STRIVERDI RESPIMAT- olodaterol hydrochloride spray, metered
Boehringer Ingelheim Pharmaceuticals, Inc.
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2 -adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2 -adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, the active ingredient in STRIVERDI RESPIMAT. The safety and efficacy of STRIVERDI RESPIMAT in patients with asthma have not been established. STRIVERDI RESPIMAT is not indicated for the treatment of asthma [see Contraindications (4), Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
1.1 Maintenance Treatment of COPD
STRIVERDI RESPIMAT is a long-acting beta2 -agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
1.2 Important Limitations of Use
STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2) ].
STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established.
2 DOSAGE AND ADMINISTRATION
The recommended dose of STRIVERDI RESPIMAT is two inhalations once-daily at the same time of the day. Do not use STRIVERDI RESPIMAT more than two inhalations every 24 hours.
Prior to first use, the STRIVERDI RESPIMAT cartridge is inserted into the STRIVERDI RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17.2) ].
No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally-impaired patients. There are no data available for use of STRIVERDI RESPIMAT in severe hepatically impaired patients [see Clinical Pharmacology (12.3) ].
3 DOSAGE FORMS AND STRENGTHS
STRIVERDI RESPIMAT consists of a STRIVERDI RESPIMAT inhaler and an aluminum cylinder (STRIVERDI RESPIMAT cartridge) containing olodaterol (as the hydrochloride). The STRIVERDI RESPIMAT cartridge is intended for use with the STRIVERDI RESPIMAT inhaler only.
Each actuation from the STRIVERDI RESPIMAT inhaler delivers 2.7 mcg olodaterol hydrochloride, equivalent to 2.5 mcg olodaterol. Two actuations equal one dose.
4 CONTRAINDICATIONS
All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication [see Warnings and Precautions (5.1) ]. STRIVERDI RESPIMAT is not indicated for the treatment of asthma.
5 WARNINGS AND PRECAUTIONS
5.1 Asthma-Related Death [see Boxed Warning ]
Data from a large placebo-controlled study in asthma patients showed that long-acting beta2 -adrenergic agonists may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2 -adrenergic agonists.
A 28-week, placebo-controlled US study comparing the safety of another long-acting beta2 -adrenergic agonist (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 long-acting beta2 -adrenergic agonists, including STRIVERDI RESPIMAT. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with STRIVERDI RESPIMAT has been conducted. The safety and efficacy of STRIVERDI RESPIMAT in patients with asthma have not been established. STRIVERDI RESPIMAT is not indicated for the treatment of asthma [see Contraindications (4) ].
