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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Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.

A dose decrease is recommended when administering inssrt to patients with moderate hepatic impairment Child-Pugh class B e. Summary of the safety profile The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.

Sign Up Log In Cancel. Knsert disorders and administration site conditions. Hepatic impairment In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver. The following risks, including appropriate action to be taken, are discussed in greater detail in section 4. Qualitative and quantitative composition 3.

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Axitinkb adverse reactions identified in clinical studies are also included. Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required.

packagee Each pack contains 28 or 56 film-coated tablets. In vitro studies indicated that axitinib has a potential to inhibit CYP1A2. When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.

Liver-related adverse reactions In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.

Fatal cardiac failure was reported in 0. Thyroid stimulating hormone increased. Venous embolic and thrombotic events c,d,i.

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

Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy see section 4. Name of the medicinal product 2. This medicinal product does not require any special storage conditions.

In cases of suspected overdose, axitinib should be withheld and supportive care instituted. Method of administration Axitinib is for oral use.

There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy.

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. The plasma half life of axitinib ranges from 2. This medicinal product contains lactose.

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Carcinogenicity Carcinogenicity studies have not been performed with axitinib.

Date of first authorisation: Hyperthyroidism was reported in 1. Respiratory, thoracic and mediastinal disorders. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Marketing authorisation number s 9. Antineoplastic agents, protein kinase inhibitors, ATC code: Pregnancy There are no data regarding the use of axitinib in pregnant women.

Inlyta 1 mg film-coated tablets

Hepatic impairment No dose adjustment is required when administering axitinib to patients with mild hepatic impairment Child-Pugh class A.

Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Renal impairment No dose adjustment is required see section 5. The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied.