EXJADE dispersible tablets (deferasirox)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Deferasirox, Exjade

Date published: 08/02/2012 11:41

Type of SPC Change: Revised SPC

Generic drug name: Deferasirox

Drug brand name: Exjade

Legal status: POM - Black Triangle

Pharmaceutical manufacturer: Novartis Pharmaceuticals UK Limited

Summary
by: Atisha Sharma

There have been significant updates to several sections of the SPC, including the following:

 

Change to section 4.2 - Posology and method of administration

 

EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE must be used with caution in such patients. Hepatic function in all patients should be monitored before treatment; every 2 weeks during the first month and then every month (see section 4.4).

 

Change to section 4.4 - Special warnings and precautions for Use

 

EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).

 

Please refer to SPC link below for full information on all changes.

SPC

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