AXITINIB PACKAGE INSERT PDF

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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Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib. Tabulated list of adverse reactions Table 1 presents adverse reactions reported in a pooled dataset axitinjb patients who received axitinib in clinical studies for the treatment of patients with RCC see section 5.

Company contact details Pfizer Limited. Genotoxicity findings are not considered clinically relevant at exposure levels observed in humans. Axitinib was axitini mutagenic or clastogenic in conventional genotoxicity assays in vitro.

Fertility Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5.

Routine laboratory assessments detected elevated haemoglobin above ULN in 9. Post-marketing adverse axitknib identified in clinical studies are also included.

Grade 4 arterial embolic and thrombotic events were reported in 1. In cases of suspected overdose, axitinib should be withheld and supportive care instituted. No data are available.

Each pack contains 28 or 56 film-coated tablets. 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.

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Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median T max ranging from 2.

In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver. Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine.

Axitinib has minor influence on the ability to drive and use machines. Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup.

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

Qualitative and quantitative composition 3. This information is intended for use by health professionals. In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1. The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.

The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis 7. In vitro studies with P-glycoprotein In vitro studies indicated that axitinib inhibits P-glycoprotein. This medicinal product contains lactose. In clinical studies with axitinib, arterial embolic and thrombotic events including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion were reported see section 4.

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. Inlyta 5 mg film-coated tablet Each film-coated tablet contains In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions were reported in 4. For the full list of excipients, see section 6.

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Summary of the safety profile The following risks, including appropriate action to be taken, are discussed in greater detail in section 4. Gastrointestinal perforation and fistula c,k. 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. Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported see section 4.

Musculoskeletal and connective tissue disorders. 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 60 film-coated tablets. Axitinib should be used with caution in patients who are at risk for, or who have a history of, these events. Table 1 presents adverse reactions reported in a pooled dataset of patients who received axitinib in clinical studies for the treatment of patients with RCC see section 5.

Posology The recommended dose of axitinib is 5 mg twice daily. Grade 3 venous embolic and thrombotic events were reported in 0.

Inlyta 1 mg film-coated tablets

If the dose of axitinib is increased, the patient should be monitored carefully for toxicity. The primary endpoint, progression-free survival PFSwas assessed using a blinded independent central review. A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each 0. Polycythaemia see Elevation of haemoglobin or haematocrit in section 4.