Medical Editor: John P. Cunha, DO, FACOEP
What Is Bevespi Aerosphere?
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol is a combination of an anticholinergic and a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
What Are Side Effects of Bevespi Aerosphere?
Common side effects of Bevespi Aerosphere include:
- urinary tract infection and
Dosage for Bevespi Aerosphere
The dosage of Bevespi Aerosphere for maintenance treatment of COPD is 2 inhalations twice daily.
What Drugs, Substances, or Supplements Interact with Bevespi Aerosphere?
Bevespi Aerosphere may interact with other adrenergic drugs, xanthine derivatives, steroids, diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, other drugs that prolong the QTc interval, beta-blockers, and anticholinergics. Tell your doctor all medications and supplements you use.
Bevespi Aerosphere During Pregnancy or Breastfeeding
During pregnancy, Bevespi Aerosphere should be used only if prescribed. Tell your doctor if you become pregnant while taking Bevespi Aerosphere. It is unknown if Bevespi Aerosphere passes into breast milk. Breastfeeding while taking Bevespi Aerosphere is not recommended.
Our Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events. BEVESPI AEROSPHERE is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].
The following adverse reactions are described in greater detail elsewhere in the labeling:
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
- Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for BEVESPI AEROSPHERE included 4,911 subjects with COPD in two 24-week lung function trials, one long-term safety extension study of 28 weeks, and 10 other trials of shorter duration. A total of 1,302 subjects have received at least 1 dose of BEVESPI AEROSPHERE. The safety data described below are based on the two 24-week trials and the one 28-week long-term safety extension trial. Adverse reactions observed in the other trials were similar to those observed in these confirmatory trials.
The incidence of adverse reactions with BEVESPI AEROSPHERE in Table 1 is based on reports in two 24-week, placebo-controlled trials (Trials 1 and 2; n=2,100 and n=1,610, respectively). Of the 3,710 subjects, 56% were male and 91% were Caucasian. They had a mean age of 63 years and an average smoking history of 51 pack-years, with 54% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 51% (range: 19% to 82%) and the mean percent reversibility was 20% (range: -32% to 135%).
Subjects received one of the following treatments: BEVESPI AEROSPHERE, glycopyrrolate 18 mcg, formoterol fumarate 9.6 mcg, or placebo twice daily or active control.
Table 1 : Adverse Reactions with BEVESPI AEROSPHERE
≥2% Incidence and More Common than with Placebo in Subjects with Chronic
Obstructive Pulmonary Disease
|Adverse Reaction||BEVESPI AEROSPHERE
|Glycopyrrolate 18 mcg BID
|Formoterol Fumarate 9.6 mcg BID
|Respiratory, thoracic, and mediastinal disorders|
|Infections and infestation|
|Urinary tract infection||2.6||1.8||1.5||2.3|
Other adverse reactions defined as events with an incidence of >1% but less than 2% with BEVESPI AEROSPHERE but more common than with placebo included the following: arthralgia, chest pain, tooth abscess, muscle spasms, headache, oropharyngeal pain, vomiting, pain in extremity, dizziness, anxiety, dry mouth, fall, influenza, fatigue, acute sinusitis, and contusion.
Long-Term Safety Extension
Trial In a 28-week long-term safety extension trial, 893 subjects who successfully completed Trial 1 or Trial 2 were treated for up to an additional 28 weeks for a total treatment period of up to 52 weeks with BEVESPI AEROSPHERE, glycopyrrolate 18 mcg, formoterol fumarate 9.6 mcg administered twice daily or active control. Because the subjects continued from Trial 1 or Trial 2 into the safety extension trial, the demographic and baseline characteristics of the long-term safety extension trial were similar to those of the placebo-controlled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the 24-week placebo-controlled trials.
Additional Adverse Reactions
Other adverse reactions that have been associated with the component formoterol fumarate include: hypersensitivity reactions, hyperglycemia, sleep disturbance, agitation, restlessness, tremor, nausea, tachycardia, palpitations, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles).
The following adverse reactions have been identified during post approval use of BEVESPI AEROSPHERE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In postmarketing experience with BEVESPI AEROSPHERE, hypersensitivity and urinary retention have been reported.
Read the entire FDA prescribing information for Bevespi Aerosphere (Glycopyrrolate and Formoterol Fumarate Inhalation Aerosol)
© Bevespi Aerosphere Patient Information is supplied by Cerner Multum, Inc. and Bevespi Aerosphere Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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