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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Axitonib unused medicinal product or waste material should be disposed of in accordance with local requirements. In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported see section 4.

A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment Child-Pugh class B see section 4.

Dose adjustments Dose increase or reduction is recommended based on individual safety and tolerability.

Mild to severe hypertension may be present. There was no effect on mating or fertility in male mice at exposure levels approximately fold the expected human zxitinib. Axitinib should be used with caution in patients who are packahe risk for, or who have a history of, these events. The decision packagf resume axitinib therapy after surgery axitiinb be based on clinical judgment of adequate wound healing.

Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months. Dose adjustment is not required on the basis of patient age, race, gender, or body weight. If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension see section 4.

Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy see section 4. The next prescribed dose should be taken at the usual time.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Thyroid stimulating hormone TSH increased was reported as an adverse reaction in 5. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Sign Up Log In Cancel. In vitro studies with P-glycoprotein In vitro studies indicated that axitinib inhibits P-glycoprotein.

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Genotoxicity findings are not considered clinically relevant at exposure levels observed in humans. Absorption and distribution Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median T max ranging from 2.

The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase ALTaspartate aminotransferase ASTand blood bilirubin see section 4.

axittinib Routine laboratory assessments detected elevated haemoglobin above ULN in 9. If haemoglobin or haematocrit becomes elevated above the normal level, patients should be treated according to standard medical practice to decrease haemoglobin or haematocrit to an acceptable level.

In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in Inlyta 1 mg film-coated tablets. HDPE bottle with a silica gel desiccant and a polypropylene closure containing film-coated azitinib. Thyroid dysfunction 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. Objective response rate; OS: In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.

No dose adjustment is required see section 5. Carcinogenicity Carcinogenicity studies have not been performed with axitinib.

Arterial embolic and thrombotic events c,d,j. Hepatic impairment In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment Child-Pugh class B compared to subjects with pacakge hepatic function.

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. Excipients with known effect Inlyta 1 mg film-coated tablet Each film-coated tablet contains Show table of contents Hide table of contents 1. In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions were reported in 4.

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Inlyta 1 mg film-coated tablets

In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1. Axitinib has not been studied in patients with severe hepatic impairment Child-Pugh class C and should not be used in this population.

Perinatal and postnatal developmental toxicity studies have not been conducted. Pregnancy There are no data regarding the use of inssert in pregnant women. Grapefruit may also increase axitinib plasma concentrations. 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. For the full list of excipients, see section 6.

Fatal packabe failure was reported in 0.

This site uses cookies. Breast-feeding It is unknown whether axitinib is excreted in human milk. Hepatic impairment In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver.

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

Posterior reversible encephalopathy syndrome e. These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Two of the subgroups were too small to give reliable results prior temsirolimus treatment or prior bevacizumab treatment. 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.

John’s wort] may decrease axitinib plasma concentrations.