Description
Revefenacin is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is used long-term to improve breathing problems. This medicine will not relieve a COPD attack that has already started.
Inhaled revefenacin is a long-acting bronchodilator. This medicine is breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, and troubled breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
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
Use in children is not recommended. 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 revefenacin in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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.
- Potassium Citrate
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.
- Aclidinium
- Amitriptyline
- Amoxapine
- Asciminib
- Atropine
- Belladonna
- Benztropine
- Biperiden
- Brompheniramine
- Carbinoxamine
- Carisoprodol
- Ceftobiprole Medocaril
- Chlorpheniramine
- Chlorpromazine
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Cyclobenzaprine
- Cyclopentolate
- Cyclosporine
- Cyproheptadine
- Darifenacin
- Darolutamide
- Desipramine
- Dicyclomine
- Dimenhydrinate
- Diphenhydramine
- Doxepin
- Elexacaftor
- Eltrombopag
- Encorafenib
- Fesoterodine
- Flavoxate
- Fluphenazine
- Gemfibrozil
- Glucagon
- Glycopyrrolate
- Glycopyrronium Tosylate
- Homatropine
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 problems or
- Enlarged prostate or
- Glaucoma, narrow angle or
- Trouble urinating—Use with caution. May make these conditions worse.
- COPD attack, severe—Should not be used if you are having a severe COPD attack, or if symptoms of COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.
- Kidney disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Liver disease—Use is not recommended.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.
Inhaled revefenacin comes with a Medication Guide and patient instructions. Read the instructions carefully before using this medicine and with each refill. There may be new information. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the nebulizer to make sure you are using it properly.
To use this medicine:
- Use the vials only in a standard jet nebulizer machine with a mouthpiece connected to an air compressor. Do not swallow or inject the liquid in the vial. Do not mix this medicine with any other medicine in your nebulizer.
- Do not remove the vial from the sealed pouch until you are ready to use it. Use the vial right away once you have opened the pouch.
- Check the liquid in the vial. It should be clear and colorless. Do not use it if it is discolored.
- Squeeze all of the medicine from the vial into the nebulizer cup.
- Connect the mouthpiece to the nebulizer cup with the expiratory valve facing up.
- Insert one end of the tubing to the compressor and the other end to the bottom of the nebulizer cup.
- Sit in an upright position. Place the mouthpiece in your mouth and close your lips around it. Turn on the compressor.
- Take one long, steady, deep breath in through your mouth until no more mist is seen in the nebulizer cup. Your treatment will take about 8 minutes and will end when you do not see any mist in the nebulizer anymore. Turn the compressor off.
- Do not use the nebulizer for this medicine with any other medicine.
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 inhalation dosage form (solution):
- For maintenance treatment of COPD:
- Adults—1 vial by oral inhalation once a day. Each vial contains 175 micrograms (mcg) per 3 milliliters (mL) solution.
- Children—Use is not recommended.
- For maintenance treatment of COPD:
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.
Do not use more than 1 vial in a day.
Storage
Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.
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.
Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
Talk to your doctor or get medical care right away if your symptoms do not improve after using this medicine within a few days or if they become worse, or your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.
If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.
Check with your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
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:
Less common
- Blurred vision
- body aches or pain
- chills
- cough
- cough producing mucus
- difficulty breathing
- dizziness
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- nervousness
- pounding in the ears
- slow or fast heartbeat
- sneezing
- sore throat
- stuffy or runny nose
- tightness in the chest
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in vision
- eye pain or redness
- loss of vision
- nausea
- severe constipation
- vomiting
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
- Back pain
- mouth and throat pain
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.
CON-XXXXXXXX
