Sprycel Film-Coated Tablets (dasatinib as monohydrate)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Dasatinib, Sprycel

Date published: 08/02/2012 10:33

Type of SPC Change: Revised SPC

Generic drug name: Dasatinib

Drug brand name: Sprycel

Legal status: POM - Black Triangle

Pharmaceutical manufacturer: Bristol-Myers Squibb Pharmaceuticals Ltd

Summary
by: Atisha Sharma

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

 

Change to section 4.4 - Special warnings and precautions for Use

 

Treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia. Their occurrence is more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML. In imatinib resistant or intolerant patients, complete blood counts should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated. In patients with newly diagnosed chronic phase CML, complete blood counts should be performed every 2 weeks for the first 6 weeks, every 3 months for 2 years and then every 6 months thereafter. Myelosuppression was generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction (see sections 4.2 and 4.8).

 

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

SPC

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