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.
|Published (Last):||2 May 2014|
|PDF File Size:||4.59 Mb|
|ePub File Size:||8.62 Mb|
|Price:||Free* [*Free Regsitration Required]|
Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Caution should inser exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Inlyta 7 mg film-coated tablet Each film-coated tablet contains Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib.
In case of severe or persistent arterial hypertension and symptoms suggestive insery posterior reversible encephalopathy syndrome Axitimib see belowa diagnostic brain magnetic resonance image MRI should be considered. Carcinogenicity Carcinogenicity studies have not been performed with axitinib. Summary of the safety profile The following risks, including appropriate action to be taken, are discussed in greater detail in section 4. Fatal cardiac failure was reported in 0.
There were no statistically significant differences between the arms in OS in the overall population or in the subgroups by prior therapy.
Inlyta 1 mg film-coated tablets
Axitinib inhibited the phosphorylation of VEGFR-2 in xenograft tumour vasculature that expressed the target in vivo and produced tumour growth delay, regression, and inhibition of metastases in many experimental models of cancer. The haemorrhagic adverse reactions in patients treated xxitinib axitinib included epistaxis 7. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. These findings were observed in mice at exposure levels approximately fold the expected human exposure, and in inssert at exposure levels below the expected human exposure.
The plasma half life of axitinib ranges from 2.
Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival. HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets. Insret In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported see section 4.
Axitinib should be discontinued if the patient develops nephrotic syndrome.
PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other inserh and neurologic disturbances. In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
Reproduction toxicity Axitinib-related findings in the testes and epididymis included decreased organ weight, atrophy or degeneration, decreased numbers of germinal cells, hypospermia or abnormal sperm forms, and reduced sperm density and count.
Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
Inlyta 5 mg film-coated tablet Each film-coated tablet contains This information is intended knsert use by health professionals. An increase in red blood cell mass may increase the risk of embolic and axihinib events. Hepatic impairment No dose adjustment is required when administering axitinib to patients with mild hepatic impairment Child-Pugh class A. Aitinib a controlled clinical study with axitinib for the treatment of patients with RCC that excluded patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in Special populations Elderly, gender, and race Population pharmacokinetic analyses in patients with advanced cancer including advanced RCC and healthy volunteers indicate that there are no clinically relevant effects of age, gender, body weight, race, renal function, UGT1A1 genotype, or CYP2C19 genotype.
Qualitative and quantitative composition 3. Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product. For the full list of lnsert, see section 6.
Toxicity findings in immature animals Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure. Hypersensitivity to axitinib or to any of the excipients listed in section 6.
The magnitude of median PFS insertt was different in the subgroups by prior therapy. The primary endpoint, progression-free survival PFSwas assessed using a blinded independent central review. Skin and subcutaneous tissue disorders. To bookmark a medicine you must sign up and log in. Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months.
At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and hour AUC were The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known. Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib. 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.