Ensifentrine Oral Inhalation

WHY is this medicine prescribed?

Ensifentrine oral inhalation is used to control wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Ensifentrine is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation and muscle tightness in the lungs, which results in relaxing and opening air passages in the lungs, making it easier to breathe.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ensifentrine comes as a suspension (liquid) to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled). It is usually inhaled twice a day, in the morning and in the evening. Inhale ensifentrine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ensifentrine exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

Do not use ensifentrine during a sudden COPD attack. Your doctor will prescribe a short-acting (rescue) inhaler to use during COPD attacks.

Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Ensifentrine controls COPD but does not cure it. Continue to use ensifentrine even if you feel well. Do not stop using ensifentrine without talking to your doctor. If you stop using ensifentrine, your symptoms may get worse.

Before you use ensifentrine for the first time, read the written instructions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you how to use the nebulizer and compressor. Practice using the nebulizer and compressor while he or she watches.

Ensifentrine oral inhalation should be used only in a standard jet nebulizer with a mouthpiece connected to an air compressor. Do not swallow or inject ensifentrine nebulizer suspension. Do not mix the solution with anything else.

To inhale the suspension using a jet nebulizer, follow these steps:

1. Remove one ampule of inhalation suspension from the foil pouch.
2. Shake the ampule well to mix the medication evenly. After shaking, ensifentrine inhalation suspension should be cloudy and yellow to pale yellow.
3. Twist off the top of one ampule of ensifentrine suspension and squeeze all of the liquid into the nebulizer reservoir. Do not mix other medications with ensifentrine in the reservoir.
4. Connect the mouthpiece to the nebulizer reservoir. Connect the nebulizer to the compressor.
5. Sit in an upright, comfortable position. Place the mouthpiece in your mouth or put on the face mask.
6. Turn on the compressor.
7. Breathe in calmly, deeply, and evenly for about 5 to 7 minutes until mist stops forming in the nebulizer chamber.
8. Dispose of the empty ampule and its top in a trash can that is out of the reach of children and pets.
9. Clean your nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using ensifentrine inhalation,

• tell your doctor and pharmacist if you are allergic to ensifentrine, any other medications, or any of the ingredients in ensifentrine oral inhalation. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had depression, mood problems, or other mental health problems; thoughts about harming or killing yourself, or planning or trying to do so; high blood pressure; or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ensifentrine, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ensifentrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• back pain
• diarrhea
• difficult or painful urination

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sudden shortness of breath immediately after inhaling the medication
• new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; new or worsening anxiety; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement.

Ensifentrine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Keep the nebulizer ampules sealed in their foil pouches until you are ready to use them. Do not freeze the nebulizer suspension.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• headache
• fast, pounding, or irregular heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.