Tafinlar Dosage

Generic name: dabrafenib
Dosage form: capsule

This dosage information does not include all the information needed to use Tafinlar safely and effectively. See full prescribing information for Tafinlar.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Patient Selection

Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR [see Warnings and Precautions (5.2)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.

Recommended Dosing

The recommended dose for TAFINLAR is 150 mg orally taken twice daily, approximately 12 hours apart, until disease progression or unacceptable toxicity occurs. Take either at least 1 hour before or at least 2 hours after a meal [see Clinical Pharmacology (12.3)].

A missed dose can be taken up to 6 hours prior to the next dose. Do not open, crush, or break TAFINLAR capsule.

Dose Modifications

For New Primary Cutaneous Malignancies: No dose modifications are recommended.

Table 1. Recommended Dose Modifications for TAFINLAR

Target Organ

Adverse Reactionsa

Dose Modification

Febrile

Drug

Reaction

Fever of 101.3ºF to 104°F

Withhold TAFINLAR until adverse reaction resolves. Then resume TAFINLAR at same dose or at a reduced dose level (see Table 2).

Fever higher than 104°F
Fever complicated by rigors, hypotension, dehydration, or renal failure

Either

Permanently discontinue TAFINLAR

Or

Withhold TAFINLAR until adverse reaction resolves. Then resume TAFINLAR at a reduced dose level (see Table 2).
 

Other

Intolerable Grade 2 Adverse Reactions
Any Grade 3 Adverse Reactions

Withhold TAFINLAR until adverse reaction resolves to Grade 1 or less. Then resume TAFINLAR at a reduced dose level (see Table 2).

First occurrence of Any Grade 4 Adverse Reaction

Either

Permanently discontinue TAFINLAR

Or

Withhold TAFINLAR until adverse reaction resolves to Grade 1 or less. Then resume TAFINLAR at a reduced dose level (see Table 2).
 
Recurrent Grade 4 Adverse Reaction
Intolerable Grade 2 or Any Grade 3 or 4 Adverse Reaction on TAFINLAR 50 mg twice daily

Permanently discontinue TAFINLAR.

 

a Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Table 2. Recommended TAFINLAR Dose Reductions
 
Dose Reductions
 
Dose and Schedule
 
First dose reduction
 
100 mg orally twice daily
 
Second dose reduction
 
75 mg orally twice daily
 
Third dose reduction
 
50 mg orally twice daily
 
If unable to tolerate 50 mg twice daily
 
Discontinue TAFINLAR
Hide
(web1)