Dabrafenib (TAFINLAR)

Melanoma, adjuvant with BRAF V600E or BRAF V600K mutation

Melanoma, advanced or metastatic with BRAF V600E or BRAF V600K mutation

Melanoma, adjuvant with BRAF V600E or BRAF V600K mutation

• Dose – Oral: 150 mg twice daily continuously for up to 12 months
• Given in combination with trametinib

Melanoma, advanced or metastatic with BRAF V600E or BRAF V600K mutation

• Dose – Oral: 150 mg twice daily continuously until disease progression or unacceptable toxicity
• Given as monotherapy or in combination with trametinib

Available as 50 mg and 75 mg capsules. Capsules should NOT be opened. Store at room temperature.

BRAF Inhibitor

Take on an empty stomach at least 1 hour before or 2 hours after a meal

If a dose is missed, patients should be instructed to take it as soon as they can if it is within 6 hours of the missed dose. If it is over 6 hours since the missed dose, patients should skip the missed dose and resume with the next scheduled dose.

Common: Fatigue, Pyrexia, Hyperglycemia.

Less Common: Secondary cutaneous or non-cutaneous malignancies, Renal failure, QT prolongation.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, creatinine, sodium, potassium, calcium, magnesium, alkaline phosphatase, ALT, albumin, ECG, LDH, MUGA scan or echocardiogram, blood pressure.

During treatment: Creatinine, sodium, potassium, calcium, magnesium, alkaline phosphatase, ALT, albumin, LDH, blood pressure, MUGA scan or echocardiogram, ECG, dermatologic evaluation.

• May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
• Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Pyrexia is a common side effect. Manage according to the Canadian Consensus statement on BRAF pyrexia management.
• Secondary malignancies have been reported with dabrafenib including cutaneous squamous cell carcinoma, new primary melanomas, and non-cutaneous malignancies. Skin examination should be performed prior to, during, and after treatment has ended.

BC Cancer. BC Cancer Drug Manual. Dabrafenib. Vancouver, British Columbia: BC Cancer Agency. Available at: http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Dabrafenib_monograph.pdf. Updated September 1, 2018. Accessed January 22, 2024.

Lexicomp. Dabrafenib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/4519183?cesid=4bFBAARQYBD&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Ddabrafenib%26t%3Dname%26acs%3Dfalse%26acq%3Ddabrafenib. Updated January 24, 2024. Accessed January 28, 2024.

Cancer Care Ontario. Dabrafenib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: .https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/44326. Updated June 2021. Accessed January 22, 2024.

Novartis Pharmaceuticals Canada Inc. TAFINLAR® Product monograph. Dorval, Quebec. Updated January 16, 2024.