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Rifapentine Shortage

Update - April 27, 2020:

On March 25, 2020, the U.S. Food and Drug Administration (FDA) announced that rifapentine was on allocation, with intermittent supply availability, because of increased demand.  Allocation typically means that the manufacturer (here, Sanofi-Aventis) distributes the drug in volumes proportionate to the buying history of its current customers.  We do not know when rifapentine supplies will be restored to meet demand.

Rifapentine is primarily used, with isoniazid, in the weekly 12-dose regimen (3HP) for treating latent tuberculosis infection (LTBI) for preventing tuberculosis (TB) disease.  Of the three regimens that are recommended as preferred in the February 2020 treatment guidelines from NTCA and CDC, 3HP is the only one that has an intermittent dose schedule for facilitating directly observed therapy (DOT) including electronic/remote DOT.  During this shortage, we suggest that the 3HP regimen be reserved for patients or settings when DOT is the local standard of practice.  The regimen should be started only if enough medication is available for completion.

For self-administration treatment of LTBI, we suggest close communication with your local supplier and health department, and while rifapentine on shortage, suggest one of the other two preferred regimens: 4 months of daily rifampin only (4R) or 3 months of daily isoniazid plus rifampin (3HR).  Both regimens of these regimens offer rates of completion and efficacy similar to those of 3HP.  Regimens of isoniazid only for 6 months (6H) or 9 months (9H) may be considered but are not preferred because of lower rates of completion and of more frequent drug-induced liver injuries than for the briefer rifamycin-based regimens.

For updates on the rifapentine shortage, check the FDA drug shortage web page, https://www.accessdata.fda.gov/scripts/drugshortages/.  

 

Original Information - March 27, 2020:

Priftin® is the only pharmaceutical drug containing rifapentine available in the US.  Some parts of the United States have indicated difficulty in accessing the drug.  The U.S. Food and Drug Administration (FDA) has it listed as on allocation with intermittent supply as a result of an unexpected demand increase for Priftin.  

Sanofi has substantially increased the production volume of Priftin and is working to increase its manufacturing capacity but expects that the sharp ramp up after years of stable, low demand will create tension in the delivery schedule. Sanofi will do its best effort to meet demand in 2020 and is closely monitoring the distribution channel inventory to help ensure Priftin availability to customers.  

The anticipated arrival of Generic competitors on donor-funded markets outside of the US will be expected to increase the availability of rifapentine in the coming months that may bring some relief for the overall supply situation.