Generic name: DABRAFENIB MESYLATE 50mg
Dosage form: capsule
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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) and Clinical Studies (14.1)]. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Warnings and Precautions (5.2) and Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC 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 (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 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 (RVO), retinal pigment epithelial detachment (RPED), 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.
|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|
|Severity of Adverse
|Febrile Drug Reaction|
||Withhold TAFINLAR until fever resolves. Then resume at same or lower dose level.|
||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.
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- Drug class: multikinase inhibitors