Description
Brincidofovir is used to treat human smallpox disease caused by the variola virus.
This medicine is available only with your doctor's prescription.
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of brincidofovir in the pediatric population.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brincidofovir in the elderly.
Breastfeeding
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Liver disease—Use with caution. May make this condition worse.
- Weak immune system—Use with caution. May increase risk for serious side effects.
Proper Use
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.
To use the 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.
To use the 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.
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 smallpox:
- For oral dosage form (tablets):
- Adults and children weighing 48 kilograms (kg) or more—200 milligrams (mg) (two 100 mg tablets) once a week for 2 doses (on Days 1 and 8).
- Children weighing less than 48 kg—Use of oral liquid is recommended.
- For oral dosage form (suspension):
- Adults and children weighing 48 kilograms (kg) or more—20 milliliters (mL) once a week for 2 doses (on Days 1 and 8).
- Children weighing less than 48 kg—Dose is based on body weight and must be determined by your doctor.
- Children weighing 10 kg to less than 48 kg—4 milligrams per kilogram (mg/kg) of body weight once a week for 2 doses (on Days 1 and 8).
- Children weighing less than 10 kg—6 mg/kg of body weight once a week for 2 doses (on Days 1 and 8).
- For oral dosage form (tablets):
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.
Throw away any unused oral liquid.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 2 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.
Do not use this medicine if you are also receiving cidofovir injection.
This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, general tiredness or weakness, light-colored stools, nausea and vomiting, upper right stomach pain, or yellow eyes and skin.
Check with your doctor right away if you have diarrhea, nausea, vomiting, or stomach pain. These could be symptoms of a serious stomach or bowel problem.
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.
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
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:
More common
- Diarrhea
- nausea
Less common
- Stomach pain or cramps
- swelling of hands, ankles, feet, or lower legs
- vomiting
Incidence not known
- Dark urine
- decreased appetite
- light-colored stools
- unusual tiredness or weakness
- yellow eyes and skin
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
- Acid or sour stomach
- belching
- change in taste
- heartburn
- indigestion
- itching skin
- loss of taste
- muscle weakness
- rash with flat lesions or small raised lesions on the skin
- stomach discomfort or upset
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.
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