Tpoxx (oral/injection)

Tecovirimat is used to treat smallpox disease caused by the Variola virus in people who weigh at least 7 pounds (3 kg).

Tecovirimat may also be used for reasons that are not included in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use tecovirimat injection if you have severe kidney problems.

Tell your doctor if you have ever had:

• diabetes;
• a weak immune system; or
• kidney problems.

It is not known if tecovirimat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed. Talk to your doctor about the best way to feed your baby if you are using tecovirimat.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Tpoxx may lead to serious side effects. Contact your doctor immediately if you experience:

• low blood sugar--weakness, confusion, tremors, sweating, fast heartbeats, sleepiness, dizziness, headache, hunger, irritability.

Common side effects of Tpoxx may include:

• bruising, swelling, warmth, redness, oozing, or bleeding at the site of the IV needle (tecovirimat injection);
• headache (tecovirimat oral); or
• nausea, vomiting, stomach pain (tecovirimat oral).

This is not a complete list of side effects, and others may happen. Reach out to your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tecovirimat oral is taken by mouth.

Tecovirimat oral doses are based on weight. Your dose may change if you gain or lose weight. Take this medicine for the full 14 day course treatment.

Take tecovirimat oral within 30 minutes after a fatty meal. Talk with your doctor about what types of foods to eat.

Take tecovirimat oral with a full glass of water.

If you cannot swallow a capsule whole, open it and mix the medicine with milk, infant formula, pudding or applesauce. Swallow the mixture right away without chewing.

Tecovirimat injection is given in a vein by a healthcare provider slowly over 6 hours using an infusion pump.

Store tecovirimat oral in the original container at room temperature away from moisture and heat.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses at one time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's directions regarding any limits on food, drinks, or activities.

Tell your doctor about all your other medicines, especially repaglinide.

This list is not complete. Other drugs may affect repaglinide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• What is TPOXX used to treat?