Tecovirimat oral/injection

Generic name: Tecovirimat (oral/injection)
Brand names: Tpoxx
Drug class: Miscellaneous antivirals

Usage of 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 purposes not listed in this medication guide.

Tecovirimat oral/injection side effects

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.

    Before taking Tecovirimat oral/injection

    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.

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    How to use Tecovirimat oral/injection

    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

    Warnings

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

    What other drugs will affect Tecovirimat oral/injection

    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.

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