Osimertinib INN

Composition: Osinib: Each film coated tablet contains Osimertinib 80 mg as Osimertinib Mesylate INN.

Indications: Osinib 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.

Dosage and Administration: The recommended dose of Osinib is 80 mg tablet once a day until disease progression or unacceptable toxicity. It can be taken with or without food. If a dose is missed, one should not make up the missed dose and take the next dose as scheduled. Or, as directed by the registered physician.

Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women using Osimertinib. If it is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Lactation: There are no data on the presence of Osimertinib in human milk, the effects of Osimertinib on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Osimertinib, a lactating woman should be advised not to breastfeed during treatment with Osinib and for 2 weeks after the final dose.

Packaging: Each box contains 3x10's tablets in Alu- Alu blister pack.

Prescribing Description

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