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Tafinlar Dosage

Generic name: DABRAFENIB MESYLATE 50mg
Dosage form: capsule

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

​2.1 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 (5.2)]. 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​.

​2.2 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 (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.

​2.3 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.
bSee Table 1 for recommended dose reductions of TAFINLAR.
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