Tpoxx

What is 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 of Tpoxx in children 17 years of age and younger.
• Tpoxx may not work well in people who have a weakened immune system (immunocompromised).

Who should not use 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.

What should I tell my healthcare provider before using Tpoxx?

Before taking or receiving Tpoxx, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have diabetes.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if Tpoxx can harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with Tpoxx.
• are breastfeeding or plan to breastfeed. It is not known if Tpoxx passes into your breast milk. You should not breastfeed during treatment with Tpoxx.
  • You should not breastfeed if you have smallpox because of the risk of passing variola virus to the breastfed infant.
  • Talk to your healthcare provider about the best way to feed the baby during treatment with 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.

How should I take Tpoxx capsules?

• Stay under the care of your healthcare provider during treatment with Tpoxx.
• Take Tpoxx capsules exactly as your healthcare provider tells you. Do not change the dose or stop taking Tpoxx without talking to your healthcare provider.
• For adults and children who weigh at least 40 kg and less than 120 kg, take 3 capsules of Tpoxx 2 times a day (every 12 hours) by mouth for 14 days.
• For adults and children who weigh at least 120 kg, take 3 capsules of Tpoxx 3 times a day (every 8 hours) by mouth for 14 days.
• Tpoxx should be taken within 30 minutes after eating a full meal of moderate or high fat (approximately 600 calories and 25 grams of fat). Swallow capsules whole with 6 to 8 ounces of water. 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 capsules for instructions on how to prepare and take a dose of Tpoxx if:
  • your child weighs less than 88 pounds (40 kg), or
  • you or your child have trouble swallowing Tpoxx capsules.
• 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 miss an oral dose of Tpoxx, you should take the dose as soon as possible and anytime up to 8 hours before the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and take your next dose as scheduled.
• If you take too much Tpoxx, call your healthcare provider or go to the nearest hospital emergency room right away.

How should I use Tpoxx injection?

Tpoxx injection is given to you or your child by intravenous (IV) infusion into a vein slowly over 6 hours using an infusion pump by a health care provider.

What are the possible side effects of Tpoxx?

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

General information about the safe and effective use of Tpoxx

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tpoxx for a condition for which it was not prescribed. Do not give Tpoxx to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tpoxx that is written for health professionals.

How should I store Tpoxx?

• Store Tpoxx at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Tpoxx in its original container.

Keep Tpoxx and all other medicines out of the reach of children.

What are the ingredients in Tpoxx?

Active ingredient: tecovirimat

Inactive ingredients:

Capsules: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell is made of gelatin, FD&C blue No.1, FD&C red No.3, FD&C yellow No.6, and titanium dioxide.

Injection 200mg in each 20ml vial: hydroxypropyl β-cyclodextrin and water for injection.

For more information, go to www.SIGA.com or call 1-888-899-3472.

Instructions for use for Tpoxx capsules

Tpoxx (Tē-Pox or Tee-pahx)
(tecovirimat)
capsules, for oral use

This Instructions for Use contains information on how to prepare and give a dose of Tpoxx capsules to children who weigh 28 pounds (13 kg) to less than 88 pounds (40 kg) or adults or children who have trouble swallowing Tpoxx capsules whole.

Read this Instructions for Use before taking Tpoxx and follow the steps below to prepare and give a dose of Tpoxx to adults or children who have trouble swallowing Tpoxx capsules.

Step 1: Gather the supplies you need to prepare a dose of Tpoxx:

• 1 bottle of Tpoxx (1 capsule = 200 mg of medicine)
• 1 tablespoon
• 1 small bowl
• Your choice of liquid or soft food:
  • Liquid such as milk, chocolate milk or infant formula
  • Soft food such as applesauce or yogurt

Step 2: Find the weight of the person taking the medicine on the Tpoxx Dosing Table below.

Step 3: Find the prescribed dose in the same row as the weight of the person taking the medicine on the Tpoxx Dosing Table below.

Step 4:

• Get a small bowl and place it on a flat surface.
• Add the correct amount of liquid or soft food to the bowl.

Step 5: Find the number of Tpoxx capsules needed in the same row as the weight of the person taking the medicine on the Tpoxx Dosing Table below.

• Take out the correct number of Tpoxx capsules from the bottle.

Step 6: Hold the Tpoxx capsule in a sideways (horizontal) position directly over the bowl to make sure none of the medicine is lost.

• Hold the ends of the Tpoxx capsule between the thumb and index (pointer) finger of both hands.
• Gently and slowly twist the ends of the capsule and pull it apart. Empty the contents of the capsule into the bowl. Repeat this for each capsule that is needed for your total dose.
• Throw away the empty capsule shells.

Step 7: Use the tablespoon to mix together the capsule contents and the liquid or soft food.

• The powder may not completely dissolve.
• The food and medicine mixture is now ready to take.

Step 8: Swallow the Tpoxx medicine mixture.All the Tpoxx medicine mixture should be swallowed to make sure the entire dose it taken.

• The Tpoxx mixture must be taken within 30 minutes after a meal containing approximately 25 grams of fat and within 30 minutes after mixing it.
• For people weighing 28 pounds (13 kg) to less than 264 pounds (120 kg), Tpoxx medicine mixture should be given 2 times a day (every 12 hours), by mouth, for 14 days.
• For people weighing 264 pounds (120 kg) and above, Tpoxx medicine mixture should be given 3 times a day (every 8 hours), by mouth, for 14 days.

^{aGiven twice daily every 12 hours, by mouth, for 14 days.
bGiven three times a day every 8 hours, by mouth, for 14 days.}

How should I store Tpoxx Capsules?

• Store Tpoxx at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Tpoxx in its original container.

Keep Tpoxx and all medicines out of the reach of children.

Instructions for use revised 05/2022.