Roflumilast

Roflumilast
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Roflumilast is a Phosphodiesterase inhibitor that is FDA approved for the treatment of COPD exacerbations. Common adverse reactions include diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• DALIRESP® is 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

• DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Dosage

• The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.

Dosage Forms And Strengths

• DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “500” on the other side. Each tablet contains 500 mcg of roflumilast.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Roflumilast FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Roflumilast in pediatric patients.

Contraindications

The use of DALIRESP is contraindicated in the following condition:

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

Warnings

Treatment of Acute Bronchospasm

• DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.

Psychiatric Events including Suicidality

• Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. In 8 controlled clinical trials 5.9% (263) of patients treated with DALIRESP 500 mcg daily reported psychiatric adverse reactions compared to 3.3% (137) treated with placebo. The most commonly reported psychiatric adverse reactions were insomnia, anxiety, and depression which were reported at higher rates in those treated with DALIRESP 500 mcg daily (2.4%, 1.4%, and 1.2% for DALIRESP versus 1.0%, 0.9%, and 0.9% for placebo, respectively). Instances of suicidal ideation and behavior, including completed suicide, have been observed in clinical trials. Three patients experienced suicide-related adverse reactions (one completed suicide and two suicide attempts) while receiving DALIRESP compared to one patient (suicidal ideation) who received placebo. Cases of suicidal ideation and behavior, including completed suicide, have been observed in the post-marketing setting in patients with or without a history of depression.

• Before using DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with DALIRESP in such patients. Patients, their caregivers, and families should be advised of the need 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. Prescribers should carefully evaluate the risks and benefits of continuing treatment with DALIRESP if such events occur.

Weight Decrease

• Weight loss was a common adverse reaction in DALIRESP clinical trials and was reported in 7.5% (331) of patients treated with DALIRESP 500 mcg once daily compared to 2.1% (89) treated with placebo. In addition to being reported as adverse reactions, weight was prospectively assessed in two placebo-controlled clinical trials of one year duration. In these studies, 20% of patients receiving roflumilast experienced moderate weight loss (defined as between 5-10% of body weight) compared to 7% of patients who received placebo. In addition, 7% of patients who received roflumilast compared to 2% of patients receiving placebo experienced severe (>10% body weight) weight loss. During follow-up after treatment discontinuation, the majority of patients with weight loss regained some of the weight they had lost while receiving DALIRESP. Patients treated with DALIRESP should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of DALIRESP should be considered.

Drug Interactions

• A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2. The administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in exposure, which may result in a decrease in the therapeutic effectiveness of DALIRESP. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with DALIRESP is not recommended

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Roflumilast in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Roflumilast in the drug label.

Drug Interactions

There is limited information regarding Roflumilast Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Roflumilast in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Roflumilast in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Roflumilast during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Roflumilast with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Roflumilast with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Roflumilast with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Roflumilast with respect to specific gender populations.

Race

There is no FDA guidance on the use of Roflumilast with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Roflumilast in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Roflumilast in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Roflumilast in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Roflumilast in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Roflumilast Administration in the drug label.

Monitoring

There is limited information regarding Monitoring of Roflumilast in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Roflumilast in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Roflumilast in the drug label.

Pharmacology

There is limited information regarding Roflumilast Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Roflumilast Mechanism of Action in the drug label.

Structure

File:Roflumilast01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Roflumilast in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Roflumilast in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Roflumilast in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Roflumilast in the drug label.

How Supplied

Storage

There is limited information regarding Roflumilast Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Roflumilast in the drug label.

Precautions with Alcohol

• Alcohol-Roflumilast interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Roflumilast Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Roflumilast Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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