Trametinib tablets 2 mg/tablet, 30 tablets/box

Medication Safety Tips

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Contraindications

Warnings and Precautions
• New primary malignancies, skin toxicity and non-dermatotoxicity: may occur when LuciTram is used with darafenib. Monitor patients for new malignancies before, during, and after treatment discontinuation.
• Bleeding: Serious bleeding events may occur. Monitor for signs and symptoms of bleeding.
• Colitis and gastrointestinal perforation: Patients treated with LuciTram may develop colitis and gastrointestinal perforation.
• Venous thromboembolic events: Patients treated with LuciTram may develop deep venous thrombosis (DVT) and pulmonary embolism (PE).
• Cardiomyopathy: left ventricular ejection fraction (LVEF) is assessed before treatment, one month after treatment, and every 2 to 3 months thereafter.
• Ocular Toxicity: Perform an ophthalmic assessment of any visual impairment. For retinal vein occlusion (RVO), permanently discontinue LuciTram.
• Interstitial lung disease (ILD)/pneumonia: Suspend LuciTram in case of new or progressive unexplained pulmonary symptoms. For treatment-related ILD or pneumonia, permanently discontinue LuciTram.
• Severe febrile reaction: may occur when LuciTram is used with dalafenib.
• Severe skin toxicity: Monitor for skin toxicity and secondary infections. For unbearable grade 2 or 3 or 4 rashes, permanently discontinue LuciTram even if it does not improve within 3 weeks of discontinuation. For severe skin adverse reactions (scar), permanently discontinue.
• Hyperglycemia: Monitor blood glucose levels in patients with diabetes or hyperglycemia.
• Hemophagocytic lymphohistiocytosis (HLH): discontinuation of treatment for suspected HLH. If confirmed to have HLH, discontinue treatment.
• Embryo-fetal toxicity: May cause harm to the fetus. Women of childbearing potential are advised to be aware of the potential risks to the fetus and to use effective contraception.

Medication risks

Adverse Reactions
The most common adverse effects (≥ 20%) of LuciTram monotherapy include rash, diarrhea, and lymphedema.
The most common adverse effects (≥ 20%) of LuciTram in combination with dalafenib include:
• Unresectable or metastatic melanoma: fever, nausea, rash, chills, diarrhea, vomiting, Blood Pressure, and peripheral edema.
• Adjuvant treatment for melanoma: fever, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, joint pain, and myalgia.
• NSCLC: fever, fatigue, nausea, vomiting, diarrhea, dry skin, loss of appetite, edema, rash, chills, bleeding, cough, and difficulty breathing.
• Adult patients with solid tumors: fever, fatigue, nausea, rash, chills, headache, bleeding, cough, vomiting, constipation, diarrhea, myalgia, joint pain, and edema.
• Children with solid tumors: fever, rash, vomiting, fatigue, dry skin, cough, diarrhea, acne-like dermatitis, headache, abdominal pain, nausea, bleeding, constipation, and gingivitis.
• Children with LGG: fever, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, bleeding, abdominal pain, and acne-like dermatitis.