Zuellig Pharma
Concise Prescribing Info
As monotherapy or in combination w/ dabrafenib for unresectable or metastatic melanoma w/ a BRAF V600 mutation. In combination w/ tafinlar for adjuvant treatment of stage III melanoma w/ BRAF V600E or V600K mutation & involvement of lymph node(s). In combination w/ dabrafenib for advanced non-small cell lung cancer (NSCLC) w/ a BRAF V600 mutation.
Dosage/Direction for Use
Monotherapy or in combination w/ dabrafenib 2 mg once daily. Dose adjustment: 1st dose reduction: 1.5 mg once daily. 2nd dose reduction: 1 mg once daily.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.
Hypersensitivity. Childn <18 yr. Elderly >65 yr.
Special Precautions
Evaluate LVEF in all patients prior to initiation of treatment w/ periodic follow-up w/in 8 wk of initiating therapy, then continue during treatment; patients w/ conditions that may impair LVEF. Haemorrhage may occur. Disorders associated w/ visual disturbances, including chorioretinopathy or retinal pigment epithelial detachment & retinal vein occlusion (RVO). Not recommended in patients w/ history of retinal vein occlusion. Perform a thorough ophth evaluation at baseline & during treatment. Permanently discontinue if RVO occurs. Rash. DVT/pulmonary embolism. Increased incidence & severity of pyrexia. Monitor serum creatinine & other evidence of renal function during & following severe events of pyrexia. Patients w/ risk factors for GIT perforation, including history of diverticulitis & GIT metastases, & concomitant use w/ drugs w/ recognised risk of GI perforation. Severe renal, & moderate or severe hepatic impairment. Pregnancy & lactation.
Adverse Reactions
HTN, haemorrhage; cough, dyspnea; diarrhoea, nausea, vomiting, constipation, abdominal pain, dry mouth; rash, dermatitis acneiform, dry skin, pruritus, alopecia; fatigue, peripheral oedema, pyrexia; UTI, nasopharyngitis; neutropenia; decreased appetite; headache, dizziness; arthralgia, myalgia, pain in extremity; chills, asthenia; increased alanine aminotransferase & aspartate aminotransferase; erythema, hyperkeratosis; muscle spasm; increased blood alkaline phosphatase.
ATC Classification
L01EE01 - trametinib ; Belongs to the class of mitogen-activated protein kinase (MEK) inhibitors. Used in the treatment of cancer.
Mekinist FC tab 0.5 mg
Mekinist FC tab 2 mg
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