Gefinix 250

• Metastatic non-small cell lung cancer (NSCLC): with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations

Gefitinib reversibly inhibits the kinase activity of wild-type and certain activating mutations of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor, thereby inhibiting further downstream signalling and blocking EGFR-dependent proliferation. Gefitinib binding affinity for EGFR exon 19 deletion or exon 21 point mutation L858R mutations is higher than its affinity for the wild-type EGFR.

Adult Dose:

• 250 mg once daily with or without food
• Continue until disease progression or unacceptable toxicity
• Do not take a missed dose within 12 hours of the next dose

Difficulty Swallowing Solids:

• Immerse tablet in 4-8 ounces of water
• Stir for approximately 15 minutes
• Drink liquid immediately or administer through naso-gastric tube

* Use as directed by the registered physician

Common Side Effects:

• Diarrhea
• Dry skin
• Loss of appetite
• Nausea
• Rash
• Stomatitis
• Vomiting
• Weakness

Serious Side Effects: Interstitial Lung Disease, Hepatotoxicity, Gastrointestinal Perforation, Severe Diarrhea, Keratitis, Bullous and Exfoliative Skin Disorders.

Use in Pregnancy: Unsafe during pregnancy. There is definite evidence of risk to the developing baby.

Precautions:

• Interstitial Lung Disease (ILD): Withhold and investigate if respiratory symptoms worsen.
• Hepatotoxicity: Regular liver function testing. Discontinue in severe hepatic impairment.
• Gastrointestinal Perforation: Permanently discontinue if occurs.
• Severe Diarrhea: Withhold for severe or persistent diarrhea.
• Avoid during pregnancy and lactation.

Overdose: Overdose may cause myelosuppression, paresthesias and severe rash. Appropriate blood counts and supportive therapy.

Storage: Store between 20-25°C in a cool and dry place, away from sunlight. Keep out of reach of children.