Medical Editor: John P. Cunha, DO, FACOEP
What Is Utibron Neohaler?
Utibron Neohaler (indacaterol and glycopyrrolate) inhalation powder is a combination of a long-acting beta2-adrenergic agonist (LABA) and an anticholinergic indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
What Are Side Effects of Utibron Neohaler?
Common side effects of Utibron Neohaler include:
Dosage for Utibron Neohaler
The dose for the maintenance treatment of COPD is the inhalation of the powder contents of one Utibron capsule twice-daily.
What Drugs, Substances, or Supplements Interact with Utibron Neohaler?
Utibron Neohaler may interact with other adrenergic drugs, xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, drugs that prolong QTc interval, beta-blockers, and anticholinergics. Tell your doctor all medications and supplements you use.
Utibron Neohaler During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or become pregnant while using Utibron Neohaler. It is unknown if the medications in Utibron Neohaler pass into breast milk. Consult your doctor before breastfeeding.
Our Utibron Neohaler (indacaterol and glycopyrrolate) inhalation powder 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.
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The following clinically significant adverse reactions are described in greater detail in other sections:
- Serious Asthma-Related Events - Hospitalizations, Intubations, Death [see WARNINGS AND PRECAUTIONS]
- Paradoxical Bronchospasm [see WARNINGS AND PRECAUTIONS].
- Hypersensitivity Reactions, including Anaphylaxis [see 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, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
The UTIBRON NEOHALER safety database included 2654 subjects with COPD in two 12-week lung function trials and one 52-week long-term safety study. A total of 712 subjects received treatment with UTIBRON NEOHALER 27.5 mcg/15.6 mcg twice daily. The safety data described below are based on the two 12-week trials and the one 52-week trial.
The incidence of adverse reactions associated with UTIBRON NEOHALER in Table 1 is based on two 12-week, placebo-controlled trials (Trials 1 and 2; N = 1,001 and N = 1,042, respectively). Of the 2040 subjects, 63% were male and 91% were Caucasian. They had a mean age of 63 years and an average smoking history of 47 pack-years, with 52% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was55%(range: 29% to 79%), the mean post-bronchodilator FEV1/forced vitalcapacity(FVC) ratio was 50% (range: 19% to 71%), and the mean percent reversibility was 23% (range: 0% to 144%).
The most common adverse reaction (incidence greater than or equal to 2% and higher than placebo) was nasopharyngitis and hypertension.
The proportion of patients who discontinued treatment due to adverse reactions was 2.95% for the UTIBRON NEOHALER treated patients and 4.13% for placebo-treated patients.
Subjects received 1 dose twice daily of the following: UTIBRON NEOHALER 27.5 mcg/15.6 mcg, indacaterol 27.5 mcg, glycopyrrolate 15.6 mcg, or placebo.
Table 1: Adverse Reactions with UTIBRON NEOHALER (greater than or equal to 1% incidence and higher than placebo) in COPD Patients
|Adverse Reaction||UTIBRON NEOHALER 27.5/15.6 mcg twice daily
(N = 508) n (%)
|Indacaterol 27.5 mcg twice daily
(N = 511) n (%)
|Glycopyrrolate 15.6 mcg twice daily
(N = 513) n (%)
(N = 508) n (%)
|Nasopharyngitis||21 (4.1)||13 (2.5)||12 (2.3)||9 (1.8)|
|Hypertension||10 (2.0)||5 (1.0)||3 (0.6)||7 (1.4)|
|Back pain||9 (1.8)||7 (1.4)||2 (0.4)||3 (0.6)|
|Oropharyngeal pain||8 (1.6)||4 (0.8)||8 (1.6)||6 (1.2)|
Other adverse reactions occurring more frequently with UTIBRON NEOHALER than with placebo, but with an incidence of less than 1% include dyspepsia, gastroenteritis, chest pain, fatigue, peripheral edema, rash/pruritus, insomnia, dizziness, bladder obstruction/urinary retention, atrial fibrillation, palpitations, tachycardia.
In a long-term safety trial, 614 subjects were treated for up to 52 weeks with indacaterol/glycopyrrolate 27.5 mcg/15.6 mcg twice daily, indacaterol/glycopyrrolate 27.5/31.2 mcg twice daily or indacaterol 75 mcg once daily. The demographic and baseline characteristics of the long-term safety 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 placebo-controlled trials of 12 weeks. Additional adverse reactions that occurred with a frequency greater than or equal to 2% in the group receiving indacaterol/glycopyrrolate 27.5 mcg/15.6 mcg twice daily that exceeded the frequency of indacaterol 75 mcg once daily in this trial were upper and lower respiratory tract infection, pneumonia, diarrhea, headache, gastroesophageal reflux disease, hyperglycemia, rhinitis.
The following additional adverse reactions of angioedema and dysphonia have been identified during worldwide post-approval use of indacaterol/glycopyrrolate at higher than the recommended dose. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of indacaterol, a component of UTIBRON NEOHALER, may be potentiated [see WARNINGS AND PRECAUTIONS].
Xanthine Derivatives, Steroids, Or Diuretics
Concomitant treatment with xanthine derivatives, steroids, or diureticsmay potentiateany hypokalemic effect of beta2adrenergic agonists, such as indacaterol, a component of UTIBRON NEOHALER [see WARNINGS AND PRECAUTIONS].
The electrocardiographic (ECG) changes and/or hypokalemia that may result from the administration of non-potassiumsparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as indacaterol, a component of UTIBRON NEOHALER, especially when the recommended dose of the beta-agonist is exceeded.
Although the clinical relevance of these effects is not known, caution is advised in the coadministration of UTIBRON NEOHALER with non-potassium-sparing diuretics.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc-Prolonging Drugs
Indacaterol, one ofthecomponents of UTIBRON NEOHALER, as with other beta 2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may have an increased risk of ventricular arrhythmias.
Beta-adrenergic receptor antagonists (beta-blockers) and UTIBRON NEOHALER may interfere with the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of UTIBRON NEOHALER with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Inhibitors Of Cytochrome P450 3A4 And P-gp Efflux Transporter
Drug interaction studies with indacaterol, a component of UTIBRON NEOHALER, were carried out using potent and specific inhibitors of CYP3A4 and P-gp (i.e., ketoconazole, erythromycin, verapamil, and ritonavir). The data suggest that systemic clearance of indacaterol is influenced by modulation of both P-gp and CYP3A4 activities and that the 2-fold area under the curve (AUC) increase caused by the strong dual inhibitor ketoconazole reflects the impact of maximal combined inhibition. Indacaterol was evaluated in clinical trials for up to 1 year at doses up to 600 mcg. Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, has no impact on safety of therapeutic doses of indacaterol. Therefore, no dose adjustment is warranted at the recommended 27.5/15.6 mcg twice-daily dose for UTIBRON NEOHALER when administered concomitantly with inhibitors of CYP3A4 and P-gp [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Utibron Neohaler (Indacaterol and Glycopyrrolate Inhalation Powder, for Oral Inhalation Use)
© Utibron Neohaler Patient Information is supplied by Cerner Multum, Inc. and Utibron Neohaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.