Ensifentrine (inhalation)

Ensifentrine is an inhalation suspension used to treat COPD (chronic obstructive pulmonary disease) in adults.

Ensifentrine (inhalation) may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ensifentrine inhalation is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical help if your breathing problems worsen quickly, or if you think your medications are not working as well.

Use one ampule of ensifentrine inhalation twice each day (in the morning and in the evening).

Ensifentrine inhalation is for use only with a special nebulizer device. Do not mix other medicines in the nebulizer chamber.

Do not take this medicine out of its foil pouch until you are ready to use it in the nebulizer device.

Shake the ampule vigorously before each use. Pour the medicine into the nebulizer chamber. Attach the mouthpiece, then attach the chamber to the compressor. Sit up straight and place the mouthpiece in your mouth. Turn on the compressor.

Dispose of the ampule after one use, even if there is still medicine left inside.

Breathe slowly through your mouth until there is no more mist and the drug chamber is empty. Clean the nebulizer after each use, following the provided directions.

Continue using this medicine even if you feel well. Ask your doctor before stopping the medicine.

Store this medicine upright in the original container at room temperature, away from moisture, direct sunlight, and heat. Do not freeze.

Stop using this medicine and contact your doctor immediately or seek emergency medical help if you experience wheezing, choking, or other breathing issues after using this medicine.

Inform your doctor right away if you notice new or sudden changes in your mood or behavior, such as new or worsening depression or anxiety, difficulty sleeping, or feelings of impulsiveness, irritability, agitation, hostility, aggression, restlessness, or thoughts about suicide or self-harm.

You should not use ensifentrine (inhalation) if you are allergic to it.

Tell your doctor if you have or have ever had:

• mental illness, including depression or suicidal thoughts or actions; or
• liver disease.

It is not known if ensifentrine (inhalation) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using ensifentrine.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Be aware of changes in your mood or symptoms. Your family or caregivers should also monitor for sudden changes in your behavior.

Stop using ensifentrine and call your doctor immediately or get emergency medical help if you experience wheezing, choking, or other breathing problems after using this medicine.

Ensifentrine may cause serious side effects. Call your doctor right away if you have:

• suicidal thoughts or actions;
• new or worsening symptoms of depression or anxiety;
• trouble sleeping;
• changes in mood or behavior; or
• feelings of impulsiveness, irritability, agitation, hostility, aggression, or restlessness.

Common side effects of ensifentrine may include:

• diarrhea;
• high blood pressure;
• back pain; or
• pain and burning when you urinate.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease:

3 mg inhaled orally twice a dayComments:-Administer dose once in the morning and once in the evening using a standard jet nebulizer equipped with a mouthpiece.Use: For the maintenance treatment of COPD

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include headache, and racing or pounding heartbeats.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may impact ensifentrine (inhalation), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.