Key messages
- There is an ongoing national shortage of Pfizer Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringes
- Pfizer Bicillin L-A 600,000 unit prefilled syringes for injections - The estimated return to supply date is April 2025.
- Pfizer Bicillin L-A 1.2 million unit prefilled syringes for injections - A new shortage is anticipated from 20 December 2024 to 10 January 2025.
- The shortage may impact the management of conditions such as syphilis, acute rheumatic fever/rheumatic heart disease and other group A streptococcal diseases.
- The Therapeutic Goods Administration has approved a second overseas-registered product, Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) under Section 19A of the Therapeutic Goods Act 1989. This will be available from the 24 November 2024 to cover any potential supply gaps.
- Since 1 April 2024, the Extencilline benzathine benzylpenicillin product is subsidised by the Pharmaceutical Benefits Scheme.
- The Extencilline benzathine benzylpenicillin products require reconstitution and have different administration instructions to Bicillin L-A pre-filled syringe.
- Clinicians, pharmacies and health services providing care to patients with conditions that typically require treatment or prevention with benzathine benzylpenicillin are recommended to conserve adequate stock for priority conditions and groups and consider the use of appropriate alternative antibiotic agents in suitable patients.
- The shortage situation continues to evolve and may change on short notice. Clinicians, pharmacies and health services are advised to anticipate and prepare for disruptions to benzathine benzylpenicillin supply into 2025.
Advice to support clinical practice during the shortage
Temporary prioritisation of antibiotic prescribing and medication stock management are recommended for clinicians and health services during the benzathine benzylpenicillin shortage.
- Consider whether antibiotics are indicated for patient care.
- Consider whether benzathine benzylpenicillin is indicated for a priority condition. If so, consider whether the Extencilline benzathine benzylpenicillin product can be given instead of Pfizer Bicillin L-A.
- Consider whether an alternative antibiotic agent can be prescribed instead of benzathine benzylpenicillin, and seek advice from an infectious diseases specialist, Therapeutic and/or relevant condition-specific clinical guidelines as required.
Prioritised use of benzathine benzylpenicillin
Benzathine benzylpenicillin should be prioritised for use in the following conditions during the shortage:
- treatment of definite, probable and possible acute rheumatic fever
- secondary prophylaxis of acute rheumatic fever and/or rheumatic heart disease
- treatment of syphilis in those with proven or suspected infection and their recent sexual contacts, particularly pregnant women and their partners or in people where the likelihood of non-adherence to alternative oral therapy is high.
- treatment for group A streptococcal infection of the respiratory tract and skin in patients who are at high risk of acute rheumatic fever, rheumatic heart disease or post-streptococcal glomerulonephritis, where oral therapy is not acceptable, or the likelihood of non-adherence is high.
If benzathine benzylpenicillin is required, consider prescribing the Extencilline benzathine benzylpenicillin product where possible.
Pfizer Bicillin L-A prefilled syringes should be conserved for use in:
- neonatal and paediatric patients.
- health care settings where the use of the alternative benzathine benzylpenicillin medication is not appropriate, including rural and remote settings and some Aboriginal Medical Services or Aboriginal Community Controlled Health Organisations.
- patients who are unable to receive the Extencilline or Brancaster Pharma benzathine benzylpenicillin products or alternative antibiotic agents, such as due to allergies or other contraindications.
Alternative antibiotic agents
During the benzathine benzylpenicillin shortage, clinicians should consider prescribing an alternative antibiotic agent where appropriate.
Refer to the Australian Therapeutic , relevant condition-specific guidelines and/or infectious disease specialists for advice.
Alternative benzathine benzylpenicillin medication
Information on the Section 19A benzathine benzylpenicillin products
Extencilline benzathine benzylpenicillin (France)
The Therapeutic Goods Administration approved the importation and supply of the overseas-registered Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) product in Australia under Section 19A of the Therapeutic Goods Act 1989. From 1 April 2024, this medication is subsidised by the Pharmaceutical Benefits Scheme.
The Extencilline benzathine benzylpencillin 1.2 million unit vial (France) product can be used as an alternative medication to Pfizer Bicillin L-A prefilled syringes in the treatment and prevention of conditions such as syphilis, acute rheumatic fever / rheumatic heart disease and other group A streptococcal diseases. Both Pfizer Bicillin L-A and Extencilline product contain long-acting benzathine benzylpenicillin. The recommended dose and frequency for these conditions are unchanged with the Extencilline product, which is considered safe for people of all ages and for use in pregnancy and breastfeeding.
It is important to note that there are differences in the presentation, storage, additional excipients and administration of Extencilline benzathine benzylpenicillin product compact to Pfizer Bicillin L-A. Notably, the Extencilline benzathine benzylpenicillin product must be reconstituted and results in a larger administration volume.
In Australia, the Entencilline benzathine benzylpenicillin product is being ordered and supplied by Orspec Pharma.
Procurement of Section 19A benzathine benzylpenicillin in Victoria
Health services and pharmacies are recommended to stay up to date on the ongoing benzathine benzylpenicillin shortage situation, closely monitor their medication stock and plan for forecasted usage.
Services that anticipate an ongoing demand of benzathine benzylpenicillin are recommended to:
- continue contacting their regular distributors to try and procure Pfizer Bicillin L-A.
- order the Extencilline) product (benzathine benzylpenicillin 1.2 million unit vial) as soon as possible to prevent disruptions in medication stock.
- implement interim prioritisation of antibiotic prescribing and medication stock management to conserve benzathine benzylpenicillin products, including Pfizer Bicillin L-A and Extencilline.
- consider liaising with other local health services and community pharmacies, particularly in regional and rural areas, to support patient pathways for accessing benzathine benzylpenicillin.
Pharmacies and health services should contact Orspec Pharma on 02 4339 4239 for details on ordering and supply of the Extencilline benzathine benzylpenicillin 1.2 million unit vial (France) product.
Where benzathine benzylpenicillin is the only suitable medication for a patient and there are difficulties with access to supply, clinicians and health services are recommended seek advice from their Local Public Health Unit.
Additional resources
For more information on the Bicillin L-A shortage, see:
- Therapeutic Goods Administration: About the 2024-2025 shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringe for
- Therapeutic Goods Administration: Medicine Shortages Information
For more information on antibiotic prioritisation during the shortage and use of the Section 19A benzathine benzylpenicillin product, see:
- Australian Commission on Safety and Quality in Health Care - Safety considerations during benzathine benzylpenicillin (Billin L-A) supply disruption - Fact
- Rheumatic Health Disease Australia: S19A EXTENCILLINE product - Clinical guide for
- Australian Injectable Drugs Handbook: AIDH - Login
For more information on alternative antibiotic agents, refer to the Australian Therapeutic , relevant condition-specific guidelines and/or infectious disease specialists for advice.
Reviewed 06 December 2024