Prescribing information

 

 

ADAKVEO® (crizanlizumab) is indicated for the prevention of recurrent VOCs in patients with sickle cell disease (SCD) who are aged 16 years and over. It can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as a monotherapy in patients for whom HU/HC is inappropriate or inadequate1

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

Choose ADAKVEO® because VOC prevention matters2

Four images under title: Choose ADAKVEO® because VOC prevention matters4.

ADAKVEO® safety

The SUSTAIN* study demonstrated ADAKVEO® had a manageable safety profile10

  • The rate of adverse events (AEs) were well balanced between ADAKVEO® and placebo groups10
  • The most frequently reported adverse drug reactions (≥10% of patients) in the ADAKVEO® 5 mg/kg group were arthralgia, nausea, back pain, pyrexia and abdominal pain1
  • Severe adverse events were less common: arthralgia and pyrexia (each 0.9%)1
  • Two patients on ADAKVEO® discontinued treatment due to adverse reactions vs. three patients on placebo11

 

Banner: Reducing the burden of SCD1,4.

 

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.

*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; IV, intravenous; SCD, sickle cell disease; VOCs, vaso-occlusive crises.

References

  1. ADAKVEO® Summary of Product Characteristics.
  2. Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
  3. Darbari DS, et al. PLoS One. 2013;8(11):e79923.
  4. Conran N, et al. Hemoglobin. 2009;33(1):1–16.
  5. Steinberg MH. N Engl J Med. 1999;340(13):1021–1030.
  6. Madigan C & Malik P. Expert Rev Mol Med. 2006;8(9):1–23.
  7. Steinberg MH. Sickle cell disease and associated hemoglobinopathies. In: Goldman L, Ausiello D, eds, Cecil Medicine, 23rd ed. Philadelphia, PA; Saunders Elsevier; 2008:1217–1226.
  8. McClish DK, et al. Health Qual Life Outcomes. 2005;3:50.
  9. 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/fundingopportunities-and-contacts/.... Date accessed: April 2021.
  10. ADAKVEO® EPAR CHMP assessment report. 2020.
  11. Kutlar A, et al. Am J Hematol. 2019;94(1):55–61.
Rate this content: 
Average: 5 (1 vote)
UK | May 2021 | 104632
×

Ask Speakers

×

Medical Information Request

 

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]