Mektovi

— THERAPEUTIC CATEGORIES —
  • Melanoma and other skin cancers

Mektovi Generic Name & Formulations

General Description

Binimetinib 15mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—180

Manufacturer

Generic Availability

NO

Mektovi Indications

Indications

In combination with encorafenib, for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Mektovi Dosage and Administration

Adult

Confirm BRAF V600E or V600K mutation prior to initiation. 45mg twice daily (approx. 12hrs apart) with encorafenib until disease progression or unacceptable toxicity. Moderate or severe hepatic impairment: 30mg twice daily. Dose modifications for adverse reactions: see full labeling. Refer to encorafenib labeling for dosing. Discontinue if encorafenib is permanently discontinued.

Children

Not established.

Mektovi Contraindications

Not Applicable

Mektovi Boxed Warnings

Not Applicable

Mektovi Warnings/Precautions

Warnings/Precautions

Cardiomyopathy: assess LVEF prior to initiating, 1 month after initiation, and then every 2–3 months during treatment. Patients with baseline LVEF below 50% or LLN: not established. Cardiovascular risk factors; monitor closely. Venous thromboembolism (DVT & PE). Ocular toxicities (serious retinopathy, retinal vein occlusion [RVO], uveitis): assess for visual symptoms at each visit; perform ophthalmologic exams regularly and for new or worsening visual disturbances (esp. within 24hrs for RVO). Assess new or progressive unexplained pulmonary symptoms or for possible interstitial lung disease. Hepatotoxicity: monitor liver tests before initiation, monthly during treatment, and as clinically indicated. Rhabdomyolysis: monitor CPK and creatinine prior to initiating, periodically during, and as clinically indicated. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for ≥30 days after final dose. Nursing mothers: not recommended (during and for 3 days after final dose).

Mektovi Pharmacokinetics

See Literature

Mektovi Interactions

Mektovi Adverse Reactions

Adverse Reactions

In combination with encorafenib: fatigue, nausea, diarrhea, vomiting, abdominal pain; hemorrhage.

Mektovi Clinical Trials

See Literature

Mektovi Note

Not Applicable

Mektovi Patient Counseling

See Literature