Bicillin® L-A (benzathine benzylpenicillin) shortage

There is a global shortage of Bicillin® L-A (benzathine benzylpenicillin pre-filled syringes due to manufacturing issues and increased demand.

The shortage is affecting:

  • Bicillin® L-A 600,000 unit pre-filled syringes: Unavailable.
  • Bicillin® L-A 1,200,000 unit pre-filled syringes: Available as emergency stock only. Healthcare professionals can contact Pfizer Australia on 1800 675 229 for information on accessing stock.

For up-to-date information on supply impact dates, refer to the Therapeutic Goods Administration (TGA) medicine shortage reports database and website.

Temporary supply of alternatives to Bicillin® L-A pre-filled syringes have been approved by the TGA under Section 19A (s19A) of the Therapeutic Goods Act 1989.

These alternatives are limited to overseas-registered 1,200,000-unit products and are not suitable in all clinical scenarios. They have specific safety and suitability considerations including:

  • The need for reconstitution with a diluent and immediate administration (which may make them less suitable in some patient cohorts and settings, e.g. rural or remote)
  • A larger volume of administration, making them unsuitable for infants and children.

There may also be supply issues affecting s19A alternatives to Bicillin® L-A. Therefore, it is important to carefully consider whether treatment with benzathine benzylpenicillin is necessary, and, if so, which formulation is appropriate. Not all s19A products are currently listed on the Pharmaceutical Benefits Scheme (PBS); refer to the PBS website for up-to-date information.

Recommendations for health professionals

  • Only prescribe products containing benzathine benzylpenicillin for the following priority indications:

Acute rheumatic fever and rheumatic heart disease

Syphilis

    • Treatment of syphilis for proven or suspected infection and their recent sexual contacts. Refer to the Australian STI Management Guidelines.
    • Note: Doxycycline is not considered first-line treatment for syphilis due to efficacy concerns but may be used in non-pregnant people when no alternative is available; close follow-up is required.

    • Consider referring patients requiring syphilis treatment to Adelaide Sexual Health Centre.

Group A streptococcal infections

    • 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.
    • Consider referring patients to Priority Care Centres and SA Health Urgent Care Hubs (BRIGHT) if you are not able to access or source benzathine benzylpenicillin.
  • See the Therapeutic Guidelines and Australian Medicines Handbook for the treatment of other infections.
  • Regularly review benzathine benzylpenicillin pre-filled syringe stock levels at health services and order s19A products promptly to minimise supply disruptions.
  • Conserve any available stock of Bicillin® L-A pre-filled syringe for use in:
    • Neonatal and paediatric patients (due to the larger volume of administration in alternative products).
    • Healthcare settings where use of alternative products is not appropriate due to need for reconstitution and immediate administration, for example some rural and remote settings.
    • Patients with ARF and RHD, to maintain continuity of Bicillin® L-A treatment and reduce risk of medication errors.
  • Order alternative antibiotics for prescriber bags.
  • Consider the use of s19A products for other patients requiring treatment with benzathine benzylpenicillin. For details on ordering, supply and administration of s19A products, refer to the s19A approvals database and Product Information. Different suppliers may need to be contacted to access stock.
  • Contact the Communicable Disease Control Branch (CDCB) for advice if you are unable to access the s19A-approved alternative products OR have a patient with ARF/RHD or untreated syphilis who is lost to follow up.

For details on ordering, supply and administration of s19A products, refer to the TGA s19A approvals database.

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