Erlocent 150 Tablet

Erlocent 150 mg Tablet

Generic Name: Erlotinib
Strength: 150 mg
Dosage Form: Tablet
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1 × 10 tablets

Indications

Erlocent (Erlotinib) 150 mg is an EGFR (Epidermal Growth Factor Receptor) tyrosine kinase inhibitor indicated for:

• First-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 substitution (L858R) mutations.
• Maintenance treatment of locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
• Second/third-line treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Pharmacology

Erlotinib reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor and thereby inhibiting downstream signaling pathways involved in tumor cell proliferation. Erlotinib's binding affinity for EGFR exon 19 deletion or exon 21 (L858R) mutations is higher than for the wild-type receptor.

Dosage & Administration

The recommended dose for NSCLC is 150 mg orally once daily, taken on an empty stomach (at least 1 hour before or 2 hours after food). Continue until disease progression or unacceptable toxicity.

Dose adjustments:

• Reduce by 50 mg decrements if using strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir, etc.) or CYP3A4 + CYP1A2 inhibitors (e.g., ciprofloxacin).
• Increase by 50 mg increments at 2-week intervals (max 450 mg) if using CYP3A4 inducers (rifampin, phenytoin, carbamazepine, St. John's Wort).
• Concurrent smokers: Increase in 50 mg increments at 2-week intervals (max 300 mg); reduce immediately on smoking cessation.

Contraindications

No absolute contraindications. Use with caution in patients with hepatic impairment (contraindicated in total bilirubin > 3× ULN).

Side Effects

Common (≥20%): rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, vomiting. Serious reactions include: Interstitial Lung Disease (ILD), renal failure, hepatotoxicity, gastrointestinal perforation, bullous/exfoliative skin disorders, myocardial infarction/ischemia, cerebrovascular accident, microangiopathic hemolytic anemia with thrombocytopenia, and ocular disorders.

Drug Interactions

• Warfarin/anticoagulants: May increase INR and bleeding risk — monitor closely.
• CYP3A4 inhibitors: Increase Erlotinib exposure — reduce dose.
• CYP3A4 inducers: Decrease Erlotinib exposure — increase dose as tolerated.
• Gastric pH-modifying drugs (PPIs, H2 blockers): Reduce Erlotinib absorption significantly — avoid or separate doses.

Pregnancy & Lactation

Pregnancy Category D. Can cause fetal harm. Women of childbearing potential should use effective contraception. Avoid breastfeeding during treatment.

Use in Special Populations

Pediatric: Safety and efficacy not established. Geriatric: No overall differences in safety or efficacy observed vs. younger patients.

Storage

Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.

Pricing

Unit Price: ৳450.00 per tablet (Strip of 10 tablets: ৳4,500.00)

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.