Version July 2025
Chronic obstructive pulmonary disease, maintenance:
Note: Depending on symptoms and exacerbation risk, may use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), use in combination with long-acting muscarinic antagonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Nebulization solution: Oral inhalation: 15 mcg twice daily.
No dosage adjustment necessary.
No dosage adjustment necessary. However, arformoterol is primarily metabolized in the liver and plasma levels may be increased; use with caution and monitor closely.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
2% to 10%:
Cardiovascular: Chest pain (7%), peripheral edema (3%)
Central nervous system: Pain (8%)
Dermatologic: Skin rash (4%)
Gastrointestinal: Diarrhea (6%)
Neuromuscular & skeletal: Back pain (6%), leg cramps (4%)
Respiratory: Dyspnea (4%), sinusitis (5%), flu-like symptoms (3%), respiratory congestion (2%)
<2%: Abscess, agitation, arteriosclerosis, arthralgia, arthritis, atrial flutter, atrioventricular block, bone disease, calcium crystalluria, cardiac failure, cerebral infarction, constipation, cystitis, decreased glucose tolerance, dehydration, digitalis intoxication, drowsiness, ECG changes, edema, fever, gastritis, glaucoma, glycosuria, gout, heart block, hematuria, hernia, hyperglycemia, hyperlipidemia, hypersensitivity reaction, hypoglycemia, hypokalemia, hypokinesia, inversion T wave on ECG, lung carcinoma, melena, myocardial infarction, neck stiffness, neoplasm, nephrolithiasis, nocturia, oral candidiasis, paradoxical bronchospasm, paralysis, paresthesia (circumoral), pelvic pain, periodontal abscess, prolonged QT interval on ECG, prostate specific antigen increase, pyuria, rectal hemorrhage, retroperitoneal hemorrhage, rheumatoid arthritis, skin discoloration, skin hypertrophy, supraventricular tachycardia, tendinous contracture, tremor, urinary tract abnormality, urine abnormality, viral infection, visual disturbance, voice disorder, xeroderma
Hypersensitivity to arformoterol, racemic formoterol, or to any component of the formulation; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. The use of LABAs as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART [Nelson 2006]; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large, randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Arformoterol is not indicated for the treatment of asthma.
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this reaction should be distinguished from inadequate response. Discontinue immediately if paradoxical bronchospasm occurs and institute alternative therapy.
• Hypersensitivity reactions: Immediate hypersensitivity reactions (anaphylaxis, urticaria, angioedema, rash, bronchospasm) have been reported.
• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, arrhythmia, hypertension, HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta-2 agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.
• Chronic obstructive pulmonary disease: Appropriate use: Do not use for acute episodes of chronic obstructive pulmonary disease (COPD). Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Available data do not suggest an increased risk of death with use of LABA in patients with COPD.
• Diabetes: Use with caution in patients with diabetes mellitus. Beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Hepatic impairment: Use with caution in patients with hepatic impairment; systemic exposure is increased.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism; may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).
• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.
Special populations:
• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.
Other warnings/precautions:
• Patient information: Patients using inhaled, short-acting beta-2 agonists (eg, albuterol) should be instructed to discontinue routine use of these medications prior to beginning treatment; short-acting agents should be reserved for symptomatic relief of acute symptoms. Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of short-acting beta-2 agonists may indicate deterioration of COPD, and medical evaluation must not be delayed.
• Tolerance/Tachyphylaxis: Tolerance to the bronchodilator effect, measured by FEV1, has been observed in studies.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Nebulization Solution, Inhalation:
Brovana: 15 mcg/2 mL (2 mL)
Generic: 15 mcg/2 mL (2 mL)
Yes
Nebulization (Arformoterol Tartrate Inhalation)
15 mcg/2 mL (per mL): $2.50 - $10.69
Nebulization (Brovana Inhalation)
15 mcg/2 mL (per mL): $12.17
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Oral inhalation: Nebulization solution: Remove each vial from individually sealed foil pouch immediately before use. Use with standard jet nebulizer connected to an air compressor; administer with mouthpiece or face mask. Administer vial undiluted; compatibility with other medications (eg, budesonide, ipratropium) in nebulizer has been reported (Ref); also refer to institution-specific policies.
Chronic obstructive pulmonary disease, maintenance: Long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Atomoxetine: May increase tachycardic effects of Beta2-Agonists. Atomoxetine may increase hypertensive effects of Beta2-Agonists. Risk C: Monitor
Atosiban: Beta2-Agonists may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May decrease bronchodilatory effects of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor
Beta-Blockers (Nonselective): May decrease bronchodilatory effects of Beta2-Agonists. Risk X: Avoid
Beta2-Agonists (Long-Acting): May increase adverse/toxic effects of Beta2-Agonists (Long-Acting). Risk X: Avoid
Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification
Loop Diuretics: Beta2-Agonists may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Loxapine: Agents to Treat Airway Disease may increase adverse/toxic effects of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid
Methacholine: Beta2-Agonists (Long-Acting) may decrease therapeutic effects of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider Therapy Modification
Monoamine Oxidase Inhibitors: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Theophylline Derivatives: May increase hypokalemic effects of Beta2-Agonists. Beta2-Agonists may increase adverse/toxic effects of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Risk C: Monitor
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Tricyclic Antidepressants: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
Beta-agonists may interfere with uterine contractility if administered during labor.
Arformoterol in an enantiomer of formoterol. Refer to the Formoterol monograph for information.
It is not known if arformoterol is present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium. Monitor for increased use of short-acting beta 2-agonist inhalers; may be marker of a deteriorating COPD condition, hypersensitivity reactions, decreased bronchodilator response (tachyphylaxis).
Arformoterol, the (R,R)-enantiomer of the racemic formoterol, is a long-acting beta2-agonist that relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on cardiovascular system.
Onset of action: 7-20 minutes
Peak effect: 1-3 hours
Absorption: A portion of inhaled dose is absorbed into systemic circulation
Protein binding: 52% to 65%
Metabolism: Hepatic via direct glucuronidation and secondarily via O-demethylation; CYP2D6 and CYP2C19 (to a lesser extent) involved in O-demethylation
Half-life elimination: 26 hours
Time to peak: 0.5-3 hours
Hepatic function impairment: The systemic exposure (Cmax and AUC) to arformoterol increased 1.3- to 2.4-fold in subjects with hepatic impairment.
