Gefinix 250 mg (Tablet)

Indications

• First-line treatment for metastatic non-small cell lung cancer (NSCLC)
• Patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations

Pharmacology

• Reversibly inhibits kinase activity of wild-type and certain activating mutations of EGFR
• Prevents autophosphorylation of tyrosine residues
• Blocks EGFR-dependent proliferation
• Higher binding affinity for EGFR mutations than for wild-type EGFR
• Inhibits IGF and PDGF-mediated signaling

Dosage & Administration

• Recommended dose: 250 mg orally once daily with or without food
• Do not take a missed dose within 12 hours of the next dose
• Administration to patients who have difficulty swallowing solids: tablets should be immersed in water and stirred before consumption

Interaction

• CYP3A4 inducer increases metabolism and decreases plasma concentrations
• Strong CYP3A4 inhibitors decrease metabolism and increase plasma concentrations

Contraindications

• Known hypersensitivity to Gefitinib or any other components of the drug

Side Effects

• Interstitial Lung Disease
• Hepatotoxicity
• Gastrointestinal Perforation
• Severe or Persistent Diarrhea
• Ocular Disorders including Keratitis
• Bullous and Exfoliative Skin Disorders

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Potential hazard to fetus or risk for loss of pregnancy
• Not known whether excreted in human milk
• Advised to discontinue breast-feeding during treatment

Precautions & Warnings

• ILD occurrence in patients with worsening respiratory symptoms
• Hepatotoxicity requiring periodic liver function testing
• Gastrointestinal perforation
• Severe or persistent diarrhea
• Ocular disorders including keratitis
• Bullous and exfoliative skin disorders

Use in Special Populations

• Safety and effectiveness not established in pediatric patients
• No clinical studies in patients with severe renal impairment
• Adverse reactions monitoring in patients with moderate and severe hepatic impairment

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

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

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