Osicent 80: Each tablet contains Osimertinib Mesylate INN equivalent to Osimertinib 80 mg.
QTc Interval Prolongation: Electrocardiograms and electrolytes should be monitored 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. Osimertinib should be withheld then restarted at a reduced dose or permanently discontinued.
Cardiomyopathy: Occurred in 1.4% of patients. Left ventricular ejection fraction (LVEF) should be assessed before treatment and then every 3 months thereafter.
Embryo-Fetal Toxicity: Osimertinib can cause fetal harm. Females should be advised of potential risk to the fetus and to use effective contraception during treatment with Osimertinib and for 6 weeks after final dose. Males should be advised to use effective contraception for 4 months, after the last dose of Osimertinib.
There are no data on the presence of Osimertinib in human milk, the effects of Osimertinib on the breastfed infant or on milk production. Lactating woman should be advised not to breastfeed during treatment.
The safety and effectiveness of Osimertinib in pediatric patients have not been established.
No overall differences in safety were observed between patients 65 years and older and those younger than 65 years.
Concomitant administration of Osimertinib should be avoided with strong CYP3A inhibitors, including macrolide antibiotics (e.g., telithromycin), antifungals (e.g., itraconazole), antivirals (e.g., ritonavir), nefazodone, as concomitant use of strong CYP3A inhibitors may increase Osimertinib plasma concentrations. If no other alternative exists, patients should be monitored more closely for adverse reactions.
Strong CYP3A Inducers
Concomitant administration of Osimertinib should be avoided with strong CYP3A inducers (e.g., phenytoin, rifampicin, carbamazepine, St. John’s Wort) as strong CYP3A inducers may decrease Osimertinib plasma concentrations.
Osicent 80 Container Pack: Each bottles contains 30 tablets.
Osicent 80: Each box contains 1 blister strip of 10 tablets.