Instructions for Use

UTIBRON NEOHALER consists of both the inhaler and the blister-packaged capsules. Each package contains UTIBRON capsules and a NEOHALER inhaler.

Advise patients that they should not use UTIBRON capsules with any other capsule inhaler, and do not use the NEOHALER inhaler to take any other capsule medicine.                

UTIBRON NEOHALER inhaler is designed to deliver all of the medicine contained in the blister-packaged capsules. The capsules are clear, so patients can see that the capsule is empty; if the capsule is empty the full dose has been received. Remind patients that the capsules are not intended for oral use.

How Your Patients Should Use the UTIBRON NEOHALER

Read the step-by-step Instructions for Using UTIBRON NEOHALER at the end of the Medication Guide.

  • Do not use UTIBRON NEOHALER unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Use UTIBRON NEOHALER exactly as your healthcare provider tells you to use it. Do not use UTIBRON NEOHALER more often than prescribed for you.
  • Do not swallow UTIBRON capsules. Only use UTIBRON capsules with the UTIBRON NEOHALER inhaler.
  • Use 1 UTIBRON capsule inhaled through the NEOHALER inhaler 2 times each day (1 capsule in the morning and 1 capsule in the evening).
  • To make sure that the full dose has been taken, you should open the inhaler to check that there is no powder left in the capsule. As long as the capsule is empty, you have received 1 full dose.
  • If you miss a dose of UTIBRON NEOHALER, take it as soon as you remember. Take your next dose at your usual time.
    • Do not use 2 capsules at one time.
    • Do not use more than 2 capsules in a day.
  • UTIBRON capsules should always be stored in the blister strip and only removed immediately before use. Peel the backing foil away from the blister to open it, do not push the capsule through the foil.
  • Always use the new NEOHALER inhaler that is provided with each new prescription.
  • UTIBRON NEOHALER does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have a rescue inhaler prescribed for you.
  • Do not stop using UTIBRON NEOHALER or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with UTIBRON NEOHALER, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.

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

A Video Guide to Using the UTIBRON NEOHALER

Can’t see the video? Read or download the full Instructions for Use.

Important Safety Information & Indication

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-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-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-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. 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.