Instructions for Use

It is important for patients to understand how to correctly administer UTIBRON capsules using the NEOHALER device. Instruct patients that UTIBRON capsules should only be administered via the NEOHALER device and the NEOHALER device should not be used for administering other medications. Remind patients that the contents of UTIBRON capsules are for oral inhalation only and must not be swallowed.

Instruct patients always to store UTIBRON capsules in sealed blisters and to only remove 1 UTIBRON capsule immediately before use or it may not be as effective. Instruct patients to discard unused additional UTIBRON capsules that are exposed to air (i.e., not intended for immediate use).

Inform patients to use 1 inhalation of UTIBRON NEOHALER orally twice-daily (1 capsule in the morning and 1 capsule in the evening) at the same time every day.

Inform patients that if they miss a dose of UTIBRON NEOHALER, they should use their next capsule at the usual time. Instruct patients to not use 2 capsules at one time and to not use more than 2 capsules in a day.


Learn the 3 I’s for helping patients remember the detailed steps for using the UTIBRON NEOHALER.

Help patients remember the 13 detailed steps in the Instructions for Use by learning the 3 I's for using UTIBRON NEOHALER. You can also watch the brief video below. Before patients use the UTIBRON NEOHALER, they should refer to the full Prescribing Information, including Boxed Warning, and Medication Guide.

Learn the 3 I’s for helping patients remember the detailed steps for using the UTIBRON NEOHALER.

Help patients remember the 13 detailed steps in the Instructions for Use by learning the 3 I's for using UTIBRON NEOHALER. You can also watch the brief video below. Before patients use the UTIBRON NEOHALER, they should refer to the full Prescribing Information, including BOXED WARNING, and Medication Guide.

Pull off NEOHALER cap

Step 1. Pull off cap

Open NEOHALER inhaler

Step 2. Open inhaler

Hold the base of the inhaler firmly and tilt the mouthpiece to open the inhaler.

Prepare UTIBRON capsule

Step 3. Prepare capsule

Separate 1 of the blisters from the blister card by tearing along the perforation.

Take 1 blister and peel away the protective backing to expose the capsule.

Do not push the capsule through the foil to remove it from the blister.

Remove a UTIBRON capsule

Step 4. Remove a UTIBRON capsule

Capsules should always be stored in the blister and only removed immediately before use.

With dry hands, remove 1 capsule from the blister.

Do not swallow the UTIBRON capsule.

Insert UTIBRON capsule

Step 5. Insert capsule

Place the capsule into the capsule chamber.

Do not place a capsule directly into the mouthpiece.

Close the NEOHALER inhaler

Step 6. Close the inhaler

Close the inhaler fully. You should hear a ‘click’ as it fully closes.

Pierce the UTIBRON capsule

Step 7. Pierce the capsule

Hold the inhaler upright with the mouthpiece pointing up.

Press both piercing buttons together firmly at the same time. You should hear a 'click' as the capsule is being pierced.

Do not press the piercing buttons more than 1 time.

Release the piercing buttons fully

Step 8. Release the piercing buttons fully

Breathe out

Step 9. Breathe out

Before placing the mouthpiece in your mouth, breathe out fully.

Do not blow into the mouthpiece.

Inhale the medicine

Step 10. Inhale the medicine

Before breathing in:

  • Hold the inhaler as shown in the figure for Step 10. Make sure that the piercing buttons are to the left and right of the inhaler (not up and down).
  • Place the mouthpiece in your mouth and close your lips firmly around the mouthpiece.
  • Breathe in rapidly but steadily, as deeply as you can. Do not press the piercing buttons.
Note the whirring noise from the inhaler

Step 11. Note

As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise. You may experience a sweet flavor as you inhale the medicine.

If you do not hear a whirring noise, the capsule may be stuck in the capsule chamber. If this occurs, open the inhaler and carefully loosen the capsule by tapping the base of the inhaler. Do not press the piercing buttons to loosen the capsule. (Repeat steps 9 and 10 if necessary.)

Hold breath

Step 12. Hold breath

Continue to hold your breath for at least 5 to 10 seconds or as long as comfortably possible while removing the inhaler from your mouth. Then breathe out.

Remove UTIBRON capsule from the NEOHALER inhaler

Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule, close the inhaler and repeat steps 9 to 12. Most people are able to empty the capsule with 1 or 2 inhalations.

Some people may cough soon after inhaling the medicine. If you do, don’t worry, as long as the capsule is empty, you have received 1 full dose.

Step 13. Remove capsule

After you have finished taking your daily dose of UTIBRON NEOHALER, open the mouthpiece again, remove the empty capsule by tipping it out of the capsule chamber, and throwing it away. Close the inhaler and replace the cap.

Do not store the capsules in the NEOHALER inhaler.


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.

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

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.