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

Summary

• The shortage of Bicillin L-A 600,000 unit prefilled syringes for injection has been extended to 12 December 2025.
• Bicillin L-A 1.2 million unit prefilled syringes for injection remain in shortage until the end of November 2025, with limited supply available. The sponsor is working with wholesalers to support fair distribution of available supplies.
• An overseas-registered alternative product, Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal), is available and is listed on the Pharmaceutical Benefits Scheme (PBS).
• Other unapproved products can be accessed via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathway (see Accessing unapproved benzylpenicillin products below).
• Benzathine benzylpenicillin products should be prioritised for use in high-priority patient groups, based on previous advice from the Medicine Availability Working Group (see Information for healthcare professionals below). 

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. 

Pharmaceutical company Pfizer Australia has notified us that Bicillin L-A 1.2 million unit prefilled syringes for injection will be in shortage until the end of November 2025. Additionally, the shortage of Bicillin L-A 600,000 unit prefilled syringes for injection will continue until 12 December 2025. While there is limited supply of the 1.2 million unit product, the 600,000 unit formulation remains unavailable.

These shortages are due to manufacturing issues. 

We understand the significant impact a shortage of this medicine can have. To help cover supply gaps, we have approved the supply of an overseas-registered alternative benzathine benzylpenicillin product:

• Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal)

This product is approved under section 19A of the Therapeutic Goods Act 1989 and is subsidised on the Pharmaceutical Benefits Scheme (PBS). For ordering information, please contact the approval holder Neon Healthcare on (02) 7255 8455.

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

Reconstitution advice 

Please note that overseas-registered benzathine benzylpenicillin products may require reconstitution before administration or have different administration instructions to the Australian-registered Bicillin L-A prefilled syringe products. 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 these overseas-registered alternative products (both currently and previously approved under section 19A):

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

Accessing unapproved benzylpenicillin products

Health care professionals can also use the Special Access Scheme (SAS) or the Authorised Prescriber (AP) pathway to access unapproved benzathine benzylpenicillin products for their patients. These products are not subsidised under the PBS and we do not have information about their availability. 

Information for patients and carers

If you or someone you care for is unable to access Bicillin L-A, you should consult your treating healthcare professional for advice. They may prescribe a different brand of benzathine benzylpenicillin or a different antibiotic.

Note this important allergen information relating to benzathine benzylpenicillin products: 

• Bicillin L-A and Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal) contain lecithin (source unavailable) or soy lecithin and are not suitable for patients with an allergy to soy or peanuts.
• Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal) is packaged together with an amber ampoule of diluent that contains lidocaine hydrochloride. This diluent is not suitable for patients with allergies to lidocaine.  

Your healthcare professional should determine if the prescribed alternative medicine is suitable for you. 

Information for healthcare professionals

The supply of Bicillin L-A 1.2 million unit prefilled syringes for injection has resumed but remains limited. Additionally, the 600,000 unit formulation remains unavailable.

As Bicillin L-A is available in packs of 10, consider prescribing or supplying in quantities aligned with immediate clinical need, such as 1 to 2 dosage units, depending on the indication being treated. This will help to support equitable access until supply returns to full capacity.  

To ensure that the limited supply of Bicillin L-A prefilled syringes is conserved for the treatment of high-priority patient groups, please utilise the following advice, which was developed and endorsed by clinical experts during the previous shortages of benzathine benzylpenicillin in 2023:

Products containing benzathine benzylpenicillin should be prioritised for use in the following conditions: 

• Treatment and secondary prophylaxis of acute rheumatic fever (ARF), and secondary prophylaxis of rheumatic heart disease (RHD).
• Patients who require treatment for group-A streptococcal infection of the respiratory tract and skin who are at high risk of acute rheumatic fever, rheumatic heart disease or acute poststreptococcal glomerulonephritis (APSGN), where oral therapy is not acceptable or the likelihood of non-adherence is high.
• Treatment for syphilis in proven or suspected cases, or if identified as a sexual contact of syphilis.

Where patients fall outside the above priority conditions and settings, prescribers should refer to the Australian Therapeutic Guidelines, appropriate local guidelines and/or infectious disease experts for advice on alternative antibiotic agents.

If you are unable to access Bicillin L-A, overseas-registered benzathine benzylpenicillin products are available under section 19A, via the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.

Information on overseas-registered products currently approved under section 19A is also available from the Section 19A Approvals Database.

Reconstitution and administration instructions may differ between the overseas-registered benzathine benzylpenicillin products. Please refer to the above links to the ACSQHC factsheet and AIDH monograph or, alternatively, to the corresponding overseas product information for instructions about reconstitution and administration.

Note this important allergen information relating to benzathine benzylpenicillin products: 

• Bicillin L-A and overseas-registered product Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal) contain lecithin (source unavailable) or soy lecithin and are not suitable for patients with an allergy to soy or peanuts.
• Lentocilin S 1200 benzathine benzylpenicillin 1,200,000 IU/4 mL powder and solvent for suspension for injection (Portugal) is packaged together with an amber ampoule of diluent that contains lidocaine hydrochloride. This diluent is not suitable for patients with allergies to lidocaine.  

Prior to prescribing, healthcare professionals should determine if the overseas-registered product is suitable for the patient. 

To support ongoing supply, please order quantities based on your current needs and do not stockpile these products. 

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 products and will update this advice as needed.