Utibron Neohaler

Generic name: glycopyrrolate and indacaterol
Drug class: Bronchodilator combinations

Medically reviewed by  A Ras MD.

What is Utibron Neohaler?

Utibron Neohaler combines a long-acting beta2 adrenergic agonist (LABA) medicine (indacaterol) and an anticholinergic medicine (glycopyrrolate).

• LABA and anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. This makes it hard to breathe.
• Utibron Neohaler is used to treat chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
• Utibron Neohaler is for long-term use and should be taken, 2 times each day, to improve symptoms of COPD for better breathing.
• Utibron Neohaler is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
• Utibron Neohaler is not for the treatment of asthma. It is not known if Utibron Neohaler is safe and effective in people with asthma.
• Utibron Neohaler should not be used in children. It is not known if Utibron Neohaler is safe and effective in children.

DESCRIPTION

UTIBRON NEOHALER consists of a dry powder formulation for delivery of a combination of indacaterol and glycopyrrolate to patients by oral inhalation only with the NEOHALER device. The inhalation powder is packaged in hypromellose (HPMC) capsules with yellow transparent cap and uncolored transparent body.

Each capsule contains a dry powder blend of 27.5 mcg/15.6 mcg of indacaterol/glycopyrrolate with approximately 24.9 mg of lactose monohydrate (which contains trace levels of milk protein) and 0.03 mg of magnesium stearate.

One active component of UTIBRON NEOHALER is indacaterol maleate, a (R) enantiomer. Indacaterol maleate is a selective beta₂-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8- hydroxy-1H-quinolin-2-one maleate; its structural formula is :

Indacaterol maleate has a molecular weight of 508.56, and its empirical formula is C₂₄H₂₈N₂O₃ • C₄H₄O₄. Indacaterol maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol maleate is slightly soluble in ethanol and very slightly soluble in water.

The other active component of UTIBRON NEOHALER is glycopyrrolate, which is chemically described as (3RS)-3[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl) oxy]-1,1-dimethylpyrrolidinium bromide. This synthetic quaternary ammonium compound acts as a competitive antagonist at muscarinic acetylcholine receptors, also referred to as anticholinergic. Glycopyrrolate, C₁₉H₂₈BrNO₃, is a white powder that is freely soluble in water and sparingly soluble in absolute ethanol. It has a molecular mass of 398.33. The structural formula is:

The NEOHALER device is a plastic inhalation device used to inhale the dry powder within the UTIBRON capsule. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time.

Under standardized in vitro testing at a fixed flow rate of 90 L/min for 1.3 seconds, the NEOHALER inhaler delivered 20.8 mcg of indacaterol and 12.8 mcg glycopyrrolate for the 27.5 mcg/15.6 mcg dose strength (equivalent to 27.5 mcg/12.5 mcg of indacaterol/glycopyrronium) from the mouthpiece. This in vitro testing revealed that the NEOHALER device had a specific resistance of 0.059 cm H2O½/L/min. Peak inspiratory flow rates (PIFR) achievable through the NEOHALER device were evaluated in 26 adult patients with COPD of varying severity. Mean PIFR was 95 L/min (range 52 to 133 L/min) for adult patients. Twenty-five of 26 patients (96%) in this study generated a PIFR through the device exceeding 60 L/min.

What is the most important thing I should know about Utibron Neohaler?

Do not swallow Utibron capsules. Utibron capsules are used only with the Neohaler inhaler that comes with Utibron Neohaler. Do not place a capsule in the mouthpiece of the Neohaler inhaler.

Who should not use Utibron Neohaler?

Do not use Utibron Neohaler if you:

• have asthma.
• are allergic to indacaterol, glycopyrrolate, or any of the ingredients in Utibron Neohaler. Ask your healthcare provider if you are not sure. See “What are the ingredients in Utibron Neohaler?” at the end of this Patient Information guide for a complete list of ingredients in Utibron Neohaler.

What should I tell my healthcare provider before using Utibron Neohaler?

Before using Utibron Neohaler, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have kidney problems
• have eye problems such as glaucoma. Utibron Neohaler may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. Utibron Neohaler may make these problems worse.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Utibron Neohaler can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if the medicines in Utibron Neohaler pass into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will take Utibron Neohaler or breastfeed.
• are allergic to Utibron Neohaler or any of its ingredients, any other medicines, or food products.

