Usual Adult Dose for Smallpox Prophylaxis

SMALLPOX AND MONKEYPOX PROPHYLAXIS (FDA Authorized Use):
Two subcutaneous doses of 0.5 mL each, 4 weeks apart

Comment:

• For subcutaneous injection only

Use: Prevention of smallpox and monkeypox disease in adults 18 years or older at high risk of infection.

EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:
Two intradermal doses of 0.1 mL each, 4 weeks apart

Comments:

• For intradermal injection only
• This drug has not been approved for this use.

Use: Issued as EUA for prevention of monkeypox disease in adults 18 years or older at high risk of infection.

Usual Adult Dose for Monkeypox

SMALLPOX AND MONKEYPOX PROPHYLAXIS (FDA Authorized Use):
Two subcutaneous doses of 0.5 mL each, 4 weeks apart

Comment:

• For subcutaneous injection only

Use: Prevention of smallpox and monkeypox disease in adults 18 years or older at high risk of infection.

EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:
Two intradermal doses of 0.1 mL each, 4 weeks apart

Comments:

• For intradermal injection only
• This drug has not been approved for this use.

Use: Issued as EUA for prevention of monkeypox disease in adults 18 years or older at high risk of infection.

Usual Pediatric Dose for Monkeypox

EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:
Two subcutaneous doses of 0.5 mL each, 4 weeks apart

Comments:

• For subcutaneous injection only
• This drug has not been approved for this use

Use: Issued as EUA for prevention of monkeypox disease in individuals younger than 18 years of age.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• None reported

Safety and efficacy of the FDA approved dosing of this drug to prevent smallpox and monkeypox, have not been established in patients younger than 18 years.
Intradermal modified dose for adults, and subcutaneous use in patients younger than 18 years old have been authorized as part of the EUA to address the monkeypox public health emergency.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General administration advice:

• Allow the vaccine to reach room temperature before use.
• When thawed, this vaccine should be a milky, light yellow pale suspension. Inspect visually for particulate matter and discoloration prior to administration. If any of these exist, do not administer.
• Swirl the vial gently before administration (at least for 30 seconds), then withdraw the dose into a sterile syringe for injection.
• Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration.

Subcutaneous injection:

• Administer by subcutaneous injection only, preferably into the upper arm (deltoid) in children older than 1 year old and adults.
• Administer into the anterolateral thigh for infants less than 1 year old.

Intradermal injection for adult patients:

• Each dose should contain 0.1 mL of vaccine (5 doses can be extracted from a single vial). If the amount remaining in the vial cannot provide a full dose of 0.1 mL, discard the vial and its contents. Do not pool a dose from multiple vials.
• Administer intradermal, preferably into the inner side of the forearm.

Storage requirements:

• Keep frozen at -25C to -15C (-13F to 5F)
• Store in original package to protect from the light.
• Once thawed, keep at 2C to 8C (36F to 46F) for 12 hours.
• Once thawed, do not refreeze.
• Do not use after the expiration date shown in the vial label.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use) or the Fact Sheet for Recipients and Caregivers provided by your health care provider.
• This vaccine requires two doses 4 weeks apart.
• Report any adverse events to your health care provider or to the Vaccine Adverse Reporting System: https://vaers.hhs.gov.