TPOXX

TPOXX is a prescription medication used to treat smallpox disease caused by a type of virus called variola virus in adults and children who weigh at least 13 kg.

TPOXX belongs to a group of drugs called antipoxvirals. It works by blocking cellular transmission of the virus, thus preventing the disease.

This medication comes in capsule form and is taken twice a day for 14 days. TPOXX is taken within 30 minutes after a meal of moderate or high fat.

Common side effects of TPOXX include headache, nausea, abdominal pain, and vomiting. TPOXX can also cause dizziness. Do not drive or operate heavy machinery until you know how TPOXX affects you.

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 13 kg.

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with TPOXX. See the “TPOXX Precautions” section.

Common side effects of TPOXX include the following:

• headache
• nausea
• abdominal pain
• vomiting

This is not a complete list of TPOXX side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• repaglinide, a blood glucose-lowering agent
• midazolam, a central nervous system depressant

This is not a complete list of TPOXX drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with TPOXX including the following:

• low blood sugar (hypoglycemia). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugar:
  • hunger
  • shakiness
  • dizziness
  • confusion
  • sweating
  • fast heartbeat
  • irritability
  • difficulty speaking
  • feeling anxious or weak

TPOXX can cause dizziness. Do not drive or operate heavy machinery until you know how TPOXX affects you.

Do not take TPOXX if you:

• are allergic to TPOXX or to any of its ingredients

No known food interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of TPOXX, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking TPOXX, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to TPOXX or to any of its ingredients
• have diabetes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with TPOXX. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if TPOXX crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using TPOXX.

Take TPOXX exactly as prescribed.

TPOXX comes in capsule form and is taken twice a day for 14 days.

• TPOXX should be taken within 30 minutes after eating a full, fatty meal. Talk to your healthcare provider about examples of foods that you can eat that contain about 25 grams of fat. Always take TPOXX with food.

• See the “Instructions for Use” that comes with your TPOXX for instructions on how to prepare and take a dose of TPOXX if:

  • your child weighs less than 40 kg, OR
  • you or your child have trouble swallowing TPOXX capsules.

Stay under the care of your healthcare provider during treatment with TPOXX.

Do not change your dose or stop taking TPOXX without talking to your healthcare provider.

• It is important to take TPOXX for the full 14 day course of treatment. Do not miss or skip a dose of TPOXX.

• If you take too much TPOXX, call your healthcare provider or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends is based on your weight.

TPOXX comes in 200 mg capsules.

The recommended doses of TPOXX for the treatment of smallpox disease are the following:

• 200 mg if body weight is from 13 kg to less than 25 kg
• 400 mg if body weight is from  25 kg to less than 40 kg
• 600 mg if body weight is above 40 kg

If you take too much TPOXX, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store TPOXX at room temperature in the original bottle.
• Keep this and all medicines out of the reach of children.