Ensifentrine (inhalation)

Generic name: ensifentrine (inhalation) [ EN-si-FEN-treen ]
Brand name: Ohtuvayre
Dosage form: inhalation suspension (3 mg/ 2.5mL)
Drug class: Miscellaneous respiratory agents

Medically reviewed by Drugs.com on Jul 23, 2024. Written by Cerner Multum.

What is ensifentrine inhalation?

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

Ensifentrine inhalation may also be used for purposes not listed in this medication guide.

Ensifentrine inhalation side effects

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

Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

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

Ensifentrine may cause serious side effects. Call your doctor at once if you have:

• suicidal thoughts or actions;

• new or worsening symptoms of depression or anxiety;

• trouble sleeping;

• mood or behavior changes; or

• if you feel impulsive, irritable, agitated, hostile, aggressive, restless.

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.

Warnings

Stop using this medicine and call your doctor at once or get emergency medical help if you have wheezing, choking, or other breathing problems after using this medicine.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, or have thoughts about suicide or hurting yourself.

Before taking this medicine

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.

How should I use ensifentrine inhalation?

Follow all directions 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 attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Use one ampule of ensifentrine inhalation twice per 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 remove this medicine from its foil pouch until you are ready to place it into the nebulizer device.

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

Throw away 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.

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

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

Ensifentrine dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease:

3 mg inhaled orally twice a day

Comments:
-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

What happens if I miss a dose?

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

What happens if I overdose?

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.

What should I avoid while using ensifentrine inhalation?

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

What other drugs will affect ensifentrine inhalation?

Other drugs may affect ensifentrine inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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