About the shortage of Pegasys (peginterferon alfa-2a) injection
Pharmaceutical company Echo Therapeutics (the sponsor) has notified us about the shortage of Pegasys (peginterferon alfa 2a) injection pre-filled syringes 135 micrograms/0.5 mL and 180 micrograms/0.5 mL. They expect the shortage, which is due to changes in manufacturing sites and supply constraints due to global shortages, to continue until the end of September 2025.
Peginterferon alfa-2a is used to treat chronic hepatitis B (CHB) and chronic hepatitis C (CHC). It is also commonly prescribed off-label to treat myeloproliferative neoplasms (MPNs).
We are working with the sponsor to minimise the impact on patients and prescribers by closely monitoring the supply of both strengths and updating this page with new information as soon as it becomes available.
To improve access, we have approved the supply of overseas-registered Pegasys injection pre-filled syringes under section 19A of the Therapeutic Goods Act 1989. Go to the Section 19A approvals database for up-to-date information about these products (search by the product name 'Pegasys'). It is important to note that the approved overseas-registered products are not currently subsidised under the Pharmaceutical Benefits Scheme (PBS).
You can go to the Medicine Shortage Reports Database- external site and search for ‘Pegasys’ for the most up-to-date supply information.
Information for patients
We understand how crucial it is for patients and their caregivers to have consistent access to this medicine.
To help during the shortage, we have approved the supply of overseas-registered Pegasys pre-filled syringes in both 180 and 135 microgram strengths.
Please note that currently, the Australian-registered Pegasys 135 micrograms/0.5 mL injection pre-filled syringe comes in a pack of 4 pre-filled syringes, whereas the overseas-registered substitute is only available as a single pre-filled syringe.
The sponsor has informed us that during the shortage, the 180 microgram strength of Pegasys will be more readily available. If your doctor recommends that you switch from the 135 microgram to the 180 microgram strength, you will need a new prescription.
If you are having difficulty getting your medicine, speak to your doctor about the situation.
Information for pharmacists
Pegasys products are currently being exclusively supplied to patients through the Pegasys Home Delivery Program. If a patient comes to your pharmacy with a prescription for Pegasys, you should direct them to: www.echotherapeutics.com.au/echocarepegasyspatient.
We have approved overseas-registered substitutes for the Australian-registered Pegasys products. You can go to our Section 19A approvals database for details.
Information for prescribers
Your patients may want to discuss other treatment options while Pegasys products are in shortage. This could include switching to the other strength of Pegasys when it is available, as the sponsor has informed us that the 180 microgram strength will be more readily available during the shortage. In this case, you should instruct patients how to administer the correct dose of the alternative strength.
Pegasys is currently being exclusively supplied to patients through the Pegasys Home Delivery Program, which has been in place since September 2024 to address supply chain concerns. You can find out more about the program at: EchoCare | Echo Therapeutics.
When prescribing Pegasys injections during the shortage, please note that the overseas-registered products that are available are currently not subsidised on the PBS.
Also keep in mind that the overseas-registered Pegasys 180 micrograms/0.5 mL injection is supplied as a single pre-filled syringe, unlike the Australian-registered product that is supplied as a 4-pack of single pre-filled syringes. Visit the Section 19A approvals database for more details.
General information
Please note that the dates given for this shortage may change and we encourage you to check the Medicine Shortage Reports Database - external site for updates.
Also keep in mind that we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.
While we can suggest approaches to manage the supply of medicines during shortages, we do not have the power to regulate the clinical decisions of health professionals.
We will continue to monitor the supply of Pegasys products and work with the supplier and relevant health professionals to update this advice if needed.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.