Ositag 80 mg (Tablet)

Unit Price: ৳ 550.00 (3 x 10: ৳ 16,500.00)
Strip Price: ৳ 5,500.00

Medicine Details

Category Details
Generic Osimertinib
Company Beacon pharmaceuticals plc

Title

  • Osigat
  • Osimertinib Tablets

Categories

  • Cancer Treatment
  • Medication
  • Pharmacology
  • Medical Drug

Description

  • First-line treatment of metastatic non-small cell lung cancer (NSCLC)
  • Pharmacological profile of Osimertinib
  • Recommended dosage and administration
  • Potential drug interactions
  • Common side effects
  • Use in pregnancy and lactation
  • Precautions and warnings
  • Special population considerations
  • Therapeutic class of Osimertinib
  • Storage conditions

Dosage Form

Tablet

Dosage

80 mg tablet once a day

Indications

  • Metastatic non-small cell lung cancer with EGFR mutations
  • Treatment post progression on EGFR tyrosine kinase inhibitor therapy

Pharmacology

  • Kinase inhibitor of the epidermal growth factor receptor (EGFR)
  • Irreversible binding to mutant forms of EGFR
  • Exhibits anti-tumor activity against NSCLC lines with EGFR mutations
  • Exhibits linear pharmacokinetics
  • Mainly eliminated in feces

Mode of Action

  • Binds irreversibly to mutant forms of EGFR
  • Exhibits anti-tumor activity against NSCLC lines with EGFR mutations

Absorption

Median time to Cmax of Osimertinib is 6 hours

Distribution

Mean volume of distribution at steady state (Vss/F) is 986 L

Elimination

  • Population estimated mean half-life of Osimertinib is 48 hours
  • Oral clearance (CL/F) is 14.2 (L/h)

Metabolism

Mainly metabolized by oxidation and dealkylation

Excretion

  • Primarily eliminated in the feces (68%)
  • To a lesser extent in the urine (14%)

Interaction

  • Avoid concomitant administration with strong CYP3A inhibitors
  • Effect on other drugs

Side Effects

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

Pregnancy & Lactation

  • Can cause fetal harm
  • No data on presence in human milk or effects on breastfed infant

Contraception

  • Females to use effective contraception during treatment and for 6 weeks after final dose
  • Males to 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
  • QTc Interval Prolongation
  • Cardiomyopathy
  • Embryo-Fetal Toxicity

Use in Special Populations

  • No clinically significant differences based on age, sex, ethnicity, body weight, renal impairment
  • Safety and effectiveness not established in pediatric patients
  • No dose adjustments in renal impairment
  • No recommended dose for patients with severe hepatic impairment

Therapeutic Class

Cytotoxic Chemotherapy

Storage Conditions

Store below 30°C, protect from moisture & light, and keep out of reach of children

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