Osicent 80 mg (Tablet)
Unit Price: ৳ 500.00 (1 x 10: ৳ 5,000.00)
Strip Price: ৳ 5,000.00
Medicine Details
Category | Details |
---|---|
Generic | Osimertinib |
Company | Incepta pharmaceuticals ltd |
Indications
- First-line treatment of metastatic non-small cell lung cancer (NSCLC)
- Treatment of EGFR T790M mutation-positive NSCLC
- Indicated for tumors with EGFR exon 19 deletions or exon 21 L858R mutations
- FDA-approved test requirement for detection
- Disease progression after EGFR tyrosine kinase inhibitor (TKI) therapy
- Metastatic EGFR T790M mutation-positive NSCLC
Pharmacology
- Kinase inhibitor of the epidermal growth factor receptor (EGFR)
- Binds irreversibly to mutant forms of EGFR (T790M, L858R, exon 19 deletion)
- Inhibits activity of HER2, HER3, HER4, ACK1, and BLK
- Exhibits anti-tumor activity against NSCLC lines harboring EGFR-mutations
- Metabolized predominantly by CYP3A
Dosage & Administration
- Recommended dose: 80 mg tablet once a day
- Can be taken with or without food
- Instructions for missed dose handling and dispersal in water
- Administration via nasogastric tube guidelines
Interaction
- Avoid concomitant administration with strong CYP3A inhibitors
- Avoid concomitant administration with strong CYP3A inducers
- Potential effect on drugs sensitive to CYP3A, BCRP, or CYP1A2 substrates
Side Effects
- Common adverse reactions include diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, decreased appetite
Pregnancy & Lactation
- Potential fetal harm when administered to pregnant women
- Advisory for effective contraception during treatment for females and males
Precautions & Warnings
- Risk of Interstitial lung disease (ILD)/pneumonitis
- Potential QTc interval prolongation
- Monitoring of left ventricular ejection fraction (LVEF) required
- Potential Embryo-Fetal Toxicity
- Dosage adjustment and use in special populations (pediatric, geriatric, renal and hepatic impairment)
Use in Special Populations
- No clinically significant differences in pharmacokinetics based on various factors
- No established safety and effectiveness in pediatric patients
- Exploratory analysis suggests a higher incidence of adverse reactions in patients 65 years or older
- No recommended dose for patients with end-stage renal disease or severe hepatic impairment
Therapeutic Class
- Cytotoxic Chemotherapy
Storage Conditions
- Store below 30°C
- Protect from moisture & light
- Safely throw away expired or unneeded medicine
- Keep out of reach of children