Information about the abatacept (Orencia®) Shortage

There are currently shortages of abatacept (Orencia®) products in Australia. If you are currently taking abatacept (Orencia®), these shortages may affect your treatment.

The shortages are for the first half of 2022, for:

  • ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange extender (AUST R: 206764)
  • ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector (AUST R: 236039)

Stock of the intravenous (IV) abatacept Orencia presentation has recently improved and new patients can be started on this medicine.

Due to the limited amounts of abatacept prefilled syringe and ClickJect prefilled autoinjector, specialists need to reduce the usage of abatacept. Your specialist may need to change your treatment – please contact them as soon as possible to discuss your options.

If you are staying on abatacept, your specialist will give you a form to take to your pharmacy. When you go to the pharmacy to get your abatacept, give the form to your pharmacist with your script. They need the form to order your medicine.

To assist consumers, the Therapeutic Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument for abatacept, and this has recently been extended to 30 June 2022. You may need to switch between the abatacept prefilled syringe or the ClickJect prefilled autoinjector during the shortage. Your pharmacist can offer you whichever subcutaneous product is available while the Serious Scarcity Substitution Instrument for abatacept, is in effect.

At your next appointment, ask your treating health practitioner to show you how to use both products in case you need to swap. If you are offered a substitute medicine, at the pharmacy, your pharmacist will explain to you the differences between the prefilled syringe and the ClickJect autoinjector and how to administer it.

The TGA, Bristol Myers Squibb (BMS), the Australian Rheumatology Association (ARA), and Arthritis Australia are working closely together to manage the shortages and minimise the impact on patients in Australia. BMS Australia are regularly reviewing shortage dates, and any updates will be published on the Medicine shortage reports database.

The ARA have developed criteria about consumers who can access abatacept subcutaneous during the shortage:

  • Consumers who have Prior use of two other biologic or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs)
  • Consumers who have a relative or absolute contraindication to other b/tsDMARDs

The ARA has also recommended that no new patients be initiated on abatacept and that patients are not moved from the prefilled syringe or ClickJect prefilled autoinjector to the IV presentation except in exceptional circumstances

Consumers should contact their rheumatologists for further advice.

 

Consumer webinar

A Consumer Webinar was held and recorded on 2 March 2022 to share more about this issue and have questions answered by representatives from the ARA, TGA, BMS Australia and Arthritis Australia.

Panellists:

Catherine Hill, Australian Rheumatology Association

Elspeth Kay, Therapeutic Goods Administration

Neil MacGregor, Bristol-Myers Squibb Australia

Louise Hardy, Arthritis Australia

Watch the recording of this webinar

 

Further information and support

 

Useful links for Pharmacists

  • Information for pharmacies can be found on the TGA website here
  • BMS have provided a form with instructions for pharmacists regarding the ordering process for abatacept subcutaneous presentations during the shortage -https://www.tga.gov.au/sites/default/files/shortage-abatacept-orencia-medicines.pdf


Additional useful links

 

Updated 2 May 2022