Substitution instrument to address shortage of abatacept (Orencia)

The Therapeutic Goods Administration (TGA) has been notified of shortages of multiple presentations of abatacept (Orencia) products due to manufacturing delays.

Abatacept (Orencia) is used to treat several types of arthritis including rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.

To assist with timely access for patients using subcutaneous formulations of abatacept (Orencia) the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022. This SSSI declares the following as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level:

• 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)

Both Orencia products are in short supply and have limited availability. This SSSI allows a pharmacist to dispense either product to a patient when one is available without prior approval to substitute from the prescriber. The pharmacist will then notify the prescriber of the substitution soon after.

The SSSI is in force from 9 February 2022 until 30 June 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. This SSSI is in effect in all states and territories.

For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).

In this section: Information for pharmacists | Information for prescribers | Information for patients

Information for pharmacists

The SSSI allows you to substitute the specified Orencia products without prior approval from the prescriber so long as the permitted circumstances provided within the SSSI are met. See both the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI for abatacept.

Use your professional and clinical judgement to determine whether a patient is suitable for substitution and ensure the patient is fully informed and consents to the change. Products can only be substituted in adults (at least 18 years of age).

Patients usually get instructions on how to administer these medicines from their specialist. Due to limited supply, and to reduce burden in obtaining a new prescription, this SSSI allows the Orencia single dose syringe and the ClickJect autoinjector to be interchanged. However, the patient will need instructions on administration.

Pharmacists need to ensure patients understand the differences between the products and are instructed on how to administer the substituted medicine. If a patient does not know how to administer the substitute medicine, you can advise them or refer them to a suitably qualified health practitioner as outlined in the Specific permitted circumstances.

Ensure the patient has access to information to support them in administering these medicines such as the Consumer Medicines Information (CMI) leaflet. The sponsor of these medicines also has leaflets with links to instructional videos which can be provided to patients. Contact the sponsor for information about the leaflets.

Information for prescribers

Consider the current shortage of Orencia single dose syringe and the Orencia ClickJect autoinjector when prescribing, particularly when initiating new patients on treatment for the registered (abatacept) Orencia indications. Make sure you provide instructions on administration for both devices as patients may be offered a substitute product by the pharmacist.

Patients may be given information and guidance on how to administer the substitute product by their pharmacist, or they may be asked by pharmacists to contact you or a suitably qualified health practitioner for this information.

Patients are advised to contact you if neither medicine is available from their pharmacy.

Information for patients

Talk to your prescribing doctor or pharmacist if you have any questions about this substitution.

If you are prescribed either the Orencia single dose syringe or the Orencia ClickJect autoinjector, at your next appointment, ask your specialist to show you how to use both products in case you need to swap temporarily.

Pharmacists can swap between Orencia single dose syringe and the Orencia ClickJect autoinjector under certain conditions. Both products contain the same medicine, at the same strength, and are administered by subcutaneous injection, however the device to administer the medicine is different.

If you have been prescribed either the Orencia single dose syringe or the Orencia ClickJect autoinjector and you have been offered a substitute medicine, your pharmacist will explain to you the differences between the single dose syringe and the ClickJect autoinjector and how to administer it.

Ask your pharmacist for information to support you in administering these medicines. Your pharmacist may provide you with both the Consumer Medicines Information (CMI) leaflet and information from the sponsor of these medicines.

If neither medicine is available from your pharmacy, contact your specialist.

Medicine disruptions occur for a range of reasons and sometimes shortages cannot be prevented. The TGA continues to actively monitor the supply of important rheumatology medicines and is committed to assisting you in situations where your medicine supply may be disrupted.