Cerinib 150 mg (Capsule)

Indications

• Treatment of metastatic non-small cell lung cancer (NSCLC)

Pharmacology

• Kinase inhibitor targeting ALK, IGF-1R, InsR, and ROS1
• Peak plasma levels achieved at 4 to 6 hours after administration
• 97% bound to human plasma proteins
• Geometric mean apparent plasma terminal half life (t½) is 41 hours
• CYP3A is the major enzyme involved in its metabolism
• 92.3% of the administered dose recovered in the feces

Dosage & Administration

• Recommended dose of 450 mg orally once daily with food
• Dose makeup if missed within 12 hours
• Avoid additional dose if vomiting occurs

Interaction

• Avoid concomitant use with strong CYP3A inhibitors
• Avoid concurrent use with strong CYP3A inducers
• Avoid coadministration with sensitive CYP3A substrates
• Caution with CYP2C9 substrates
• Avoid grapefruit and grapefruit juice consumption

Contraindications

• Known hypersensitivity to Ceritinib or any components of the product

Side Effects

• Gastrointestinal adverse reactions
• Hepatotoxicity
• Interstitial Lung Disease/Pneumonitis
• QT Interval Prolongation
• Hyperglycemia
• Bradycardia
• Pancreatitis

Pregnancy & Lactation

• Potential fetal harm during pregnancy
• Advised not to breastfeed during treatment

Precautions & Warnings

• Monitoring and management of gastrointestinal adverse reactions
• Monitoring with liver laboratory tests for hepatotoxicity
• Monitoring for pulmonary symptoms indicative of ILD/pneumonitis
• Periodic monitoring with electrocardiograms for QT interval prolongation
• Monitoring of fasting serum glucose for hyperglycemia
• Regular monitoring of heart rate and blood pressure for bradycardia
• Monitoring of amylase and lipase levels for pancreatitis
• Advised effective contraception during treatment for females
• Condom use advised for males with female partners of reproductive potential
• Safety and effectiveness in pediatric patients not established
• No overall differences in safety or effectiveness observed in geriatric patients
• Dose reduction recommended for patients with severe hepatic impairment

Use in Special Populations

• Potential fetal harm in pregnant women
• Advised effective contraception during treatment for females
• Condom use advised for males with female partners of reproductive potential
• Safety and effectiveness not established in pediatric patients
• No overall differences in safety or effectiveness observed in geriatric patients
• Dose adjustment recommended for patients with severe hepatic impairment

Storage Conditions

• Store below 30°C in a cool and dry place

Related Brands