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Osicent 80 mgOsicent 80 mg is 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, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.Theropeutic ClassCytotoxic ChemotherapyPharmacologyOsicent 80 mg is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) that predominate in non-small cell lung cancer (NSCLC) tumours following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, Osicent 80 mg is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in poor prognosis for late-stage disease. Furthermore, Osicent 80 mg has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity.Dosage of Osicent 80 mgThe recommended dose of Osicent 80 mg is 80 mg once a day until disease progression or unacceptable toxicity. Osicent 80 mg can be taken with or without food. If a dose of Osicent 80 mg is missed, do not make up the missed dose and take the next dose as scheduled.Administration of Osicent 80 mgAdministration To Patients Who Have Difficulty Swallowing Solids:?Disperse tablet in 60 ml (2 ounces) of non-carbonated water only. Stir until 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?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 of Osicent 80 mgStrong CYP3A4 Inducers: If concurrent use is unavoidable, increase Osicent 80 mg dosage to 160 mg daily when coadministering with a strong CYP3A inducer. Resume Osicent 80 mg at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducerSide Effects of Osicent 80 mgCommon side effects are?Interstitial Lung Disease or Pneumonitis,?QTc Interval Prolongation, Cardiomyopathy, KeratitisPregnancy & LactationUse in Pregnancy:?There are no or limited amount of data from the use of Osicent 80 mg in pregnant women. Studies in animals have shown reproductive toxicity. Based on its mechanism of action and preclinical data, Osicent 80 mg may cause foetal harm when administered to a pregnant woman. Administration of Osicent 80 mg to pregnant rats was associated with embryolethality, reduced foetal growth and neonatal death at exposures similar to what is expected in humans. Osicent 80 mg is not recommended during pregnancy and in women of childbearing potential not using contraception.Use in Lactation:?It is not known whether Osicent 80 mg or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of Osicent 80 mg or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should discontinue during treatment with Osicent 80 mg.Fertility:?There are no data on the effect of Osicent 80 mg on human fertility. Results from animal studies have shown that Osicent 80 mg has effects on male and female reproductive organs and could impair fertilityStorage ConditionsStore Osicent 80 mg at room temperature between 20?C to 25?C. Safely throw away medicine that is out of date or that you no longer need. Keep Osicent 80 mg and all medicines out of the reach of children.Drug ClassesCytotoxic ChemotherapyMode Of ActionOsicent 80 mg is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) that predominate in non-small cell lung cancer (NSCLC) tumours following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, Osicent 80 mg is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in poor prognosis for late-stage disease. Furthermore, Osicent 80 mg has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity.PregnancyUse in Pregnancy:?There are no or limited amount of data from the use of Osicent 80 mg in pregnant women. Studies in animals have shown reproductive toxicity. Based on its mechanism of action and preclinical data, Osicent 80 mg may cause foetal harm when administered to a pregnant woman. Administration of Osicent 80 mg to pregnant rats was associated with embryolethality, reduced foetal growth and neonatal death at exposures similar to what is expected in humans. Osicent 80 mg is not recommended during pregnancy and in women of childbearing potential not using contraception.Use in Lactation:?It is not known whether Osicent 80 mg or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of Osicent 80 mg or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should discontinue during treatment with Osicent 80 mg.Fertility:?There are no data on the effect of Osicent 80 mg on human fertility. Results from animal studies have shown that Osicent 80 mg has effects on male and female reproductive organs and could impair fertility