Update on Access to Benzathine Benzylpenicillin

08 May 2024

There continues to be a global shortage of Bicillin L-A® (benzathine benzylpenicillin pre-filled syringes of 600,000 units/ 1.17mL AND 1,200,000 units/ 2.3mL suspension for injection) due to a manufacturing issue and increases in consumer demand. The shortage is predicted to continue throughout 2024. Efforts are being made to maintain supplies; however, strategies are needed to ensure access for critical indications where no suitable alternative exists. See https://shorturl.at/lvE46 for further details of the shortage.

Approval for the alternative UK-registered product (Brancaster Pharma) lapsed on 31 March 2024; however, if purchased prior to that date it can still be supplied by pharmacists. The Therapeutic Goods Administration (TGA) has approved another 1,200,000 unit product, Extencilline® (France), supplied by ORSPEC Pharma under Section 19A (S19A) of the Therapeutic Goods Act 1989. Extencilline is equivalent in pharmacokinetics to Bicillin L‑A but presents as a powder for reconstitution and has a higher volume for injection. It is not currently listed on the PBS. See for details: https://shorturl.at/sGPQ8

Doctors are recommended to:

  • Use products containing benzathine benzylpenicillin for the following priority indications:
    • Treatment and secondary prophylaxis of acute rheumatic fever (ARF), and secondary prophylaxis of rheumatic heart disease (RHD). Refer to www.sahealth.sa.gov.au/rhd for information on ARF/RHD for health professionals.
    • Treatment of syphilis in those with proven or suspected infection and their recent sexual contacts. Refer to the Australian STI Management Guidelines (https://sti.guidelines.org.au/) for stage-appropriate treatment. Note: doxycycline is not considered first-line treatment for syphilis.
    • Treatment of group A streptococcal infections (sore throats and skin sores) for people at high risk of ARF and post-streptococcal glomerulonephritis, where oral therapy is not acceptable, or the likelihood of non-adherence is high.
  • Conserve the pre-filled syringe product of Bicillin L‑A for use in:
    • Neonatal and paediatric patients
    • Healthcare settings where use of alternative product is not appropriate, including rural and remote settings and some Aboriginal medical services and Aboriginal community-controlled health services.
  • Discuss with pharmacists at your health organisation to arrange direct supply of emergency stock of Bicillin L‑A if required from Pfizer (1800 629 921).
  • Consider referring patients to priority care centres (www.sahealth.sa.gov.au/prioritycarecentres) and CALHN integrated care which have products containing benzathine benzylpenicillin in stock for management of the priority indications, if not available at your health organisation.
  • Consider referring patients requiring syphilis treatment to Adelaide Sexual Health Centre (7117 2800), if appropriate.
  • Consider use of Extencilline if Bicillin L‑A or the Brancaster Pharma product is not available through the above channels. For details on ordering and supply of Extencilline, contact ORSPEC Pharma (02 4339 4239).
  • Restrict ordering of Bicillin L‑A for prescriber bag supplies, unless there is a reasonable expectation that a high number of patients with the priority indications listed above will be encountered. Order alternative antibiotics for prescriber bags (https://www.pbs.gov.au/browse/doctorsbag) where it is unlikely that a high number of patients with priority indications for Bicillin L‑A will be encountered.
  • Contact CDCB if you are unable to access BOTH Bicillin L‑A AND the S19A-approved alternative ORSPEC Pharma benzathine benzylpenicillin products.\

For all enquires please contact the CDCB on 1300 232 272 (24 hours/7 days).

Dr Louise Flood – Director, Communicable Disease Control Branch