Gefikin 250 mg (Tablet)

Indications

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

Pharmacology

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

Dosage & Administration

• Recommended dose: 250 mg orally once daily
• Can be taken with or without food
• Do not take a missed dose within 12 hours of the next dose
• For patients with difficulty swallowing solids: tablets can be immersed in water and administered

Interaction

• CYP3A4 inducers increase metabolism and decrease plasma concentrations
• 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 the fetus or risk for loss of the pregnancy
• Unknown excretion in human milk
• Discontinue breastfeeding during treatment

Precautions & Warnings

• ILD-like adverse drug reactions occurred in 1.3% of patients
• Prompt investigation for ILD in case of worsened respiratory symptoms
• Periodic liver function testing required
• Discontinue in case of severe hepatic impairment or gastrointestinal perforation
• Withhold for severe or persistent diarrhea or ocular disorders

Use in Special Populations

• Safety and effectiveness in pediatric patients not established
• Monitor adverse reactions in patients with renal or 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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