On January 17, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of Extencilline (benzathine benzylpenicillin injection, powder, for suspension), a medication used to treat syphilis in pregnancy. The FDA has exercised enforcement discretion for the temporary importation and use of this treatment to mitigate the effects of the Bicillin L-A® drug shortage. Extencilline has been determined to be equivalent to Bicillin L-A® in terms of clinical use and dose. Extencilline is currently authorized and marketed in other countries.
Our organizations support the use of Extencilline (Benzylpenicillin Benzathine) when Bicillin L-A® is unavailable, for the treatment of syphilis in pregnant and lactating individuals who meet the clinical criteria.
The FDA has provided distribution and administration information in a letter to healthcare professionals. Notably, the preparation and administration of Extencilline and the contraindications for prescribing differ from those for Bicillin-LA®. Extencilline will only be available by prescription in the United States.
Clinicians should continue to refer to the CDC STI Treatment Guidelines on appropriate management, including staging, of syphilis cases.