Published: 10 May 2023
Updated:  21 November 2023

Safety Information

Monitoring communication

Patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Interleukin inhibitors and the possible risk of pancreatitis

Update to original communication

20 Nov 2023

During the monitoring period (10 May 2023 to 1 November 2023), Medsafe/Centre for Adverse Reactions Monitoring (CARM) received one report of pancreatitis with the interleukin inhibitor tocilizumab. There were no reports of pancreatitis received for other approved interleukin inhibitors.

The data sheet for Actemra products (tocilizumab)¹ has been updated to include pancreatitis as a post-market adverse reaction. However, there is insufficient evidence to confirm a risk of pancreatitis as a class effect for interleukin inhibitors. No further action is required at this time.

The benefit-risk balance for interleukin inhibitors remains positive.

1. Roche Products (New Zealand) Limited. 2023. Actemra 20 mg/mL, concentrate for solution for intravenous infusion, Actemra 162 mg/0.9mL, solution for subcutaneous injection New Zealand data sheet. 29 June 2023. URL: https://www.medsafe.govt.nz/profs/Datasheet/a/Actemrainf.pdf (accessed 8 November 2023).

Original communication

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
• Additional information
• Regulator actions
• Reporting

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

1. As per the approved Medsafe data sheet - medsafe.govt.nz/Medicines/infoSearch.asp
2. 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

1. 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).