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Active Pharma Ingredients / 24 Sep 2026

DABRAFENIB

Generic Name: DABRAFENIB

ABSTRACT -

Dabrafenib is a BRAF kinase inhibitor used in selected BRAF V600 mutation-positive cancers, often in combination with a MEK inhibitor depending on indication. This document is not a prescribing guide.

DOSAGE -

  • Follow the approved label for the cancer type and mutation status.
  • Common adult dosing is oral twice-daily administration in labeled regimens, with product-specific dose modifications.
  • Combination with trametinib or other therapy must follow approved labeling.

SIDE EEFECTS -

  • Fever, fatigue, chills, headache, nausea, vomiting, diarrhea, rash, arthralgia, or cough may occur.
  • Skin lesions, hyperkeratosis, hemorrhage, hyperglycemia, ocular events, and cardiac effects may occur.
  • Secondary malignancies and severe febrile reactions are important risks.

ALLERGIC REACTIONS -

  • Immediate rash, hives, itching, flushing, or generalized skin reaction
  • Facial, lip, tongue, or throat swelling
  • Wheezing, chest tightness, shortness of breath, or severe dizziness
  • Severe hypotension, collapse, or anaphylaxis requires emergency care
  • Any suspected allergy should be documented and reported to future healthcare providers

DRUG INTERACTIONS-

  • Strong CYP3A4/CYP2C8 inhibitors or inducers may alter exposure.
  • Dabrafenib can affect exposure to hormonal contraceptives and other CYP substrates.
  • Concomitant QT-risk or anticancer agents require review.

PREAUTONS–

  • Confirm BRAF mutation before treatment.
  • Monitor fever, skin exams, cardiac function, glucose, ocular symptoms, and liver tests.
  • Use contraception and avoid pregnancy during and after treatment as directed by label.

WARNINGS –

  • Serious fever, bleeding, cardiomyopathy, ocular toxicity, severe skin reactions, or new cancers require urgent evaluation.
  • Do not use in wild-type BRAF tumors unless specifically indicated.
  • Keep out of reach of children.

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