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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.

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) 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.

NSCLC

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.

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.

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 (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.

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.

b See Table 1 for recommended dose reductions of TAFINLAR.

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