Patient information: uses, side effects, how to take - 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 receive TPOXX injection?
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.
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 takea 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?
- Stay under the care of your healthcare provider during treatment with TPOXX.
TPOXX capsules:
- 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.
TPOXX Injection for Intravenous Infusion (IV)
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
- drowsiness
- hunger
- feeling jittery or shaky
- dizziness
- confusion
- sweating
- weakness
- fast heartbeat
- irritability
The most common side effects of TPOXX capsules include:
- headache
- nausea
- stomach pain
- 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.
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.
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.
What are the ingredients in TPOXX?
TPOXX capsules: 200 mg
Active ingredient:tecovirimat
Inactive ingredients: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.
TPOXX injection: 200 mg in each 20 mL vial
Active ingredient:tecovirimat
Inactive ingredients:hydroxypropyl β-cyclodextrin and water for injection.
TPOXX capsules manufactured by:
Catalent Pharma Solutions
1100 Enterprise Drive
Winchester, KY 40391
TPOXX injection manufactured by:
Patheon Manufacturing Services LLC
5900 Martin Luther King Jr. Highway
Greenville, NC 27834
Distributed By:
SIGA Technologies, Inc.
4575 SW Research Way, Suite 110
Corvallis, OR 97333
For more information, go to www.SIGA.comor call 1-888-899-3472.
INSTRUCTIONS FOR USE 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 capsules. There may be new information. This Instructions for Use does not take the place of talking to your healthcare provider about your medicinal condition or treatment. |
Step 1:Gather the supplies you need to prepare a dose of TPOXX:
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| Step 2:Find the weight of the person taking the medicine on the TPOXX Dosing Table (see Figure A). |
| Step 3:Find the prescribed dose in the same row as the weight of the person taking the medicine on the TPOXX Dosing Table (see Figure A). |
Step 4:
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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 (see Figure A).
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Step 6:Hold the TPOXX capsule in a sideways (horizontal) position directly over the bowl or cup to make sure none of the medicine is lost.
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Step 7:Use the tablespoon to mix together the capsule contents and the liquid or soft food.
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Step 8:Swallow the TPOXX medicine mixture. All the TPOXX medicine mixtureshould be swallowed to make sure the entire dose it taken.
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aGiven twice daily every 12 hours, by mouth, for 14 days. bGiven three times a day every 8 hours, by mouth, for 14 days. | ||||
| TPOXX Dosing Table (Figure A) | ||||
Body Weight | Prescribed Dose | Amount of Liquid or Soft Food | Number of Capsules | Food and Medicine Mixture Instructions |
28 pounds (13 kg) to less than 55 pounds (25 kg) a | 200 mg (1 capsule) Every 12 hours | 2 tablespoons | 1 TPOXX capsule | Mix entire contents of 1 TPOXX capsule with 2 tablespoons of liquid or soft food. |
55 pounds (25 kg) to less than 88 pounds (40 kg) a | 400 mg (2 capsules) Every 12 hours | 2 tablespoons | 2 TPOXX capsules | Mix entire contents of 2 TPOXX capsules with 2 tablespoons of liquid or soft food. |
88 pounds (40 kg) to less than 265 pounds (120 kg) a | 600 mg (3 capsules) Every 12 hours | 2 tablespoons | 3 TPOXX capsules | Mix entire contents of 3 TPOXX capsules with 2 tablespoons of liquid or soft food. |
265 pounds (120 kg) and above b | 600 mg (3 capsules) Every 8 hours | 2 tablespoons | 3 TPOXX capsules | Mix entire contents of 3 TPOXX capsules with 2 tablespoons of liquid or soft food. |
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.
TPOXX capsules Manufactured by:
Catalent Pharma Solutions
1100 Enterprise Drive
Winchester, KY 40391
TPOXX injection manufactured by:
Patheon Manufacturing Services LLC
5900 Martin Luther King Jr. Highway
Greenville, NC 27834
Distributed by:
SIGA Technologies, Inc.
4575 SW Research Way, Suite 110
Corvallis, OR 97333
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 05/2022