Brincidofovir Suspension

What is this medication?

BRINCIDOFOVIR (brihn sih DAH fuh veer) treats infections caused by viruses. It belongs to a group of medications called antivirals. It does not kill the virus and it may still be possible to spread the virus to others. It will not treat colds, the flu, or infections caused by bacteria.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tembexa

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Immune system problems
• Liver disease
• An unusual or allergic reaction to brincidofovir, cidofovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the label. Shake well before using. Use a specially marked oral syringe to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Talk to your care team about the use of this medication in children. While it may be prescribed to children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir

This medication may interact with the following:

• Certain antivirals for hepatitis, such as glecaprevir, paritaprevir, pibrentasvir, velpatasvir, voxilaprevir
• Certain antivirals for HIV, such as atazanavir, cobicistat, fostemsavir, lopinavir
• Clarithromycin
• Cyclosporine
• Erythromycin
• Gemfibrozil
• Rifampin
• Smallpox vaccine (live)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 2 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 2 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Keep this medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.