Description
Tecovirimat is used to treat human smallpox disease caused by the variola virus.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tecovirimat in children weighing 13 kilograms (kg) or more.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tecovirimat in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cariprazine
- Mavacamten
- Paclitaxel
- Paclitaxel Protein-Bound
- Repaglinide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Calcium Acetate
- Clopidogrel
- Lanthanum Carbonate
- Midazolam
- Sevelamer Carbonate
- Sevelamer Hydrochloride
- Sucroferric Oxyhydroxide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diabetes—Use with caution. May cause side effect to become worse when used together with diabetes medicine (eg, repaglinide).
- Weak immune system—Use with caution. The effects of may be decreased in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the capsule whole with 6 to 8 ounces of water. Take this medicine within 30 minutes after a moderate or high fat meal.
If you cannot swallow the capsule, you may open it and mix the contents in 30 milliliters (mL) of liquid (eg, milk, chocolate milk, or infant formula) or soft food (eg, applesauce, yogurt). Take the mixture within 30 minutes after preparing it.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For smallpox:
- Adults and children weighing 120 kilograms (kg) or more—600 milligrams (mg) (3 capsules) taken 3 times a day for 14 days.
- Adults and children weighing 40 kg to less than 120 kg—600 milligrams (mg) (3 capsules) taken 2 times a day for 14 days.
- Children weighing 25 kg to less than 40 kg—400 mg (2 capsules) taken 2 times a day for 14 days.
- Children weighing 13 kg to less than 25 kg—200 mg (1 capsule) taken 2 times a day for 14 days.
- Children weighing less than 13 kg—Use of tecovirimat injection is recommended.
- For smallpox:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, take it as soon as possible and anytime up to 8 hours before your next scheduled dose. If it is less than 8 hours before your next scheduled dose, skip the missed dose and take your next dose as scheduled.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause hypoglycemia (low blood sugar). Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Headache, severe and throbbing
Incidence not known
- Anxiety
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- dizziness
- fast heartbeat
- headache
- increased hunger
- nausea
- nervousness
- nightmares
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Belching
- bloated, full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- chapped lips
- chest pain or discomfort
- difficulty in moving
- discouragement
- dry mouth
- excess air or gas in the stomach
- feeling sad or empty
- fever
- general feeling of discomfort or illness
- heartburn
- indigestion
- irritability
- itching, skin rash
- lack of appetite
- loss of interest or pleasure
- loss of taste
- moderate diarrhea
- mouth or throat pain
- muscle pain or stiffness
- nausea
- pain, swelling, or redness in the joints
- redness or swelling of the face
- stomach discomfort, upset, or pain
- thirst
- trouble concentrating
- trouble sleeping
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
