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SPC, UK: INLYTA (2013)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Pfizer Limited
Διεύθυνση :
Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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Δωρεάν εγγραφή

Name of the medicinal product

Inlyta 1 mg film-coated tablets. Inlyta 3 mg film-coated tablets. Inlyta 5 mg film-coated tablets. Inlyta 7 mg film-coated tablets.

Qualitative and quantitative composition

1 mg film-coated tablets: Each film-coated tablet contains 1 mg of axitinib. 3 mg film-coated tablets: Each film-coated tablet contains 3 mg of axitinib. 5 mg film-coated tablets: Each film-coated tablet ...

Pharmaceutical form

Film-coated tablet (tablet). 1 mg: Red oval film-coated tablet debossed with Pfizer on one side and 1 XNB on the other. 3 mg: Red round film-coated tablet debossed with Pfizer on one side and 3 XNB on ...

Therapeutic indications

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.

Posology and method of administration

Treatment with Inlyta should be conducted by a physician experienced in the use of anticancer therapies. Posology The recommended starting dose of axitinib is 5 mg twice daily. Treatment should continue ...

Contraindications

Hypersensitivity to axitinib or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below. Hypertension In a controlled clinical study with axitinib for the ...

Interaction with other medicinal products and other forms of interaction

In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1. CYP3A4/5 inhibitors Ketoconazole, ...

Fertility, pregnancy and lactation

Pregnancy There are no data regarding the use of axitinib in pregnant women. Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman. Studies ...

Effects on ability to drive and use machines

Axitinib has a minor influence on the ability to drive and use machines. Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.

Undesirable effects

Summary of the safety profile The most important serious adverse reactions reported in patients receiving axitinib were arterial embolic and thrombotic events, venous embolic and thrombotic events, haemorrhage ...

Overdose

There is no specific treatment for axitinib overdose. In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE17 Mechanism of action Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth ...

Pharmacokinetic properties

After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous administration. The plasma half life of axitinib ranges from 2.5 to 6.1 hours. Dosing of ...

Preclinical safety data

Repeat dose toxicity 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 ...

List of excipients

Tablet core: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate Tablet film-coating: Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin (E1518) Iron ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

1 mg, 3 mg, 5 mg, 7 mg film-coated tablets: Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets. 1 mg film-coated tablets: HDPE bottle with a ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom

Marketing authorization number(s)

EU/1/12/777/001 EU/1/12/777/002 EU/1/12/777/003 EU/1/12/777/004 EU/1/12/777/005 EU/1/12/777/006 EU/1/12/777/007 EU/1/12/777/008 EU/1/12/777/009 EU/1/12/777/010 EU/1/12/777/011 EU/1/12/777/012

Date of first authorization / renewal of the authorization

Date of first authorisation: 3 September 2012

Date of revision of the text

08/2013