TREATMENT OF MONKEYPOX – INFORMATION FOR VIRGINIA HEALTHCARE PROVIDERS

Currently there is no treatment approved specifically for monkeypox virus infections. However, antivirals developed for use in patients with smallpox may prove beneficial against monkeypox. CDC provides Interim Clinical Guidance for the Treatment of Monkeypox.  

Guidance on Tecovirimat (TPOXX) for Monkeypox 

Many people infected with monkeypox virus have a mild, self-limiting disease course in the absence of specific therapy. However, the prognosis for monkeypox depends on multiple factors, such as previous vaccination status, initial health status, concurrent illnesses, and comorbidities among others. More information can be found on the CDC’s Interim Clinical Guidance for the Treatment of Monkeypox

For information regarding who is eligible for tecovirimat (TPOXX) treatment, see the CDC Guidance for Tecovirimat

For information about Monkeypox Treatment in patients with HIV, see the CDC Clinical Considerations for Treatment and Prophylaxis of Monkeypox Virus Infection in People with HIV.

As a healthcare provider, how do I request TPOXX treatment?

TPOXX is available through the CDC’s Strategic National Stockpile (SNS). To request TPOXX, clinicians may complete the TPOXX Treatment Initiation Interest Form. The VDH has a small stock available for deployment upon request and has the ability to order more at any time through the SNS. The VDH also has the ability to request direct shipment from the SNS to the clinician, if needed. 

Prescribers must complete the TPOXX Patient Initiation Survey for all patients who are started on TPOXX.

What are the requirements for TPOXX prescribing/initiating? 

The CDC holds an intermediate-size patient population EA-IND (IND 116,039/Protocol 6402) to allow access to and use of TPOXX for orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the PREP Act for compensation to patients if injured via the Countermeasure Injury Compensation Program (CICP). 

Clinicians interested in prescribing TPOXX for the treatment of monkeypox should review the CDC requirements. Clinicians wishing to initiate treatment for Monkeypox should be prepared to complete the following documentation:

  1. FDA Form 1572. One signed 1572 per facility suffices for all tecovirimat treatments administered under the EA-IND at the same facility.
  2. Informed consent. Obtain prior to treatment.
  3. Patient intake form
  4. Clinical Outcome Form. Provides clinical progress of patients during TPOXX therapy (e.g., at Day 7). If the patient’s clinical condition necessitates performing clinical labs, please include a copy of the results.
  5. Adverse event form. Life-threatening or serious adverse events associated with TPOXX use should be reported to CDC (regaffairs@cdc.gov) within 24 hours of occurrence, or as soon as possible.

Optional documentation: 

  • Photos of lesions. Ideally, a photograph of at least 1 lesion prior to tecovirimat treatment and then the same lesion photographed again during treatment between days 7 and 14 (indicated dates on photos). Provide photo(s) of any new lesions that develop during or up to 7 days after completion of TPOXX treatment.
  • Samples of lesions for molecular testing. Ideally, a sample from at least 1 lesion prior to tecovirimat treatment but only if baseline diagnostic testing wasn’t performed, as well as samples from any new lesions that develop during TPOXX treatment or up to 7 days afterwards to assess for development antiviral resistance mutations. Submit samples to CDC with CDC Form 50.34, and indicate Poxvirus Molecular Detection (CDC-10515) as the test order (code).

Providers who agree to complete the above documentation and submit documentation to the CDC may obtain TPOXX by completing the TPOXX Treatment Initiation Interest Form. Prescribers must complete the TPOXX Patient Initiation Survey for all patients who are started on TPOXX.

What precautions are associated with TPOXX?

Adverse reactions and drug interactions, as well as special population considerations (pregnancy/lactation and pediatrics) can be found on the CDC’s Interim Clinical Guidance for the Treatment of Monkeypox.

Can I charge my patient for TPOXX?

No, the drug should be provided at no cost. There is no funding available to assist with laboratory testing. Testing plasma PK samples collected and sent by the hospital to the lab contracted to test PK samples and/or blood or specimens sent via the health department to CDC for serology or virologic testing would not have a cost to the patient. 

Page updated: Aug 08, 2022

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