Meqsel Tablet

Trametinib is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Trametinib is indicated, in combination with dabrafenib, 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 and duration of response. 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: Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma Trametinib ® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, 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 Trametinib is used with dabrafenib. Monitor patients for new malignancies prior to, or while on therapy, and following discontinuation of treatment. Hemorrhage: Major hemorrhagic events can occur. Monitor for signs and symptoms of bleeding. Colitis and Gastrointestinal Perforation: Colitis and gastrointestinal perforation can occur in patients receiving Trametinib. Venous Thromboembolic Events: Deep vein thrombosis (DVT) and pulmonary embolism (PE) can occur in patients receiving Trametinib. Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before treatment, after one month of treatment, then every 2 to 3 months thereafter. Ocular Toxicities: Perform ophthalmological evaluation for any visual disturbances. For Retinal Vein Occlusion (RVO), permanently discontinue Trametinib. Interstitial Lung Disease (ILD)/Pneumonitis: Withhold Trametinib for new or progressive unexplained pulmonary symptoms. Permanently discontinue Trametinib for treatment-related ILD or pneumonitis. Serious Febrile Reactions: Can occur when Trametinib is used with dabrafenib. Serious Skin Toxicities: Monitor for skin toxicities and for secondary infections. Permanently discontinue Trametinib for intolerable Grade 2 or for Grade 3 or 4 rash not improving within 3 weeks despite interruption of Trametinib. Permanently discontinue for severe cutaneous adverse reactions (SCARs). Hyperglycemia: Monitor serum glucose levels in patients with preexisting diabetes or hyperglycemia. 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 effective contraception. New Primary Malignancies Cutaneous Malignancies Trametinib Administered with Dabrafenib (Adult): In the pooled safety population, cutaneous squamous cell carcinomas (cuSCCs) and keratoacanthomas occurred in 2% of patients. Basal cell carcinoma and new primary melanoma occurred in 3% and < 1% of patients, respectively. Trametinib Administered with Dabrafenib (Pediatric): In the pooled safety population, new primary melanoma occurred in < 1% of patients. Perform dermatologic evaluations prior to initiation of Trametinib when used with dabrafenib, every 2 months while on therapy, and for up to 6 months following discontinuation of the combination. Non-Cutaneous Malignancies Based on its mechanism of action, dabrafenib may promote growth and development of malignancies with activation of RAS through mutation or other mechanisms; refer to the prescribing information for dabrafenib. 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 Hemorrhage Colitis and Gastrointestinal Perforation Venous Thromboembolic Events Cardiomyopathy Ocular Toxicities Interstitial Lung Disease/Pneumonitis Serious Febrile Reactions Serious Skin Toxicities Hyperglycemia Hemophagocytic Lymphohistiocytosis There are additional adverse reactions associated with dabrafenib. Refer to the dabrafenib prescribing information for additional information. Most common adverse reactions (≥ 20%) for Trametinib as a single agent include rash, diarrhea, and lymphedema. Most common adverse reactions (≥ 20%) for Trametinib in combination with dabrafenib include: Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema. 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 Trametinib 2 mg orally, once daily as a single agent in 329 patients with various solid tumors enrolled in METRIC, MEK113583, and MEK111054. Among these 329 patients who received Trametinib as a single agent, 33% were exposed for 6 months or longer and 9% 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.