Shortage of Abatacept (Orencia®) – update

Bristol Myers Squibb (BMS), the manufacturer of abatacept (Orencia®), has announced ashortage of both the ClickJect (autoinjector) and pre-filled syringe subcutaneous formulations of the medication.

The unavailability of abatacept has commenced earlier than anticipated for a period expected to be several months. BMS have advised us that this is due to manufacturing delays and increased demand, and that Australia is not the only country affected.

In response to the shortage, Arthritis Australia is working with BMS, the Australian Rheumatology Association (ARA) and the Therapeutic Goods Administration (TGA) to manage supply.

Unfortunately, most patients currently using subcutaneous abatacept will need to switch to an alternative biological or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as soon as possible.

If your treating rheumatologist or clinical immunologist has not yet been in touch with you, we recommend that you contact them as soon as possible.

Update: May 16. 2024.

If you have been told by your specialist that you should remain on abatacept, you may need to switch between the Orencia prefilled syringe and the ClickJect (autoinjector) during the shortage when only one of these products is available.

•Both products contain the same medicine (abatacept), at the same strength (125 mg/mL), and are given by subcutaneous injection, but the injection device is different.
•If your pharmacist offers you a substitute medicine, they should explain the differences between the prefilled syringe and the ClickJect (autoinjector) and how to give the product you have been switched to.
•At your next appointment with your specialist, ask them to show you how to use both products in case you need to switch temporarily.
•Talk to your specialist or pharmacist if you have any questions about this substitution.

The Australian Rheumatology Association (ARA) has issued recommendations to rheumatologists to manage the shortage effectively:
• no new patients should be started on subcutaneous or intravenous abatacept
• patients should be switched to an alternative biological or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) where possible
• stock should be conserved for patients who have previously used two other b/tsDMARDs, or who have a relative or absolute contraindication to other b/tsDMARDs.

BMS have put in place an Orencia® Stock Hypercare Plan (OSHP) to manage orders of abatacept (Orencia®) and dispensing from pharmacies over the period of the shortage.
Consumers will need to:
• Have their treating specialist (rheumatologist or clinical immunologist) confirm whether they are eligible to continue on abatacept.
• If they are eligible, they will need to receive a completed OSHP Eligibility Form from their specialist and present it to their pharmacy (the form can also be emailed directly to the pharmacy by the specialist).

Individuals affected by the shortage are encouraged to contact their treating rheumatologist or clinical immunologist promptly for further guidance.

As details unfold, we are actively working with Bristol Myers Squibb (BMS), the Therapeutic Goods Administration (TGA), the Australian Rheumatology Association (ARA) and pharmacists to provide the latest information to consumers.