TPOXX

Generic name: Tecovirimat
Dosage form: capsules and injection
Drug class: Miscellaneous antivirals

Usage of TPOXX

TPOXX is a prescription medicine used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 7 pounds (3 kg).

The effectiveness of TPOXX has been studied only in animals with orthopoxvirus diseases. There have been no human studies in people who have smallpox disease.

The safety of TPOXX was studied in adults. There have been no studies in children 17 years of age and younger.

TPOXX may not work well in people who have a weakened immune system (immunocompromised).

TPOXX works as an antiviral by inhibiting the orthopoxvirus VP37 envelope wrapping protein.

TPOXX side effects

TPOXX may cause serious side effects, including:

  • Low blood sugar (hypoglycemia). Low blood sugar can happen when TPOXX is taken or received with repaglinide, a medicine used to treat type 2 diabetes. Tell your healthcare provider if you get any of the following symptoms of low blood sugar:
  • headache
  • dizziness
  • weakness
  • drowsiness
  • confusion
  • fast heartbeat
  • hunger
  • sweating
  • irritability
  • feeling jittery or shaky
  • The most common side effects of TPOXX capsules include:

  • headache
  • stomach pain
  • nausea
  • vomiting
  • The most common side effects of TPOXX injection include:

  • reactions at the site of your IV infusion
  • These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking TPOXX

    Do not receive TPOXX injection if you or your child have severe kidney problems.

    TPOXX injection contains an ingredient called hydroxypropyl β-cyclodextrin which is cleared from your body through the kidneys. Tell your healthcare provider if you or your child have kidney problems because receiving TPOXX injection may not be right for you or your child.

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    How to use TPOXX

    Usual Pediatric and Adult Dosage for Smallpox

    Pediatric and Adult Patients weighing 40 kg or more (Oral Dosing):

  • 40 kg to less than 120 kg: 600 mg of TPOXX every 12 hours for 14 days
  • 120 kg or more: 600 mg of TPOXX every 8 hours for 14 days
  • Pediatric and Adult Patients weighing 13 kg or more and those who cannot swallow capsules (Oral Dosing):

    TPOXX Capsules can be administered by carefully opening the number of capsule noted below and mixing and administering the entire contents in 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt):

  • 13 kg to less than 25 kg: 200 mg (1 Capsule) of TPOXX every 12 hours for 14 days
  • 25 kg to less than 40 kg: 400 mg (2 Capsules) of TPOXX every 12 hours for 14 days
  • 40 kg to less than 120 kg: 600 mg (3 Capsules) of TPOXX every 12 hours for 14 days.
  • 120 kg or more: 600 mg (3 capsules) every 8 hours for 14 days
  • Pediatric and Adult Patients weighing 3 kg and above (2.5) (Intravenous Dosing):

  • 3 kg to less than 35 kg: 6 mg/kg every 12 hours by intravenous infusion over 6 hours for up to 14 days
  • 35 kg to less than 120 kg: 200 mg every 12 hours by intravenous infusion over 6 hours for up to 14 days
  • 120 kg and above: 300 mg every 12 hours by intravenous infusion over 6 hours for up to 14 days.
  • Comment: - Pediatric patients weighing 13 kg or more should be switched to TPOXX Capsules to complete the 14-day treatment course as soon as oral therapy can be tolerated. Use: treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.

    What other drugs will affect TPOXX

    Tell your healthcare provider about all of the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Using TPOXX with certain other medicines may affect each other causing possible serious side effects.

    You can ask your healthcare provider or pharmacist for a list of medications that interact with TPOXX.

    Especially tell your healthcare provider if you take a medicine used to treat type 2 diabetes called repaglinide.

    Know the medicines you or your child take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

    Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TPOXX with other medicines.

    Disclaimer

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