July 1, 2016
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Tafinlar

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Tafinlar

Indications
Dosage
How Supplied

INDICATIONS

BRAF V600E Mutation-Positive Unresectable Or Metastatic Melanoma

TAFINLAR® is indicated as a single agent 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 is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

Limitation Of Use

TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

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]. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and 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 regimen of TAFINLAR is 150 mg orally taken twice daily, approximately 12 hours apart as a single agent or with trametinib. Continue treatment until disease progression or unacceptable toxicity occurs.

Take TAFINLAR at least 1 hour before or 2 hours after a meal [see CLINICAL PHARMACOLOGY]. Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR. Do not open, crush, or break TAFINLAR capsules.

Dose Modifications

Review the Full Prescribing Information for trametinib for recommended dose modifications. Dose modifications are not recommended for TAFINLAR when administered with trametinib for the following adverse reactions of trametinib: retinal vein occlusion, retinal pigment epithelial detachment, interstitial lung disease/pneumonitis, and uncomplicated venous thromboembolism.

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.

Table 1: Recommended Dose Reductions

Dose Reductions for TAFINLAR  
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

Table 2: Recommended Dose Modifications for TAFINLAR

Severity of Adverse Reactiona TAFINLARb
Febrile Drug Reaction
  • Fever of 101.3°F to 104°F
Withhold TAFINLAR until fever resolves. Then resume at same or lower dose level.
  • 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.
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.
Cardiac
  • 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.
Uveitis
  • Uveitis including iritis and iridocyclitis
If mild or moderate uveitis does not respond to ocular therapy, or for severe uveitis, withhold TAFINLAR for up to 6 weeks.
  • If improved to Grade 0-1, then resume at the same or at a lower dose level.
  • If not improved, permanently discontinue.
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.
  • 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.
  • Recurrent Grade 4 adverse reaction
Permanently discontinue TAFINLAR.
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
b See Table 1 for recommended dose reductions of TAFINLAR.

HOW SUPPLIED

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'.

Storage And Handling

50 mg capsules: Dark red capsule imprinted with 'GS TEW' and '50 mg' available in bottles of 120 (NDC 0173-0846-08). Each bottle contains a silica gel desiccant.

75 mg capsules: Dark pink capsule imprinted with 'GS LHF' and '75 mg' available in bottles of 120 (NDC 0173-0847-08). Each bottle contains a silica gel desiccant.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: November 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/22/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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