Important Safety Information

New Primary Malignancies, Cutaneous and Noncutaneous. Perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following...

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INDICATIONS

TAFINLAR® (dabrafenib) capsules, in combination with MEKINIST® (trametinib) tablets, is indicated:

  • for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test
  • for 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
  • for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test

Limitations of Use: TAFINLAR is not indicated for the treatment of patients with wild-type BRAF melanoma or wild-type BRAF NSCLC.

IMPORTANT SAFETY INFORMATION

New Primary Malignancies, Cutaneous and Noncutaneous. Perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following discontinuation of the combination.

Monitor patients closely for signs or symptoms of noncutaneous malignancies. Permanently discontinue TAFINLAR for monomeric G protein (RAS)-mutation–positive noncutaneous malignancies.

Tumor Promotion in BRAF Wild-type Tumors. Increased cell proliferation can occur with BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation status prior to initiation of therapy.

Hemorrhage. Major hemorrhagic events, sometimes fatal, can occur in patients receiving TAFINLAR and MEKINIST. Monitor for signs and symptoms of bleeding. Permanently discontinue TAFINLAR and MEKINIST for all grade 4 hemorrhagic events and for any persistent grade 3 hemorrhagic events. Withhold therapy for grade 3 hemorrhagic events; if improved, resume at the next lower dose level.

Colitis and Gastrointestinal Perforation. Colitis and gastrointestinal perforation, including fatal outcomes, have been reported in patients receiving MEKINIST. Monitor patients closely for colitis and gastrointestinal perforations.

Venous Thromboembolism. Advise patients to seek medical care immediately if they develop symptoms of deep venous thrombosis (DVT) or pulmonary embolism (PE), such as shortness of breath, chest pain, or arm or leg swelling. Permanently discontinue TAFINLAR and MEKINIST for life-threatening PE. Withhold MEKINIST for uncomplicated DVT and PE for up to 3 weeks; if improved, MEKINIST may be resumed at a lower dose.

Cardiomyopathy. Cardiomyopathy, including cardiac failure, can occur. Assess left ventricular ejection fraction before treatment with TAFINLAR and MEKINIST, after 1 month of treatment, then every 2 to 3 months thereafter.

Ocular Toxicities.
Retinal vein occlusion (RVO) may lead to macular edema, decreased visual function, neovascularization, and glaucoma. Urgently (within 24 hours) perform ophthalmologic evaluation for a patient-reported loss of vision or other visual disturbances. Permanently discontinue MEKINIST in patients with documented RVO.

Retinal pigment epithelial detachment (RPED) can occur with MEKINIST administration. Withhold MEKINIST if RPED is diagnosed. If resolution of the RPED is documented on repeat ophthalmologic evaluation within 3 weeks, resume MEKINIST at same or reduced dose. Reduce the dose or discontinue MEKINIST if no improvement after 3 weeks.

Uveitis (including iritis and iridocyclitis) can occur with TAFINLAR. Perform ophthalmologic evaluation for any visual disturbances. Monitor patients for visual signs and symptoms of uveitis (eg, change in vision, photophobia, and eye pain). Permanently discontinue TAFINLAR for persistent grade 2 or greater uveitis of >6 weeks.

Interstitial Lung Disease (ILD). Withhold MEKINIST in patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations. Permanently discontinue MEKINIST for patients diagnosed with treatment-related ILD or pneumonitis.

Serious Febrile Reactions. Serious febrile reactions or fever of any severity complicated by hypotension, rigors or chills, dehydration, or renal failure can occur with TAFINLAR and MEKINIST. The incidence and severity of pyrexia increase when TAFINLAR is administered with MEKINIST.

Serious Skin Toxicity. Monitor for skin toxicities or for secondary infections. Withhold TAFINLAR and MEKINIST for intolerable or severe skin toxicity. Resume TAFINLAR and MEKINIST at lower doses in patients with improvement or recovery from skin toxicity within 3 weeks. Permanently discontinue TAFINLAR and MEKINIST if skin toxicity has not improved within 3 weeks.

Hyperglycemia. Monitor serum glucose levels upon initiation, and as clinically appropriate in patients with preexisting diabetes or hyperglycemia. Initiate or optimize antihyperglycemic medications as clinically indicated.

Glucose-6-Phosphate Dehydrogenase Deficiency. Closely monitor for hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency.

Embryo-fetal Toxicity. TAFINLAR and MEKINIST can cause fetal harm.

Most Common Adverse Reactions. Most common adverse reactions (≥20%) for TAFINLAR with MEKINIST include:

  • Metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema, and cough
  • Adjuvant 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

Please see full Prescribing Information for TAFINLAR and full Prescribing Information for MEKINIST.