II. Mechanism

  1. Phosphodiesterase-4 Inhibitor increases lung, intracellular cAMP
  2. Bronchodilates and reduces inflammation

III. Indications

  1. Severe, refractory COPD with Chronic Bronchitis and frequent exacerbations

IV. Medications

  1. Roflumilast Tablets: 250 mcg 500 mcg

V. Dosing

  1. Roflumilast 500 mcg orally daily

VI. Adverse Effects

  1. Gastrointestinal (common, intolerable in 5%)
    1. Diarrhea
    2. Nausea
    3. Weight loss (may be >10%)
  2. Other common symptoms
    1. Headache
    2. Insomnia
  3. Psychiatric (3%)
    1. Suicidality
    2. Depression
    3. Anxiety

VII. Safety

  1. Unknown safety in pregnancy
  2. Unknown safety in Lactation
    1. Avoid in Lactation (is excreted in Breast Milk)

VIII. Drug Interactions

  1. Cytochrome P450 3A4 Inhibitors
  2. Cytochrome P450 3A4 and Cytochrome P450 1A2 Inducers

IX. Efficacy

  1. NNT: 24 severe COPD patients to prevent 1 hospitalization per year
  2. Does not reduce mortality

XI. References

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Cost: Medications

roflumilast (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
ROFLUMILAST 250 MCG TABLET Generic $11.66 each
ROFLUMILAST 500 MCG TABLET Generic $2.31 each
daliresp (on 1/1/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
DALIRESP 250 MCG TABLET $13.35 each
DALIRESP 500 MCG TABLET Generic $2.31 each