Patient’s Guide to Mpox Treatment with Tecovirimat (TPOXX)

About Tecovirimat

• Tecovirimat (TPOXX) is prescribed most often for people with severe mpox or people who are likely to get severely ill.
• Tecovirimat can reduce the amount of the virus in the body. It may help treat severe mpox disease affecting the eyes, mouth, throat, genitals, and anus (butthole).
• Studies show tecovirimat can be an effective treatment for orthopoxviruses (such as the virus that causes mpox) in animals, and that it is safe when taken by healthy people without the virus.
• However, because there are not enough data to say whether tecovirimat is safe and effective for treating people who have mpox, tecovirimat is still considered an investigational drug for mpox. Investigational means the drug is still being tested to determine whether it is safe and effective to treat a specific disease.
• If you are prescribed tecovirimat, you will be asked to sign a consent form stating you understand tecovirimat is an investigational drug that has not yet been approved by the FDA for treatment of mpox.
• Conducting studies to assess tecovirimat’s safety and effectiveness in people with mpox is essential. If your healthcare provider thinks you have mpox, they may ask you to consider taking part in a clinical trial called the Study of Tecovirimat for Human Monkeypox Virus (STOMP).
• STOMP is trying to find out how well tecovirimat works against mpox infection in people. Researchers are looking for people who may have mpox to participate in studies that give them more data.
• Participation in STOMP is voluntary. You have no obligation to enroll in the trial. If you decide not to take part, your provider might still prescribe tecovirimat for you if you are severely ill or are likely to become severely ill.
• If you are part of the STOMP trial, you may be part of a group that receives either the medication or a placebo, and you won’t know which one. Or you could be part of a group in which everyone gets tecovirimat.
• During the trial, you’ll fill out a diary to keep track of your symptoms and do daily skin checks at home. If you live near a trial site, you will get check-ups there. If you don’t live near a trial site, you can enroll remotely and get check-ups remotely.
• If you think you might benefit from tecovirimat, ask your provider. You can also contact the STOMP trial for more information about enrolling.
• The trial is being conducted by the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health.

Tecovirimat is not right for everyone

• Healthcare providers can only prescribe tecovirimat to people with mpox symptoms under special permission from the FDA, known as expanded access or compassionate use.
• When tecovirimat is prescribed too often to people with milder mpox symptoms, it may increase the chance that the virus that causes mpox will develop resistance to the medication. This means the drug might no longer work for mpox.
• The CDC and FDA are taking steps to reduce the possibility of resistance from happening by recommending that tecovirimat only be prescribed to people with severe illness or who are likely to become severely ill.
• However, patients do not have to have severe disease or be at high risk of severe illness to enroll in the STOMP trial.

How to know if Tecovirimat is right for you

A healthcare provider may prescribe tecovirimat for:

• People with severe mpox symptoms, such as:
  • bleeding or infected sores or rash
  • lesions that have merged into larger lesions
  • any other conditions that require hospitalization
• People with immunocompromising conditions, such as HIV that is not controlled, leukemia, lymphoma, or autoimmune diseases; or who are undergoing chemotherapy or had an organ transplant
• People with rash or lesions in areas such as the eyes, mouth, throat, genitals, and anus (butthole) that are at risk for severe disease in both the short-term (pain, swelling, pockets of pus, etc.) and the long-term (scarring, etc.)
• People with an active disease or condition that affects the skin, such as atopic dermatitis, eczema, psoriasis, impetigo, severe acne, herpes, or burns
• Children, especially if they’re younger than 1 year of age
• People who are pregnant or breastfeeding

How to pay for Tecovirimat

• Tecovirimat is currently free.

Contact a healthcare provider

• If you have mpox symptoms, even if you’ve had the mpox vaccine.
• To find out if tecovirimat is right for you.
• If your mpox symptoms get worse.