Osimatab 80 mg (Tablet)

Unit Price: ৳ 500.00 (3 x 10: ৳ 15,000.00)
Strip Price: ৳ 5,000.00

Medicine Details

Category Details
Generic Osimertinib
Company Eskayef pharmaceuticals ltd
Also available as
Osimatab 40 mg tablet

Product Title and Categories

  • Osimertinib Tablets
  • Anti-cancer Medication
  • EGFR Kinase Inhibitor
  • Prescription Medicine

Dosage Strength

80 mg

Indications

  • First-line treatment for metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
  • Treatment for metastatic EGFR T790M mutation-positive NSCLC after progression on or after EGFR TKI therapy

Pharmacology

  • Target: Epidermal growth factor receptor (EGFR) kinase
  • Binding Affinity: Irreversible binding to mutant forms of EGFR (T790M, L858R, and exon 19 deletion)
  • Anti-tumor Activity: Effective against NSCLC lines with EGFR mutations and wild-type EGFR amplifications
  • Metabolism:
    • Oxidation (predominantly CYP3A)
    • Dealkylation
  • Plasma Protein Binding: 95%
  • Elimination:
    • Primarily in feces (68%)
    • To a lesser extent in urine (14%)
  • Half-life: 48 hours
  • Volume of Distribution: 986 L
  • Inhibition of Activity:
    • HER2
    • HER3
    • HER4
    • ACK1
    • BLK

Dosage & Administration

Take 80 mg tablet once a day with or without food until disease progression or unacceptable toxicity. Disperse the tablet in 60 ml of non-carbonated water only and swallow immediately. Do not crush, heat, or ultrasonicate during preparation.

Interaction

  • Avoid with Strong CYP3A Inhibitors:
    • Macrolide antibiotics (e.g., Telithromycin)
    • Antifungals (e.g., Itraconazole)
    • Antivirals (e.g., Ritonavir)
    • Nefazodone
  • Avoid with Strong CYP3A Inducers:
    • Phenytoin
    • Rifampicin
    • Carbamazepine
    • St. John's Wort
  • Effects on other drugs:
    • Sensitivity to CYP3A, BCRP, or CYP1A2 substrates
    • Narrow therapeutic index drugs

Side Effects

  • Diarrhea
  • Rash
  • Dry skin
  • Nail toxicity
  • Stomatitis
  • Fatigue
  • Decreased appetite

Pregnancy & Lactation

  • Fetal Harm: Can cause fetal harm when administered to pregnant women
  • Contraception:
    • Females: Use effective contraception during treatment and for 6 weeks after the final dose
    • Males: Use effective contraception during and for 4 months following the final dose
  • Infertility: May impair fertility in females and males of reproductive potential

Precautions & Warnings

  • Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.9% of the treated patients; 0.4% of cases were fatal
  • QTc Interval Prolongation: Monitor patients with history or predisposition for QTc prolongation
  • Cardiomyopathy: Assess LVEF before treatment and every 3 months thereafter
  • Embryo-Fetal Toxicity: Can cause fetal harm, advise effective contraception for females and males

Use in Special Populations

  • Age, Sex, Ethnicity, and Body Weight: No clinically significant differences in pharmacokinetics
  • Renal Impairment: No dose adjustment recommended for mild, moderate, or severe impairment
  • Hepatic Impairment: No recommended dose for severe impairment
  • Pediatric Use: Safety and effectiveness not established
  • Geriatric Use: No overall differences in effectiveness based on age

Therapeutic Class

Cytotoxic Chemotherapy

Storage Conditions

Store below 30°C, protect from moisture & light. Safely dispose of expired or unneeded medicine. Keep out of reach of children.

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