OSIMERT 80 MG (OSIMERTINIB)

OSIMERT 80 MG (OSIMERTINIB)

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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

CONTRAINDICATIONS
Hypersensitivity to Osimertinib or to any of the additives.

WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD}/ Pneumonitis
Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.3% of patients. Permanently discontinue Osimertinib (Osimert) in patients diagnosed with ILD/Pneumonitis.

QTc Interval Prolongation
Monitor electrocardiograms and electrolytes in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Withhold then restart at a reduced dose or permanently discontinue Osimertinib (Osimert).

every 3 months thereafter. Keratitis
Advise patients to contact their healthcare provider immediately
if they develop eye symptoms (eye inflammation, lacrimation, light sensitivity, eye pain, red eye or changes in vision)

Embryo-Fetal Toxicity
Osimertinib (Osimert) can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with Osimertinib (Osimert) and for 6 weeks after final dose. Advise males to use effective contraception for 4 months, after the last dose of Osimertinib (Osimert).

ADVERSE REACTIONS
Most common adverse reactions (? 25%) were diarrhea, rash, dry skin and nail toxicity.

DRUG INTERACTIONS
Effect of Other Drugs on Osimertinib
Strong CYP3A Inhibitors
Avoid concomitant administration of Osimertinib (Osimert) with strong CYP3A inhibitors, including macrolide antibiotics (e.g., Telithromycin), antifungals (e.g., ltraconazole), antivirals (e.g., Ritonavir), Nefazodone, as concomitant use of strong CYP3A inhibitors may increase Osimertinib (Osimert) plasma concen- trations. If no other alternative exists, monitor patients more closely for adverse reactions of Osimertinib (Osimert).

Strong CYP3A Inducers
Avoid concomitant administration of Osimertinib (Osimert) with strong CYP3A inducers (e.g., Phenytoin, Rifampicin, Carbamaz- epine, St. John’s Wort) as strong CYP3A inducers may decrease Osimertinib (Osimert) plasma concentrations.

EWect of Osimertinib on Other Drugs
Avoid concomitant administration of Osimertinib (Osimert) with drugs that are sensitive substrates of CYP3A, breast cancer resistance protein (BCRP), or CYP1A2 with narrow therapeutic indices, including but not limited to Fentanyl, Cyclosporine, Quinidine, Ergot Alkaloids, Phenytoin, Carbamazepine, as Osimertinib (Osimert) may increase or decrease plasma concentrations of these drugs.

USE IN SPECIFIC POPULATIONS
Pregnancy
Osimertinib (Osimert) can cause fetal harm when administered to a pregnant woman. There is no available data on Osimertinib (Osimert) use in pregnant women.

Lactation
There is no data on the presence of Osimertinib (Osimert) in human milk, the effects of Osimertinib (Osimert) on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Osimerti- nib (Osimert), advise a lactating woman not to breastfeed during treatment with Osimertinib (Osimert) and for 2 weeks after the final dose.

Females and Males of Reproductive Potential
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with Osimertinib (Osimert) and for 6 weeks after the final dose.

Males
Advise male patients with female partners of reproductive potential to use effective contraception during and for 4 months following the final dose of Osimertinib (Osimert).

Infertility
Based on animal studies, Osimertinib (Osimert) may impair fertility in temales and males of reproductive potential. It is not known if the effects on fertility are reversible.

Pediatric Use
The safety and effectiveness of Osimertinib (Osimert) in pediatric patients have not been established.

Geriatric Use
No overall differences in effectiveness were observed based on age. Exploratory analysis suggest a higher incidence of Grade 3
Osimert
Osimertinib 80 mg

Renal Impairment
No dedicated clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of Osimertinib. Based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild [creatinine clearance (CLcr) 60-89 mL/min] or moderate (CLcr 30-59 mL/min) renal impairment. There is no recommended dose of Osimertinib (Osimert) for patients with severe renal impairment (CLcr<30 mL/min) or end-stage-renal disease. Hepatic Impairment No dedicated clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of Osimertinib. Based on population pharmacokinetic (PK) analysis, no dose adjustment is recommended in patients with mild hepatic impairment [total bilirubin

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