Ensifentrine (en-si-FEN-treen)

Treats chronic obstructive pulmonary disease (COPD).

Brand Name(s):

Ohtuvayre

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Under Pressure

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or a history of mental health problems (including depression, suicidal thoughts).
• • Increased risk of paradoxical bronchospasm (trouble breathing right after use)
  • Unusual changes in mood or behavior
• Do not use this medicine to treat a COPD attack. Your doctor may prescribe another medicine that you should use when you have a COPD flare-up.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, headache, nervousness, pounding in the ears
• Change in how much or how often you urinate, difficult or painful urination
• Changes in behavior, thoughts of hurting yourself or others
• Increased trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088