Patient Medication Information: uses, side effects, how to take - Tpoxx
What is TPOXX used for:
TPOXX is used to treat smallpox disease in adults and in children and adolescents who weigh at least 13 kilograms (kg).
How TPOXX works:
TPOXX stops the virus that causes smallpox disease from spreading from cell to cell within the body. This prevents the virus from spreading through your body. Your own body can then build up protection against the virus until you are better.
The ingredients in TPOXX are:
Medicinal ingredients: Tecovirimat monohydrate
Non-medicinal ingredients: ammonium hydroxide, colloidal silicon dioxide, crocarmellose sodium, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin hydroxypropyl methylcellulose, isopropyl alcohol, lactose monohydrate, magnesium stearate microcrystalline cellulose, n-butyl alcohol, propylene glycol, shellac, simethicone, sodium lauryl sulfate, and titanium dioxide.
TPOXX comes in the following dosage form(s):
As capsules containing 200 mg tecovirimat (as tecovirimat monohydrate).
Do not use TPOXX if:
- You are allergic to tecovirimat.
- You are allergic to any of the other ingredients in TPOXX or a component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TPOXX. Talk about any health conditions or problems you may have, including if you:
- Have a weakened immune system. TPOXX may not work as well for you.
- Plan to receive a live smallpox vaccine. Taking TPOXX at the same time may make the vaccine less effective.
- Are taking the medicine repaglinide, used to treat diabetes. Taking TPOXX along with repaglinide may make your blood sugar too low.
- Are taking the medicine midazolam, used to treat seizures, anxiety and sleep problems. TPOXX may make midazolam less effective.
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13KG BASED ON LIMITED CLINICAL TESTING IN HUMANS.”
Are pregnant, think you might be pregnant or are planning to become pregnant.
- Are breastfeeding.
Other warnings you should know about:
- Talk to your doctor or pharmacist before taking TPOXX.
- TPOXX has only been studied in adults. It has not been studied in children and adolescents 17 years of age and younger. The effectiveness of TPOXX has only been studied in animals. It has not been studied in people with smallpox disease.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following medicines may interact with TPOXX:
- Repaglinide, used to treat diabetes.
- Midazolam, used to treat seizures, anxiety and sleep problems.
Any of the following used in people with end-stage renal disease (ESRD) to lower the amount of phosphate in the blood:
- Sevelamer carbonate;
- Calcium acetate;
- Sucroferric oxyhydroxide;
- Lanthanum carbonate
How to take TPOXX:
- Always take TPOXX exactly as your healthcare professional has told you.
- Check with your healthcare professional if you are not sure.
- Always take TPOXX with food.
- TPOXX must be taken no more than 30 minutes after eating a full meal of moderate or high fat. This is to make sure that TPOXX is absorbed by your body properly. A meal of moderate to high fat contains about 25 grams of fat. Talk to your healthcare professional if you are not sure what kind of meal you should eat with TPOXX.
- Do not stop taking this medicine without consulting your healthcare professional first.
- You must take TPOXX for the full 14-day treatment period for it to work properly. Do not miss or skip a dose.
If you find swallowing capsules difficult, your healthcare professional may recommend opening the capsules and mixing with food. Follow these instructions:
- Wash and dry your hands before and after preparation.
- Carefully open the capsule so that the contents do not spill or escape into the air.
- Hold the capsule with the cap facing up and pull the cap away from the body of the capsule.
- Empty the capsule contents into a small container for mixing.
- Mix the entire contents of the capsule with 30 mL of liquid such as milk or chocolate milk or soft food such as yogurt or applesauce.
- The mixture should be taken within 30 minutes after mixing and within 30 minutes of eating a meal.
- Swallow the entire mixture to make sure the entire dose is taken.
- Throw away the empty capsule shell.
- Refer to the dosing information under “Usual dose” for the contents of how many capsules you should be taking. This differs for adults, children and adolescents according to body weight.
Usual dose:
Adults who weigh at least 40 kg and less than 120 kg:
Three (3) capsules every 12 hours (2 times per day) for 14 days. TPOXX must be taken within 30 minutes after a full meal that contains moderate or high fat.
Adults who weigh 120 kg and above:
Three (3) capsules every 8 hours (3 times per day) for 14 days. TPOXX must be taken within 30 minutes after a full meal that contains moderate or high fat.
Children and Adolescents who weight at least 13 kg:
The amount of TPOXX that children and adolescents should take depends on their weight in kilograms (kg). See table below for details. This medicine is not recommended for use in children who weigh less than 13 kg. TPOXX must be taken no more than 30 minutes after a full meal that contains moderate or high fat.
Recommended Doses for Children and Adolescents
| Body Weight | TPOXX Dose |
|---|---|
| 13 kg to less than 25 kg | One (1) capsule every 12 hours (2 times per day) for 14 days |
| 25 kg to less than 40 kg | Two (2) capsules every 12 hours (2 times per day) for 14 days |
| 40 kg to less than 120 kg | Three (3) capsules every 12 hours (2 times per day) for 14 days |
| 120 kg and above | Three (3) capsules every 8 hours (3 times per day) for 14 days |
Overdose:
If you think you, or a person you are caring for, have taken too much TPOXX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose of TPOXX, take it as soon as you remember. Take you next dose at the regularly scheduled time.
Possible side effects from using TPOXX:
These are not all the possible side effects you may feel when taking TPOXX. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Dizziness
- Nausea or vomiting
- Diarrhea
- Dry mouth
- Feeling tired or sleeping
- Being unable to concentrate or having a low attention span
- Experiencing taste disturbances
- Constipation
- Indigestion or upset stomach
- Abdominal pain or discomfort
- Chapped lips
- Belching or burping
- Joint pain or stiffness
- Fever
- Chills
- Generally feeling unwell (malaise)
- Feeling thirsty
Serious side effects and what to do about them
| Symptom/ effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Headache | ✓ | ||
| COMMON | |||
| Abdominal Pain | ✓ | ||
| RARE | |||
| Red or purple spots on the skin that do not turn white when applying pressure | ✓ | ||
| Mouth pain | ✓ | ||
| Facial swelling, redness or itchiness | ✓ | ||
| Feeling uneasy or dissatisfied | ✓ | ||
| Depression or anxiety | ✓ | ||
| Irritability | ✓ | ||
| Panic attack: feeling of loss of control or danger, shortness of breath, shaking | ✓ | ||
| Tingling or numbness in the hands, feet, or mouth | ✓ | ||
| Itching, rash, or hives | ✓ | ||
| Pain | ✓ | ||
| Abnormal scan of electrical activity of the brain called an electrocephalogram | ✓ | ||
| Blood test result that shows you have lower numbers of red blood cells than usual | ✓ | ||
| Increased heart rate | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store TPOXX at room temperature (15°C to 25°C).
Do not use this medicine after the expiry date shown on the bottle.
Keep out of reach and sight of children.
If you want more information about TPOXX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/); the manufacturer’s website www.siga.com or by calling 1-888-899-3472.