Tecovirimat (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 not mentioned in this medication guide.

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.

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 serious kidney issues.

Inform your doctor if you have ever had:

• diabetes;
• a weakened immune system; or
• kidney issues.

It is unknown if tecovirimat will harm an unborn baby. Let your doctor know if you are pregnant or planning to become pregnant.

Do not breastfeed. Discuss with your doctor the best way to feed your baby while using tecovirimat.

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

Tecovirimat may cause serious side effects. Call your doctor right away 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.

Usual Adult Dose for Smallpox:

Oral dosage by body weight:13 kg to less than 25 kg: 200 mg (1 capsule) every 12 hours25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours120 kg and above: 600 mg (3 capsules) every 8 hoursDuration of therapy: 14 daysIntravenous infusion dosage by body weight:3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours120 kg and above: 300 mg every 12 hours by IV infusion over 6 hoursDuration: up to 14 daysComments: -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 hours25 kg to less than 40 kg: 400 mg (2 capsules) every 12 hours40 kg to less than 120 kg: 600 mg (3 capsules) every 12 hours120 kg and above: 600 mg (3 capsules) every 8 hoursDuration of therapy: 14 daysIntravenous infusion dosage by body weight:3 kg to less than 35 kg: 6 mg/kg every 12 hours by IV infusion over 6 hours35 kg to less than 120 kg: 200 mg every 12 hours by IV infusion over 6 hours120 kg and above: 300 mg every 12 hours by IV infusion over 6 hoursDuration: up to 14 daysComments: -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

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

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

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

• What is TPOXX used to treat?