This information originally appeared on the Arthritis Australia website and has been reproduced here with the permission of the author. It is current as of 25 February 2022.

 

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)

There is sufficient stock of the intravenous (IV) abatacept Orencia presentation to support current patients only.

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. 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.

Watch the recording of this webinar

Panellists:

– Catherine Hill, Australian Rheumatology Association

– Elspeth Kay, Therapeutic Goods Administration

– Neil MacGregor, Bristol-Myers Squibb Australia

– Louise Hardy, Arthritis Australia

Further Information and Support

Arthritis Australia: Infoline 1800 011 041 arthritisaustralia.com.au

TGA https://www.tga.gov.au/alert/shortage-abatacept-orencia-medicines

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

Serious Scarcity Substitution Instrument (SSSI) for abatacept

This instrument allows for pharmacists to substitute the SC formulations of abatacept without the need to contact the prescriber.

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