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Tocilizumab (Actemra) Serious Scarcity Substitution Instrument

6 August 2021

The Therapeutic Goods Administration (TGA) has been notified of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic.

To assist with timely access for patients using subcutaneous formulations of tocilizumab (Actemra) the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Tocilizumab) Instrument 2021. This SSSI declares the following as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level:

  • ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringe (AUST R: 234034)
  • ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector (AUST R: 296808)

Both Actemra products are in short supply. 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 7 August 2021 until 31 December 2021. 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).

The TGA has also published a joint statement with the Australian Rheumatology Association and Arthritis Australia containing clinical guidelines to help health professionals manage this shortage.

Information for pharmacists

The SSSI allows you to substitute the specified Actemra 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 tocilizumab.

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 Actemra pre-filled syringe and the ACTPen autoinjector to be interchanged. However, the patient will need instructions on administration. Ensure the patient has received instructions or will receive instructions on administration from their specialist, their rheumatology nurse or General Practitioner as outlined in the Specific permitted circumstances.

Ensure the patient understands the differences between the products. Both medicines are of the same strength and administered by subcutaneous injection, however the device to administer the medicine is different.

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 Actemra pre-filled syringes and pre-filled pens when prescribing, particularly when initiating new patients on treatment for the registered (tocilizumab) Actemra indications. Make sure you provide instructions on administration for both devices as patients may be offered a substitute product by the pharmacist.

Patients will be asked by pharmacists to contact you, their rheumatology nurse or General Practitioner for information on how to use the substitute product.

A joint statement with the Australian Rheumatology Association, Arthritis Australia and the TGA, providing clinical guidelines to help health professionals manage this shortage was published on the Shortages of tocilizumab (Actemra) medicines webpage.

Information for patients

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

If you are prescribed either the Actemra pre-filled syringe or the Actemra pre-filled pen (ACTPen autoinjector), at your next appointment, ask your specialist to show you how to use both products in case you need to swap temporarily.

Pharmacists will be allowed to provide you a different product that contains the same medicine you were prescribed if the prescribed product is unavailable. Both medicines are of 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 Actemra pre-filled syringe or the pre-filled pen (ACTPen autoinjector) and you have been offered a substitute medicine, your pharmacist will explain to you the differences between the pre-filled syringe and the pre-filled pen. Your pharmacist will ask you to contact your specialist, rheumatology nurse or your General Practitioner to receive information on how to administer the substitute medicine.

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. However, you should still seek advice on how to administer the medicine from your specialist, rheumatology nurse or your General Practitioner.