Logo

Indications - Gefitinib is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of Gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

Dosage & Administration - The recommended dose of Gefitinib is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. Do not take a missed dose within 12 hours of the next dose.

Side Effects - Common side effects are pruritus, rash, angioedema, urticaria, epistaxis, haematuria, alopecia, dry mouth and skin, nausea, vomiting, anorexia, stomatitis, diarrhoea, nail disorders, asthenia, pyrexia, proteinuria, eye pain, corneal erosion or ulcer, aberrant eyelash growth and elevations in blood creatinine. Rarely, pancreatitis, erythema multiforme, toxic epidermal necrolysis, corneal membrane sloughing, ocular ischemia, or ocular haemorrhage.

Contraindications - Hypersensitivity. Lactation.

Others - Pregnancy & Lactation Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).