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Summary
- The estimated return-to-supply date for Bicillin L-A 600,000 unit prefilled syringes for injection is April 2025.
- A new shortage of Bicillin L-A 1.2 million unit prefilled syringes for injection is anticipated from 20 December 2024 to 31 January 2025. A PBS-listed overseas-registered substitute product is available.
The pharmaceutical company Pfizer Australia has notified us that the ongoing shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) 600,000 unit prefilled syringes for injection is estimated to continue until April 2025.
They have also notified us about a new anticipated shortage of the high-strength Bicillin L-A 1.2 million unit prefilled syringes for injection from 20 December 2024 to 31 January 2025.
Both shortages are due to manufacturing issues.
Benzathine benzylpenicillin is a specialised injectable antibiotic which is used in the treatment of bacterial infections including rheumatic fever, syphilis and group A streptococcal infections of the throat and skin. It is also used to prevent serious conditions that follow these infections such as rheumatic heart disease, congenital syphilis and acute post-streptococcal glomerulonephritis (APSGN).
Benzathine benzylpenicillin plays a significant role in rural and remote community health care, and we acknowledge the critical importance of this medicine to First Nations people.
Up-to-date details about these shortages are available at the medicine shortage reports database- external site.
We understand the potential significant impact of the new shortage. To help, we have approved an overseas-registered product to cover any potential supply gaps. Information about ordering Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) under section 19A of the Therapeutic Goods Act 1989 is available on our Section 19A database. You can contact the approval holder, ORSPEC Pharma, on 02 4339 4239 for details on ordering and supply.
This product is also listed on the Pharmaceutical Benefits Scheme (PBS).
Please note that Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) requires reconstitution prior to administration and has different administration instructions to the Bicillin L-A pre-filled syringe. The Australian Commission on Safety and Quality in Health Care (ACSQHC) and the Australian Injectable Drugs Handbook (AIDH) have each developed resources to assist healthcare professionals in the use of this overseas-registered alternative product:
To make sure the potentially limited supply of Bicillin L-A prefilled syringes remains available for patients and in healthcare settings that can only use Bicillin L-A prefilled syringes, we recommend using Extencilline 1.2 million unit vial (France) where appropriate.
Information for patients and carers
If you or someone you care for is prescribed Bicillin L-A, you should consult your treating health professionals for advice. You may be prescribed a different brand of benzathine benzylpenicillin or a different antibiotic.
Both Bicillin L-A and the alternative overseas-registered product contain soy lecithin and are not suitable for patients with an allergy to soy or peanuts.
Information for prescribers
The overseas-registered section 19A product is a vial with powder for reconstitution and has a larger injection volume than Bicillin L-A. Please see the links to the ACSQHC factsheet and the AIDH above for information about reconstitution and administration. We recommend using the section 19A product where appropriate to make sure the potentially limited supply of Bicillin L-A remains available for:
- neonatal and paediatric patients
- healthcare settings where the use of the section 19A product is not appropriate, including rural and remote settings and some Aboriginal Medical Services or Aboriginal Community Controlled Health Organisations.
Both Bicillin L-A and the alternative overseas-registered section 19A benzathine benzylpenicillin product contain soy lecithin and are not suitable for patients with an allergy to soy or peanuts.
Information for pharmacists
Please note that the alternative overseas-registered section 19A product is supplied as a vial with powder that requires reconstitution before administration. It is recommended that orders for the overseas-registered section 19A product are placed as soon as possible to prevent a gap in supply. You can contact the approval holder, ORSPEC Pharma, on 02 4339 4239 for details on ordering and supply.
Please see the links to the ACSQHC factsheet and the AIDH above for information about reconstitution and administration.
Both Bicillin L-A and the alternative overseas-registered section 19A benzathine benzylpenicillin product contain soy lecithin and are not suitable for patients with an allergy to soy or peanuts.
To support ongoing supply of Bicillin-LA, please order quantities based on your current needs and do not stockpile the product. Please consider dispensing the section 19A product where appropriate.
General information
Please note that the return-to-supply dates we have published here may change and you should check the medicine shortage reports database- external site for updates.
Please also note we can suggest approaches to manage the supply of medicines during shortages, but do not regulate the clinical decisions of health professionals.
We will continue to work with Pfizer Australia to monitor the supply of Bicillin L-A and will update this advice as needed.