Formoterol Fumarate Inhalation Solution

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Formoterol Fumarate Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Formoterol Fumarate Inhalation Solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD Formoterol Fumarate Inhalation Solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 1.2 Important Limitations of Use Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS (5.2) ]. Formoterol Fumarate Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of Formoterol Fumarate Inhalation Solution in asthma have not been established. Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended dose of Formoterol Fumarate Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended. Formoterol Fumarate Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of Formoterol Fumarate Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) and the PRONEB® Ultra compressor. The safety and efficacy of Formoterol Fumarate Inhalation Solution delivered from non-compressor based nebulizer systems have not been established. Formoterol Fumarate Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded. If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered. The drug compatibility (physical and chemical), efficacy, and safety of Formoterol Fumarate Inhalation Solution when mixed with other drugs in a nebulizer have not been established. For oral inhalation only. One 20 mcg/2 mL vial every 12 hours ( 2 ) For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor ( 2 ) Warnings and cautions 5 WARNINGS AND PRECAUTIONS LABA as monotherapy (without inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate Formoterol Fumarate Inhalation Solution in acutely deteriorating patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dose. Excessive use of Formoterol Fumarate 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 Formoterol Fumarate Inhalation Solution immediately. ( 5.4 ) 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, Death The safety and efficacy of Formoterol Fumarate Inhalation Solution in patients with asthma have not been established. Formoterol Fumarate Inhalation Solution is not indicated for the treatment of asthma [ see CONTRAINDICATIONS (4) ]. 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, death) compared with ICS alone. • A 28-week, placebo-controlled US study comparing the safety of another LABA (sal