8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are

not listed. 

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

MEKTOVI® is indicated, in combination with encorafenib, for the treatment of patients with unresectable ormetastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see

Dosage and Administration (2.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiatingMEKTOVI [Clinical Studies (14)]. 

Information on FDA-approved tests for the detection of BRAF V600Eand V600K mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dosage

The recommended dosage of MEKTOVI is 45 mg orally taken twice daily, approximately 12 hours apart, incombination 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 misseddose 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 nextscheduled dose.

2.3 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.

Table 1: Recommended Dose Reductions for MEKTOVI for Adverse ReactionsAction Recommended DoseFirst 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.

Table 2: Recommended Dosage Modifications for MEKTOVI for Adverse Reactions

Severity of Adverse Reactiona Dose Modification for MEKTOVI

Cardiomyopathy [see Warnings and Precautions (5.1)]

 Asymptomatic, absolute decrease in

LVEF of greater than 10% from baseline

that is also below lower limit of normal

(LLN)

Withhold MEKTOVI for up to 4 weeks, eva luate LVEF every

2 weeks.

Resume MEKTOVI at a reduced dose if the following are present:

LVEF is at or above the lower limit of normal andAbsolute decrease from baseline is 10% or less and Patient is asymptomatic.

If the LVEF does not recover within 4 weeks permanentlydiscontinue MEKTOVI.

Symptomatic congestive heart failure orabsolute decrease in LVEF of greaterthan 20% from baseline that is also belowLLNPermanently discontinue MEKTOVI.