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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If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension see section 4. In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular pwckage were reported see section 4.
Inlyta 1 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)
Grade 3 arterial embolic and thrombotic events were reported in 1. Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup. An increase ibsert red blood cell mass may increase the risk of embolic and thrombotic events. Antineoplastic agents, protein kinase inhibitors, ATC code: In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3. Summary of the safety profile The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma RCC after failure of prior treatment with sunitinib or a cytokine.
Cases of ruptured aneurysms including pre-existing aneurysms have been reported, some with fatal outcome.
Proteinuria In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported see section 4. In axiitinib controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness Grade 1. Fatal pulmonary embolism was reported in one patient 0.
Renal impairment Unchanged axitinib is not detected in the urine. The current safety database for axitinib is too small to detect rare and very rare adverse reactions. 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. Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population.
Inlyta 1 mg film-coated tablets
Venous embolic and thrombotic events c,d,i. The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric 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. 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.
This information is intended for use by health professionals.
The baseline demographic and disease characteristics were similar between the axitinib and axitiniv groups with regard to age, gender, race, Eastern Cooperative Oncology Group ECOG performance status, geographic region, and prior treatment.
Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients. Axitinib has not been studied in subjects with renal impairment.
No dosage adjustment is required on the basis of patient age or race see sections 4. 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. Hyperthyroidism was reported in 1. In vitro studies indicated that axitinib inhibits P-glycoprotein.
Qualitative and quantitative composition 3.
These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer.