Prescribing information

 

Administer prepared ADAKVEO® infusion solution immediately1

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Store the prepared solution either:1

  • At room temperature up to 25°C for no more than 4.5 hours from the start of the preparation to the completion of infusion
  • Under refrigeration at 2°C to 8°C for no more than 24 hours from the start of preparation to the completion of infusion. This includes the storage of the diluted solution and the time to warm up to room temperature
Image of a red circle with a thermometer under the title 'Administer prepared ADAKVEO® infusion solution as soon as possible'. Image is representing the optimal storage temperature for ADAKVEO®.

 

Banner with text: Please refer to full summary of product characteristics for additional dosage and administration instructions.

 

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.

References

  1. ADAKVEO® Summary of Product Characteristics.  
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UK | May 2021 | 104674
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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]