UTIBRON NEOHALER in Long-Term Care

NEOHALER® device icon

UTIBRON NEOHALER for your residents’ COPD symptoms

UTIBRON NEOHALER offers the power of two bronchodilators, indacaterol and glycopyrrolate, in one inhaler to help control COPD symptoms such as wheezing, cough, chest tightness, and shortness of breath1

  • UTIBRON NEOHALER is 100% steroid free1
  • No dose adjustments were required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild to moderate renal impairment
    • UTIBRON NEOHALER should be used in patients with severe renal impairment if the expected benefit outweighs the potential risk1
Efficacy
  • Significant and sustained improvement in lung function with twice-daily dosing1
    • >230 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in two trials
      • 262 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in Trial 1
      • 231 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in Trial 2
    • The primary end point was change in FEV1 AUC0-12hr vs placebo at Week 12 from baseline in two pivotal trials
    • More information on UTIBRON NEOHALER efficacy in clinical trials
Safety
  • The safety of UTIBRON NEOHALER was established in two 12-week placebo-controlled trials and one 52-week safety trial. The most common adverse events reported in the two 12-week trials, ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis, hypertension, back pain, and oropharyngeal pain. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled trials of 12 weeks1
    • More information on UTIBRON NEOHALER safety
Dosing
  • The recommended dose of UTIBRON NEOHALER is the inhalation of the contents of 1 capsule twice daily using the device1
    • Should be administered at the same time of the day (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration is not recommended

UTIBRON NEOHALER is designed to provide audio and visual cues each time a dose is inhaled

NEOHALER® inhaler

Soft whirring noise on inhalation confirms the capsule has been correctly placed.1

UTIBRON® capsule

Clear capsule allows patient to see if there is any residual medication, and inhale the remaining dose.1

UTIBRON capsules are for oral inhalation only and should not be swallowed. 


UTIBRON NEOHALER offers the power of two bronchodilators, indacaterol and glycopyrrolate, in one inhaler to help control COPD symptoms such as wheezing, cough, chest tightness, and shortness of breath1

  • UTIBRON NEOHALER is 100% steroid free1
  • No dose adjustments were required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild to moderate renal impairment
    • UTIBRON NEOHALER should be used in patients with severe renal impairment if the expected benefit outweighs the potential risk1
Efficacy
  • Significant and sustained improvement in lung function with twice-daily dosing1
    • >230 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in two trials
      • 262 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in Trial 1
      • 231 mL improvement in FEV1 AUC0-12hr vs placebo at Week 12 in Trial 2
    • The primary end point was change in FEV1 AUC0-12hr vs placebo at Week 12 from baseline in two pivotal trials
    • More information on UTIBRON NEOHALER efficacy in clinical trials
Safety
  • The safety of UTIBRON NEOHALER was established in two 12-week placebo-controlled trials and one 52-week safety trial. The most common adverse events reported in the two 12-week trials, ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis, hypertension, back pain, and oropharyngeal pain. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled trials of 12 weeks1
    • More information on UTIBRON NEOHALER safety
Dosing
  • The recommended dose of UTIBRON NEOHALER is the inhalation of the contents of 1 capsule twice daily using the device1
    • Should be administered at the same time of the day (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration is not recommended

UTIBRON NEOHALER is designed to provide audio and visual cues each time a dose is inhaled

NEOHALER® inhaler

Soft whirring noise on inhalation confirms the capsule has been correctly placed.1

UTIBRON® capsule

Clear capsule allows patient to see if there is any residual medication, and inhale the remaining dose.1

UTIBRON capsules are for oral inhalation only and should not be swallowed. 

Prescription Icon

Residents covered by both Medicare and Medicaid are dual eligible

Residents covered by both Medicare and Medicaid are dual eligible

Dual eligibility and low-income subsidy

65 years icon

Residents aged 65 years or older are eligible for Medicare2,3

84% icon

84% of nursing home residents are aged 65 years or older4

63.5% icon

Medicaid covers, on average, 63.5% of individuals residing in nursing homes5

Dual eligible residents

Automatically qualify for low-income subsidy6,7

No co-pay or exposure to coverage gap for fully subsidized, eligible individuals7


For long-stay residents, prescription coverage is transferred to the Part D plan8


No guarantee of coverage. Check with the patient’s insurance provider for additional details.

AUC=area under the curve.
FEV1=forced expiratory volume in 1 second.
LABA=long-acting beta2-adrenergic agonist.
LAMA=long-acting muscarinic antagonist.

Dual eligibility and low-income subsidy

65 years icon

Residents aged 65 years or older are eligible for Medicare2,3

 84% icon

84% of nursing home residents are aged 65 years or older4

Medicaid covers, on average, 63.5% of individuals residing in nursing homes5

Dual eligible residents

Automatically qualify for low-income subsidy6,7

No co-pay or exposure to coverage gap for fully subsidized, eligible individuals7


For long-stay residents, prescription coverage is transferred to the Part D plan8


No guarantee of coverage. Check with the patient’s insurance provider for additional details.

AUC=area under the curve.
FEV1=forced expiratory volume in 1 second.
LABA=long-acting beta2-adrenergic agonist.
LAMA=long-acting muscarinic antagonist.


References:
1. UTIBRON NEOHALER [prescribing information]. 2018.
2. Centers for Medicare & Medicaid Services. Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual. Version 1.15. October 2017. Baltimore, MD: Centers for Medicare & Medicaid Services, US Dept of Health and Human Services; 2017. 
3. Centers for Medicare & Medicaid Services. Medicare & You 2018. Baltimore, MD: Centers for Medicare & Medicaid Services, US Dept of Health and Human Services; November 2018. 
4. Henry J. Kaiser Family Foundation. Distribution of nursing facility residents by age. https://www.kff.org/other/state- indicator/distribution-of-nursing-facility-residents-by-age/. Published 2018. Accessed March 5, 2018. 
5. American Health Care Association. 2013 Quality Report. https://www.ahcancal.org/qualityreport/Documents/AHCA_2013QR_ONLINE.pdf. Accessed March 5, 2018. 
6. National Council on Aging. Medicare low income subsidy: get extra help paying for Part D. https://www.ncoa.org/economic-security/benefits/prescriptions/lis-extrahelp/. Accessed March 6, 2018. 
7. Centers for Medicare & Medicaid Services. Prescription drug benefit manual: chapter 13—premium and cost-sharing subsidies for low-income individuals. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/Chapter13.pdf. Published 2008. Revised 2011. Accessed March 5, 2018. 
8. US Department of Health and Human Services. Availability of Medicare Part D Drugs to Dual-Eligible Nursing Home Residents. Washington, DC: US Dept of Health and Human Services; June 2008. 

Important Safety Information & Indication

Important Safety Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (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 all LABAs, including indacaterol, one of the active ingredients in UTIBRON NEOHALER.

The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma.



All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; UTIBRON NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.

UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.

Immediate hypersensitivity reactions have been reported with UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

As with other inhaled medicines, UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted.

Indacaterol, like other beta2-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.

As with other beta2-adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.

As with other beta2-adrenergic agonists, UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%).

UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see the full Prescribing Information, including BOXED WARNING and Medication Guide, for UTIBRON NEOHALER.



Indication
 

UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important limitations: UTIBRON NEOHALER is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.