Tpoxx

Tpoxx (tecovirimat) comes as both an oral capsule and an intravenous (IV) infusion for smallpox and monkeypox. The typical dose depends on your body weight. Usually, Tpoxx (tecovirimat) is taken by mouth 2 to 3 times a day, within 30 minutes of eating a full, fatty meal. In very young children or adults who can't take medications by mouth, Tpoxx (tecovirimat) is given as an infusion every 12 hours into the vein, each infusion lasting about 6 hours. The complete treatment course typically takes 2 weeks.

If your child has trouble swallowing capsules, you can carefully open the capsule and mix the medication in 30 mL of liquid, such as milk, or soft food, such as applesauce or yogurt. Give the mixture to your child within 30 minutes. Alternatively, Tpoxx (tecovirimat) can be given by the provider as an infusion into the vein or by a feeding tube inserted through the nose.

Tpoxx (tecovirimat) is the first medication approved to treat smallpox and it was given Fast Track and Priority Review by the FDA during the review process. The development of a medication is considered Fast Track by the FDA if that medication will be used to treat a serious medical condition that currently no other medication can treat. A medication that's given Priority Review means the FDA must make a decision on whether to approve the medication or not more quickly (within 6 months) than the typical time frame. Even though naturally-occurring smallpox cases is almost never seen anymore, there's a concern that smallpox can be used as a bioweapon. That's why the United States Congress encouraged the development of a medication to treat smallpox.

Tpoxx (tecovirimat) is available through the Strategic National Stockpile. This is a federal (or government) program that will provide Tpoxx (tecovirimat) if there is an emergency need for the medication. Even though naturally-occuring smallpox cases is almost never seen anymore, there's a concern that smallpox can be used as a bioweapon. That's why the United States Congress encouraged the development of a medication to treat smallpox. Tpoxx (tecovirimat) is placed in the Strategic National Stockpile in case smallpox is ever used as a bioweapon and treatment for smallpox is needed.

Tpoxx (tecovirimat) has been approved by the FDA to treat smallpox, but not monkeypox. The viruses that cause smallpox and monkeypox belong to the same group of viruses called Orthopoxvirus. Due to the outbreak of monkeypox in 2022, the CDC expanded access to this medication to treat monkeypox as well. This allows Tpoxx (tecovirimat) to be available for treating monkeypox before all paperwork is submitted, with the hopes that there won't be delays in treatment. All forms requested under the EA-IND can be submitted to the CDC after Tpoxx (tecovirimat) is given.