Arformoterol - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events.

Do not initiate arformoterol tartrate inhalation solution in acutely deteriorating patients.

Do not use for relief of acute symptoms.

Concomitant short-acting beta 2 -agonists can be used as needed for acute relief.

Do not exceed the recommended dose.

Excessive use of arformoterol tartrate inhalation solution, or use in conjunction with other medications containing long-acting beta 2 -agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) Life-threatening paradoxical bronchospasm can occur.

Discontinue arformoterol tartrate inhalation solution immediately.

Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. ( 5.6 , 5.7 ) 5.1 Serious Asthma-Related Events - Hospitalizations, Intubations, Deaths The safety and efficacy of arformoterol tartrate inhalation solution in patients with asthma have not been established.

Arformoterol tartrate inhalation solution is not indicated for the treatment of asthma [see Contraindications ] .

Use of long-acting beta 2 -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 also suggest that use of LABA as monotherapy increases the 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.

A 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs.

3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34).

The increased risk of asthma-related death is considered a class effect of the LABA, including arformoterol tartrate inhalation solution.

No study adequate to determine whether the rate of asthma-related death is increased in patients treated with arformoterol tartrate 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.

5.2 Deterioration of Disease and Acute Episodes Arformoterol tartrate inhalation solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

The use of arformoterol tartrate inhalation solution in this setting is inappropriate.

Arformoterol tartrate inhalation solution is not indicated for the 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 beta 2 -agonist.

When beginning arformoterol tartrate inhalation solution, patients who have been taking inhaled short-acting beta 2 -agonists on a regular basis (e.g., 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.