Geficent 250 Tablet

Geficent 250 mg Tablet

Generic Name: Gefitinib
Strength: 250 mg
Dosage Form: Tablet
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1 × 10 tablets

Indications

Geficent (Gefitinib) is an EGFR (Epidermal Growth Factor Receptor) tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an approved diagnostic test.

Pharmacology

Gefitinib reversibly inhibits the kinase activity of wild-type and certain activating mutations of EGFR, preventing autophosphorylation of tyrosine residues and blocking EGFR-dependent tumor cell proliferation. Its binding affinity for EGFR exon 19 deletion or exon 21 (L858R) mutations is higher than for the wild-type receptor. It also inhibits IGF and PDGF-mediated signaling at clinically relevant concentrations.

Dosage & Administration

Recommended dose: 250 mg orally once daily with or without food, until disease progression or unacceptable toxicity.

Missed dose: Do not take a missed dose within 12 hours of the next scheduled dose.

Patients with difficulty swallowing: Immerse tablet in 4–8 oz of water for ~15 minutes, stir, and drink immediately. Rinse container with water and drink again. May also be administered through a nasogastric tube.

Dose adjustment with CYP3A4 inducers: Increase to 500 mg/day; resume 250 mg/day 7 days after discontinuing the strong inducer.

Contraindications

Hypersensitivity to Gefitinib or any component of the formulation.

Side Effects

Serious adverse reactions: Interstitial Lung Disease (ILD, 1.3%), hepatotoxicity (elevated ALT 11.4%, AST 7.9%, bilirubin 2.7%), gastrointestinal perforation (0.1%), severe/persistent diarrhea (Grade 3–4 in 3%), ocular disorders including keratitis (0.1%), bullous and exfoliative skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Drug Interactions

• Strong CYP3A4 inducers (rifampicin, phenytoin): Decrease Gefitinib levels — increase dose to 500 mg/day.
• Strong CYP3A4 inhibitors (ketoconazole, itraconazole): Increase Gefitinib exposure — monitor for toxicity.

Precautions & Warnings

• ILD: Withhold immediately for worsening respiratory symptoms (dyspnea, cough, fever). Discontinue permanently if ILD confirmed.
• Hepatotoxicity: Monitor liver function periodically. Withhold for worsening liver function; discontinue in severe hepatic impairment.
• GI perforation: Discontinue permanently.
• Severe diarrhea: Withhold for up to 14 days for Grade 3–4 diarrhea.
• Ocular disorders: Interrupt or discontinue for severe keratitis or worsening ocular disorders.
• Bullous skin disorders: Interrupt or discontinue for severe blistering or exfoliating conditions.

Pregnancy & Lactation

No adequate well-controlled studies in pregnant women. May cause fetal harm; advise women of potential hazard if used during pregnancy. Avoid breastfeeding during treatment due to potential serious adverse reactions in nursing infants.

Use in Special Populations

Pediatric: Safety and efficacy not established. Renal impairment: No specific studies in severe renal impairment. Hepatic impairment: Monitor for adverse reactions in moderate/severe hepatic impairment.

Storage

Store at 20°–25°C in a cool, dry place away from sunlight. Keep out of reach of children.

Pricing

Unit Price: ৳120.00 per tablet (Strip of 10 tablets: ৳1,200.00)

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.