Tocilizumab (Actemra) shortages: information for health professionals and consumers

In July 2021, the sponsor of tocilizumab notified the Therapeutic Goods Administration (TGA) of shortages to multiple tocilizumab formulations (intravenous and subcutaneous) registered in Australia. The shortages were a consequence of increased global demand for the medicine in response to the COVID-19 pandemic.⁶

The formulations of tocilizumab registered in Australia are:²

• 80 mg/4 mL injection concentrated vial (intravenous; IV)
• 200 mg/10 mL injection concentrated vial (IV)
• 400 mg/20 mL injection concentrated vial (IV)
• 162 mg/0.9 mL solution for injection pre-filled syringe (subcutaneous)
• 162 mg/0.9 mL solution for injection pre-filled pen (ACTPen autoinjector; subcutaneous).

At the time of publishing, availability of tocilizumab IV formulations is extremely limited and expected to remain so until early 2022. Supply of tocilizumab subcutaneous formulations will be variable until early 2022, however it is expected that one of the two subcutaneous products should be available throughout the shortage for existing patients.⁶

Roche Products Pty Limited, the sponsor, is regularly reviewing shortage dates for each formulation.

The current shortages and updates are published on the TGA website:

See Shortages of tocilizumab (Actemra) medicines for full information.

See Medicine shortage reports database for specific notifications.

Pharmaceutical Benefits Scheme (PBS) arrangements are in place for some patients with severe active RA or JIA currently prescribed tocilizumab. These arrangements help support continuation of treatment when their usual medicine is not available. 

From 1 November, new temporary listings apply to medicines currently PBS listed for the treatment of severe active RA and severe active JIA. These listings provide prescribers and their patients with up to 24 weeks of treatment to show the new therapy is working. Please see PBS Arrangements for tocilizumab shortage – 1 November 2021 for more information.

A table of item codes to accompany these temporary listings has also been prepared for pharmacists.

To ensure timely access for existing patients who need tocilizumab subcutaneous formulations to manage their condition, the TGA issued a Serious Scarcity Substitution Instrument (SSSI) in August 2021. The SSSI makes the following products interchangeable at the pharmacy level:⁷

• 162 mg/0.9 mL solution for injection pre-filled syringe
• 162 mg/0.9 mL solution for injection pre-filled pen

This instrument allows a pharmacist to dispense either product to a patient when one is available, without needing to obtain prior approval from the prescriber to substitute, so long as the permitted circumstances are met. The pharmacist will notify the prescriber of the substitution soon after.⁷

Both products are the same tocilizumab strength and administered by subcutaneous injection. However, their delivery devices are different. Patients should be provided with information and instruction to ensure they understand these differences and how to use the devices.⁷

The instrument only applies to patients 18 years or older.

See full details about the SSSI for tocilizumab.

The TGA, Australian Rheumatology Association (ARA) and Arthritis Australia (AA) have developed a joint statement to help address the management of patients with RA, polyarticular and systemic JIA, GCA, and CRS during the current tocilizumab supply shortage. The advice provided in the statement will be updated when required as the situation changes.⁸

In general, rheumatologists are provided with advice to review the shortage dates for each formulation and their potentially affected patients, and guidance on topics such as tocilizumab initiation, access priorities, alternative treatments and ensuring patients understand how to use both the pre-filled syringe and pre-filled pen subcutaneous formulations.⁸

See the full TGA, ARA and AA guidelines for patient management for the most recent guidance.

General practitioners (GPs) should advise their patients using tocilizumab to contact their rheumatologist as soon as possible to receive guidance about their medicine.⁸

GPs and rheumatology nurses may also provide instructions to patients on how to administer the pre-filled syringe and pre-filled pen formulations.⁷

See the full TGA, ARA and AA guidelines for patient management for the most recent guidance.

Ordering tocilizumab for patients

The TGA is providing advice to pharmacies on ordering tocilizumab from wholesalers during the shortage. Pharmacies are advised to contact wholesalers directly to order stock of tocilizumab even if wholesaler portals show zero stock quantity.

See Actemra shortage – Instructions for pharmacies for full guidance for pharmacists and pharmacies. 

Substitution

Pharmacists should advise people using tocilizumab to contact their rheumatologist as soon as possible to receive the most recent guidance about their medicine.⁸

The tocilizumab SSSI allows pharmacists to use their professional and clinical judgement to dispense whichever product is available: the pre-filled syringe or the pre-filled pen, without prior approval from the prescriber to substitute, so long as the permitted circumstances provided within the SSSI are met.⁷

The permitted circumstances include:⁷

• the patient is aged 18 years and over; and
• the pharmacist has advised the patient or person acting on behalf of the patient:

• to obtain instructions from the prescriber, or a GP or rheumatology nurse, on how to administer the substitute product; and
• the dose to be taken.

See full details about the SSSI permitted circumstances.

See full details about the PBS subsidy arrangements when substituting subcutaneous formulations of tocilizumab.

Advise patients and consumers that if they, or someone they provide care for, uses tocilizumab, they should contact their rheumatologist as soon as possible for guidance on managing their treatment during the shortage.⁶

If either the pre-filled syringe or pre-filled pen is used by the patient, they may need to switch between these two products to ensure continued treatment during the supply shortage. The patient should ask their rheumatologist, rheumatology nurse or GP to show them how to use both formulations in case they need to switch.⁶

Pain Australia has produced a consumer information sheet with instructions for consumers and carers on how to access tocilizumab during the shortage.

For more information:

Arthritis Australia Frequently asked questions – Tocilizumab (Actemra) shortage

NPS MedicineWise Biological medicines and COVID-19 FAQs.

The Australian COVID-19 treatment guidelines provide regularly updated guidance on the off-label use of tocilizumab for patients diagnosed with COVID-19.^5,6

See the Australian COVID-19 guidelines for updated guidance on tocilizumab.

In response to the shortage of tocilizumab, the Medicine Availability Working Group (MAWG), made up of the TGA and state and territory health departments, is working with the sponsor to assess stock levels and availability of tocilizumab for patients with COVID-19. The TGA is also regularly providing guidance on conservation measures for tocilizumab for the clinical care of people with COVID-19.^6,9

See Shortages of tocilizumab (Actemra) medicines for full information.