Published: 10 May 2023
Safety Information
Monitoring communication
Interleukin inhibitors and the possible risk of pancreatitis
9 May 2023
Monitoring closes 1 November 2023
The Medicines Adverse Reaction Committee (MARC) discussed whether interleukin inhibitors may cause pancreatitis at the March 2023 meeting.
The MARC did not consider there was strong evidence of an association between all interleukin inhibitors and pancreatitis. They recommended that Medsafe publish a monitoring communication to gain further information on this topic.
The aim of this communication is to encourage reporting of any cases where pancreatitis may have been associated with an interleukin inhibitor medicine.
Products affected
| Product name (active ingredient) | Interleukin target | Indicated conditionsa | Sponsor |
|---|---|---|---|
| Ilarisb (canakinumab) | Interleukin 1 beta | Cryopyrin-associated periodic syndromes | Novartis New Zealand Ltd |
| Simulect (basiliximab) | Interleukin 2 | Prophylaxis of acute organ rejection in de novo renal transplantation | Novartis New Zealand Limited |
| Nucala (mepolizumab) | Interleukin 5 | Eosinophilic asthma | GlaxoSmithKline NZ Limited |
| Fasenra (benralizumab) | Interleukin 5 | Eosinophilic asthma | AstraZeneca Limited |
| Actemra (tocilizumab) | Interleukin 6 | Rheumatoid arthritis, giant cell arteritis, COVID-19, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis | Roche Products (NZ) Ltd |
| Sylvant (siltuximab) | Interleukin 6 | Multicentric Castleman's disease | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics |
| Stelara (ustekinumab) | Interleukin 12, and 23 | Psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis | Janssen-Cilag (New Zealand) Ltd |
| Cosentyx (secukinumab) | Interleukin 17A | Plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, juvenile idiopathic arthritis | Novartis New Zealand Ltd |
| Skyrizi (risankizumab) | Interleukin 23 | Psoriatic arthritis, plaque psoriasis | AbbVie Limited |
- As per the approved Medsafe data sheet - medsafe.govt.nz/Medicines/infoSearch.asp
- Ilaris is not currently marketed in New Zealand.
Interleukin inhibitors reduce inflammation by stopping the action of immune cell signalling molecules, called interleukins.1
Each interleukin inhibitor medicine targets one or more interleukin and is indicated for the treatment of specific inflammatory conditions.
Additional information
At the March 2023 meeting, Medsafe asked the MARC to consider if there was evidence for an association between tocilizumab (an inhibitor of interleukin 6) and pancreatitis, and whether pancreatitis could be a class effect for all interleukin inhibitors.
The MARC considered that the evidence showed an association between tocilizumab treatment and pancreatitis. The MARC recommended updates to the data sheets for tocilizumab and siltuximab (the other interleukin 6 inhibitor available in New Zealand). Based on the available evidence, the MARC did not consider that pancreatitis was a class effect for all interleukin inhibitors. They recommended a monitoring communication to gain further information on this topic.
See the meeting minutes for further details of the MARC’s discussions. The report presented to the MARC can be found here (pdf 354KB, 28 pages).
See the consumer medicine information (CMI) and data sheets for each medicine for advice on how to take interleukin inhibitor medicines and the known side effects.
Search for consumer medicine information and data sheets
Regulator actions
Medsafe is placing this potential safety signal on the Medicines
Monitoring ()
scheme to encourage reporting of pancreatitis with any interleukin inhibitor.
Reporting
Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).
Medsafe cannot give advice about an individual’s medical condition. If you have concerns about a medicine you are taking, please talk to your health care professional.
References
- Heimall J. 2023. The adaptive cellular immune response: T cells and cytokines. In: UpToDate. 30 January 2023. URL: uptodate.com/contents/the-adaptive-cellular-immune-response-t-cells-and-cytokines (accessed 17 March 2023).
