Tafinlar Dosage
Medically reviewed by Drugs.com. Last updated on Jan 28, 2022.
Generic name: DABRAFENIB MESYLATE 50mg
Dosage form: capsule
Patient Selection
Melanoma
- 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), 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), Clinical Studies (14.2, 14.3)].
- Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
NSCLC
- Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.4)].
- Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.
ATC
- Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.5)]. An FDA-approved test for the detection of BRAF V600E mutation in ATC is not currently available.
Recommended Dosage for Unresectable or Metastatic Melanoma
The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, as a single agent or in combination with trametinib, until disease progression or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.
Recommended Dosage for the Adjuvant Treatment of Melanoma
The recommended dosage of TAFINLAR is 150 mg orally taken twice daily in combination with trametinib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the trametinib prescribing information for recommended trametinib dosing information.
Recommended Dosage for NSCLC
The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.
Recommended Dosage for ATC
The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.
Administration
- Take TAFINLAR at doses approximately 12 hours apart.
- 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.
Dosage Modifications for Adverse Reactions
Dose reductions for adverse reactions associated with TAFINLAR are presented in Table 1.
Action | Recommended Dose |
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 if unable to tolerate TAFINLAR 50 mg orally twice daily |
Dosage modifications for adverse reactions associated with TAFINLAR are presented in Table 2.
aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. bSee Table 1 for recommended dose reductions of TAFINLAR. cDose 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. Dose modification of TAFINLAR is not required for new primary cutaneous malignancies. |
|
Severity of Adverse Reactiona | Dosage Modification for TAFINLARb |
New Primary Malignancies [see Warnings and Precautions (5.1)] | |
Non-Cutaneous RAS Mutation-positive Malignancies | Permanently discontinue TAFINLAR. |
Cardiomyopathy [see Warnings and Precautions (5.4)] | |
|
Withhold TAFINLAR until LVEF improves to at least the institutional LLN and absolute decrease to less than or equal to 10% compared to baseline, then resume at same dose. |
Uveitis [see Warnings and Precautions (5.5)] | |
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For mild or moderate uveitis does not respond to ocular therapy, or for severe uveitis, withhold TAFINLAR for up to 6 weeks.
|
Febrile Reactions [see Warnings and Precautions (5.6)] | |
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Withhold TAFINLAR until fever resolves, then resume at same or lower dose. |
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Skin Toxicities [see Warnings and Precautions (5.7)] | |
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Withhold TAFINLAR for up to 3 weeks.
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Permanently discontinue TAFINLAR. |
Other Adverse Reactionsc, including Hemorrhage [see Warnings and Precautions (5.3)] | |
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Withhold TAFINLAR.
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Permanently discontinue TAFINLAR. |
Refer to the trametinib prescribing information for dose modifications for adverse reactions associated with trametinib.
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