
3200 Walnut Street
Boulder, CO 80301

© 2020 Array BioPharma Inc. All...

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