UPDATE: Abatacept (Orencia®)



Update: Abatacept (Orencia®)

1 August 2024

As of August 1, 2024, Bristol Myers Squibb (BMS) has announced an improved supply situation for Orencia® (abatacept).

This update brings significant changes for patients and healthcare providers:

  • Improved Supply: BMS has received approximately 16 weeks’ worth of abatacept ClickJect autoinjector ahead of schedule, which is expected to meet normal demand.
  • OSHP Form No Longer Required: From August 1, prescribers will no longer need to complete an OSHP form for patients requiring abatacept.
  • Patient Switching: Patients may be switched back to abatacept if clinically appropriate.
  • Dosing Adjustments: Patients whose dosing intervals were increased during the shortage may return to their previous dose if clinically appropriate.
  • New Patients: Both subcutaneous (SC) and intravenous (IV) abatacept can now be prescribed to new patients.
  • Serious Scarcity Substitution Instrument (SSSI): The SSSI will remain in effect until October 31, 2024. This allows pharmacists to substitute the abatacept ClickJect autoinjector for the pre-filled syringe without a new prescription.
  • Pre-filled Syringe Supply: The next shipment of abatacept pre-filled syringes is expected in late September.

It’s important to note that while the supply situation has improved, patients should consult with their healthcare providers regarding any changes to their treatment regimen.


 

17 May 2024

Pharmacists are now able to substitute Orencia prefilled syringe with the ClickJect (autoinjector) depending on stock levels.

Patients may need to switch between the Orenicia prefilled syringe and the ClickJect (autoinjector) over the coming months due to the ongoing shortage of Abatacept. It is important to know:

  • Both products contain the same medicine (abatacept)
  • Both products have the same strength (125mg/ml)

If your pharmacist offers you a substitute please make sure:

  1. They explain the differences between the prefilled syringe and the ClickJect (autoinjector)
  2. They fully explain how to administer the medication you have been switched to

If you have any concerns or questions speak with your specialist and ask them to show you how to use both products so you are aware in the event you are offered a susbstitute.

As always, talk to your pharmacist or your specialist if you have any questions.


 

16 May 2024

The Government has released further information regarding current Abatacept shortage (refer to LINK ).

It is estimated two thirds of patients currently prescribed Abatacept will need to be moved to other medications where possible.

Patients unable to be moved to other medications will require their Rheumatologist to complete the necessary eligibility form.

All consumers currently prescribed Abatacept are strongly encouraged to take the following actions as a matter of priority:

  1. Speak with your Rheumatologist to discuss possible alternative medications
  2. If you and your Rheumatologist determine alternative medications are not possible, your Rheumatologist will need complete the necessary eligibility form.

10 May 2024

Abatacept is now expected to be unavailable for several months. BMS have stated that this is due to manufacturing delays and increased demand.  Australia is not the only country affected.

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 you are currently using subcutaneous abatacept and your treating rheumatologist or clinical immunologist has not been in touch with you, we recommend contacting them as soon as possible.

The Australian Rheumatology Association (ARA) has issued the following 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 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.

Read more

TGA: Medicine Shortages Information Initiative | Therapeutic Goods Administration (TGA)

Rheumatology Republic: Abatacept shortage strikes again – Rheumatology Republic

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