Alecnib 150 mg (Capsule)

Indications

• Treatment of ALK-positive NSCLC patients

Pharmacology

• Highly selective ALK and RET tyrosine kinase inhibitor
• Inhibits tumor cell death
• In vitro and in vivo activity against mutant forms of ALK enzyme
• Not a substrate of p-glycoprotein or BCRP

Dosage

• Recommended dose of 600 mg given orally twice daily
• 450 mg dose for patients with severe hepatic impairment
• Should be taken with food and swallowed whole

Administration

• Recommended until disease progression or unmanageable toxicity
• Dose modifications may be required based on tolerability

Interaction

• Weak inhibition and induction potential of various CYP enzymes
• No influence on exposure of sensitive CYP3A substrate

Contraindications

• Known hypersensitivity to alectinib or any excipients

Side Effects

• Common adverse reactions include constipation, edema, myalgia, nausea, increased bilirubin, anemia, and rash

Pregnancy & Lactation

• Advised to avoid pregnancy and breastfeeding
• Use of highly effective contraception during treatment and for at least 3 months following the last dose

Precautions & Warnings

• Monitoring for pulmonary symptoms indicative of pneumonitis
• Immediate interruption in case of ILD/pneumonitis diagnosis
• Monitoring and potential discontinuation in cases of hepatotoxicity

Use in Special Populations

• Safety and efficacy not studied in children and adolescents
• No dose adjustment in geriatric, mild/moderate renal impairment
• Dose adjustment for severe hepatic impairment

Therapeutic Class

• Protein kinase inhibitor within anti neoplastic preparations

Storage Conditions

• Keep below 30°C, away from light and moisture
• Keep out of the reach of children

Related Brands

• Alecensa 150 mg (Capsule) - roche-bangladesh-ltd