Bicillin L-A (benzathine benzylpenicillin) shortage

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.

1. Consider whether antibiotics are indicated for patient care.
2. 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.
3. Consider whether an alternative antibiotic agent can be prescribed instead of benzathine benzylpenicillin, and seek advice from an infectious diseases specialist, Therapeutic Guidelines 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 Guidelines, 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.

Brancaster Pharma benzathine benzylpenicillin

The Therapeutic Goods Administration Section 19 A approval for the importation and supply of the overseas-registered Brancaster Pharma benzathine benzylpenicillin product (benzathine benzylpenicillin 1.2 million unit vial) in Australia under Section 19A arrangements of the Therapeutic Goods Act 1989 lapsed on 30 March 2024.

The Brancaster Pharma product can still be supplied by pharmacists if purchased prior to 30 Mar 2024 and can be used as an alternative medication to Pfizer Bicillin L-A prefilled syringes.

It is important to note that there are differences in the presentation, storage, additional excipients and administration of Brancaster Pharma product compared to Pfizer Bicillin L-A. Notably, the Brancaster Pharma product must be reconstituted and results in a larger administration volume.

Both Bicillin L-A and the alternative overseas-registered section 19A benzathine benzylpenicillin products contain soy lecithin and are not suitable for patients with an allergy to soy or peanuts.

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 shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringe for injection | Therapeutic Goods Administration (TGA)
• Therapeutic Goods Administration: Medicine Shortages Information Initiative | Therapeutic Goods Administration (TGA)

For more information on antibiotic prioritisation during the shortage and use of the Brancaster Pharma benzathine benzylpenicillin product, see:

• Australian Commission on Safety and Quality in Health Care - About the shortage of Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringe for injection fact sheet
• Rheumatic Heart Disease Australia: Brancaster clinical guidance | Rheumatic Heart Disease Australia (rhdaustralia.org.au)
• Australian Injectable Drugs Handbook: AIDH - Login (hcn.com.au)

For more information on alternative antibiotic agents, refer to the Australian Therapeutic Guidelines, relevant condition-specific guidelines and/or infectious disease specialists for advice.