What to Know About Drug Name Daliresp (Roflumilast)

An Anti-Inflammatory Drug Used in COPD Treatments

Understanding photphodiesterase-4-inhibitors like Daliresp. Istockphoto.com/Stock Photo©endopack

Daliresp (roflumilast) is a type of oral medication used to treat chronic obstructive pulmonary disease (COPD) and other lung diseases. It is part of a category of drugs called phosphodiesterase-4-inhibitors (PDE4), which work to suppress inflammation in the airways of people who are resistant to standard treatment. Daliresp and the generic form, roflumilast, are the only two PDE4 inhibitors currently approved in the United States.

Uses

Daliresp is primarily used in people with severe COPD, but may also be used in other conditions, including:

  • Asthma
  • Psoriasis
  • Psoriatic arthritis

Daliresp works by blocking the effects of phosphodiesterase 4, an enzyme that breaks down a molecule called cyclic adenosine monophosphate (cAMP). The resultant increase in cAMP (because it's not broken down by phosphodiesterase 4) acts to decrease inflammation in the lungs.

By increasing cAMP levels and decreasing inflammation, PDE4 inhibitors can, in turn, decrease the number of COPD exacerbations and improve the function of the lungs. Increasing cAMP means they may also cause some bronchodilation. It's important to note that these drugs do not repair the lungs, they work instead to decrease inflammation and prevent further damage and exacerbation of symptoms.

A hallmark of COPD is chronic inflammation, and people with COPD and asthma often have an overproduction of PDE4 contributing to this inflammation.

By decreasing inflammation, Daliresp may decrease the mucus overproduction characteristic of COPD, and decrease airway remodeling. It's important to note, however, that Daliresp may help control COPD symptoms but doesn't cure COPD.

Before Taking

Daliresp should be used after other first-line treatments for COPD have been exhausted. Daliresp is generally used to improve lung function in people with stable COPD who are resistant to standard treatment. In those with COPD, it appears to be of most benefit to people with chronic bronchitis who have frequent exacerbations of their disease.

Since Daliresp and PDE4 drugs work on chronic inflammation, they aren't useful for acute attacks of COPD or asthma, but rather for chronic maintenance of the disease.

The effect of PDE4 inhibitors appears to be additive with corticosteroids. If you're using a corticosteroid inhaler, check with your doctor about whether you need to alter your inhaler usage when you start taking Daliresp.

Precautions and Contraindications

Because Daliresp has been shown to have severe psychological side effects, be warned that if you have pre-existing depression, you may want to avoid taking Daliresp, even though it's not technically contraindicated by the manufacturer. According to one study, depression, anxiety, and insomnia occur twice as often in those on Daliresp as those taking a placebo.

Additionally, if you have liver disease or liver complications (hepatic insufficiency), you shouldn't take Daliresp.

Dosage

Daliresp is taken once daily by mouth and is available in two different doses: a 250 micrograms (mcg) oral tablet and a 500 mcg oral tablet. The 250 mcg dose is a starting dose only: you'll take it daily for four weeks before moving up to the 500 mcg dosage after the four-week mark. Alternatively, you may start on the 500 mcg dose. Your doctor will determine which dose is right for you to start on. You'll take Daliresp once daily, with or without food.

Tell your doctor if you're pregnant or breastfeeding before taking Daliresp. If you're planning on becoming pregnant while taking Daliresp, be sure to also communicate this to your doctor, as it's unknown how the medication will affect the baby.

How to Take and Store

Daliresp may be taken with or without food, and should only be taken once daily. If you miss a dose, take the skipped dose as soon as you remember, unless it's nearly time for your next scheduled dose. Taking an extra dose of Daliresp may result in a dangerous overdose and should be treated at a poison control center.

Symptoms of overdose may include:

  • Dizziness
  • Lightheadedness
  • Headache
  • Cold, clammy skin
  • Rapid heartbeat

As with most medications, Daliresp should be stored at room temperature away from heat and moisture—i.e. not in the bathroom. Don't share your medication with anyone else. Be sure to keep up with every scheduled doctor's appointment while you're taking Daliresp.

Side Effects

There are several side effects to taking Daliresp. It's important to be aware of them and discuss them with your doctor before taking this medication.

Common

The main side effects of PDE4 inhibitors include diarrhea, nausea, and headaches, but also back pain, dizziness, flu-like symptoms, and decreased appetite. Daliresp may cause weight loss in two out of three patients, so weight should be monitored during treatment. You may need to stop taking Daliresp if you lose too much weight.

Severe

Daliresp has also caused major psychological symptoms for some people, including suicidal thoughts and behavior, trouble sleeping (insomnia), anxiety, depression, and other changes in behavior and mood. If you start to notice any of these symptoms, tell your doctor right away.

Warnings and Interactions

Due to their metabolism by a liver enzyme called cytochrome P-450, PDE4 inhibitors may interfere (increase or decrease) with other medications also metabolized in this way, for example, medications such as erythromycin, cimetidine, birth control pills, some seizure medications, and others. Be sure to inform your doctor if you're taking any of these medications, as an interaction between PDE4 inhibitors could mean that too much or not enough of either drug remains in your bloodstream and may result in undesired side effects or ineffective treatment.

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Article Sources

  • Bazaldua OV, Babb, FC. Roflumilast (Daliresp) for Chronic Obstructive Pulmonary Disease. Am Fam Physician. 2014. 89(4):300-301.

  • Chong J, Leung B, Poole P. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD002309. doi:10.1002/14651858.CD002309.pub5

  • Mulhall A, Droege C, Ernst N, Panos R, Zafar M. Phosphodiesterase 4 inhibitors for the treatment of chronic obstructive pulmonary disease: a review of current and developing drugs. Expert Opinion on Investigational Drugs. 2015. 24(12):1597-611.

  • Reid D, Pham N. Roflumilast: a novel treatment for the chronic obstructive pulmonary disease. Annals of Pharmacotherapy. 2012. 46(4):521-9.

  • U.S. National Library of Medicine. MedlinePlus. Roflumilast. 2016.