Pronunciation:

tek-oh-VIR-i-mat

Brand Names:

• Tpoxx

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antiviral

Uses of This Medicine:

Tecovirimat is used to treat human smallpox disease caused by the variola virus.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tecovirimat in the elderly.

Breast-feeding—

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.

Other medicines—

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.

• Repaglinide

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 of This Medicine:

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. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 soft food (eg, apple sauce, 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 and dose must be determined by your doctor.

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.

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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

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 of This Medicine:

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

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

Anxiety

belching

bloated, full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

chapped lips

chest pain or discomfort

chills

difficulty in moving

discouragement

dry mouth

excess air or gas in the stomach

fast or pounding heartbeat

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

unusual tiredness or weakness

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.