Tafinlar Dosage & Drug Information

Information is sourced from publicly available references. The information is for educational purpose of healthcare professionals and we are not liable for any loss or damage.

Core Prescribing Info

Contents

Dabrafenib mesylate

Indications/Uses

Monotherapy or in combination w/ trametinib in patients w/ unresectable or metastatic melanoma w/ BRAF V600 mutation. In combination w/ trametinib for adjuvant treatment of patients w/ melanoma w/ BRAF V600 mutation & involvement of lymph node(s) following complete resection; for advanced NSCLC w/ BRAF V600 mutation; in patients w/ locally advanced or metastatic anaplastic thyroid cancer w/ BRAF V600 mutation & no satisfactory locoregional treatment options; in ped patients ≥1 yr w/ low-grade glioma w/ BRAF V600E mutation who require systemic therapy.

Dosage/Direction for Use

Hard cap Adult 150 mg bd. Ped patient weighing ≥51 kg 150 bd, 38-50 kg 100 mg bd, 26-37 kg 75 kg bd. Dispersible tab Patient weighing ≥51 kg 150 mg bd, 46-50 kg 130 mg bd, 42-45 kg 110 mg bd, 38-41 kg 100 mg bd, 34-37 kg 90 mg bd, 30-33 kg 80 mg bd, 26-29 kg 70 bd, 22-25 kg 60 mg bd, 18-21 kg 50 mg bd, 14-17 kg 40 mg bd, 10-13 kg 30 mg bd, 8-9 kg 20 mg bd.

Administration

Should be taken on an empty stomach: Take at least 1 hr before or at least 2 hr after meal, leaving an interval of approx 12 hr between doses. Hard cap: Swallow whole w/ glass of water. Do not chew or crush. Dispersible tab: Take as susp only. Do not swallow whole, chew or crush.

Contraindications

Hypersensitivity.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EC02 - dabrafenib ; Belongs to the class of B-Raf serine-threonine kinase (BRAF) inhibitors. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Tafinlar dispersible tab 10 mg

Packing/Price

1's

Form

Tafinlar hard cap 50 mg

Packing/Price

1's

Form

Tafinlar hard cap 75 mg

Packing/Price

1's

Tafinlar

dabrafenib

Manufacturer:

Novartis