Roflumilast — Membership Pricing

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What Roflumilast is approved for (FDA label)

Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablets are not a bronchodilator and are not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Source: Read the full FDA label on DailyMed. Label effective date: September 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Roflumilast (FDA label)

Roflumilast 250 mcg tablets supplied as yellowish, round, beveled-edge tablets, debossed with "A" over "116" on one side and plain on other side. Roflumilast 500 mcg tablets are supplied as white to off-white, round, beveled-edge tablets, debossed with "A" over "117" on one side and plain on other side. Tablets: 250 mcg, 500 mcg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: cb3781ff-5350-4f9a-b247-0b04eb0f2b92. SPL document ID: 0dcd9104-401e-4675-9166-939f0d3aae4b. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Roflumilast (FDA label)

The following adverse reactions are described in greater detail in other sections: Psychiatric Events Including Suicidality [see Warnings and Precautions (5.2) ] Weight Decrease [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Call or contact Amici Pharma, Inc. at 1-866-760-2646 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions in Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: cb3781ff-5350-4f9a-b247-0b04eb0f2b92. SPL document ID: 0dcd9104-401e-4675-9166-939f0d3aae4b. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Roflumilast (FDA label)

The use of Roflumilast tablets are contraindicated in the following condition: Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6) ] . Moderate to severe liver impairment (Child-Pugh B or C) ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: cb3781ff-5350-4f9a-b247-0b04eb0f2b92. SPL document ID: 0dcd9104-401e-4675-9166-939f0d3aae4b. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Roflumilast (FDA label)

Acute Bronchospasm: Do not use for the relief of acute bronchospasm. ( 5.1 ) Psychiatric Events including Suicidality: Advise patients, their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with roflumilast in patients with a history of depression and/or suicidal thoughts or behavior. ( 5.2 ) Weight Decrease: Monitor weight regularly.

Source: FDA prescribing information (DailyMed). Set ID: cb3781ff-5350-4f9a-b247-0b04eb0f2b92. SPL document ID: 0dcd9104-401e-4675-9166-939f0d3aae4b. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Roflumilast (FDA label)

A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2 [see Clinical Pharmacology (12.3) ] . Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit. ( 7.2 ) 7.1 Drugs that Induce Cytochrome P450 (CYP) Enzymes Strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectiveness of roflumilast tablets.

Source: FDA prescribing information (DailyMed). Set ID: cb3781ff-5350-4f9a-b247-0b04eb0f2b92. SPL document ID: 0dcd9104-401e-4675-9166-939f0d3aae4b. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.