Tecovirimat (Oral)

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

This medicine is available only with a prescription from your doctor.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look for any unwanted effects.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it might bring. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research done so far has not shown any specific problems in children weighing 13 kilograms (kg) or more that would limit the use of tecovirimat.

Geriatric

Research done so far has not shown any specific problems in elderly patients that would limit the use of tecovirimat.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are noteworthy but may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Repaglinide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Diabetes—Use with caution. May worsen side effects when used with diabetes medicine (e.g., repaglinide).

• Weak immune system—Use with caution. The effects of the medicine may be reduced in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Severe and throbbing headache

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Anxiety
• Belching
• Feeling bloated or full
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling sensations
• Change in taste
• Chapped lips
• Chest pain or discomfort
• Chills
• Difficulty moving
• Feeling discouraged
• 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 or skin rash
• Lack of appetite
• Loss of interest or pleasure
• Loss of taste
• Moderate diarrhea
• Pain in the mouth or throat
• 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Tpoxx

Available Dosage Forms:

• Capsule

Therapeutic Class: Antiviral

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.

• What is TPOXX used to treat?