Prescribing information

 

 

 

Two images under ADAKVEO safety. A) Orange magnifying glass with text next to it saying 'adverse events'. B) Blue magnifying glass with text next to it saying 'infection rates'.
Two images under ADAKVEO safety. A) Orange magnifying glass with text next to it saying 'adverse events'. B) Blue magnifying glass with text next to it saying 'infection rates'.
 

 

Banner: ADAKVEO is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card scheme (website given) or directly to Novartis.

 

ADAKVEO® is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of ADAKVEO® is important to understand the safety profile of the treatment for SCD patients.

Indication: ADAKVEO® (crizanlizumab) is indicated for the prevention of recurrent VOCs in patients with SCD who are aged 16 years and over. It can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.1

ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.

Abbreviations: HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; VOC, vaso-occlusive crisis.

Reference

  1. ADAKVEO® Summary of Product Characteristics.  

 

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UK | May 2021 | 121653
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ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.

For more information, refer to the ADAKVEO® ▼ (crizanlizumab) prescribing information available here:  https://www.health.novartis.co.uk/sites/health.novartis.co.uk/files/adak...

Legal Category: POM.

Marketing Authorisation (MA) number, quantities and price: EU/1/20/1476/001  £1,038.00 per 10ml vial

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]