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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Excipients with known effect Inlyta 1 mg film-coated tablet Each film-coated tablet contains Hepatic impairment In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver. In clinical studies with axitinib for the treatment of patients with RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported see section 4.
The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population inssert treatment of kidney and renal pelvis carcinoma excluding nephroblastoma, nephroblastomatosis, packagf cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney see section 4.
If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension 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. Hyperthyroidism was reported in 1.
The sulfoxide and N-glucuronide metabolites show approximately fold and fold less in vitro potency, respectively, against VEGFR-2 compared to axitinib. Arterial embolic and thrombotic events c,d,j. Renal impairment No dose adjustment is required see section 5.
Before initiating axitinib therapy in patients with pre-existing aneurysms, this risk should be carefully considered. Axitinib may be administered with or without food see section 4. Breast-feeding It is unknown whether axitinib is excreted in human milk.
The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.
Inlyta 1 mg film-coated tablets
No dose adjustment is required when administering axitinib to patients with mild hepatic impairment Child-Pugh class A.
To email a medicine you must sign up and log in. 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. Method of administration Axitinib is for oral use. For the full list of excipients, see section 6. Dose adjustments Dose increase or reduction is recommended based on individual safety and tolerability.
In vitro studies indicated that axitinib aixtinib a potential to inhibit CYP1A2. Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Pxckage Cooperative Oncology Group ECOG performance status, geographic region, and prior treatment.
Of the patients enrolled in this study, patients 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.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Inlyta 5 mg film-coated tablet Each film-coated tablet contains Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.
Grade 4 venous embolic and thrombotic events were reported in 1.
Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing. An increase in pakcage blood cell mass may increase the risk of embolic and thrombotic events.
The average C max and AUC increased proportionally over an axitinib dosing range of 5 to 10 mg. Kaplan-Meier curve of progression-free survival by independent assessment for the overall population.
The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase ALTaspartate aminotransferase ASTand blood bilirubin see section 4.
Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required. Each pack contains 28 or 56 film-coated tablets. 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.
Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported see section 4. Magnetic resonance imaging is necessary to confirm the diagnosis of PRES. Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib. A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each 0. 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.
Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population see sections 4. It is unknown whether axitinib is excreted in human milk.
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. 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.
Polycythaemia see Elevation of haemoglobin or haematocrit in section 4. The magnitude of median PFS effect was different in the subgroups by prior therapy. They should be swallowed whole paackage a glass of water. In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.