Gefitinib INN

Composition: Getinib: Each film coated tablet contains Gefitinib INN 250 mg.

Indications: Getinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Dosage and Administration: The recommended dose of Getinib is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. One should not take a missed dose within 12 hours of the next dose. Administration to Patients who have Difficulty Swallowing Solids: Getinib tablets should be immersed in 4 to 8 ounces of water by dropping the tablet in water, and stirred for approximately 15 minutes. The liquid should be immediately drunk or administered through a naso-gastric tube. The container should be rinsed with 4 to 8 ounces of water and immediately drunk or administered through the naso- gastric tube. Or, as directed by the registered physician.

Use in pregnancy and lactation: There are no adequate and well controlled studies in pregnant women using Gefitinib. 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: It is not known whether Getinib is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Getinib, women should be advised to discontinue breast-feeding during treatment with Getinib.

Packing: Getinib:Each box contains 4x7's tablets in Alu- Alu blister pack.

Prescribing Description

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