Tafinlar (Dabrafenib) – NSCLC | DengYue Medicine

Tafinlar Application Scope

Tafinlar is an oral kinase inhibitor (dabrafenib) targeting BRAF V600 mutations in various cancers.

Characteristics

• Ingredients: Dabrafenib

• Properties:

  • Oral BRAF V600 kinase inhibitor

  • Available as hard capsules (50 mg, 75 mg) and 10 mg oral suspension tablets

• Packaging Specification: Capsules in bottles of 28 or 120, with a silica-gel desiccant inside

• Storage: Store in original container with desiccant; details follow regional labeling

• Expiry Date: ​See pack/container; refer to the original packaging labeling

• Executive Standard: Follows EMA and FDA prescribing information

• Approval Number:

  • EU: EMA/538918/2013

  • US: FDA label numbers

• Date of Revision:

  • FDA label revised 3/2023; prescribing info updated 4/2025

  • EMA info last updated 12/2024

• Manufacturer:

  • Novartis Europharm Limited (Ireland)

  • Capsules made by Lek Pharmaceuticals d.d., Ljubljana, Slovenia

Guidelines for the Use of Tafinlar

• Dosage and Administration:

  • Adults:

    • 150 mg oral capsules twice daily (total 300 mg/day)

    • at least 1 hour before or 2 hours after food

  • Pediatrics (≥26 kg): weight-based dosing per local guidelines

  • Dose reductions: step down to 100 mg, 75 mg, or 50 mg twice daily, depending on tolerance

• Adverse Reactions:

  • As monotherapy:

    • hyperkeratosis, headache, fever, arthralgia, papilloma

    • alopecia, palmar-plantar erythrodysesthesia (≥20%)

  • With trametinib: fever, rash, chills, headache, arthralgia, cough (≥20%)

• Contraindications:

  • Hypersensitivity to dabrafenib or its ingredients

  • No absolute contraindications are listed in the current FDA label

• Precautions:

  • Monitor for new primary malignancies, skin cancers

  • Hemorrhage risk when combined with trametinib

  • Cardiomyopathy and uveitis precautions

  • Teratogenic – use effective contraception

  • Not for wild-type BRAF tumors

  • Use caution in hepatic impairment and the elderly

Tafinlar Interactions

• Drug Interactions:

  • Interacts with CYP3A4 modulators: dose adjustments required with inhibitors or inducers

  • May reduce the efficacy of oral contraceptives

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.