Australian Human Monkeypox Treatment
Guidelines
Published Friday, 24 June 2022

Australian Human Monkeypox1 Treatment
Guidelines
Including the management of Vaccinia virus vaccine complications

Executive summary
Guiding principles
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In the current phase of the Australian monkeypox outbreak2, seek expert guidance forclinical management of human monkeypox from an infectious diseases or sexual healthphysician. Because most infections are mild in the current outbreak, most patients will
not require antiviral treatment. However, patients requiring antiviral treatment formonkeypox should have it initiated in consultation with an infectious diseases physician
and/or a sexual health physician involved in case management.
Patients with monkeypox requiring hospital admission should ideally be managed in acentre with a suitable level of biocontainment care capability3 such as a designated High
Consequence Infectious Diseases (HCID) facility wherever possible. Such facilities canmake the most of dedicated trained personnel in managing HCID.
In patients who do not require admission to hospital, management should becoordinated with the patient's primary medical practitioner, with input from relevant
specialists and public health units.
Available treatment options remain investigational. It is important to carefully consider
the benefits and risks before initiating treatment in individual patients.
Consultation with an infectious diseases physician is also required for patients withcomplications following Vaccinia vaccination.

Purpose of guidelines
The purpose of these guidelines is to outline the current therapeutic options for the
management of human monkeypox virus4 infection and vaccine related complications.
These guidelines will be reviewed regularly as the monkeypox situation evolves and astherapeutic options change.

1This guidance document also includes the management of infections associated with Vaccinia virus-based
vaccine complications.
2
If the outbreak becomes prolonged, clinical management and treatment initiation by primary care medical
practitioners (SHPs and GPs) may become routine.
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For hospitalised patients, end to end patient management should be coordinated by a hospital incident
management team. Biocontainment in a single room may be sufficient in uncomplicated cases. If aerosol
generating procedures are undertaken, a single room with negative pressure may be required. A positive
pressure room should not be used.
4
Monkeypox is caused by viruses (e.g., monkeypox viruses) in the species Monkeypox virus within the genus
Orthopoxvirus. Taxonomic constructs follow the traditional binomial approach with genus and species epithets
italicised. Virus names are not italicised. Zerbini, F. M., et al. (2022).

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Scope
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This guidance focuses on the off-label treatment options for patients with confirmedmonkeypox virus infection or complications related to replication-competent vaccinia
virus vaccines (e.g., ACAM2000™).
This guidance further provides pharmacological options for post-exposure prophylaxis(PEP) in those at risk of severe complications following monkeypox exposure (e.g.,
severely immunocompromised).
This guidance does not elaborate on the diagnostic work up and clinical management ofpatients prior to the confirmation of monkeypox virus infection or vaccine related
complications.
For further information on diagnostic workflow: Public Health Laboratory Network(PHLN) Laboratory Case Definition.
For further information on vaccination
https://health.gov.au/resources/publications/atagi-clinical-guidance-on-vaccinationagainst-monkeypox
For further information on infection prevention and control guidance for hospital andhospital in the home https://health.gov.au/resources/publications/iceg-interimguidance-on-monkeypox-for-health-workers
For further information on public health response guidance
https://health.gov.au/resources/publications/cdna-monkeypox-virus-infection-case-andcontact-management-guidelines

Treatment of symptomatic infection
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Monkeypox is generally a self-limited infection. Most cases will not require specifictreatment other than supportive management or treatment of complications (e.g.,
antibiotics for secondary cellulitis).
Antiviral therapy should be initiated in consultation with an infectious diseases and/or
sexual health physician5.
Patients admitted to a hospital should be managed in a centre with suitablebiocontainment care capability6.
In clinically well patients, outpatient management is recommended along with sharedcare with the patient’s primary medical practitioner.
Tecovirimat is the preferred treatment for severe monkeypox virus infection.

