DESCRIPTION
Osimert 80 mg
Osimertinib
COMPOSITION
Osimert Tablet: Each film coated tablet contains Osimertinib mesylate INN 95.4 mg equivalent to Osimertinib 80 mg.
INDICATIONS AND USAGE
Osimertinib (Osimert) is a kinase inhibitor indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy.
DOSAGE AND ADMINISTRATION
Recommended Dosage Regimen
The recommended dose of Osimertinib (Osimert) is 80 mg tablet once a day until disease progression or unacceptable toxicity. Osimertinib (Osimert) can be taken with or without food. If a dose of Osimertinib (Osimert) is missed, do not make up the missed dose and take the next dose as scheduled.
Administration to Patients Who Have Difficulty in Swallowing Solids Disperse tablet in 4 tablespoons (approximately 50 mL) of non- carbonated water only. Stir until tablet is completely dispersed and swallow or administer through naso-gastric tube immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.
Dose Modification for Adverse Reactions
Table: Recommended Dose Modifications for Osimertinib
(Osimert).
Target Organ Adverse Reaction Dose Modification
Pulmonary Interstitial lung disease (ILD)/Pneumonitis Permanently discontinue Osimertinib (Osimert).
QTc interval greater than 500 msec on at least 2 separate ECGs Withhold Osimertinib (Osimert) until QTc interval is less than 481 msec or recovery to baseline. If baseline QTc is greater than or equal to 481 msec, then resmea40mgdose.
QTc interval prolongation with signs/ symptoms of life-threatening arrhythmia Permanently discontinue Osimertinib (Osimert).
Asymptomatic, absolute decrease in LVEF of 10% frOM baseline and beIOW
50% Withhold Osimertinib (Osimert) for up to 4 weeks.
⦁ If improved to baseline
LVEF, resume.
⦁ If not improved to baseline, permanently discontinue.
Symptomatic congestive heart failure Permanently discontinue Osimertinib (Osimert).
Other Adverse reaction of Grade 3 or greater severity w thhold Osimertinib (Osimert) for up to 3 weeks.
If improvement to Grade 0-2 within 3 weeks Resume at 80 mg or 40 mg daily.
If no improvement within 3 weeks Permanently discontinue Osimertinib (Osimert).
ECGs = Electrocardiograms
LVEF = Left Ventricular Ejection Fraction QTc = QT interval corrected for heart rate
Manufactured By
Everest Pharmaceuticals Ltd.
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