About the 2024-2025 shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringe for injection

Summary

• Both Bicillin L-A 600,000 unit and 1.2 million unit prefilled syringes for injection will be in shortage until September 2025. 
• We have reissued the approval to import an alternative overseas-registered benzathine benzylpenicillin product to help reduce the impact on patients.

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. 

The pharmaceutical company Pfizer Australia has notified us that Bicillin L-A 1.2 million unit prefilled syringes for injection will be in shortage until September 2025. Additionally, the shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) 600,000 unit prefilled syringes for injection will continue until late September 2025.

These shortages are due to manufacturing issues.

We understand the potential significant impact a shortage of this medicine can have. To help cover any supply gaps for these products, we have reissued the approval to import and supply an alternative overseas-registered product, Extencilline benzathine benzylpenicillin 1.2 million unit vial (France), under section 19A of the Therapeutic Goods Act 1989. 

Information about ordering Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) from the approval holder, ORSPEC Pharma (call 02 4339 4239), is available on our Section 19A database. 

This substitute product is listed on the Pharmaceutical Benefits Scheme - external site (PBS).

Please note that this overseas-registered product, Extencilline benzathine benzylpenicillin 1.2 million unit vial (France), requires reconstitution before administration and has different administration instructions to the Bicillin L-A prefilled 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:

• ACSQHC Fact Sheet- external site - external site 
• AIDH monograph- external site - external site. 

Up-to-date details about these shortages are available at the medicine shortage reports database- external site - external site. 

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. 

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. 

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 overseas-registered 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 - 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.