Daliresp (roflumilast) is a once-daily medication indicated for use by individuals with a history of COPD exacerbations and severe COPD associated with chronic bronchitis. It is a maintenance therapy, and is not indicated for use as a rescue or immediate treatment option. Daliresp is a phosphodiesterase 4 (PDE4) inhibitor that is designed to reduce the number of flare-ups and exacerbations in adults with COPD. Individuals with a history of moderate to severe liver impairment or liver conditions should not take Daliresp. Individuals taking Daliresp should be monitored for severe changes in weight and signs of psychiatric distress, including changes in mental health or suicidal thoughts.
What are the ingredients in Daliresp?
The active ingredient in Daliresp is roflumilast.
How does Daliresp work?
The active ingredient in Daliresp, roflumilast, is a PDE4 inhibitor, meaning it blocks the action of PDE4. PDE4 is an enzyme that plays a critical role in several pathways in the body, including pathways that affect the immune system and the inflammatory response. PDE4 also impacts smooth muscle relaxation in the body, including smooth muscle relaxation in the airways. By blocking PDE4, Daliresp acts as an anti-inflammatory medication, as well as a smooth muscle relaxant. Inflammation and bronchoconstriction (the tightening of the muscles in the airway) both play key roles in the development and exacerbation of COPD. By inhibiting these processes, a PDE4 medication, like Daliresp, may be able to reduce COPD symptoms and exacerbations for those taking it.
What are the possible side effects of Daliresp?
Many clinical trials evaluated the safety and efficacy of Daliresp. The most common side effects experienced by those taking Daliresp include:
- Weight decrease
- Insomnia (trouble sleeping)
- Decreased Appetite
- Back Pain
- Influenza or flu-like symptoms
This is not an exhaustive list of all potential side effects of Daliresp. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.
Things to know about Daliresp
One of the major warnings for Daliresp is that it may cause psychiatric distress or mental health problems. This includes experiencing suicidal thoughts or behaviors. Individuals taking Daliresp are encouraged to seek medical help immediately if they notice any of the following:
- New or worsening depression
- New or worsening anxiety
- Insomnia (trouble sleeping)
- Suicidal thoughts
- Suicidal behaviors or attempts to commit suicide
- Acting impulsively or dangerously
- Any other changes in mood or behavior
Individuals with a history of mental health issues should disclose this information to their doctor before starting Daliresp. Daliresp may also cause sudden and significant weight loss in those taking the medication. Individuals taking Daliresp should monitor their weight regularly and watch for signs of significant weight change. Prescribing physicians should also monitor individuals taking Daliresp for changes in weight.
Before staring Daliresp, you should tell your doctor or healthcare team if you:
- Have a history of mental health issues, especially depression or previous suicidal thoughts or behaviors
- Have a history of liver issues or liver conditions
- Are pregnant or planning to become pregnant
- Are breastfeeding or planning to breastfeed
- Have any other medical conditions
- Are taking any other medications, supplements, or vitamins
Daliresp may be impacted by other medications, as well as affect the way other medications work. Some of these medications include P450 enzyme inducers like phenobarbital or carbamazepine, as well as CYP3A4 inhibitors or CYP3A4 and CYP1A2 dual inhibitors like erythromycin and ketoconazole. Your doctor will be able to tell you if any medications you are currently on fall into these categories or if they might impact your treatment with Daliresp. Pregnant or nursing mothers should not use Daliresp, as it is not known if the medication will impact a developing fetus or if Daliresp is excreted through breast milk.
The most common dosage of Daliresp is one 500mcg tablet once a day. It is also common for individuals to take 250mcg once a day for the first four weeks of treatment, and then increase the dosage to 500mcg daily moving forward. Your exact dosage or treatment schedule may vary, and it is important to follow your healthcare provider’s instructions for use of Daliresp. Daliresp can be taken with or without food. If too much Daliresp is taken at once, seek medical attention immediately.1
For more information, read the full prescribing information of Daliresp.1
- Daliresp [Prescribing Information]. St. Louis, MO: Forest Pharmaceuticals, Inc.; Revised January 2018.