Roflumilast (Systemic)
Brand names: Daliresp
Drug class:
Antineoplastic Agents
Usage of Roflumilast (Systemic)
COPD
Reduction of risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Not a bronchodilator and not indicated for relief of acute bronchospasm.
Effects on COPD exacerbations when added to a fixed-combination preparation containing a long-acting β2-adrenergic agonist and orally inhaled corticosteroid not established.
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How to use Roflumilast (Systemic)
Administration
Oral Administration
Administer orally once daily without regard to meals.
Dosage
Adults
COPD Oral500 mcg once daily.
Special Populations
Dosage adjustment not necessary based on gender or race.
Hepatic Impairment
Dosage of 500 mcg once daily not studied in patients with hepatic impairment. Consider the risks and benefits of using roflumilast in patients with mild hepatic impairment (Child-Pugh class A). Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh class B or C). (See Special Populations under Pharmacokinetics.)
Renal Impairment
Dosage adjustment not necessary.
Geriatric Patients
Dosage adjustment not necessary.
Warnings
Contraindications
Warnings/Precautions
Acute Bronchospasm
Not a bronchodilator; do not use for relief of acute bronchospasm.
Psychiatric Events and Suicidality
Increased risk of adverse psychiatric effects; insomnia, anxiety, and depression most frequently reported. Suicidal ideation or behavior, including completed suicide and suicide attempts, also reported.
Carefully weigh the risks and benefits before using the drug in patients with a history of depression and/or suicidal thoughts or behavior. Carefully evaluate the risks and benefits of continuing therapy with roflumilast if such effects occur. Some clinicians recommend avoiding the drug in patients with depression. (See Advice to Patients.)
Weight Loss
Moderate or severe weight loss (defined as 5–10% or >10% of body weight, respectively) reported. Most patients regained some of the lost weight following treatment discontinuance.
Regularly monitor patient’s weight. If unexplained or clinically important weight loss occurs, evaluate weight loss and consider discontinuing roflumilast. Some clinicians avoid use of roflumilast therapy in underweight patients.
Interactions
Concomitant use with potent CYP3A4 inducers (e.g., Carbamazepine, phenobarbital, phenytoin, rifampin) not recommended. (See Specific Drugs under Interactions.)
Specific Populations
PregnancyCategory C.
Do not use during labor and delivery. Effect on preterm labor or labor at term in humans unknown; however, labor and delivery disrupted in animals.
LactationRoflumilast and/or its metabolites distributed into milk in rats. Distribution likely into human milk. Effects in breast-fed infants not established. Do not use in nursing women.
Pediatric UseSafety and efficacy not established in pediatric patients; COPD does not occur in children.
Geriatric UseNo substantial differences in safety and efficacy relative to younger adults. Clinical experience has not revealed age-related differences, but increased sensitivity cannot be ruled out. Dosage adjustment not necessary.
Hepatic ImpairmentConsider the risks and benefits of using roflumilast in patients with mild hepatic impairment (Child-Pugh class A). Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh class B or C). (See Special Populations under Pharmacokinetics.)
Common Adverse Effects
Diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, decreased appetite.
What other drugs will affect Roflumilast (Systemic)
Metabolized by CYP3A4 and CYP1A2 to roflumilast N-oxide; roflumilast N-oxide metabolized mainly by CYP3A4, to a lesser extent by CYP2C19 and extrahepatic CYP1A, and glucuronidated.
Roflumilast and roflumilast N-oxide do not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.
Roflumilast does not induce CYP isoenzymes 1A2, 2A6, 2C9, 2C19, or 3A4/5 and is a weak inducer of CYP2B6.
Roflumilast and roflumilast N-oxide do not inhibit the P-glycoprotein transport system.
Drugs Affecting Hepatic Microsomal Enzymes
Potent CYP3A4 inducers: Decrease systemic exposure and may reduce the therapeutic efficacy of roflumilast. Concomitant use not recommended.
CYP3A4 inhibitors or inhibitors of both CYP3A4 and CYP1A2: May result in increased systemic exposure to roflumilast and increased adverse effects. Carefully weigh risk of concurrent use against benefit.
Specific Drugs
Drug
Interaction
Comments
Albuterol
No clinically important pharmacokinetic interactions observed with orally inhaled albuterol
No dosage adjustment recommended
Antacids (aluminum hydroxide/magnesium hydroxide)
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)
Decreased systemic exposure and possible reduced therapeutic efficacy of roflumilast
Concomitant use not recommended
Budesonide
No clinically important pharmacokinetic interactions observed with orally inhaled budesonide
No dosage adjustment recommended
Cimetidine
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
Use concomitantly with caution; weigh risk of concurrent use against benefit
Digoxin
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended
Enoxacin (no longer commercially available in US)
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
Use concomitantly with caution; weigh risk of concurrent use against benefit
Erythromycin
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
Use concomitantly with caution; weigh risk of concurrent use against benefit
Fluvoxamine
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
Use concomitantly with caution; weigh risk of concurrent use against benefit
Formoterol
No clinically important pharmacokinetic interactions observed with orally inhaled formoterol
No dosage adjustment recommended
Ketoconazole
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
Use concomitantly with caution; weigh risk of concurrent use against benefit
Midazolam
No clinically important pharmacokinetic interactions observed with oral midazolam
No dosage adjustment recommended
Montelukast
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended
Oral contraceptives (fixed combination of gestodene [not commercially available in US] and ethinyl estradiol)
Increased peak plasma concentrations and AUC of roflumilast; decreased peak plasma concentrations and increased AUC of roflumilast N-oxide
May increase risk of adverse effects
Use concomitantly with caution; weigh risk of concurrent use against benefit
Rifampin
Decreased peak plasma concentrations and AUC of roflumilast; increased peak plasma concentrations and decreased AUC of roflumilast N-oxide
Possible reduced efficacy of roflumilast
Concomitant use not recommended
Sildenafil
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended
Theophylline
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended; however, some clinicians do not recommend concomitant use
Warfarin
No clinically important pharmacokinetic interactions observed
No dosage adjustment recommended
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