Dabrafenib mesylate

Dabrafenib mesylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Dabrafenib mesylate is a BRAF Inhibitor that is FDA approved for the treatment of malignant melanoma. Common adverse reactions include peripheral edema, alopecia, hyperkeratosis, abdominal pain, constipation, anemia, arthralgia, cough.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR® as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR, in combination with trametinib, is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate [see Clinical Studies (14.2)]. Improvement in disease-related symptoms or overall survival has not been demonstrated for TAFINLAR in combination with trametinib.

Limitation of Use

TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma.

Dosing

Recommended Dosing

• The recommended dosage regimens of TAFINLAR are:

• 150 mg orally taken twice daily, approximately 12 hours apart, as a single agent

• 150 mg orally taken twice daily, approximately 12 hours apart, in combination with trametinib 2 mg orally taken once daily

• Continue treatment until disease progression or unacceptable toxicity occurs. Take TAFINLAR as a single agent, or TAFINLAR in combination with trametinib, at least 1 hour before or 2 hours after a meal[see Clinical Pharmacology (12.3)]. Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR. Do not open, crush, or break TAFINLAR capsule.

• When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning dose or the evening dose of TAFINLAR.

Dose Modifications

• For New Primary Cutaneous Malignancies: No dose modifications are required.

• For New Primary Non-Cutaneous Malignancies: Permanently discontinue TAFINLAR in patients who develop RAS mutation-positive non-cutaneous malignancies. If used in combination with trametinib, no dose modifications are required for trametinib in patients who develop non-cutaneous malignancies.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

DOSAGE FORMS AND STRENGTHS

• 50 mg Capsules: Dark red capsule imprinted with ‘GS TEW’ and ‘50 mg’.

• 75 mg Capsules: Dark pink capsule imprinted with ‘GS LHF’ and ‘75 mg’.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dabrafenib mesylate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dabrafenib mesylate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Dabrafenib mesylate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dabrafenib mesylate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dabrafenib mesylate in pediatric patients.

Contraindications

There is limited information regarding Dabrafenib mesylate Contraindications in the drug label.

Warnings

There is limited information regarding Dabrafenib mesylate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dabrafenib mesylate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dabrafenib mesylate in the drug label.

Drug Interactions

There is limited information regarding Dabrafenib mesylate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Dabrafenib mesylate in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dabrafenib mesylate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dabrafenib mesylate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dabrafenib mesylate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dabrafenib mesylate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dabrafenib mesylate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dabrafenib mesylate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dabrafenib mesylate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dabrafenib mesylate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dabrafenib mesylate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dabrafenib mesylate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dabrafenib mesylate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Dabrafenib mesylate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Dabrafenib mesylate in the drug label.

Overdosage

There is limited information regarding Dabrafenib mesylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Dabrafenib mesylate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dabrafenib mesylate Mechanism of Action in the drug label.

Structure

There is limited information regarding Dabrafenib mesylate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dabrafenib mesylate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dabrafenib mesylate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dabrafenib mesylate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dabrafenib mesylate in the drug label.

How Supplied

Storage

There is limited information regarding Dabrafenib mesylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dabrafenib mesylate in the drug label.

Precautions with Alcohol

• Alcohol-Dabrafenib mesylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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