Brincidofovir (brin-sye-DOF-oh-vir)

Treats smallpox.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Tablet:
  • Swallow the tablet whole. Do not crush, divide, or break it.
  • You may take this medicine on an empty stomach or with a low-fat meal.
• Oral liquid:
  • Shake the bottle well just before each use.
  • Measure the oral liquid medicine with a marked oral syringe.
  • It is best to take this medicine on an empty stomach.
  • If you cannot swallow the oral liquid, you may give it through a nasogastric or gastrostomy tube.
• Do not touch the broken or crushed tablet or oral liquid. If you touch it, wash your hands with soap and water. If it got in your eyes, rinse your eyes with water.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Throw away any unused oral liquid.

Drugs and Foods to Avoid:

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

• Do not use this medicine if you are also receiving cidofovir injection.
• Some medicines can affect how brincidofovir works. Tell your doctor if you are using clarithromycin, cyclosporine, erythromycin, gemfibrozil, rifampin, or medicine to treat HIV or hepatitis C infection.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment for at least 2 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed if you have smallpox, because you may give the infection to your baby through your breast milk.
• Tell your doctor if you have liver disease or a weak immune system.
• This medicine may cause the following problems:
  • Liver problems
  • Stomach or bowel problems, including diarrhea
• Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• 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
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Diarrhea, 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