Prescribing information

 

 

Red circle with an image of a human body, with text next to it under the heading 'Vaso-occlusion and VOCs can lead to end-organ damage and multiorgan failure1-4'.

Vaso-occlusion and VOCs can lead to end-organ damage and multiorgan failure1–4

Sickle cell disease (SCD) is a multicellular disorder that can affect nearly every organ in the body, including the heart, eyes and bones5–8

 
Red circle with an outline image of a person with a spark representing pain, with text next to it under the heading 'Every VOC matters1-4'.

Every VOC matters1–4

VOCs are unpredictable, extremely painful events that can last an average of 10 days, but the VOC burden can last a lifetime9–13*

 
Red circle with a line graph with text next to it under the heading 'One severe VOC alone can increase the risk of death and decrease quality of life14'.

One severe VOC alone can increase the risk of death and decrease quality of life14

One or more severe VOCs per year have been associated with an increased risk of death at an earlier age14†

 
Red circle with a curved arrow and a line striked through, with text next to it under the heading 'Severe VOCs in adults may cause irreversible organ damage15†‡'.

Severe VOCs in adults may cause irreversible organ damage15†‡

In a 40-year observational study of 1,056 patients with SCD, VOCs leading to hospitalisation in adults were significantly associated with an increased risk of irreversible organ damage15

 
Red circle with an image of a hosiptal with text next to it under the heading 'VOCs are the leading cause of hospitalisations and accident & emergency (A&E) visits in patients with SCD, 3'.

VOCs are the leading cause of hospitalisations and accident & emergency (A&E) visits in patients with SCD16–19

  • 74% (n=470/632§) of hospital admissions in England for patients with SCD may be due to VOCs20**
  • 32% (n=~96/299) of people in the UK experiencing a VOC in the past year had to be hospitalised21††
 

 

Banner title: VOC prevention matters.

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.22

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

*Data accessed via literature review accomplished by PubMed search of ‘sickle cell disease’ in combination with other key terms: pain, vision, hearing, education, cognition, school performance, language, employment, depression, mobility, emotional problems, or behavioural problems. No restriction was placed on year of publication, no articles older than 1986 were used.13

VOCs were defined as a sickle cell acute painful episode in people that were hospitalised.14

Irreversible organ damage defined as comorbid clinical conditions that do not spontaneously improve with time.15

§A spell is comprised of one or more continuous finished consultant episodes.20

**Results of an analysis of admissions between January 2008 and July 2010 in London.20

††Results from the 299 UK patients that contributed to the International Sickle Cell World Assessment Survey (SWAY).21

Abbreviations: A&E, accident and emergency; HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; SWAY, Sickle Cell World Assessment Survey; VOC, vaso-occlusive crisis.

References

  1. 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.
  2. Conran N, et al. Hemoglobin. 2009;33(1):1–16.
  3. Steinberg MH. N Engl J Med. 1999;340(13):1021–1030.
  4. Madigan C & Malik P. Expert Rev Mol Med. 2006;8(9):1–23
  5. Piel FB, et al. N Engl J Med. 2017;376(16):1561–1573.
  6. Serjeant GR. J R Coll Physicians Lond. 1996;30:37–41.
  7. Rees DC, et al. Lancet. 2010;376:2018–2031.
  8. Vichinsky EP, et al. N Engl J Med. 2000;342(25):1855–1865.
  9. Ballas SK, et al. Blood. 2012;120(18):3647–3656.
  10. Ballas SK, et al. Hemoglobin. 1995;19(6):323–333.
  11. Hasan S, et al. J Natl Med Assoc. 2003;95(5):533–538.
  12. Brandow AM, et al. Br J Haematol. 2009;144(5):782–788.
  13. Swanson ME, et al. Am J Prev Med. 2011;41(6 Suppl 4):S390–S397.
  14. Darbari DS, et al. PLoS One. 2013;8(11):e79923.
  15. Powars DR, et al. Medicine (Baltimore). 2005;84(6):363–376.
  16. American Society of Hematology. State of Sickle Cell Disease: 2016 Report. Washington, DC: 2016. Available at: http://www.scdcoalition.org/report.html. Date accessed: March 2021.
  17. Lentz MB & Kautz DD. Nursing. 2017;41(1):67–68.
  18. Wilson BH & Nelson J. Pain Management Nursing. 2015;16(2):146–151.
  19. Ballas SK & Lusardi M. Am J Hematol. 2005;79(1):17–25.
  20. Green SA, et al. J R Soc Med Sci Sh Rep. 2012;3(37):1–7.
  21. Inusa B, et al. UK Patient Perceptions on the Symptomatic and Emotional Burden of Vaso-Occlusive Crises Resulting From Sickle Cell Disease. Poster presented at the Annual Scientific Meeting of the British Society for Haematology 2020; Nov 09–14: Virtual Event.
  22. ADAKVEO® Summary of Product Characteristics.
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UK | May 2021 | 121671
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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]