Drug Database: Fidaxomicin

What is fidaxomicin?

Fidaxomicin is an antibacterial prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of diarrhea caused by enteric infection with the bacterium Clostridioides difficile.

Certain bacterial enteric infections can be opportunistic infections (OIs) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems —such as people with HIV—than in people with healthy immune systems.

To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

How is fidaxomicin used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV include recommendations on the use of fidaxomicin to treat bacterial enteric infection caused by Clostridioides difficile.

The recommended uses may not always be consistent with FDA-approved uses of fidaxomicin. See the Guidelines for complete information on recommended uses of fidaxomicin in adults and adolescents with HIV. Fidaxomicin may have other recommended uses not listed above.

What should I tell my health care provider before taking fidaxomicin?

Before taking fidaxomicin, tell your health care provider:

• If you are allergic to fidaxomicin or any other medicines.
• About any medical conditions you have or have had.
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills. A liquid form of fidaxomicin is available for people who have difficulty swallowing pills.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking fidaxomicin during pregnancy.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Fidaxomicin may affect the way other medicines or products work, and other medicines or products may affect how fidaxomicin works. Ask your health care provider if there are interactions between fidaxomicin and the other medicines you take.

Ask your health care provider about possible side effects from fidaxomicin. Your health care provider will tell you what to do if you have side effects.

How should I take fidaxomicin?

Take fidaxomicin according to your health care provider’s instructions. Your health care provider will tell you how much fidaxomicin to take and when to take it. Before you start fidaxomicin and each time you get a refill, read any printed information that comes with your medicine.

How should fidaxomicin be stored?

• Store fidaxomicin tablets at room temperature, 68°F to 77°F (20°C to 25°C).
• Store fidaxomicin granules for oral suspension at room temperature, 68°F to 77°F (20°C to 25°C). Keep the granules for oral suspension in the original package, and do not open the pouch until time of use. After fidaxomicin granules are reconstituted (mixed) with purified water, store the oral suspension in a refrigerator at 36°F to 46°F (2°C to 8°C) for up to 12 days.
• Keep fidaxomicin in the container that it came in and keep the container tightly closed.
• Do not use fidaxomicin if the original seal over the container opening is broken or missing.
• Throw away fidaxomicin that is no longer needed or expired (out of date). Follow FDA Guidelines on how to safely dispose of unused medicine.
• Keep fidaxomicin and all medicines out of reach of children.

Where can I find more information about fidaxomicin?

• Recommendations on the HIV-related uses of fidaxomicin, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated), granule (for suspension). The Patient Package Insert includes information for people taking fidaxomicin.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for fidaxomicin available from MedlinePlus.
• Fidaxomicin-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)