Rafinlar Capsule

Dabrafenib is a kinase inhibitor 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. Dabrafenib is indicated, in combination with trametinib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Limitations of Use: Dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for treatment of patients with wild-type BRAF solid tumors. BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma Dabrafenib ® 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. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

New Primary Malignancies, Cutaneous and Non-Cutaneous: Can occur when Dabrafenib is administered as a single agent or with trametinib. Monitor patients for new malignancies prior to, or while on therapy, and following discontinuation of treatment. Tumor Promotion in BRAF Wild-type Tumors: Increased cell proliferation can occur with BRAF inhibitors. Hemorrhage: Major hemorrhagic events can occur in patients receiving Dabrafenib with trametinib. Monitor for signs and symptoms of bleeding. Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment with Dabrafenib and trametinib, after one month of treatment, then every 2 to 3 months thereafter. Uveitis: Perform ophthalmological evaluation for any visual disturbances. Serious Febrile Reactions: Incidence and severity of pyrexia are increased with Dabrafenib and trametinib. Serious Skin Toxicities: Monitor for skin toxicities. Discontinue for intolerable Grade 2 or for Grade 3 or 4 rash not improving within 3 weeks despite interruption of Dabrafenib. Permanently discontinue for severe cutaneous adverse reactions (SCARs). Hyperglycemia: Monitor serum glucose levels in patients with preexisting diabetes or hyperglycemia. Glucose-6-phosphate Dehydrogenase Deficiency (G6PD): Closely monitor for hemolytic anemia. Hemophagocytic Lymphohistiocytosis (HLH): Interrupt treatment for suspected HLH. Discontinue treatment if HLH is confirmed. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use an effective non-hormonal method of contraception. New Primary Malignancies Cutaneous Malignancies Dabrafenib Monotherapy (Adult): In the pooled safety population, cutaneous squamous cell carcinomas (cuSCC), and keratoacanthomas occurred in 11% and 4% of patients, respectively. Basal cell carcinoma and new primary melanoma occurred in 4% and 1% of patients, respectively. Dabrafenib Administered with Trametinib (Adult): In the pooled safety population, the incidence of cuSCC (including keratoacanthomas) occurred in 2% of patients. Basal cell carcinoma and new primary melanoma occurred in 3% and < 1% of patients, respectively. Dabrafenib Administered with Trametinib (Pediatric): In the pooled safety population, new primary melanoma occurred in < 1% of patients. Perform dermatologic evaluations prior to initiation of Dabrafenib, every 2 months while on therapy, and for up to 6 months following discontinuation of Dabrafenib. Non-Cutaneous Malignancies Based on its mechanism of action, Dabrafenib may promote the growth and development of malignancies with activation of RAS through mutation or other mechanisms. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: New Primary Malignancies Tumor Promotion in BRAF Wild-Type Tumors Hemorrhage Cardiomyopathy Uveitis Serious Febrile Reactions Serious Skin Toxicities Hyperglycemia Glucose-6-Phosphate Dehydrogenase Deficiency Hemophagocytic Lymphohistiocytosis There are additional adverse reactions associated with trametinib. Refer to the trametinib prescribing information for additional information. Most common adverse reactions (≥ 20%) for Dabrafenib as a single agent are hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome. Most common adverse reactions (≥ 20%) for Dabrafenib in combination with trametinib include: Unresectable or metastatic melanoma: pyrexia, rash, chills, headache, arthralgia, and cough. Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea. Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema. Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia. Pediatric patients with LGG: pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage, abdominal pain, and dermatitis acneiform.. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Safety Pools The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to Dabrafenib 150 mg orally, twice daily as a single agent in 586 patients with various solid tumors, including BRAF V600 mutation-positive unresectable or metastatic melanoma, enrolled in BREAK-2, BREAK-3, BREAK-MB, BRF113220, and BRF112680. Among these 586 patients who received Dabrafenib as a single agent, 46% were exposed for 6 months or longer and 15% were exposed for greater than one year. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.