Patient’s Guide to Mpox Treatment with Tecovirimat (TPOXX)
- There are no treatments specifically for mpox. But because the viruses that cause mpox and smallpox are similar, antiviral drugs developed to protect against smallpox may be used to treat mpox effectively.
- The antiviral drug tecovirimat (TPOXX) has been approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children. Drugs developed to treat smallpox may be used to treat mpox.
- 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. Investigational means there is not currently enough data available from testing in people on the safety and effectiveness of tecovirimat for treating people with mpox.
- Research is currently happening to test the safety and effectiveness for all people with mpox.
- Tecovirimat is currently only for people with severe mpox disease or who are at high risk of severe disease, like people with weakened immune systems or skin conditions, such as HIV that is not virally suppressed and eczema.
- Tecovirimat may help prevent or minimize severe mpox disease involving the eyes, mouth, throat, genitals, and anus (butthole). It may provide relief for short-term symptoms such as pain, swelling, and abscesses and long-term effects such as scarring.
- If you have mpox symptoms, visit a healthcare provider.
About Tecovirimat
- Tecovirimat is for people with severe disease or those at high risk of developing severe disease.
- Tecovirimat can reduce the amount of the virus in the body. Tecovirimat is considered investigational for the treatment of mpox because sufficient data are not yet available on the safety and effectiveness of tecovirimat in treating people with mpox.
- Research focused on safety in healthy people without mpox virus infection showed the drug was safe.
- There are current studies looking at tecovirimat as a treatment for mpox in people. Additionally, previous studies including a variety of animal species show tecovirimat can be an effective treatment for orthopoxviruses (such as mpox) in animals.
- Drugs that are effective in animal studies are not always effective in humans. Conducting studies to assess tecovirimat’s safety and efficacy in humans with mpox infections is essential.
The FDA has not yet approved tecovirimat for treatment against mpox. Under the expanded access investigational new drug (EA-IND) protocol, CDC, in partnership with FDA, has made tecovirimat easier for healthcare providers to prescribe to people with mpox who have or who are at high risk of severe disease.
Learn about the Study of Tecovirimat for Human Mpox Virus (STOMP), a NIAID-funded clinical trial to evaluate the effectiveness of the antiviral tecovirimat, also known as TPOXX.
CDC is providing this information as a resource for people who may be interested in the NIH-funded tecovirimat study.
Tecovirimat is not right for everyone
- Healthcare providers should not prescribe tecovirimat to people with milder mpox symptoms.
- When tecovirimat is prescribed too often to people with milder mpox symptoms, it may increase the chance that the mpox virus develops 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 those who need it the most at this time.
- Treatment for mpox should also include efforts to manage your symptoms. Medicines like ibuprofen (Advil, Motrin) and acetaminophen (Tylenol) can help you feel better.
Most people with mpox recover fully within 2 to 4 weeks without the need for medical treatment. Learn more about taking care of yourself.
A healthcare provider may prescribe tecovirimat for the following people:
- With severe mpox disease such as:
- bleeding or infected lesions/rash
- lesions that have merged into larger lesions
- any other conditions that require hospitalization
- With immunocompromised conditions (such as HIV that is not virally suppressed, leukemia, lymphoma, persons undergoing chemotherapy, organ transplantation, or autoimmune diseases)
- 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, abscesses etc.) and the long-term (scarring, etc.)
- With an active disease or condition that affects the skin (such as atopic dermatitis, eczema, psoriasis, impetigo, severe acne, herpes, or burns)
- Who are children, particularly those under 1 year old
- Who are pregnant or breastfeeding
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.
Based on community feedback and the need to understand tecovirimat for treating mpox in people with severe and mild disease, the National Institutes of Health, in association with the AIDS Clinical Trials Group, will be conducting a research study to understand its effectiveness.