Table of Contents:
Section 1: Overview
Section 2: Patient Presentation
Section 3: Infection Prevention / Precautions
Section 4: Testing and Reporting
Section 5: Treatment
Section 6: Prophylaxis
Monkeypox is a rare infection caused by the Monkeypox virus. While this virus is classified in the same family as the variola virus which causes smallpox, symptoms are generally milder and rarely fatal. Cases outside of central and western Africa were previously uncommon and linked to imported animals. An outbreak of Monkeypox has been spreading across several countries, including the United States. The Center for Disease Control and Prevention’s U.S. Monkeypox Case Trends Reported to CDC can be utilized to track cases.
Transmission of the current outbreak is primarily through close, intimate contact with someone who has Monkeypox (direct body/contaminated clothes contact, respiratory secretions). Incubation after exposure is roughly 1-2 weeks. The virus can spread to a fetus through the placenta.
Patient presentation is similar to the clinical course of ordinary discrete smallpox. Initial prodromal symptoms include:
Shortly after the prodrome, a rash and lesions begin to develop on any given part of the body. Lesions progress through four stages including macular → papular → vesicular → pustular → scabbing / resolving. Severity of illness is dependent on baseline patient health, route of exposure, and strain of the virus. Symptoms generally resolve after 2-4 weeks. Patients are no longer contagious once scabs have resolved and normal skin forms underneath.
a. Screen and act fast to isolate patient (Contact+Droplet+Respirator)
b. Ensure private room and personal protective equipment (PPE) is available:
c. Use hospital disinfectants with ‘emerging viral pathogen’ claim
d. Report all suspected and confirmed cases to Infection Prevention for public health reporting.
e. Healthcare personnel (HCP) potentially exposed to confirmed cases will be notified by management. Exposed HCP should self-monitor themselves for symptoms and will be given these forms from Associate & Occupational Health (AOH).
Testing for Monkeypox infection includes preliminary testing for non-variola orthopoxvirus. Orthopoxvirus positive results during the current pandemic are presumed to be Monkeypox given the lack of other orthopoxviruses circulating in the United States. Swabs from two lesions in separate parts of the body should be collected. Vigorous swabbing is recommended to collect adequate DNA. De-roofing of the lesion prior to swabbing is unnecessary. Break off the end of each swab’s applicator into a 1.5-or 2-mL screw-capped tube with O-ring or place the entire swab in a sterile container that has a gasket seal and is able to be shipped under the required conditions. Refer to local state Department of Health and Infection Prevention instructions for specific specimen collection, shipping, and reporting requirements. Other tests may be required as well, including chickenpox, herpes, syphilis, etc.
In most cases, Monkeypox infection will present as mild and self-limiting in the absence of a specific therapy. For severe disease or patients at high-risk for severe disease, use of the antiviral t tecovirimat(SIGA) may be beneficial. Current supply is limited therefore procurement via the expanded access investigational new drug protocol (EA-IND), also known as “compassionate use”, from the Strategic National Stockpile (SNS) is required.
Risks of using available alternative therapeutics may not outweigh potential benefits. Therefore alternative agents are not recommended at this time unless tecovirimat is unavailable and after shared decision-making.
Refer to the CDC Monkeypox - Information for Healthcare Professionals for more information.
|Tecovirimat (SIGA) - EA-IND Protocol, Package Insert|
|Indications||FDA-approved for the treatment of smallpox in adults and children weighing at least 3 kg. CDC holds an EA-IND also known as “compassionate use” for treatment of Monkeypox. Efficacy data against Monkeypox is derived primarily from animal studies.|
|Mechanism of Action||Inhibitor of the orthopoxvirus VP37 envelope wrapping protein|
|Criteria for Use|
Limited supply available therefore use is restricted to the treatment of confirmed active Monkeypox infection in individuals meeting at least one of the following criteria:
|Use of the IV formulation is restricted to the following patients:|
|Formulations / Dosing||Oral 200 mg capsules:|
|Warnings / Adverse Events||Contraindications:|
|Pregnancy / Lactation: No human data available at this time. Animal data does not show evidence of reproductive harm. Use requires shared decision-making between the local/state health department, CDC, the patient’s provider, and the patient or caregiver themselves.|
|Drug Interactions||Repaglinide - increased risk for hypoglycemia requiring close monitoringMidazolam - reduced effectiveness of midazolam|
Refer to the CDC Guidance page, Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox, for the most up-to-date procedures.
Patients must be educated and consented prior to use. See Page 22 of the Package Insert for the Medication Guide.
JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) is FDA-approved for the prevention of Monkeypox in adults and is available under Emergency-Use Authorization (EUA) for high-risk children and as an alternative regimen for high-risk adults to expand immunization access during the current pandemic. The product is being distributed by the SNS at this time and may be administered as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) based on availability and local guidance. Refer to CDC Monkeypox - Considerations for Monkeypox Vaccination and Advisory Committee on
Immunization Practices recommendations for JYNNEOS® for more information.
|Smallpox and Monkeypox Vaccine, Live, Non-replicating (JYNNEOS®) - EUA Fact Sheet, Prescribing Information|
FDA-approved for the prevention of smallpox or Monkeypox in patients 18 years or older.
On August 9, 2022, the FDA issued an EUA for the intradermal administration of the JYNNEOS® vaccine in adults 18 years or older at high-risk of for Monkeypox infection and for subcutaneous administration in individuals younger than 18 years of age at high-risk for Monkeypox infection. This approval will expand access to the current vaccine product by lowering the required injection volume (one fifth) for adults allowing for multiple doses per vial. Efficacy data against Monkeypox is based on clinical human and animal data.
|Mechanism of Action||Live-attenuated Vaccinia virus|
|Criteria for Use|
Vaccination as PrEP or PEP may be considered in all patients at high-risk for Monkeypox infection.
Efficacy and safety has been demonstrated in patients living with HIV who are virologically suppressed with CD4 counts >100 cells/mm3,8-10
|Formulation / Dosing|
Dosing and Administration:
Frozen ( -20°C), if freezer capacity is available, OR Refrigerated (2-8°C). Do not refreeze.
|Warnings / Adverse Events|
Contraindications: previous severe allergic reaction to JYNNEOS® (precaution in patients with severe gentamicin, ciprofloxacin, or chicken/egg protein allergies - may require 30 minute observation period)
Adverse Events: injection site pain, swelling, induration, itching, redness, fatigue, headache, muscle pain. Local reactions may be more common when the vaccine is administered via intradermal route.
Pregnancy / Lactation: No human data. Animal data does not show evidence of reproductive harm. Unlikely to pose a risk of infection from the vaccine to infants during breastfeeding.
Due to limited supply JYNNEOS® is being distributed by the SNS.