Erlocent 100 Tablet

Erlocent 100 mg Tablet

Generic Name: Erlotinib
Strength: 100 mg
Dosage Form: Tablet
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1 × 10 tablets

Indications

Erlocent (Erlotinib) 100 mg is an EGFR tyrosine kinase inhibitor indicated for:

• Pancreatic Cancer: First-line treatment of locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
• NSCLC: Also indicated (at 150 mg dose) for metastatic Non-Small Cell Lung Cancer with EGFR exon 19 deletions or exon 21 substitution mutations, maintenance treatment after platinum-based chemotherapy, and after failure of prior chemotherapy.

Pharmacology

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

Dosage & Administration

Pancreatic Cancer: 100 mg orally once daily in combination with gemcitabine. Take 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 with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir, etc.) or dual CYP3A4/CYP1A2 inhibitors (e.g., ciprofloxacin).
• Increase by 50 mg increments at 2-week intervals with strong 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 upon smoking cessation.

Contraindications

Use with caution in patients with hepatic impairment. Contraindicated when total bilirubin >3× ULN.

Side Effects

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

Drug Interactions

• Warfarin/anticoagulants: Increased INR and bleeding risk — monitor INR regularly.
• CYP3A4 inhibitors: Increase Erlotinib exposure — reduce dose.
• CYP3A4 inducers: Decrease Erlotinib exposure — increase dose as tolerated.
• Gastric pH-modifying drugs (PPIs, H2 blockers): Significantly reduce Erlotinib absorption — 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: ৳300.00 per tablet (Strip of 10 tablets: ৳3,000.00)

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.