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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In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions inswrt reported in 4. Name of the medicinal product 2. If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.

In cases of suspected overdose, axitinib should be withheld and supportive care instituted. Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.

Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib. Gastrointestinal perforation and fistula formation see section 4. In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver.

Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib. Liver-related adverse reactions In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported. In the overall patient population and the two main subgroups prior sunitinib treatment and prior cytokine treatmentthere was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS see Table 2 and Figures 1, 2 and 3.

The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis 7. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs that cannot be managed by concomitant medicinal products or dose adjustments. Table 1 presents adverse reactions reported in a pooled dataset of patients who received axitinib in clinical studies for the treatment of patients with Axiginib see section 5.

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Axitinib should be discontinued if the patient pakage nephrotic syndrome. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. Date of first authorisation: Respiratory, thoracic and mediastinal disorders.

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

Hepatic impairment No dose adjustment is required when administering axitinib to patients with mild hepatic impairment Child-Pugh class A. General disorders and administration site conditions. Axitinib has not been studied in subjects with severe hepatic impairment Child-Pugh class C and should not be used in this population see section 4. For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.

Thyroid stimulating hormone TSH increased was reported as an adverse reaction in 5. The plasma half life inserr axitinib ranges from 2. Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5.

A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each 0. The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing. Major toxicity findings in mice and dogs following repeated dosing for up to 9 months were the gastrointestinal, haematopoietic, reproductive, skeletal and dental systems, with No Observed Adverse Effect Levels NOAEL approximately equivalent to or below expected human exposure at the recommended clinical starting dose based on AUC levels.

Breast-feeding It is unknown whether axitinib is excreted in human milk.

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They should be swallowed whole with a glass of water. Dosing of axitinib at 5 axitiinib twice daily resulted in less than two-fold accumulation compared to administration of a single dose.

Posterior reversible encephalopathy syndrome e. Last updated on eMC: Cases of ruptured aneurysms including pre-existing aneurysms have been reported, some with fatal outcome. However, axitinib is pwckage expected to inhibit P-glycoprotein at therapeutic plasma concentrations. HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets. These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer.

In the case of persistent hypertension, despite use of antihypertensive medicinal products, the axitinib dose should be reduced.

Palmar-plantar erythrodysaesthesia hand-foot syndrome.

Inlyta 1 mg film-coated tablets

Continue typing to refine. Excipients with known effect Inlyta 1 mg pxckage tablet Each film-coated tablet contains Genotoxicity Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro. For the full list of excipients, see section 6. Proteinuria In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 axitinin, was reported see section 4.

Pregnancy There are no data regarding the use of axitinib in pregnant women. An increase in red blood cell mass may increase the risk of embolic and thrombotic events.

Blood pressure should be well-controlled prior to initiating axitinib. This medicinal product does not require any special storage conditions. Renal impairment Unchanged axitinib is not detected in the urine. The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase ALTaspartate aminotransferase ASTand blood bilirubin see section 4.