Important Safety Information

New Primary Malignancies, Cutaneous and Noncutaneous. Can occur when TAFINLAR is administered as a single agent or with MEKINIST. Perform dermatologic evaluations prior to initiation of therapy...

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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
  • 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. MEKINIST is not indicated for the treatment of patients with melanoma who have progressed on prior BRAF-inhibitor therapy.

IMPORTANT SAFETY INFORMATION for TAFINLAR® (dabrafenib) capsules and MEKINIST® (trametinib) tablets

New Primary Malignancies, Cutaneous and Noncutaneous. Can occur when TAFINLAR is administered as a single agent or with MEKINIST. 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. No dose modifications are required in patients who develop new primary cutaneous malignancies.

Noncutaneous Malignancies: Monitor patients closely for signs or symptoms of noncutaneous malignancies. Permanently discontinue TAFINLAR for RAS-mutation-positive noncutaneous malignancies. No dose modification of MEKINIST is required for patients who develop noncutaneous malignancies.

Tumor Promotion in BRAF Wild-type Melanoma and NSCLC. 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 with 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, can occur in patients receiving MEKINIST. Monitor patients closely for colitis and gastrointestinal perforations.

Venous Thromboembolism. Deep vein thrombosis (DVT) and pulmonary embolism (PE) can occur in patients receiving MEKINIST. Advise patients to seek medical care immediately if they develop symptoms of DVT or PE, such as shortness of breath, chest pain, or arm or leg swelling. Permanently discontinue 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 level.

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 ophthalmic evaluation periodically and at any time 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 ophthalmic evaluation within 3 weeks, resume MEKINIST. 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 more than 6 weeks duration.

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 Drug Reactions. Can occur when MEKINIST is used with TAFINLAR. Serious febrile reactions and 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 and for secondary infections. Withhold TAFINLAR and MEKINIST for intolerable or severe skin toxicity. TAFINLAR and MEKINIST may be resumed at lower doses in patients with improvement or recovery from skin toxicity within 3 weeks. Discontinue for intolerable grade 2, 3, or 4 rash not improving within 3 weeks, despite interruption of TAFINLAR or MEKINIST.

Hyperglycemia. Hyperglycemia requiring an increase in the dose or initiation of insulin or oral hypoglycemic agent therapy can occur when TAFINLAR is administered with MEKINIST. Monitor serum glucose levels in patients with pre-existing diabetes or hyperglycemia.

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. Advise patients to contact their health care provider if they become pregnant, or if pregnancy is suspected, while taking TAFINLAR and MEKINIST.

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

  • Melanoma: pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema, and cough
  • 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.