Conmana Icotinib Hydrochloride Tablets

1. Indications and Usage
Non-Small Cell Lung Cancer (NSCLC):
Indicated as a monotherapy for the treatment of locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy regimen.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY.
Recommended Dosage:
Dose: 125 mg (one tablet) administered orally three times daily.
Duration: Continue until disease progression or unacceptable toxicity.
Administration Instructions:
Swallow tablets whole with water.
Can be taken on an empty stomach or with food.
Warning: High-calorie meals may significantly increase drug absorption and should be avoided to prevent potential toxicity.
Missed Dose:
If a dose is missed, do not take it. Resume at the regularly scheduled time for the next dose.
3. Mechanism of Action
EGFR-TKI:
Icotinib is a highly selective EGFR tyrosine kinase inhibitor.
Signal Pathway Blockade:
It competitively binds to the ATP-binding site of the EGFR intracellular tyrosine kinase domain, inhibiting phosphorylation and activation of EGFR. This blocks downstream signaling pathways (PI3K/Akt, MAPK), leading to the inhibition of tumor cell proliferation and induction of apoptosis.
4. Safety and Warnings
Interstitial Lung Disease (ILD):
Monitor for signs of ILD (acute onset, progressive dyspnea, cough). If ILD is confirmed, discontinue treatment immediately.
Hepatic Impairment:
Transient elevations in ALT/AST have been observed. Monitor liver function regularly. Contraindicated in patients with severe hepatic impairment.
Embryo-Fetal Toxicity:
May cause fetal harm. Pregnant and breastfeeding women are contraindicated.
5. Adverse Reactions
Most Common:
Rash, diarrhea, and increased aminotransferases (ALT/AST). Most are Grade 1-2, reversible, and typically occur within the first 1-3 weeks.
6. Drug Interactions
CYP450 Modulators:
Icotinib is primarily metabolized by CYP2C19 and CYP3A4. Avoid concomitant use with strong CYP3A4 inducers (e.g., rifampicin, phenytoin) or inhibitors.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Icotinib Hydrochloride (125 mg per tablet).
Storage:
Protect from light and moisture. Store in a sealed container.