Prescribing information

 

In patients treated with ADAKVEO®, infection rates were similar to those of placebo1

  • Overall rates of infections were 53.0% for ADAKVEO® vs. 53.2% for placebo
  • Serious adverse events (AEs) of infections and infestations were 12.1% (n=8) with ADAKVEO® vs. 16.1% (n=10) with placebo
  • Serious AEs considered related to study drug (occurrences >1 are indicated) including infections were:
    • ADAKVEO®: cellulitis (infectious in origin), pyrexia (2), tooth infection, lower respiratory tract infection, pneumonia, atypical pneumonia, hypotension, bradycardia, deep vein thrombosis
    • Placebo: pyrexia, sickle cell anaemia with crisis, right ventricular failure, neutrophil count decreased, gamma glutamyl transferase increased
  • Most events were single occurrences and in line with the underlying disease or concomitant medication

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.2

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

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

References

  1. ADAKVEO® EPAR CHMP assessment report. 2020. 
  2. ADAKVEO® Summary of Product Characteristics. 

 

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UK | May 2021 | 104665
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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]