Gefitinib: Brands, Price & Uses in Bangladesh

Gefitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for:

• First-line treatment (FDA-approved, established use): Metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved or validated test. Mutation testing is required before starting Gefitinib, as efficacy depends on mutation status.
• Guideline-supported use: Continued therapy in patients who have already responded to or are being treated with Gefitinib for EGFR mutation-positive NSCLC, per oncology treatment guidelines (e.g., NCCN).

Gefitinib is not indicated for NSCLC without confirmed EGFR exon 19 deletion or exon 21 L858R mutations, as efficacy has not been demonstrated in this setting.

Adult Dose (NSCLC, EGFR mutation-positive)

Missed Dose

If a dose is missed by more than 12 hours, the missed dose should be skipped and the next dose taken at the regular scheduled time; doses should not be doubled.

Renal Impairment

No dosage adjustment is required for mild-to-severe renal impairment, as less than 4% of Gefitinib is eliminated renally.

Hepatic Impairment

Patients with mild-to-moderate hepatic impairment due to metastases should be monitored closely, as exposure to Gefitinib may be increased. Gefitinib should be permanently discontinued in patients who develop severe hepatic impairment during treatment (see Precautions and Warnings).

Administration

Tablets should be swallowed whole with water. For patients unable to swallow tablets, a tablet may be dispersed in approximately 50 mL of non-carbonated drinking water (without crushing), stirred until dispersed (may take up to 20 minutes), and the resulting dispersion swallowed immediately; the glass should be rinsed with additional water and that also swallowed. A nasogastric or gastrostomy tube may be used similarly under medical guidance.

The most common adverse reactions (occurring in more than 20% of patients) with Gefitinib are skin reactions (such as rash, acne, dry skin) and diarrhea.

• Very common: diarrhea, rash, dry skin, nausea, vomiting, elevated liver enzymes (ALT/AST), stomatitis, decreased appetite.
• Common: pruritus, alopecia, conjunctivitis, blepharitis, paronychia, asthenia, fever, peripheral edema, dehydration, epistaxis, hematuria, proteinuria.
• Serious (see Precautions and Warnings for detail): interstitial lung disease, hepatotoxicity/hepatic failure, gastrointestinal perforation, severe or persistent diarrhea, bullous and exfoliative skin conditions, keratitis and corneal erosion, and rare cases of Stevens-Johnson syndrome/toxic epidermal necrolysis.