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 purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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 tecovirimat 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.

Usual Adult Dose for Smallpox:

Oral dosage by body weight:
13 kg to less than 25 kg: 200 mg (1 capsule) every 12 hours
25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours
40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours
120 kg and above: 600 mg (3 capsules) every 8 hours

Duration of therapy: 14 days

Intravenous infusion dosage by body weight:
3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours
35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours
120 kg and above: 300 mg every 12 hours by IV infusion over 6 hours

Duration: up to 14 days

Comments:
-Patients weighing at least 13 kg should be switched to oral capsules to complete the 14-day course as soon as oral therapy can be tolerated.
-Injection formulation is NOT for IV bolus injection.

Use: Treatment of human smallpox disease caused by variola virus

Usual Pediatric Dose for Smallpox:

Oral dosage by body weight:
13 kg to less than 25 kg: 200 mg (1 capsule) every 12 hours
25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours
40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours
120 kg and above: 600 mg (3 capsules) every 8 hours

Duration of therapy: 14 days

Intravenous infusion dosage by body weight:
3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours
35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours
120 kg and above: 300 mg every 12 hours by IV infusion over 6 hours

Duration: up to 14 days

Comments:
-Patients weighing at least 13 kg should be switched to oral capsules to complete the 14-day course as soon as oral therapy can be tolerated.
-Injection formulation is NOT for IV bolus injection.

Use: Treatment of human smallpox disease caused by variola virus in pediatric patients weighing at least 3 kg

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.

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 attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Tecovirimat may cause serious side effects. Call your doctor at once if you have:

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

Common side effects of tecovirimat may include:

• bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed (tecovirimat injection);

• headache (tecovirimat oral); or

• nausea, vomiting, stomach pain (tecovirimat oral).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.