Description
Ensifentrine is used to treat chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.
Ensifentrine helps the muscles in the lungs stay relaxed and prevents wheezing, coughing, chest tightness, and trouble breathing. It helps decrease swelling in the lungs.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension
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 ensifentrine 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 ensifentrine 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. 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. The effects may be increased in patients with moderate or severe liver disease.
- Mental health problems (eg, depression, suicidal thoughts), history of—Use with caution. May make these conditions worse.
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.
This medicine comes with patient information leaflet and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor for help. Also, ask your doctor to regularly check how you use the nebulizer to make sure you are using it properly.
To use this medicine:
- Ensifentrine should be used with a standard jet nebulizer with a mouthpiece that is connected to an air compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe in the spray through your mouth.
- This medicine comes in an ampule that is sealed in a foil pouch. Each ampule contains one full dose of ensifentrine. Do not mix it with other medicines.
- Remove the ampule from the foil pouch. Shake the ampule until the contents are mixed thoroughly. It will appear cloudy and yellow to pale yellow.
- Twist open the top of the ampule and use it right away. Squeeze all the medicine from the ampule into the nebulizer cup or reservoir.
- Connect the mouthpiece to the nebulizer, then connect the nebulizer to the compressor.
- Sit in an upright position. Place the mouthpiece in your mouth and close your lips around the mouthpiece.
- Use the nebulizer for about 5 to 7 minutes, or until no more mist is seen in the nebulizer reservoir.
- Follow the manufacturer's directions for care and cleaning of the nebulizer and compressor.
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 (suspension):
- For maintenance treatment of COPD:
- Adults—3 milligrams (mg) (one ampule) 2 times a day, once in the morning and once in the evening.
- Children—Use and dose must be determined by your doctor.
- 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.
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. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has 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 may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, or trouble breathing after using this medicine.
This medicine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
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
- 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
Incidence not known
- Chest tightness
- discouragement
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- thoughts of killing oneself changes in behavior
- tiredness
- trouble breathing
- trouble concentrating
- trouble sleeping
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
- diarrhea
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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