Dabrafenib is indicated for the treatment of patients with unresectable or metastatic BRAF V600E-mutated melanoma

Dabrafenib instructions

Product Name: LuciDabra

Manufacturer: Lucius Pharmaceuticals

Chinese name: dabrafenib

English name: Dabrafenib

Drug approval number: 10 L 1025/23

 

【Summary】

Dabrafenib (Tafinlar) is a BRAF inhibitor. The U.S. Food and Drug Administration (FDA) approved dabrafenib for the treatment of surgically unresectable adult melanoma or metastatic melanoma with BRAF V600E mutation on May 29, 2013. Subsequently, the FDA approved the combination of dabrafenib and trametinib for the treatment of unresectable melanoma or metastatic melanoma on January 10, 2014.

 

【Indications】

BRAF V600 mutation-positive unresectable or metastatic melanoma

This product combined with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma who are BRAF V600 mutation-positive.

 

【Specification】  

75mg/capsule, 120 capsules/box.

 

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

 

【Usage and Dosage】

The recommended dose is 150 mg once, twice a day (equivalent to a total daily dose of 300 mg). This product needs to be treated in combination with trametinib until disease progression or intolerable toxic reactions occur.

 

【Adverse Reactions】

(1) The most common adverse reactions (≥20%) to dabrafenib as a single agent are hyperkeratosis, headache, fever, arthritis, papilloma, alopecia, and palmoplantar erythrodysesthesia syndrome.

(2) The most common adverse reactions (≥20%) of dabrafenib combined with trametinib include fever, chills, fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, arthralgia, night sweats, decreased appetite, constipation, and myalgia.

  

【Notes】

New Primary Cutaneous Malignancies: Perform dermatologic evaluation prior to initiating treatment, every 3 months during treatment, and up to 6 months after discontinuation of TAFINLAR.

Tumor Promotion in BRAF Wild-Type Melanoma: Increased cell proliferation may occur with BRAF inhibitors.

Severe febrile drug reactions: Withhold TAFINLAR if fever ≥101.3°F or if concurrent fever occurs.

Hyperglycemia: Monitor serum glucose levels in patients with pre-existing diabetes or hyperglycemia.

Uveitis and iritis: Monitor patients routinely for visual symptoms.

Glucose-6-phosphate dehydrogenase deficiency: Closely monitor for hemolytic anemia.

Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. TAFINLAR may make hormonal contraceptives less effective and an alternative method of contraception should be used.