This label may not be the latest approved by FDA. For current

Positive Melanoma 7.1 Effects of Other Drugs on Dabrafenib. 1.4 BRAF V600E Mutation-Positive Metastatic NSCLC 7.2 Effects of Dabrafenib on Other Drugs. 1.5 Limitations of Use. 8 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION. 8.1 Pregnancy. 2.1 Patient Selection 8.2 Lactation TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA Package leaflet: Information for the patient. Tafinlar 50 mg hard capsule s Tafinlar 75 mg hard capsule s dabrafenib. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. disease recurrence or unacceptable toxicity for up to 1 year. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. 2.4 Recommended Dosage for NSCLC The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrenceor unacceptable toxicity. dabrafenib package insert 1.1 BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

ULN-upper limit of normal; DILI-drug induced liver injury a If no recovery after 30 day interruption, treatment will be discontinued unless the patient is deriving clinical benefit 1. Tafinlar [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; May 2024. Accessed May 2024. 2. Flaherty KT, Infante JR, Daud A, at al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2024 Nov; 367(18):. doi: 10.1056/NEJMoa. Epub 20. 3. This web page provides information on the indications, safety, and dosing of TAFINLAR and MEKINIST, a combination of BRAF and MEK inhibitors for various cancers. It does not

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