Management of complications associated with Vaccinia vaccination••

Treatment may be required for those with complications following vaccination with areplication-competent vaccinia vaccine.
Vaccinia Immunoglobulin (VIG) is the preferred treatment for Vaccinia vaccine
complications.

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If the outbreak becomes prolonged, clinical management and treatment initiation by primary care medical
practitioners (SHPs and GPs) may become routine.
6
End to end patient management should be coordinated by a hospital incident management team.

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•Information on serious adverse events associated with Vaccinia vaccination can befound in the ATAGI monkeypox vaccination guidance.
https://health.gov.au/resources/publications/atagi-clinical-guidance-on-vaccinationagainst-monkeypox

Post-exposure prophylaxis•••

Evidence for the use of antiviral agents is limited.
Antiviral agents may be used for PEP and this guideline should be read in conjunction
with advice from ATAGI on the use of vaccines for monkeypox.
https://health.gov.au/resources/publications/iceg-interim-guidance-on-monkeypox-forhealth-workers
Identifying candidates for PEP will be aided by referring to CDNA’s monkeypox nationalguidelines for public health units. https://health.gov.au/resources/publications/cdnamonkeypox-virus-infection-case-and-contact-management-guidelines

Treatment options
Current therapeutic options for human monkeypox in Australia include:••

Tecovirimat
VIG

If expert clinical judgement determines a patient requires specific treatment formonkeypox, the preferred first option for drug treatment is tecovirimat. If tecovirimat isunavailable, VIG is the next preferred option.
If the patient requires treatment for complications following vaccination with a replicationcompetent vaccinia vaccine, VIG is the preferred option.
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Tecovirimat, which is held in the National Medical Stockpile (NMS) is not approved forthe treatment of human monkeypox by the Therapeutic Goods Administration (TGA)7. It
appears to be well tolerated and active in vitro against orthopoxviruses. It is highly
efficacious as PEP and treatment in animal models. See appendix for further details.
VIG is held in the NMS in limited quantities. It is used alone or in combination withantivirals for the treatment of Vaccinia related complications.

Other treatments with potential activity•

Cidofovir, which is currently TGA registered and used in Australia for the treatment of
human cytomegalovirus (CMV) infections, other human herpesvirus, and adenovirus
infections in immunocompromised patients. Cidofovir should be carefully considered forthe treatment of monkeypox virus infection to preserve supply, particularly for patientswith difficult to treat CMV disease and other viral infections in those that haveundergone solid organ or hematopoietic stem cell transplantation. The significant
adverse events profile especially nephrotoxicity and myelosuppression may outweighthe benefit.

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The Therapeutic Goods Administration has granted an emergency exemption for the medicine Tecovirimat
for use in Australia against monkeypox.

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•Brincidofovir which is not available in Australia and not registered by the TGA. Access isonly available to those enrolled in a clinical trial.

Indications for use
Treatment of confirmed monkeypox virus infection
https://health.gov.au/resources/publications/cdna-monkeypox-virus-infection-caseand-contact-management-guidelines•••

Tecovirimat for 14 days is the preferred treatment of monkeypox virus infection
when treatment is deemed necessary.
Those who should be considered for treatment may include:o Those with severe disease (e.g., haemorrhagic disease, confluent lesions,sepsis, encephalitis, or other conditions requiring hospitalisation)o Those who may be at high risk of severe disease:▪ Those who are immunocompromised (e.g., acquired immune
deficiency syndrome with CD4 count <200 cells/µL8, leukaemia,
lymphoma, generalised malignancy, solid organ transplantation,therapy with alkylating agents, antimetabolites, radiation, tumour
necrosis factor inhibitors, high-dose corticosteroids, hematopoietic
stem cell transplant recipient <24 months post-transplant or ≥24months but with graft-versus-host disease or disease relapse, or
having autoimmune disease with immunodeficiency as a clinicalcomponent)▪ Paediatric populations, particularly patients younger than 8 years ofage▪ Persons who are pregnant or breastfeeding▪ Those with one or more complications (e.g., secondary bacterial skininfection; gastroenteritis with severe nausea/vomiting, diarrhoea, ordehydration; bronchopneumonia; concurrent disease or othercomorbidities). Other complications include aberrant infections that
include its accidental implantation in eyes, mouth, or otheranatomical areas where monkeypox might constitute a special hazard(e.g., the risk of secondary bacterial infection and Fournier’s gangrene
in relevant sites where the risk of complicated skin and soft tissue
infections are high).
Early treatment in immunocompromised and other risk groups, e.g., children andpregnant patients. In pregnant patients, VIG may be preferred over Tecovirimat. In
very young children, consider treatment for confirmed infection with serious orprogressive infection. Consult an infectious diseases paediatrician for managementof paediatric infections.

