"The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin "...
BRAF V600E Mutation-Positive Unresectable Or Metastatic Melanoma
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
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.
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.
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|
||Withhold TAFINLAR until fever resolves. Then resume at same or lower dose level.|
|• Intolerable Grade 2 skin toxicity • Grade 3 or 4 skin toxicity||Withhold TAFINLAR for up to 3 weeks.
||Withhold TAFINLAR, if improved, then resume at the same dose.|
||If mild or moderate uveitis does not respond to ocular therapy, or for severe uveitis, withhold TAFINLAR for up to 6 weeks.
||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.
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 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/22/2016
Additional Tafinlar Information
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.
Get the latest treatment options.