Tafinlar Dosage

Generic name: dabrafenib
Dosage form: capsule

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 as a single agent [see Warnings and Precautions (5.2)]. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR in combination with trametinib. 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 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.

Table 1. Recommended Dose Reductions
 
Dose Reductions for TAFINLAR When Administered as a Single Agent or in Combination With Trametinib
 
First Dose Reduction
 
100 mg orally twice daily
 
Second Dose Reduction
 
75 mg orally twice daily
 
Third Dose Reduction
 
50 mg orally twice daily
 
Subsequent Modification
 
Permanently discontinue TAFINLAR if unable to tolerate 50 mg orally twice daily
 
Dose Reductions for Trametinib When Administered in Combination With TAFINLAR
 
First Dose Reduction
 
1.5 mg orally once daily
 
Second Dose Reduction
 
1 mg orally once daily
 
Subsequent Modification
 
Permanently discontinue if unable to tolerate trametinib 1 mg orally once daily
Table 2. Recommended Dose Modifications for TAFINLAR as a Single Agent and for TAFINLAR and Trametinib Administered in Combination

Severity of Adverse

Reactiona

TAFINLARb

Trametinib

(When Used in Combination)b,c

Febrile drug reaction

Fever of 101.3°F to 104°F

Withhold TAFINLAR until fever resolves. Then resume at same or lower dose level.

Do not modify the dose of trametinib.

Fever higher than 104°F
Fever complicated by rigors, hypotension, dehydration, or renal failure
Withhold TAFINLAR until fever resolves. Then resume at a lower dose level.

Or

Permanently discontinue TAFINLAR.

Withhold trametinib until fever resolves. Then resume trametinib at same or lower dose level.

Cutaneous

Intolerable Grade 2 skin toxicity
Grade 3 or 4 skin toxicity

Withhold TAFINLAR for up to 3 weeks.

If improved, resume at a lower dose level.
If not improved, permanently discontinue.

Withhold trametinib for up to 3 weeks.

If improved, resume at a lower dose level.
If not improved, permanently discontinue.

Cardiac

Asymptomatic, absolute decrease in LVEF of 10% or greater from baseline and is below institutional lower limits of normal (LLN) from pretreatment value

Do not modify the dose of TAFINLAR.

Withhold trametinib for up to 4 weeks.

If improved to normal LVEF value, resume at a lower dose level.
If not improved to normal LVEF value, permanently discontinue.
Symptomatic congestive heart failure
Absolute decrease in LVEF of greater than 20% from baseline that is below LLN

Withhold TAFINLAR, if improved, then resume at the same dose.

Permanently discontinue trametinib.

Venous Thromboembolism

Uncomplicated DVT or PE

Do not modify the dose of TAFINLAR.

Withhold trametinib for up to 3 weeks.

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.
Life Threatening PE

Permanently discontinue TAFINLAR.

Permanently discontinue trametinib.

Ocular Toxicities

Grade 2-3 retinal pigment epithelial detachments (RPED)

Do not modify the dose of TAFINLAR.

Withhold trametinib for up to 3 weeks.

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.
Retinal vein occlusion

Do not modify the dose of TAFINLAR.

Permanently discontinue trametinib.

Uveitis and Iritis

Withhold TAFINLAR for up to 6 weeks.

If improved to Grade 0-1, then resume at the same dose.
If not improved, permanently discontinue.

Do not modify the dose of trametinib.

Pulmonary

Interstitial lung disease/pneumonitis

Do not modify the dose of TAFINLAR.

Permanently discontinue trametinib.

Other

Intolerable Grade 2 adverse reactions
Any Grade 3 adverse reaction

Withhold TAFINLAR.

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.

Withhold trametinib for up to 3 weeks.

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.
First occurrence of any Grade 4 adverse reaction
Withhold TAFINLAR until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.

Or

Permanently discontinue TAFINLAR.
Withhold trametinib until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.

Or

Permanently discontinue trametinib.
Recurrent Grade 4 adverse reaction

Permanently discontinue TAFINLAR.

Permanently discontinue trametinib.

aNational Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

bSee Table 1 for recommended dose reductions of TAFINLAR and trametinib.

cRefer to Full Prescribing Information for trametinib.

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