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.

USING
DALIRESP

(roflumilast) tablets 500 mcg

Your doctor may prescribe DALIRESP as part of your severe COPD treatment plan to help reduce your risk of future flare-ups. Flare-ups are serious events. Once you've had a flare-up, you are more likely to experience another one. DALIRESP may help you to protect yourself from future flare-ups.

Not Actual Size

TREATMENT
WITH DALIRESP

DALIRESP is the only medicine of its kind for COPD and works differently from steroids. It belongs to a group of medications called PDE4 (phosphodiesterase-4) inhibitors. This medication helps to reduce the risk of COPD flare-ups for people with severe COPD. It comes in an oral tablet form.

You may not feel anything when you take DALIRESP, but that does not mean it is not working. Just as you may not feel blood pressure or cholesterol medications working, you may not feel DALIRESP working, but it is helping to lower your risk of a future flare-up.

How to take DALIRESP


DALIRESP is a tablet that is taken once a day, with or without food. If your doctor prescribes DALIRESP, it is important that you continue to take the medication exactly as your doctor tells you to. If you take more than your prescribed dose of DALIRESP, call your doctor or go to the nearest hospital emergency room right away.

Who should not take DALIRESP?


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

Taking DALIRESP with other medicines


It is always important to tell your doctor or pharmacist about all the medicines you take because DALIRESP may affect the way other medicines work, and other medicines may affect the way DALIRESP works.

What should I tell my doctor before taking DALIRESP?


Before you take DALIRESP, tell your doctor 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 since it is not known if DALIRESP will harm your unborn baby; are breastfeeding or plan to breastfeed since it is not known if DALIRESP passes into your breast milk.

Storing DALIRESP


You should store DALIRESP at room temperature (68°F to 77°F). However, storage as low as 59°F and as high as 86°F is permitted for short periods of time. Keep DALIRESP tablets and all medicines out of the reach of children.

See Additional Important Safety Information

MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DALIRESP

SERIOUS SIDE EFFECTS

DALIRESP can cause serious side effects. Tell your doctor 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 doctor regularly to have your weight checked. If you notice that you are losing weight, call your doctor. Your doctor 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 doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Keep reading for information about most common side effects

See Additional Important Safety Information

MOST COMMON
SIDE EFFECTS

The most common side effects of DALIRESP include:

  • diarrhea
  • weight loss
  • nausea
  • headache
  • back pain
  • flu-like symptoms
  • problems sleeping (insomnia)
  • dizziness
  • decreased appetite

These are not all the possible side effects of DALIRESP. Always tell your doctor about any side effects that bother you or don’t go away.

About nausea and diarrhea


Diarrhea and nausea were the two side effects that most often caused people to discontinue treatment with DALIRESP in clinical trials. In these clinical trials, most of the people who had diarrhea and/or nausea experienced it in the beginning of their treatment, and it generally lasted less than four weeks. For some, it lasted longer and was severe.

If you experience these side effects, your doctor may be able to suggest ways to manage them. Remember, always talk to your doctor before stopping DALIRESP.

See Additional Important Safety Information

STRIDE SUPPORT PROGRAM

The STRIDE program is here to support you

If your doctor prescribes DALIRESP, the support program STRIDE (Start Treatment. Real-time Information. Disease Education.) offers easy ways to find information you may want:

  • A call center staffed by registered nurses who have been trained to help answer your questions about severe COPD and DALIRESP*

  • Answers to your questions about insurance coverage or co-pay assistance

  • Additional education and refill reminders to help keep you on track with your treatment

*STRIDE is not a substitute for the care of a qualified health care professional, and the call center nurses cannot diagnose or treat callers. Get the support you need. Join STRIDE today!

IMPORTANT SAFETY INFORMATION

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.

INDICATION

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.