Mektovi Dosage
Generic name: BINIMETINIB 15mg
Dosage form: tablet, film coated
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Oct 18, 2023.
Patient Selection
BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma
Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating MEKTOVI [see http://www.fda.gov/CompanionDiagnostics.
BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Confirm the presence of a BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI [see http://www.fda.gov/CompanionDiagnostics.
Recommended Dosage and Administration
The recommended dosage of MEKTOVI is 45 mg orally taken twice daily, approximately 12 hours apart, in combination with encorafenib until disease progression or unacceptable toxicity. Refer to the encorafenib prescribing information for recommended encorafenib dosing information.
MEKTOVI may be taken with or without food [see Clinical Pharmacology (12.3)]. Do not take a missed dose of MEKTOVI within 6 hours of the next dose of MEKTOVI.
Do not take an additional dose if vomiting occurs after MEKTOVI administration but continue with the next scheduled dose.
Dosage Modifications for Adverse Reactions
If encorafenib is permanently discontinued, discontinue MEKTOVI.
Dose reductions for adverse reactions associated with MEKTOVI are presented in Table 1.
Action | Recommended Dose |
---|---|
First Dose Reduction |
30 mg orally twice daily |
Subsequent Modification |
Permanently discontinue if unable to tolerate MEKTOVI 30 mg orally twice daily |
Dosage modifications for adverse reactions associated with MEKTOVI are presented in Table 2.
Severity of Adverse Reaction* | Dose Modification for MEKTOVI |
---|---|
|
|
Cardiomyopathy [see Warnings and Precautions (5.2)] |
|
|
Withhold MEKTOVI for up to 4 weeks, evaluate LVEF every 2 weeks.
If the LVEF does not recover within 4 weeks permanently discontinue MEKTOVI. |
|
Permanently discontinue MEKTOVI. |
Venous Thromboembolism [see Warnings and Precautions (5.3)] |
|
|
Withhold MEKTOVI.
|
|
Permanently discontinue MEKTOVI. |
Serous Retinopathy [see Warnings and Precautions (5.4)] |
|
|
Withhold MEKTOVI for up to 10 days.
|
Retinal Vein Occlusion (RVO) [see Warnings and Precautions (5.4)] |
|
|
Permanently discontinue MEKTOVI. |
Uveitis [see Warnings and Precautions (5.4)] |
|
|
If Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold MEKTOVI for up to 6 weeks.
|
|
Permanently discontinue MEKTOVI. |
Interstitial Lung Disease [see Warnings and Precautions (5.5)] |
|
|
Withhold MEKTOVI for up to 4 weeks.
|
|
Permanently discontinue MEKTOVI. |
Hepatotoxicity [see Warnings and Precautions (5.6)] |
|
|
Maintain MEKTOVI dose.
|
|
|
Rhabdomyolysis or Creatine Phosphokinase (CPK) elevations [see Warnings and Precautions (5.7)] |
|
|
Withhold MEKTOVI dose for up to 4 weeks.
|
Dermatologic [other than palmar plantar erythrodysesthesia syndrome (PPES)] [see Adverse Reactions (6.1)] |
|
|
If no improvement within 2 weeks, withhold MEKTOVI until Grade 0-1. Resume at same dose if first occurrence or reduce dose if recurrent. |
|
Withhold MEKTOVI until Grade 0-1. Resume at same dose if first occurrence or reduce dose if recurrent. |
|
Permanently discontinue MEKTOVI. |
Other Adverse Reactions (including Hemorrhage) [see Warnings and Precautions (5.8), Adverse Reactions (6.1)]† |
|
|
Withhold MEKTOVI for up to 4 weeks.
|
|
Permanently discontinue MEKTOVI, or
|
|
Consider permanently discontinuing MEKTOVI. |
|
Permanently discontinue MEKTOVI. |
Refer to the encorafenib prescribing information for dose modifications for adverse reactions associated with encorafenib.
Dosage Modifications for Moderate or Severe Hepatic Impairment
For patients with 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 3 × ULN and any AST) hepatic impairment, the recommended dosage is 30 mg orally taken twice daily [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
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