ensifentrine 3 mg/2.5 mL suspension for nebulization

Generic name:
Ensifentrine suspension - inhalation

Pronunciation
(EN-si-FEN-treen)

Brand name(s)
Ohtuvayre

This medication is used to treat and control symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). Ensifentrine works by reducing the swelling of the airways and the muscles around the airways so you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath or wheezing. If sudden breathing problems occur, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Read the Patient Information Leaflet if available from your pharmacist before you start using ensifentrine and each time you get a refill. Follow the illustrated directions for the proper use of this medication. This medication is used with a special breathing machine called a nebulizer that changes the suspension to a fine mist that you inhale. Make sure you understand how to operate the breathing machine and how to properly clean it to prevent infections. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Do not mix this medication with other solutions or products in the nebulizer.

Shake the container well before use. Using a mouthpiece with the nebulizer, inhale this medication by mouth as directed by your doctor, usually twice daily. While inhaling this medication, breathe calmly and deeply until the mist stops, usually over 5 to 7 minutes. Do not swallow or inject this medication. Discard any unused medication. Do not save for future use.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose, use it more often, or stop using this medication without first consulting your doctor.

Learn which of your inhalers/medications you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if you do not get better or if you get worse.

Back pain or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Rarely, this medication may cause sudden severe worsening of breathing problems right after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as nervousness, depression, thoughts of suicide)
• trouble sleeping

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ensifentrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• mental/mood disorders (depression, thoughts of suicide)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: headache, fast/pounding heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as lung function, blood pressure, liver function) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light, heat, and moisture. Keep the medication in the foil pouch until ready to use. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.