Description
Vibegron is used to treat symptoms of an overactive bladder. It is also used to treat symptoms of an overactive bladder in male patients taking medicine for benign prostatic hyperplasia (enlarged prostate). It helps control urinary incontinence (a strong need to urinate with leaking or wetting accidents), urgency or the need to urinate right away, and the need to urinate often. Vibegron relaxes the muscles of the bladder to prevent them from causing incontinence.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 have not been performed on the relationship of age to the effects of vibegron in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vibegron 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Colchicine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cyclosporine
- Dabigatran Etexilate
- Digoxin
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Ensartinib
- Lefamulin
- Mavorixafor
- Morphine
- Morphine Sulfate Liposome
- Posaconazole
- Ranolazine
- Relugolix
- Repotrectinib
- Tenofovir Alafenamide
- Venetoclax
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:
- Bladder blockage (hard to urinate)—Use with caution. May make this condition worse.
- End-stage kidney disease or
- Liver disease, severe—Use is not recommended in patients with these conditions.
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. To do so may increase the chance for side effects.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the tablet whole with a glass of water. You may also crush the tablet and mix it with a tablespoon (about 15 milliliters) of applesauce. Swallow the mixture right away with a glass of 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 oral dosage form (tablets):
- For bladder problems:
- Adults—75 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For bladder problems:
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may increase your risk of having urinary retention (trouble passing urine or not fully emptying the bladder), especially if you have bladder blockage or when using another medicine. Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine (dribbling), or painful urination.
This medicine may cause a serious allergic reaction called angioedema, which can be life threatening and requires immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, or throat, or trouble breathing.
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
- Bladder pain
- bloody or cloudy urine
- blurred vision
- difficult, burning, or painful urination
- dizziness
- frequent urge to urinate
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- slow or fast heartbeat
Less common
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- loss of voice
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Incidence not known
- Decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- itching, skin rash, encrusted, scaly and oozing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- trouble breathing
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
- Constipation
- cough or cough producing mucus
- diarrhea
- dry mouth
- feeling of warmth
- muscle aches
- nausea
- redness of the face, neck, arms and occasionally, the upper chest
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.
DRG-20507673
