Prescribing information





Image a magnifying glass next to a red banner title: Access the SUSTAIN study.


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 sickle cell disease (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 inadequate1

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

*The SUSTAIN study assessed the efficacy and safety of ADAKVEO® in patients between the ages of 16–65 years at 69 sites in three countries. The SUSTAIN study was a Phase II, double-blind, randomised trial where patients received 5 mg/kg ADAKVEO® (n=67); 2.5 mg/kg ADAKVEO® (n=66); or placebo (n=65), administered intravenously at week 0, 2, 6 and 4 weekly intervals thereafter over a period of 52-weeks.2

Key inclusion criteria:2

  • 16 to 65 years of age
  • Confirmed medical history or diagnosis of SCD (including HbSS, HbSC, HbSβ+-thalassaemia, HbSβ0-thalassaemia or other genotypes)
  • With or without HU/HC
  • Experienced 2–10 VOCs in the preceding 12 months
  • Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests

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

  1. ADAKVEO® Summary of Product Characteristics.
  2. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
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UK | May 2021 | 104645

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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:

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 Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]