Tecovirimat (tek-oh-VIR-i-mat)

Treats smallpox.

Brand Name(s):

Tpoxx

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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 (including milk, chocolate milk, or infant formula) or soft food (including apple sauce, yogurt). Take the mixture within 30 minutes after preparing it.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: 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 at your regular schedule. Do not take extra medicine to make up for a missed dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tecovirimat works. Tell your doctor if you are using midazolam, repaglinide, or phosphate binders (including calcium acetate, lanthanum carbonate, sevelamer carbonate, sucroferric oxyhydroxide).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have diabetes or a weak immune system.
• Do not breastfeed. You can spread smallpox virus to your baby through your breast milk.
• This medicine may cause hypoglycemia (low blood sugar).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness or lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nausea, vomiting, stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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