Response to Monkeypox: Available Vaccines and Treatments

Antiviral Drugs

TPOXX® (tecovirimat)

The SNS has a supply of the smallpox antiviral drug TPOXX® (tecovirimat), which can be used to treat individuals with monkeypox with an appropriate regulatory mechanism. CDC currently has an expanded access Investigational New Drug protocol that allows its use for monkeypox.

The smallpox antiviral drug TPOXX supplied by the SNS does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label, and refer to tables 2 and 3, below, to identify the corresponding expiration date.

CDC provides treatment recommendations and clinical guidance to help healthcare professionals evaluate and manage patients with suspected or confirmed mpox.

Tembexa (brincidofovir)

SNS also holds Tembexa® (brincidofovir),, an antiviral medication that was approved by the FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

Tembexa can be considered for use under a single-patient emergency Investigational New Drug (e-IND) protocol for treatment of human monkeypox disease. Clinicians seeking Tembexa treatment for patients with monkeypox need to submit an e-IND request to FDA by email (DDI.EIND@fda.hhs.gov) or phone 301-796-3400 or 1-855-543-3784 during normal business hours (8 am-4:30 pm ET M-F). During after hours, call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or email CDER-EIND@fda.hhs.gov and call the call the CDER Emergency Coordinator at 301-796-9900.

Tembexa supplied by the SNS may not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label, and refer to tables 4 and 5, below, to identify the corresponding expiration date.