arformoterol (Rx)

Brand and Other Names:Brovana, Erdotin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nebulizer solution

  • 15mcg/2mL

Chronic Obstructive Pulmonary Disease

15 mcg inhaled via nebulization twice daily (AM & PM)

Not to exceed 30 mcg/day

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Use caution; systemic drug exposure prolonged; dose adjustment not necessary

Saftety and efficacy not established

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Interactions

Interaction Checker

and arformoterol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Back pain (6%)

            Chest pain (7%)

            Diarrhea (6%)

            Dyspnea (4%)

            Flu syndrome (3%)

            Leg cramps (4%)

            Lung disorder (2%)

            Pain (8%)

            Peripheral edema (3%)

            Rash (4%)

            Sinusitis (5%)

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            Warnings

            Contraindications

            Hypersensitivity to arformoterol or formoterol, or any ingredients

            Treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid

            Cautions

            Use only if not adequately controlled by asthma controller medications

            Use only for shortest duration of time

            Immediate hypersensitivity reactions may occur after administration of arformoterol inhalation solution as demonstrated by cases of anaphylactic reaction, urticaria, angioedema, rash and bronchospasm

            Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects; the decrease in serum potassium is usually transient, not requiring supplementation

            Beta-agonist medications may produce transient hyperglycemia in some patients; clinically significant and dose-related changes in serum potassium and blood glucose were infrequent during clinical trials with long-term administration of arformoterol inhalation Solution at recommended dose

            Use caution in patients with coexisting conditions, including convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines; doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis

            As with other inhaled beta2-agonists, arformoterol inhalation solution can produce paradoxical bronchospasm that may be life-threatening; if paradoxical bronchospasm occurs, arformoterol inhalation solution should be discontinued immediately and alternative therapy instituted

            Fatalities reported in association with excessive use of inhaled sympathomimetic drugs; as with other inhaled beta2-adrenergic drugs, arformoterol inhalation solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2-agonists

            Serious Asthma-Related Events

            • Safety and efficacy of Inhalation Solution in patients with asthma not established
            • Inhalation Solution is not indicated for treatment of asthma
            • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death
            • Available data from controlled clinical trials suggest that use of LABA as monotherapy increases risk of asthma-related hospitalization in pediatric and adolescent patients
            • These findings are considered a class effect of LABA monotherapy; when LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, and death) compared with ICS alone
            • No study adequate to determine whether the rate of asthma-related death is increased in patients treated with inhalation solution has been conducted; clinical studies with racemic formoterol suggested a higher incidence of serious asthma exacerbations in patients who received racemic formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.
            • Available data do not suggest an increased risk of death with use of LABA in patients with COPD

            Deterioration of disease and acute episodes

            • Inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition
            • Use of inhalation solution in this setting is inappropriate; arformoterol inhalation solution is not indicated for treatment of acute episodes of bronchospasm, i.e, as rescue therapy and extra doses should not be used for that purpose
            • Acute symptoms should be treated with an inhaled short-acting beta2-agonist; when beginning inhalation solution, patients who have been taking inhaled short-acting beta2-agonists on a regular basis (eg, four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms
            • When prescribing inhalation solution, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient how it should be used
            • Increasing inhaled beta2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated; COPD may deteriorate acutely over a period of hours or chronically over several days or longer
            • If inhalation solution no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta2-agonist becomes less effective or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease
            • In this setting, a reevaluation of the patient and the COPD treatment regimen should be undertaken at once; increasing the daily dosage of inhalation solution beyond recommended 15 mcg twice daily dose is not appropriate in this situation

            Cardiovascular effects

            • Arformoterol inhalation solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms
            • If such effects occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST-segment depression; use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
            • Arformoterol inhalation solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; drug should only be used during pregnancy if expected benefit outweighs potential risk to fetus; women should be advised to contact their physician if they become pregnant while receiving therapy

            The potential effect of therapy on labor and delivery is unknown; because of potential for beta-agonists interference with uterine contractility, use of inhalation solution during labor should be restricted to whom benefits clearly outweigh risk

            Animal data

            • In animal reproduction studies with rats and rabbits at exposures approximately 370 and 8,400 times adult exposure at maximum recommended human daily inhalation dose (MRHDID) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth
            • Adverse effects generally occurred at large multiples of the MRHDID when drug was administered by oral route to achieve high systemic exposures; no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the MRHDID

            Lactation

            There are no data on presence of arformoterol or its metabolites in human milk, effects on breastfed infant, or on milk production; however, arformoterol was excreted in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting beta2-agonist, R,R-enantiomer of racemic formoterol; relaxes bronchial smooth muscle by acting selectively on beta2-receptors

            Pharmacokinetics

            Excretion: Urine (67%); feces (22%)

            Onset: 7-20 min

            Half-life: 26hr

            Peak plasma time: 0.5-3hr

            Peak Plasma: 4.3 pg/mL

            AUC: 34.5 pg.hr/mL

            Protein Bound: 52-65%

            Metabolism: uridine diphosphoglucuronosyltransferases (glucuronidation), CYP2D6, CYP2C19 (O-demethylation)

            Renal Clearance: 8.9 L/hr

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.