Shortage of Orencia® ClickJectTM (abatacept) 125mg/1ml Solution for Injection Pre-filled Pens

Introduction

Orencia® ClickJectTM (abatacept) is a critical medication used for treating rheumatoid arthritis and psoriatic arthritis in adults. Due to a manufacturing issue, there will be a shortage of the pre-filled pens starting mid-June 2024. This shortage necessitates urgent action from healthcare providers to ensure patients continue to receive effective treatment.

Identified Safety Issue

• Supply Disruption: The shortage is due to delays in production, with an expected resupply from late August 2024. During this period, alternative treatment methods must be implemented to ensure patient care continuity.

Actions Required

1. Halt Initiation of New Patients: No new patients should be started on Orencia® (abatacept) products until the supply issue is resolved.
2. Identify and Prioritise Patients: Work with homecare providers to prioritise patients who will switch to Orencia® 125mg/1ml pre-filled syringes (PFS). Paediatric patients and those with severe treatment-resistant morphoea should be prioritised.
3. Switching to Intravenous Infusions: For remaining patients, switch to Orencia® 250mg powder for concentrate for solution for infusion where appropriate. Coordinate with homecare providers to manage this transition, ensuring necessary support for administration either at home or in a hospital setting.
4. Review Alternative Treatments: For cases where switching to PFS or IV infusion is not suitable, review other treatment options on a case-by-case basis.

Alternative Options and Homecare Provider Capacities

• Orencia® 125mg/1ml PFS: These remain available but can only support 15% of patients. Homecare providers will facilitate this switch and provide necessary nurse-led training for patients.
• Orencia® 250mg Powder for Infusion: Available to support the full demand. Coordination with homecare providers like Lloyds Pharmacy Clinical Homecare (LPCH) and Polar Speed is essential to understand their capacity to administer infusions at home or arrange hospital appointments where needed.
• Unlicensed Imports: Limited quantities of unlicensed imports of Orencia® pre-filled pens and syringes can be sourced, with variable lead times. Information on this is available on the SPS Medicines Supply Tool.

Patient Communication and Support

• Counselling and Education: Patients should be informed about the changes in their medication, including differences in formulation and administration frequency. Providing comprehensive support and counselling during this transition period is crucial for patient adherence and wellbeing.

Conclusion

The shortage of Orencia® ClickJectTM pre-filled pens presents a significant challenge for healthcare providers and patients. By following the actions outlined in the NatPSA, providers can ensure continued treatment and support for affected patients, mitigating the impact of this supply disruption.

Read more: CAS-ViewAlert (mhra.gov.uk)

Read more articles: Ashtons Resources – Improving quality and compliance in medicines management