8This threshold of 200 cells/µL represents a live vaccine cut-off between a moderate and severe definition of
immunocompromise in a setting of HIV infection. This threshold will also balance antiviral supply.

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Treatment of vaccine related complications
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VIG is preferred for the treatment of complications associated with replicationcompetent Vaccinia vaccination (ACAM2000™). Large doses of VIG may be required.
Information on serious adverse events associated with Vaccinia vaccination can befound in the ATAGI monkeypox vaccination guidance.
https://health.gov.au/resources/publications/atagi-clinical-guidance-on-vaccinationagainst-monkeypox
Established indications for VIG following vaccination include:(Cono, Casey, & Bell,2003)o Eczema vaccinatum, which involves widespread pustular/erosive lesions fromthe vaccinia virus, occurring particularly in areas affected by eczema/atopic
dermatitis.
o Generalised vaccinia which results from viraemia and presents with ageneralised vaccinia virus rash and can be accompanied by fever, myalgia,
and headache; but is self-limiting in immunocompetent hosts.
o Progressive vaccinia, which presents with delayed/absent local woundhealing and widespread lesions emanating from the inoculation site that canbecome necrotic. The risk is highest in people with severe
immunocompromise, particularly those with defective cell-mediatedimmunity.
Post-vaccination conditions where the role of treatment is uncertain includeo Accidental autoinoculation to sensitive sites, particularly the eyeo Postvaccinial central nervous system disease (postvaccinial encephalopathy(PVE) and postvaccinial encephalomyelitis (or encephalitis) (PVEM))
o Post-exposure prophylaxis in pregnancy to prevent fetal vaccinia

The evidence for treatment with VIG is limited in these situations. The pathophysiology isunclear and limited clinical experience from past suggests the VIG may not cause harm.
Consultation with an infectious diseases physician is imperative.(Aragón, Ulrich, Fernyak, &Rutherford, 2003; Hopkins & Lane, 2004; Melekhin, Karem, Damon, & Bloch, 2009; Van Dam
et al., 2009)

Post-exposure prophylaxis following a significant monkeypox exposure in an individual
at high-risk of complications
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Under guidance of an infectious diseases physician. Dose and duration of treatment
in appendix
PEP with Tecovirimat in high-risk, immunocompromised persons
PEP using VIG for inadvertent vaccination in pregnancy
This guideline should be read in conjunction with advice from ATAGI on the use of
vaccines for monkeypox virus infection
https://health.gov.au/resources/publications/atagi-clinical-guidance-on-vaccinationagainst-monkeypox
Identifying candidates for PEP will be aided by referring to CDNA’s monkeypox
national guidelines for public health units.

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https://health.gov.au/resources/publications/cdna-monkeypox-virus-infection-caseand-contact-management-guidelines

Drug combinations
Caution should be exercised when considering combining an antiviral agent and acompetent virus vaccine, e.g., ACAM2000™. Little human evidence is available on whether
combination therapy is superior to antiviral agent alone. The antiviral agent may reduce theactivity of replicating vaccines. There is animal evidence that Tecovirimat when used with
ACAM2000™ may ameliorate adverse events associated with ACAM2000™.(Berhanu et al.,2010; Douglas W. Grosenbach et al., 2008; Russo et al., 2020)

Accessing the National Medical Stockpile
Any request to access treatments held by the NMS must be made from a state or territory
Chief Health Officer (or authorised delegate) on the official NMS request form and emailed
to the NMS via stockpile.ops@health.gov.au. On receipt of this request, the NMS will seek
approval from the Chief Medical Officer to the deployment of the treatments.

