AXITINIB PACKAGE INSERT PDF

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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In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver. Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended. Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below inserg expected human exposure. Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5.

Musculoskeletal and connective tissue disorders. The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney see section 4.

A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment Child-Pugh class B e.

Inlyta 1 mg film-coated tablets

Enter medicine name or company Start typing packate retrieve search suggestions. Fatal venous embolic and thrombotic events were reported 0. Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro. Reduced fertility and embryonic viability were observed in female mice at all doses tested, with exposure levels at the lowest dose approximately fold the expected human exposure.

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Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)

Hypertension In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported see section 4. In cases of suspected overdose, axitinib should be withheld and supportive care instituted.

Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib. Kaplan-Meier curve of progression-free survival by independent assessment for the overall population. HDPE bottle with a silica gel desiccant and a polypropylene closure containing film-coated tablets.

Thyroid stimulating hormone TSH increased was reported as an adverse reaction in 5. Date of first authorisation: There was no effect on mating or fertility in male mice at exposure levels approximately fold the expected human exposure. The next prescribed dose should be taken at the usual time. In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.

Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival. Liver-related adverse reactions In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.

Carcinogenicity Carcinogenicity studies have not been performed with axitinib. The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis 7.

Categories have been assigned based on absolute frequencies in the pooled clinical studies data.

Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma RCC after failure of prior treatment with sunitinib or a cytokine. Pzckage 4 arterial embolic and thrombotic events were reported axittinib 1.

Summary of the safety profile The following risks, including appropriate action to be taken, are discussed in greater detail in section 4. Grade 3 arterial embolic and thrombotic events were reported in 1.

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Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state. 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.

Posology The recommended dose of axitinib is 5 mg twice daily.

Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib. Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median T max ranging from 2.

Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib. There is no specific treatment for axitinib overdose. In the overall patient population and the two main subgroups prior sunitinib treatment and prior cytokine treatmentthere was a statistically significant advantage inxert axitinib over sorafenib for the axitibib endpoint of PFS see Table 2 and Figures 1, 2 and 3.

Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib see section 4. Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.

Fatal arterial embolic and thrombotic events were reported in 0. However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.