Osimatab 40 mg (Tablet)

ProductTitle

Osimertinib 80mg Tablet

Category

Oncology/Metastatic Non-Small Cell Lung Cancer Treatment

Description

Osimertinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. It is also indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Osimertinib is a kinase inhibitor of the EGFR and is available in 80mg tablets. It exhibits anti-tumor activity against NSCLC lines harboring EGFR-mutations (T790M/L858R, L858R, T790M/exon 19 deletion, and exon 19 deletion) and, to a lesser extent, wild-type EGFR amplifications.

Attributes

• Dimensions:
  • 80mg tablet
• Color Options:
  • N/A
• Functions:
  • Kinase inhibitor of the epidermal growth factor receptor (EGFR)
  • Exhibits anti-tumor activity against NSCLC lines harboring EGFR-mutations
  • First-line treatment for metastatic NSCLC
• Material:
  • N/A
• Technical Specifications:
  • Binds irreversibly to certain mutant forms of EGFR
  • Exhibits linear pharmacokinetics
  • Mean half-life of 48 hours
  • Primarily eliminated in feces
• Design Elements:
  • Tablet form
  • Can be taken with or without food
  • Dispersion in water for administration
  • Do not crush or heat during preparation
• Usability Features:
  • Recommended daily dose of 80mg
  • Can be taken with or without food
  • Dispersion in water for administration
  • No need to make up missed doses
  • Administration via nasogastric tube possible
• Indications:
  • First-line treatment for metastatic NSCLC with specific EGFR mutations
  • Treatment for metastatic EGFR T790M mutation-positive NSCLC
• Pharmacology:
  • Binds irreversibly to certain mutant forms of EGFR
  • Exhibits anti-tumor activity against NSCLC lines harboring EGFR-mutations
  • Linear pharmacokinetics
  • Plasma protein binding of 95%
  • Primary metabolism through oxidation and dealkylation
  • Primarily eliminated in feces
• Dosage & Administration:
  • Recommended dose of 80mg tablet once a day
  • Can be taken with or without food
  • Dispersion in water for administration
  • Do not crush, heat, or ultrasonicate during preparation
• Interactions:
  • Avoid concomitant administration with strong CYP3A inhibitors
  • Avoid concomitant administration with strong CYP3A inducers
  • May affect plasma concentrations of sensitive substrate drugs
• Side Effects:
  • Common adverse reactions include diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, decreased appetite
• Pregnancy & Lactation:
  • Can cause fetal harm when administered to a pregnant woman
  • No data on presence in human milk
  • Impairs fertility in females and males
  • Requires effective contraception during treatment and for a period after the final dose
• Precautions & Warnings:
  • Risk of interstitial lung disease (ILD)/pneumonitis
  • Monitor for QTc interval prolongation and cardiomyopathy
  • Embryo-fetal toxicity
  • No significant differences based on age, sex, or specific conditions
• Use in Special Populations:
  • No clinically significant differences based on various factors
  • Safety and effectiveness in pediatric patients not established
  • No recommended dose for severe renal or hepatic impairment
• Therapeutic Class:
  • Cytotoxic Chemotherapy
• Storage Conditions:
  • Store below 30°C
  • Protect from moisture and light
  • Safely throw away expired medicine
  • Keep out of reach of children

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