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.
Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib. No data are available.
There was no effect on mating or fertility in male mice at exposure levels approximately fold the expected human exposure. The safety and efficacy of axitinib were evaluated ineert a randomised, open-label, multicenter Phase 3 study.
Hyperthyroidism was reported in 1. Fatal haemorrhage was reported in one patient 0. Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and ;ackage not be used in those patients.
Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness. They should be swallowed whole with a glass of water. Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median T max ranging from 2.
This information is intended for use by health professionals. No dosage adjustment is required on the basis of patient insret or race see sections 4. John’s wort] may decrease axitinib plasma concentrations.
The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known. Qualitative and quantitative composition 3.
Find out more here. Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy see section 4. Thyroid stimulating hormone increased.
Company contact details Pfizer Limited. Respiratory, thoracic and mediastinal disorders. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy.
Inlyta 3 mg film-coated tablet Each film-coated tablet contains 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.
Proteinuria In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported see section 4. HDPE bottle with a silica gel desiccant and a polypropylene closure containing film-coated tablets.
Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals. It is unknown whether axitinib is excreted in human milk. Grade 3 venous embolic and thrombotic events were reported in 0.
Axitinib has minor influence on the ability to drive and use machines. If the dose of axitinib is increased, the patient should be monitored carefully for toxicity.
Inlyta 1 mg film-coated tablets
Frequency categories are defined as: Perinatal and postnatal developmental toxicity studies have not been conducted. However, axitinib is not expected to inhibit P-glycoprotein at therapeutic plasma concentrations. Fatal arterial embolic and thrombotic events were reported in 0. A risk to the suckling child cannot be excluded.
Elevation of haemoglobin or haematocrit Increases in haemoglobin or haematocrit, reflective insedt increases in red blood cell mass, may occur during treatment with axitinib see section 4.
The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis 7.