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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Therefore, co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates, in vivo. Grapefruit may also increase axitinib plasma concentrations. Categories have been assigned based on absolute frequencies in the pooled clinical studies data. Wound healing complications No formal studies of the effect of axitinib on wound healing have been conducted.

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

Excipients with known effect Inlyta 1 mg film-coated tablet Each film-coated tablet contains Axitinib should not be used during breast-feeding. Fatal venous embolic and thrombotic events were reported 0. 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.

Proteinuria In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported see section 4.

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Breast-feeding It is unknown whether axitinib is excreted in human milk. There is no specific treatment for axitinib overdose.

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

Renal impairment No dose adjustment is required see section 5. In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported see section 4.

When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily. Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib. Inlyta 7 mg film-coated tablet Each film-coated tablet contains Hypertension In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported see section 4.

In a controlled clinical study with axitinib for the treatment of patients with RCC that excluded patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5.

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. In vitro studies with P-glycoprotein In vitro studies indicated that axitinib inhibits P-glycoprotein. The packagr of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied. Hyperthyroidism was reported in 1.

Mild to severe hypertension may be present. Increases in pwckage or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib see section 4. Palmar-plantar erythrodysaesthesia hand-foot syndrome.

No dosage adjustment is required on the basis of patient age or race see sections 4. Perinatal and postnatal developmental toxicity studies have not been conducted. In insrt and in vivo data indicate that axitinib is primarily metabolised by the liver. The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis 7.

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Inlyta 1 mg film-coated tablets

There are no data regarding the use of axitinib in pregnant women. Find sxitinib more here. Cardiac packagd events 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 inserf, and right ventricular failure were reported see section 4.

Dose adjustments Dose increase or reduction is recommended based on individual safety and tolerability. In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in Inlyta 1 mg film-coated tablets. Healthcare professionals are asked to report any lackage adverse reactions via the Yellow Card Scheme at www. Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.

Fertility Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans see section 5. HDPE bottle with a silica gel desiccant and a polypropylene closure containing film-coated tablets. Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro. In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.

Pregnancy There are no data regarding the use of axitinib in pregnant women.