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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Gastrointestinal perforation and fistula c,k.

Axitinib should be discontinued if the patient develops nephrotic syndrome. Cases of ruptured aneurysms including pre-existing aneurysms have been reported, some with fatal outcome. The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the insrrt 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.

Marketing authorisation number s 9. Company contact details Pfizer Limited. Blood pressure should be well-controlled prior to initiating axitinib. In vitro studies indicated that axitinib inhibits P-glycoprotein.

Grade 4 venous embolic and thrombotic events were reported in 1. In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.

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Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib. Fertility Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility indert humans see section 5.

Continue typing to refine. Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population. Objective response rate; OS: Renal impairment Unchanged axitinib is not detected in the urine.

Inlyta 1 mg film-coated tablets

Of the patients enrolled in this study, patients Clinical efficacy and safety The safety and efficacy of axitinib were evaluated in a randomised, open-label, multicenter Phase 3 study.

For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.

Polycythaemia see Elevation of haemoglobin or haematocrit in section 4.

Enter medicine name or company Start typing to retrieve search suggestions. Packave receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer. Grade 4 arterial embolic and thrombotic events were reported in 1. An increase in red blood cell mass may increase the risk of embolic and thrombotic events.

Axitinib has minor influence on the ability to drive pakage use machines. At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and hour AUC were Findings in females included signs of delayed sexual maturity, reduced or absent corpora lutea, decreased uterine weights and uterine atrophy at exposures approximately equivalent to the expected human exposure.

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

In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment Child-Pugh class B compared to subjects with normal hepatic function. This medicinal product contains lactose. HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets. No data are available. A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment Child-Pugh class B e.

In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported see section 4.

There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy. Kaplan-Meier curve of progression-free survival by independent assessment for the overall population. Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median T max ranging from 2. To view the changes to a medicine you must sign up and log in.

There is no specific treatment for axitinib overdose. Musculoskeletal and connective tissue disorders.