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Appendix
Tecovirimat (FDA, 2022; Russo et al., 2018; Russo et al., 2021)
Other names
Dose

Regulatory history
Mechanism of action

Clinical pharmacology

Efficacy

SafetyPractice points

ST-246, Tpoxx®
200 mg capsules
Adult 600 mg bd PO for 14 days; paediatric 13–25 kg: 200 mg bd, 25–
40 kg: 400 mg bd, >40 kg: 600 mg bd, with high fat meal
No dose adjustments for renal/hepatic failure
Approved by the FDA for treatment of human smallpox disease
Not TGA registered
Antiviral drug that inhibits the orthopoxvirus VP37 envelope wrapping
protein. Prevents the formation of egress competent enveloped virions
necessary for cell-to-cell and long-range dissemination of virus.
Resistance: mutations in target VP37. Treatment emergent resistancereported.(Lederman et al., 2012)
Peak serum concentration of tecovirimat under fed conditions is up to
50% higher than under fasting conditions.
Efficacy based on animal studies (95% vs 5% mortality in non-humanprimates), may be less effective in immunocompromised and if given >6days after challenge (noting incubation period in animal models aremuch shorter than in humans so day 4 is approximately the onset of
lesions)
Potential utility as post-exposure prophylaxis based on animal models,
but duration of treatment unclear
Phase 1 study in humans (n=449, n=359 received active drug) - no safety
signals. One fatal AE (PE) not related.(D. W. Grosenbach et al., 2018)
Pregnancy - animal studies - no toxicity. Detectable in breast milk.
Common side effects include headache, nausea, abdominal pain, andvomiting.
Interactions: repaglinide (hypoglycaemia)
For patients who have trouble swallowing capsules; capsules can beadministered by carefully opening the capsule and mixing the entire
contents in 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g.,
apple sauce, yogurt). The entire mixture should be administered within
30 minutes of its preparation.

Vaccinia immune globulin (VIG) (CDC, 2022; FDA, 2018)
Other names
Proposed dose

Regulatory history

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Vaccinia Immune Globulin Intravenous (Human)
Dose of 6000 Units/kg intravenous.
Consider higher doses where the patient does not respond to the initialdose. Multiple and repeated treatments may be required.
Not TGA registered.
Indications include:- Eczema vaccinatum- Progressive vaccinia- Severe generalised vaccinia

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-Clinical pharmacology

Efficacy
SafetyPractice points

Vaccinia infections in individuals who have skin conditions suchas burns, impetigo, varicella-zoster, or poison ivy; or inindividuals who have eczematous skin lesions because of either
the activity or extensiveness of such lesions- Aberrant infections induced by vaccinia virus that include its
accidental implantation in eyes (except in cases of isolated
keratitis), mouth, or other areas where vaccinia infection would
constitute a special hazard.
VIG is not considered to be effective in the treatment of postvaccinial
encephalitis
VIG provides passive immunity for individuals with complications tovaccinia virus vaccination. The exact mechanism of action is not known
After intravenous administration of 6000 Units per kg to 31 healthy
subjects in a double-blind study, the peak plasma concentration wasachieved within 2 hours. The half-life of VIG was 30 days (range of 13 to
67 days)
Clinical studies suggest reduced pox reaction and erythema area
following VIG administration.
Contraindications:
isolated vaccinia keratitis (Altmann S, Brandt CR, Murphy CJ, etal. 2011)
anaphylaxis or prior severe systemic reaction associated with theparenteral administration of this or other human immune
globulin preparations
IgA-deficient patients with antibodies against IgA and a historyof IgA hypersensitivity, as it contains trace amounts of IgA.
Precautions: VIG administration is associated with aseptic meningitis
syndrome, transfusion-related acute lung injury, acute renal
dysfunction/failure, thrombosis, aseptic meningitis, and haemolysis.
Common adverse reactions in clinical trials (>10%) include headache,nausea, rigors, and dizziness.
Product may be stored frozen at or below –15 °C or refrigerated at 2–
8°C.
Bring VIG vials to room temperature prior to dosing. Administer 6000
U/kg intravenously through a dedicated intravenous line with theinfusion rate of no greater than 2 mL/min.

