HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to useBRAFTOVI safely and effectively. See full prescribing information forBRAFTOVI.

BRAFTOVI™ (encorafenib)capsules, for oral use

Initial U.S. Approval: 2018

INDICATIONS AND USAGE

BRAFTOVI is a kinase inhibitor indicated, in combination withbinimetinib, for the treatment of patients with unresectable or metastatic

melanoma with a BRAF V600E or V600K mutation, as detected by anFDA-approved test. (1, 2.1)

Limitations of Use:

BRAFTOVI is not indicated for treatment of patients with wild-type BRAFmelanoma. (1, 5.2)

DOSAGE AND ADMINISTRATION

Confirm the presence of BRAF V600E or V600K mutation in tumorspecimens prior to the initiation of BRAFTOVI. (2.1)

The recommended dose is 450 mg orally once daily in combinationwith binimetinib. Take BRAFTOVI with or without food.(2.2)

DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg and 75 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

New Primary Malignancies, cutaneous and non-cutaneous: Can occur.

Monitor for malignancies and perform dermatologic eva luations priorto, while on therapy, and following discontinuation of treatment. (5.1)

Tumor Promotion in BRAF Wild-Type Tumors: Increased cellproliferation can occur with BRAF inhibitors. (5.2)

Hemorrhage: Major hemorrhagic events can occur. (5.3)

Uveitis: Perform ophthalmologic eva luation at regular intervals and forany visual disturbances. (5.4)

QT Prolongation: Monitor electrolytes before and during treatment.

Correct electrolyte abnormalities and control for cardiac risk factors forQT prolongation. Withhold BRAFTOVI for QTc of 500 ms or greater.(5.5)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females withreproductive potential of potential risk to the fetus and to use effectivenon-hormonal method of contraception. (5.6, 8.1, 8.3)

ADVERSE REACTIONS

Most common adverse reactions (>25%) for BRAFTOVI, in combinationwith binimetinib, are fatigue, nausea, vomiting, abdominal pain, andarthralgia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact ArrayBioPharma at 1-844-792-7729 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Concomitant use mayincrease encorafenib plasma concentration. If concomitant use cannotbe avoided, modify BRAFTOVI dose. (2.4, 7.1)

Strong or moderate CYP3A4 inducers: Concomitant use maydecrease encorafenib plasma concentrations. Avoid concomitant use.(7.1)

Sensitive CYP3A4 substrates: Concomitant use with BRAFTOVImay increase toxicity or decrease efficacy of these agents. Avoidhormonal contraceptives. (7.2)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

Males of Reproductive Potential: BRAFTOVI may impair fertility.(8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 06/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

2.2 Recommended Dosage

2.3 Dosage Modifications for Adverse Reactions

2.4 Dose Modifications for Coadministration of Strong orModerate CYP3A4 Inhibitors

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS