DALIRESP is for adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups. DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems. UNDERSTANDING


Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that makes it hard to empty air out of the lungs, so it’s hard to breathe. Many people with COPD can have chronic bronchitis and your doctor will figure out if you have this type of COPD. Your doctor will also tell you the severity of your COPD, which may be mild, moderate, or severe.

If your doctor has told you that you have severe COPD, you may be wondering or worrying about it. The following information may help you understand and manage your COPD.


Your doctor will figure out your level of COPD severity based on symptoms, how well your lungs work (lung function), and future risk of flare-ups (exacerbations). Your doctor may tell you that there are different levels or stages of COPD, which include mild, moderate, and severe.

To find out how severe your COPD is, your doctor may ask you to have some tests such as spirometry (spy-ROM-uh-tree). Spirometry is a breathing test that measures how well your lungs work. Your doctor may also assess the risk of COPD flare-ups. The more severe your COPD, the more likely you are to have flare-ups.

You should talk to your doctor about your COPD, and how it affects you.


Coping with COPD can be tough, especially when it is severe. As COPD gets worse, COPD symptoms usually become more severe. COPD symptoms that may occur include:

Read on to learn about managing severe COPD.


Managing your condition

Managing severe COPD will include a treatment plan that helps with different parts of your condition. Your doctor will help to create a treatment plan that meets your needs, which may include any of the following:

As part of their treatment plan, people with severe COPD may also need to see a “pulmonologist” or lung specialist.

If you have severe COPD, your doctor may have prescribed quick-relief medications (called rescue inhalers) that are used for fast relief when symptoms occur, and maintenance medications used every day to help manage your disease. You may also sometimes be prescribed antibiotics, which are used to treat lung infections.

If you experience a flare-up, or a noticeable worsening of your usual breathing problems, you may require treatment with antibiotics, oral steroids and, in some cases, hospitalization.

Once you've had a flare-up, you are more likely to experience another one. If you have severe COPD, treatment with DALIRESP may help reduce your risk of future flare-ups. DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems.

Next, you’ll find out more about what flare-ups are and what you can do about them.

See Important Safety Information



Flare-ups are those times when your usual breathing problems become noticeably worse.

Warning signs of a COPD flare-up may include:

Different things can make a flare-up happen. The most common causes of a flare-up are an infection in your lungs and outdoor pollution. In some cases, the cause of the flare-up is unknown.

Contact your doctor right away if you think you are having a flare-up and make sure to have an action plan. Your doctor may do some tests to assess the severity of your flare-up. In cases of an emergency, call 911.


Flare-ups can be serious events

If you feel your COPD symptoms getting worse, you shouldn’t ignore them. Flare-ups can be serious and may last for days or weeks. Treating a flare-up may require antibiotics, oral steroids and, in some cases, hospitalization.

Once you’ve had a flare-up, you are more likely to have another one. So it’s important that you try to reduce the number of flare-ups you experience.

If you have severe COPD, DALIRESP may help you to reduce your risk of future flare-ups. DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems.

See Important Safety Information


Watch out for signs and symptoms of COPD flare-ups and take steps to reduce the risk of future flare-ups.

Here's a Flare-Up Action Plan that may help you:

  • Be Prepared

    Be sure to check your rescue inhaler to make sure it is not empty and keep it with you. Keep important contact numbers with you at all times.

  • Recognize the Symptoms

    Learn to recognize the early warning signs of a flare-up and call your doctor or 9-1-1 if you experience symptoms of a flare-up.

  • Get Help When Necessary

    Learn to recognize a severe COPD flare-up and seek immediate medical care, including calling 9-1-1 or going to an emergency room (ER).

  • Take Steps to Help Reduce the Risk of Another Flare-Up

    Avoid getting sick by getting a yearly flu shot, avoiding crowds during cold and flu season, and washing your hands often.



Talking to Your Doctor

Talking about severe COPD isn’t always easy. What would you like to know? What questions do you need to ask? It’s really important to talk to your doctor about your health condition. Being prepared for your visit can help you get the most out of it and allow your doctor to create a treatment plan that works for you.

Here is a simple 3-step guide to help you talk to your doctor.

  • 1. Be Prepared

    To help get the most from your visit, keep these tips in mind before your appointment:

    • Think about your severe COPD symptoms—have they changed; are they worse?
    • Write down any concerns you have
    • Discuss them with a friend or family member who may also come with you
  • 2. Ask Questions

    Your doctor is your greatest resource, so now is the best time to ask questions. Here are a few ways to start the conversation:

    • How concerned should I be about severe COPD?
    • What does it mean to have severe COPD? 
    • What treatments are available that may help reduce the risk of future flare-ups?
  • 3. Set Goals

    Stay active, eat right, and quit smoking. These are just a few examples of goals that you might set for yourself to help manage your severe COPD.

    Discuss your goals with your doctor at your appointment to make sure that he or she is involved in your overall health plan. Having an open conversation will help ensure that your doctor is part of your health plan.


What is the most important information I should know about DALIRESP® (roflumilast)?

DALIRESP can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking DALIRESP.

  • DALIRESP may cause mental health problems, including suicidal thoughts and behavior. Some people taking DALIRESP may develop mood or behavior problems, including thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, or other unusual changes in behavior or mood
  • Weight loss. DALIRESP can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking DALIRESP if you lose too much weight

DALIRESP may affect the way other medicines work, and other medicines may affect how DALIRESP works. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Who should not take DALIRESP?

Do not take DALIRESP if you have certain liver problems. Talk with your healthcare provider before taking DALIRESP if you have liver problems.

What should I tell my healthcare provider before taking DALIRESP?

Before you take DALIRESP, tell your healthcare provider if you:

  • Have or have had a history of mental health problems, including depression and suicidal behavior
  • Have liver problems
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. It is not known if DALIRESP will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if DALIRESP passes into your breast milk

What are the most common side effects of DALIRESP?

The most common side effects of DALIRESP include diarrhea, weight loss, nausea, headache, back pain, flu-like symptoms, problems sleeping (insomnia), dizziness, and decreased appetite. These are not all the possible side effects of DALIRESP. Always tell your healthcare provider about any side effects that bother you or don't go away.


DALIRESP is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations). DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems.