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Binimetinib Dosage

Medically reviewed by Drugs.com. Last updated on Aug 13, 2018.

Applies to the following strengths: 15 mg

Usual Adult Dose for Melanoma - Metastatic

45 mg orally every 12 hours in combination with encorafenib until disease progression or unacceptable toxicity

Comments:
-Refer to the encorafenib prescribing information for encorafenib dosing information.
-This drug may be taken with or without food.
-Do not take a missed dose within 6 hours of the next dose.
-Do not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

Use: In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

-Mild hepatic impairment (total bilirubin greater than 1 and less than or equal to 1.5 x the upper limit of normal (ULN) and any AST or total bilirubin less than or equal to ULN and AST greater than ULN: No adjustment recommended.
-Moderate (total bilirubin greater than 1.5 and less than or equal to 3 × ULN and any AST) or severe (total bilirubin levels greater than or equal to 3 × ULN and any AST) hepatic impairment: The recommended dose is 30 mg orally 2 times a day.

Dose Adjustments

If encorafenib is permanently discontinued, discontinue this drug.

Recommended Dose Reductions for Adverse Reactions:
-First dose reduction: 30 mg orally every 12 hours
-Subsequent modification: Permanently discontinue this drug if unable to tolerate 30 mg orally every 12 hours.

DOSE ADJUSTMENTS:
CARDIOMYOPATHY:
-Asymptomatic, absolute decrease in LVEF of greater than 10% from baseline that is also below lower limit of normal (LLN): Withhold this drug for up to 4 weeks; evaluate LVEF every 2 weeks. Resume this drug at a reduced dose if LVEF is at or above the lower limit or normal AND absolute decrease from baseline is 10% or less AND patient is asymptomatic. If the LVEF does not recover within 4 weeks permanently discontinue this drug.
-Symptomatic congestive heart failure or absolute decrease in LVEF or greater than 20% from baseline that is also below LLN: Permanently discontinue this drug.
VENOUS THROMBOEMBOLISM:
-Uncomplicated deep venous thrombosis (DVT) or pulmonary embolism (PE): Withhold this drug. If improves to Grade 0 or 1, resume at a reduced dose. If no improvement, permanently discontinue this drug.
-Life threatening PE: Permanently discontinue this drug.
SEROUS RETINOPATHY:
-Symptomatic serous retinopathy/retinal pigment epithelial detachments: Withhold this drug for up to 10 days. If improves and becomes asymptomatic, resume at the same dose. If not improved, resume at a lower dose level or permanently discontinue this drug.
RETINAL VEIN OCCLUSION (RVO):
-Any grade: Permanently discontinue this drug.
UVEITIS:
-Grade 1, 2, or 3: If Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold this drug for up to 6 weeks. If improved, resume at same or reduced dose. If not improved, permanently discontinue this drug.
-Grade 4: Permanently discontinue this drug.
INTERSTITIAL LUNG DISEASE:
-Grade 2: Withhold this drug for up to 4 weeks. If improved to Grade 0 or 1, resume a reduced dose. If not resolved within 4 weeks, permanently discontinue this drug.
-Grade 3 or 4: Permanently discontinue this drug.
HEPATOTOXICITY:
-Grade 2 AST or ALT increased: Maintain the dose. If no improvement within 2 weeks, withhold this drug until improved to Grade 0 or 1 or to pretreatment/baseline levels and then resume at the same dose.
-First occurrence of Grade 3 AST or ALT increased: Withhold this drug for up to 4 weeks. If improves to Grade 0 or 1 or to pretreatment/baseline levels, resume at reduced dose. If no improvement, permanently discontinue this drug.
-Recurrent Grade 3 AST or ALT increased: Consider permanently discontinuing this drug.
-First occurrence of Grade 4 AST or ALT increased: Permanently discontinue this drug OR withhold this drug for up to 4 weeks. If improves to Grade 0 or 1 or to pretreatment/baseline levels, then resume at a reduced dose. If no improvement, permanently discontinue this drug.
-Recurrent Grade 4 AST or ALT increased: Permanently discontinue this drug.
RHABDOMYOLYSIS OR CREATINE PHOSPHOKINASE (CPK) ELEVATIONS:
-Grade 4 asymptomatic CPK elevation OR any Grade CPK elevation with symptoms or with renal impairment: Withhold this drug for up to 4 weeks. If improved to Grade 0 or 1 resume at a reduced dose. If not resolved within 4 weeks, permanently discontinue this drug.
DERMATOLOGIC:
-Grade 2: If no improvement within 2 weeks, withhold this drug until Grade 0 to 1. Resume at same dose if first occurrence or reduce dose if recurrent.
-Grade 3: Withhold this drug until Grade 0 or 1. Resume at same dose if first occurrence or reduce dose if recurrent.
-Grade 4: Permanently discontinue this drug.
OTHER ADVERSE REACTIONS (INCLUDING HEMORRHAGE):
-Recurrent Grade 2 or first occurrence of any Grade 3: Withhold this drug for up to 4 weeks. If improved to Grade 0 or 1 resume at a reduced dose. If not resolved within 4 weeks, permanently discontinue this drug.
-First occurrence of any Grade 4: Permanently discontinue this drug OR withhold this drug for up to 4 weeks. If improves to Grade 0 or 1 or to pretreatment/baseline levels, then resume at a reduced dose. If no improvement, permanently discontinue this drug.

Precautions

CONTRAINDICATIONS:
-None

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is 95% bound to plasma proteins; therefore, it is unlikely to be removed by hemodialysis.

Other Comments

Administration advice:
-Refer to the encorafenib prescribing information for encorafenib dosing information.
-This drug may be taken with or without food.
-Do not take a missed dose within 6 hours of the next dose.
-Do not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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