Prescribing information

 

ADAKVEO® is the first and only once-monthly intravenous (IV) infusion treatment for the prevention of VOCs in patients with sickle cell disease (SCD)1–3

 

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Banner with text: VOC prevention is possible with ADAKVEO a once monthly IV infusion.

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; IV, intravenous; SCD, sickle cell disease; VOC, vaso-occlusive crisis.

Reference

  1. ADAKVEO® Summary of Product Characteristics.  
  2. National Heart, Lung, and Blood Institute. SBIR Success Stories. NHLBI funding leads to promising drug candidate to prevent sickle cell pain.  Available at: www.nhlbi.nih.gov/grants-and-training/fundin-opportunities-andcontacts/small-business-program/sbir-success-stories/nhlbi-funding-leads-promisingdrug-candidate-preventsickle-cell-pain. Date accessed: March 2021.   
  3. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.

 

 

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UK | May 2021 | 124153
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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]