Osicent 80mg (30pcs Pot)

Indications

Osimertinib is indicated for the treatment of patients with metastatic non-small cell lung cancer (EGFR) T790M non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, a disease that has progressed during or after treatment with an EGFR tyrosine kinase inhibitor (TKI).

Pharmacology

Osimitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that can bind to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions). These mutant forms are after first-line EGFR TKI treatment and dominate in non-small cell lung cancer tumors (NSCLC) As a third-generation tyrosine kinase inhibitor, osimertinib is specific for the guardian mutation T790M, which increases ATP and EGFR Glutathione binding activity leads to a poor prognosis of advanced disease. In addition, osimertinib has been shown to prevent wild-type EGFR during treatment, reducing nonspecific binding and limiting toxicity.

Dosage & Administration

The recommended dose of osimertinib is 80 mg once a day until disease progression or unacceptable toxicity. Osimertinib can be taken with or without food. If a dose of osimertinib is missed, do not make up the missed dose and take the next dose as scheduled.

Administration To Patients Who Have Difficulty Swallowing Solids: Disperse the tablet in 60 ml (2 ounces) of non-carbonated water only. Stir until the tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 ml to 240 ml (4 to 8 ounces of) water and immediately drink.

If administration via a nasogastric tube is required, disperse the tablet as above in 15 ml of non-carbonated water, and then use an additional 15 ml of water to transfer any residues to the syringe. The resulting 30 ml liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 ml).

Interaction

Strong CYP3A4 inducer: If concurrent use is unavoidable, increase the osimertinib dose to 160 mg per day when co-administered with strong CYP3A inducers. Resume osimertinib 80 mg 3 weeks after stopping the strong CYP3A4 inducer

Side Effects

Common side effects are interstitial lung disease or pneumonia, prolonged QTc interval, cardiomyopathy, and keratitis.

Pregnancy & Lactation

Use in Pregnancy: There are no or few data on the use of osimertinib in pregnant women. Animal studies have shown reproductive toxicity. Based on its mechanism of action and preclinical data, osimertinib may cause fetal harm when administered to a pregnant woman. Administration of osimertinib to pregnant rats was associated with similar exposures to embryonic death, reduced fetal growth, and neonatal mortality at exposure. Osimertinib is not recommended during pregnancy and in women of childbearing potential not using contraception. 

Use during lactation: It is not known whether osimertinib or its metabolites are excreted in human milk. Administration of rats during gestation and early lactation has been associated with adverse events including decreased growth rate and infant mortality. There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. A risk to the infant cannot be excluded. Breastfeeding should be discontinued during treatment with osimertinib. 

Fertility: There are no data on the effects of osimertinib on human fertility. Results from animal studies have shown that osimertinib affects the male and female reproductive organs and may decrease fertility

Storage Conditions

Store osimertinib at room temperature between 20°C and 25°C. Safely dispose of medicines that have expired or are no longer needed. Keep osimertinib and all medicines out of the reach of children.