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BRAFTOVI®Index Section (encorafenib)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

1.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

1.3 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

2.2 Recommended Dosage for BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

2.3 Recommended Dosage for BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

2.4 Administration

2.5 Dosage Modifications for Adverse Reactions

2.6 Dose Modifications for Coadministration with Strong or Moderate CYP3A4 Inhibitors

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 New Primary Malignancies

5.2 Tumor Promotion in BRAF Wild-Type Tumors

5.3 Hemorrhage

5.4 Uveitis

5.5 QT Prolongation

5.6 Embryo-Fetal Toxicity

5.7 Risks Associated with BRAFTOVI as a Single Agent

5.8 Risks Associated with Combination Treatment

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on BRAFTOVI

7.2 Effect of BRAFTOVI on Other Drugs

7.3 Drugs That Prolong the QT Interval

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

8.7 Renal 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

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

14.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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