Utibron Neohaler contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Utibron Neohaler may affect the way other medicines work, and other medicines can affect how Utibron Neohaler works. Using Utibron Neohaler with other medicines may cause serious side effects.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Utibron Neohaler?

Read the step-by-step instructions that comes with Utibron Neohaler.

• 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.

What are the possible side effects of Utibron Neohaler?

Utibron Neohaler can cause serious side effects, including:

• people with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as indacaterol (one of the medicines in Utibron Neohaler), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
  • Call your healthcare provider if breathing problems worsen over time while using Utibron Neohaler. You may need a different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler medicine, but it does not relieve your breathing problems
• COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of Utibron Neohaler, instead call your healthcare provider.
• using too much of a LABA medicine may cause:
  • chest pain
  • fast and irregular heartbeat
  • tremor
  • increased blood pressure
  • headache
  • nervousness
• sudden shortness of breath immediately after use of Utibron Neohaler. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Utibron Neohaler and call your healthcare provider or go to the nearest hospital emergency room right away.
• serious allergic reactions. Stop using Utibron Neohaler and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • swelling of the tongue, lips, and face
  • hives
  • difficulty breathing or swallowing
  • effects on your heart
  • fast or irregular heartbeat, awareness of a heartbeat
  • chest pain
  • increased blood pressure
• new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort
  • blurred vision
  • red eyes
  • nausea or vomiting
  • seeing halos or bright colors around lights
    If you have these symptoms, stop taking Utibron Neohaler and call your healthcare provider right away before taking another dose.
• new or worsened urinary retention. People who use Utibron Neohaler may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
  • difficulty urinating
  • urinating frequently
  • painful urination
  • urination in a weak stream or drips
    If you have these symptoms, stop taking Utibron Neohaler and call your healthcare provider right away before using another dose.
• changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.

Common side effects of Utibron Neohaler include sore throat and runny nose, high blood pressure, and back pain.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Utibron Neohaler. For more information, ask your healthcare provider or pharmacist.
Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Instructions for Use

UTIBRON®
NEOHALER®
(indacaterol and glycopyrrolate) inhalation powder, for oral inhalation use

For Oral Inhalation Only

Do not swallow UTIBRON capsules.

Follow the instructions below for using UTIBRON NEOHALER. You will breathe-in (inhale) the medicine in the UTIBRON capsules from the NEOHALER inhaler. If you have any questions, ask your healthcare provider or pharmacist.

Your UTIBRON NEOHALER

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

• (1) NEOHALER inhaler which consists of a cap and a base (see figure below)
• UTIBRON capsules come in blister cards to be used only in the NEOHALER inhaler (see figure below)

Your inhaler is made to give you the medicine contained in the capsules.

Only use the NEOHALER inhaler contained in this pack. Do not use UTIBRON NEOHALER capsules with any other inhaler, do not use NEOHALER inhaler to take any other capsule medicine.

How to use your inhaler:

Step 1. Pull off cap.

Step 2. Open inhaler:

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

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.

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.

Step 5. Insert capsule:

Place the capsule into the capsule chamber.

Do not place a capsule directly into the mouthpiece.

Step 6. Close the inhaler:

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

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.

Step 8. Release the piercing buttons fully.

Step 9. Breathe out:

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

Do not blow into the mouthpiece.

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.

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 loosenthe capsule. (Repeat steps 9 and 10 if necessary.)

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.

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 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 leave the used capsules in the NEOHALER inhaler.

General information about the safe and effective use of Utibron Neohaler

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Utibron Neohaler for a condition for which it was not prescribed. Do not give Utibron Neohaler to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.
For more information about Utibron Neohaler or to report side effects, go to www.Utibron.com or call 1-888-394-7377.

How should I store Utibron Neohaler?

• Store Utibron Neohaler (inhaler and blister-packaged capsules) at room temperature between 68°F and 77°F (20°C and 25°C).
• Do not remove Utibron capsules from the blister card it comes in until you are ready to use a dose of Utibron Neohaler.
• Do not store Utibron capsules in the Neohaler inhaler.
• Keep Utibron Neohaler in a dry place away from light and moisture.

Keep Utibron Neohaler and all medicines out of the reach of children.

What are the ingredients in Utibron Neohaler?

Active ingredients: indacaterol maleate, glycopyrrolate

Inactive ingredients: lactose monohydrate (contains milk proteins) and magnesium stearate.