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

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