"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 "...
DOSAGE AND ADMINISTRATION
Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR [see WARNINGS AND PRECAUTIONS]. Information on FDAapproved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.
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].
A missed dose can be taken up to 6 hours prior to the next dose. Do not open, crush, or break TAFINLAR capsule.
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||
||Withhold TAFINLAR until adverse reaction resolves. Then resume TAFLINAR at same dose or at a reduced dose level (see Table 2).|
||Permanently discontinue TAFINLAR.|
|a Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|
Table 2: Recommended TAFLINAR 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|
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: 05/2013
Last reviewed on RxList: 6/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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.
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