Blood glucose measurement in patients receiving VIG must be done witha glucose-specific method (monitor and test strips) to avoid interferenceby maltose contained in VIG. Glucose dehydrogenase
pyrroloquinolinequinone (GDH-PQQ) or glucose-dyeoxidoreductase
method (monitor and test strips) must not be used for blood glucose
testing in patients receiving VIG, since maltose in VIG products has beenshown to give falsely high blood glucose levels in these testing systems.
Cidofovir (Stittelaar et al., 2006; TGA, 2019)
Other names
Proposed dose

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Vistide; EMPOVIR
5 mg/kg body weight, intravenous
Induction treatment: Intravenous infusion at a constant rate over 1
hr administered once weekly for two consecutive weeks.

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Regulatory history
Clinical pharmacology

Efficacy

SafetyPractice points

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Maintenance treatment: Beginning two weeks after the completion of
induction treatment, intravenous infusion at a constant rate over 1 houradministered once every two weeks.
Approved by the TGA for the treatment of CMV infection in adults withacquired immunodeficiency syndrome
Inhibits viral DNA synthesis in CMV
Half-life elimination: 2.6 hours
Excretion: urine
No clinical data regarding efficacy against monkeypox in humans
Significant adverse events, including nephrotoxicity (kidney failure iscited as a common adverse effect in the PI)
In vitro activity against monkeypox and has been shown to be effective
against lethal challenge in animal models
Contraindications: renal impairment; concomitant administration ofcidofovir and potentially nephrotoxic agents (e.g., NSAIDs)
Precautions: dose-dependent nephrotoxicity; uveitis and/or iritis;
decreased intraocular pressure/ocular hypotony; neutropenia
Pregnancy category D (do not use)
Common adverse events include renal failure, neutropaenia, iritis,
uveitis, ocular hypotony, nausea, vomiting, diarrhoea, asthenia, fever,alopecia, and rash
Closely monitor renal function
With a syringe, transfer the appropriate dose of Cidofovir (5 mg/kg bodyweight) from the vial to an infusion bag containing 100 mL 0.9% (normal)
saline solution, and mix thoroughly. The entire volume should be infused
intravenously into the patient (adult aged 18 years or older) at aconstant rate over a period of 1 hour by use of a 2 standard infusion
pump.
Store at a temperature below 25 °C. Do not refrigerate or freeze.
Infusion admixtures may be stored temporarily for up to 24 hours in arefrigerator (2–8 °C) when reconstitution is performed under aseptic
conditions.
Administration of Probenecid 2 g po 3 hours before Cidofovir, and 1 g 2–
8 hours post Cidofovir is recommended for most indications to increase
blood levels. Probenecid may interact with several other medications. Ifprobenecid cannot be administered the pharmacokinetics of Cidofovir
may be less reliable.

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References
1. Aragón, T. J., Ulrich, S., Fernyak, S., & Rutherford, G. W. (2003). Risks of serious
complications and death from smallpox vaccination: A systematic review of the UnitedStates experience, 1963–1968. BMC Public Health, 3(1), 26. doi:10.1186/1471-2458-3-26
2. Berhanu, A., King, D. S., Mosier, S., Jordan, R., Jones, K. F., Hruby, D. E., & Grosenbach, D. W.
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16. TGA. (2019, 20 December). Australian Product Information - Empovir (Cidofovir)
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