INLYTA (axitinib) tablet, film coated. NDC Code(s): , ; Packager: Pfizer Laboratories Div Pfizer Inc. Package Photo. This Patient Information has been approved by the U.S. Food and Drug ( axitinib) tablets. What is INLYTA? INLYTA is a prescription medicine used to treat . prescribed for purposes other than those listed in a Patient Information leaflet. Package leaflet: Information for the patient. Inlyta® 1 mg film-coated tablets. Inlyta ® 3 mg film-coated tablets. Inlyta® 5 mg film-coated tablets. Inlyta® 7 mg.
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Proteinuria In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported see section 4. They should be swallowed whole with a glass of water. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The current safety database for axitinib is too small to detect rare and very rare adverse reactions. Last updated on eMC: Axitinib is padkage oral use.
Inlyta 1 mg film-coated tablets
Kaplan-Meier curve of progression-free survival by independent assessment for the overall population. Show table of contents Hide table of contents 1. Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure. Elevation of haemoglobin or haematocrit Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib see section 4.
Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months. Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product.
Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness Grade 1.
Antineoplastic agents, protein kinase inhibitors, ATC code: There are no data regarding the axiinib of axitinib in pregnant women. HDPE bottle with a silica gel desiccant and a polypropylene axitimib containing film-coated tablets. Axitinib should be discontinued if the patient develops nephrotic syndrome. Arterial embolic and thrombotic events In clinical studies with axitinib, arterial embolic and thrombotic events including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion were reported see section 4.
The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known. In the overall patient population and the two main subgroups prior sunitinib treatment and prior cytokine treatmentthere was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS see Table 2 and Figures 1, 2 and 3.
In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8. Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients.
The most commonly reported liver-related adverse sxitinib included increases in alanine aminotransferase ALTaspartate aminotransferase ASTand blood bilirubin see section 4.
The average C max and AUC increased proportionally over an axitinib dosing range of 5 to 10 mg. Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should pakcage be used in this population see sections 4. A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment Child-Pugh class B e.
Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.
Sign Up Log In Cancel. Hepatic impairment In clinical studies with axitinib, the systemic exposure to axitinib was axittinib two-fold higher in subjects with moderate hepatic impairment Child-Pugh class B compared to subjects with normal hepatic function. Name of the medicinal product 2.
Back to top Pfizer Limited contact details. In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1. Effect on QTc interval In a randomised, 2-way crossover study, nisert healthy subjects were administered a single oral dose of axitinib 5 mg in the absence and presence of mg ketoconazole for 7 days.
Genotoxicity Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro. Inlyta 1 mg film-coated tablets.
Frequency categories are xaitinib as: Gastrointestinal packkage and fistula formation see section 4.