Drug Database: Tecovirimat

What is tecovirimat?

Tecovirimat is an antiviral prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox in adults and children.

Currently, tecovirimat is considered an investigational drug for mpox (formerly monkeypox) and is not FDA-approved for mpox treatment. However, an expanded access program (also known as compassionate use) allows access to and use of tecovirimat outside of clinical trials for the treatment of mpox in adults and children with severe disease or in those who are at high risk of developing severe disease.

Some reports suggest that mpox could be an opportunistic infection (OI) 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. It is currently unknown whether people with HIV have a higher likelihood of getting mpox than people without HIV. Available data indicate that people with advanced HIV or who do not have viral suppression on antiretroviral therapy (ART) can be at higher risk of severe mpox disease. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

To learn more about the use of tecovirimat for treating mpox, including information on whether or not tecovirimat is right for you, visit the Centers for Disease Control and Prevention’s (CDC) webpage Patient’s Guide to Mpox Treatment with Tecovirimat (TPOXX). For more information about mpox, visit the CDC’s Mpox webpage.

How is tecovirimat used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV include information on tecovirimat and reference the CDC’s Clinical Guidance webpage for information on the management of mpox.

The CDC’s Clinical Guidance webpage contains sections titled Guidance for Tecovirimat Use and Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised, which include recommendations on the use of tecovirimat to treat mpox in people with HIV.  

The recommended uses may not always be consistent with FDA-approved uses of tecovirimat. See the CDC’s Clinical Guidance for complete information on recommended uses of tecovirimat in people with HIV. Tecovirimat may have other recommended uses not listed above.

What should I tell my health care provider before using tecovirimat?

Before using tecovirimat, tell your health care provider:

• If you are allergic to tecovirimat or any other medicines.
• About any medical conditions you have or have had, including kidney problems, diabetes, or problems with low blood sugar (hypoglycemia).
• About anything that could affect your ability to take medicines, such as difficulty swallowing pills, difficulty remembering to take pills, or any health conditions that may prevent your use of intravenous medicines.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using tecovirimat 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. Tecovirimat may affect the way other medicines or products work, and other medicines or products may affect how tecovirimat works. Ask your health care provider if there are interactions between tecovirimat and the other medicines you take.

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

How should I use tecovirimat?

Use tecovirimat according to your health care provider’s instructions. Your health care provider will tell you how much tecovirimat to use and when to use it. Before you start tecovirimat, read any printed information that your health care provider gives you.

How should tecovirimat be stored?

• Store tecovirimat capsules at room temperature, 68°F to 77°F (20°C to 25°C).
• Store tecovirimat injection vials at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep tecovirimat in the container that it came in and keep the container tightly closed.
• Do not use tecovirimat if the original seal over the container opening is broken or missing.
• Throw away tecovirimat that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep tecovirimat and all medicines out of reach of children.

Where can I find more information about tecovirimat?

• Recommendations on the HIV-related use of tecovirimat, from the CDC webpage Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised.
• This Patient Version drug summary is based on the Expanded Access IND Protocol: Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children.
• Patient’s Guide to Mpox Treatment with Tecovirimat (TPOXX) webpage available from the CDC.
• Monkeypox Fast Facts: TPOXX (tecovirimat) available from FDA.
• Tecovirimat-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.)

Last Reviewed: May 9, 2023

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