Roflumilast

Roflumilast is a prescription medicine used to treat the symptoms of chronic obstructive pulmonary disease (COPD) and plaque psoriasis.

• Roflumilast is available under the following different brand names: Daliresp, Zoryve

Adult dosage

Tablet (Daliresp)

• 250mcg
• 500mcg

Cream (Zoryve)

• 0.3%

Chronic Obstructive Pulmonary Disease (Daliresp)

Adult dosage

• 500 mcg orally once daily
• Starting treatment with 250 mcg orally once daily for 4 weeks and increasing to 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients
• NOTE: 250 mcg/day is not the effective (therapeutic) dose

Plaque psoriasis (Zoryve)

Adult dosage

• Apply the cream to affected areas once daily and rub in completely. Wash hands after application.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Roflumilast include:

• nausea,
• diarrhea,
• loss of appetite,
• minor weight loss,
• headache,
• dizziness,
• occasional sleep problems,
• back pain, and
• flu symptoms.

Serious side effects of Roflumilast include:

• mood or behavior changes,
• anxiety,
• depression,
• trouble sleeping,
• impulsive thoughts,
• thoughts of suicide,
• rapid and unintended weight loss,
• pain or burning when urinating, and
• tremors.

Rare side effects of Roflumilast include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Roflumilast has severe interactions with the following drugs:
  • bosentan
  • carbamazepine
  • dexamethasone
  • eslicarbazepine acetate
  • etravirine
  • fosphenytoin
  • nafcillin
  • nevirapine
  • oxcarbazepine
  • pentobarbital
  • phenobarbital
  • phenytoin
  • primidone
  • rifabutin
  • rifampin
  • rifapentine
  • St John's Wort
• Roflumilast has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • dabrafenib
  • enzalutamide
  • fexinidazole
  • idelalisib
  • ivosidenib
  • lonafarnib
  • ritonavir
  • secobarbital
  • tucatinib
  • voxelotor
• Roflumilast has moderate interactions with at least 41 other drugs
• Roflumilast has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Moderate-to-severe liver impairment (Child-Pugh class B or C)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Roflumilast?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Roflumilast?”

Cautions

• Not indicated for relief of acute bronchospasm; the drug is not a bronchodilator
• Psychiatric events, including suicidality, were reported (monitor for emergence or worsening of insomnia, mood disturbance, or anxiety)
• Monitor for clinically significant weight loss; this may be reversible upon discontinuance

Drug interaction overview

• Strong CYP3A4 inducers may reduce the therapeutic effectiveness of roflumilast; coadministration is not recommended
• CYP P450 enzyme inhibitors
  • CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and increase the risk for adverse effects

Pregnancy and Lactation

• Data are not available regarding use in pregnant women

Lactation

• Probable that roflumilast, its metabolites, or both are excreted into milk; avoid the use