Mpox Antivirals
Medical Countermeasures for the treatment of mpox
While there are currently no treatments specifically approved for mpox, therapeutics developed for patients with smallpox have been deployed during the 2022 mpox outbreak. Use of Tecovirimat (TPOXX) and other treatments should be considered in patients who may benefit from them.
TPOXX should no longer be requested through DPH, but instead through patient enrollment in the AIDS Clinical Trials Group (ACTG) Study of Tecovirimat for Human Monkeypox Virus (STOMP) trial or directly through CDC. Providers with patients with mpox who decline enrollment in or are ineligible for STOMP, or who require intravenous tecovirimat treatment, and meet treatment eligibility under the EA-IND protocol (e.g., have severe disease or involvement of anatomic areas that might result in serious sequelae, are at high risk for severe disease), can request tecovirimat by calling the CDC Emergency Operations Center (EOC) at (770) 488-7100 or [email protected].
Details for patients and providers about who may benefit from TPOXX or other medical countermeasures and more information on obtaining TPOXX can be found at the links below:
Obtaining TPOXX for patients and providers: https://www.cdc.gov/poxvirus/mpox/clinicians/obtaining-tecovirimat.html
TPOXX treatment and who may benefit: https://www.cdc.gov/poxvirus/mpox/clinicians/Tecovirimat.html
Other medical countermeasures: https://www.cdc.gov/poxvirus/mpox/clinicians/treatment.html
FAQs for Mpox Antiviral Therapy
How can I access oral TPOXX?
TPOXX can no longer be requested through DPH, but providers and patients can use this CDC link to identify a source of TPOXX (either through the NIH STOMP Study (855-876-9997) or the CDC EOC). https://www.cdc.gov/poxvirus/mpox/clinicians/obtaining-tecovirimat.html
What patients currently qualify for TPOXX?
Current guidance about TPOXX qualifications can be found at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/Tecovirimat.html. Recent data has shown that persons who are immunocompromised should be treated early even if severe disease is not currently present. A CDC Health Alert Network (HAN) update was released about severe monkeypox disease and prevention through use of early medical interinterventions: https://emergency.cdc.gov/han/2022/han00475.asp
Is TPOXX only effective if used within 10 days of illness onset?
No. TPOXX may benefit patients at any time during their illness. TPOXX should be started as early as possible, before symptoms worsen in persons with underlying immunocompromising conditions or others at risk of becoming severely ill.
Information about clinical manifestations or underlying risk factors for severe disease can be found at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/Tecovirimat.html
What other treatments are available?
Intravenous (IV) TPOXX, Vaccinia Immune Globulin Intravenous (VIGIV), cidofovir, and brincidofovir can be requested through consultation with the CDC Emergency Operations Center at 770-488-7100.
What documentation must be completed in order to receive TPOXX?
The CDC streamlined the process for healthcare providers to dispense TPOXX treatment to qualifying patients under EA-IND. There’s a reduced number of required forms and patients have the option of seeing their healthcare provider virtually. Required forms should be submitted electronically via the Tecovirimat (TPOXX) IND Online Registry for Providers and Facilities. Through the registry, providers can submit Form FDA 1572, Patient Intake Form, and Clinical Outcome Form. All required documents can be found at Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox | Mpox | Poxvirus | CDC.
What should be done with expired TPOXX?
Product Expiration: Providers can identify expiration date by lot number for both oral TPOXX and IV TPOXX products at Vaccines and Treatment for Monkeypox | SNS | HHS/ASPR.
There are currently no anticipated expiration extensions for oral TPOXX. Once expired, providers may dispose of the product using their established protocols for disposal. Information on safe disposal of medicines is available on the FDA website.
Provider locations should maintain records of lot numbers and quantities of products that are destroyed. While there are no expiration extensions for oral TPOXX, providers can elect to retain expired product in quarantine.
IV TPOXX may be eligible for expiration extension, and locations with expired inventory are strongly encouraged to continue storing it. As more information becomes available, the expiration dates will be updated on the ASPR website Vaccines and Treatment for Monkeypox | SNS | HHS/ASPR.
Page updated 6/21/2023