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Braftovi

encorafenib
BRAF Kinase Inhibitor FDA Approved 2018 Pfizer
Route
Oral
Half-Life
21 hrs
FDA Approved
2018
Manufacturer
Pfizer
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1. Indications and Usage

Melanoma: With binimetinib for BRAF V600E/K melanoma.
CRC: With cetuximab for BRAF V600E mCRC.

2. Dosage and Administration

Melanoma: 450 mg daily.
CRC: 300 mg daily.

3. Dosage Forms and Strengths

Capsules: 75 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • New Primary Malignancies: Dermatologic evaluations.
  • Hemorrhage: Serious events reported.
  • QT Prolongation: Monitor ECGs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (43%), Nausea (40%), Diarrhea (38%), Vomiting (28%), Abdominal Pain (26%), Arthralgia (26%), Musculoskeletal Pain (20%), Rash (18%)

Fatigue
43%
Nausea
40%
Diarrhea
38%
Vomiting
28%
Abdominal Pain
26%
Arthralgia
26%
Musculoskeletal Pain
20%
Rash
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP3A4 Inhibitors: Reduce dose.
CYP3A4 Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Kinase inhibitor targeting BRAF V600E, CRAF, and wild-type BRAF.

Pharmacokinetics

Tmax: 2h. t½: 3.5h. Feces 47%, urine 47%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Braftovi Trials on ClinicalTrials.gov ↗ 📚 PubMed: Braftovi Clinical Trials ↗
FDA-Approved Tumor Types

Braftovi has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Melanoma Colorectal Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Braftovi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Braftovi (encorafenib) approved for?

Braftovi (encorafenib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Braftovi (encorafenib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Braftovi (encorafenib) work?

Kinase inhibitor targeting BRAF V600E, CRAF, and wild-type BRAF.

What are the most common side effects?

Fatigue (43%), Nausea (40%), Diarrhea (38%), Vomiting (28%), Abdominal Pain (26%), Arthralgia (26%), Musculoskeletal Pain (20%), Rash (18%) Fatigue 43% Nausea 40% Diarrhea 38% Vomiting 28% Abdominal Pain 26% Arthralgia 26% Musculoskeletal Pain 20% Rash 18%

← All Therapies Full Prescribing Information ↗