Instructions for Use

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

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


Learn the 3 i’s for helping patients use the ARCAPTA NEOHALER.

Help patients remember the 12 detailed steps in the Instructions for Use by learning the 3 i’s for using ARCAPTA NEOHALER. You can also watch the brief video below. Before patients use the ARCAPTA NEOHALER, they should refer to the full Prescribing Information, including Boxed Warning, and Medication Guide.

Learn the 3 i’s for helping patients use the ARCAPTA NEOHALER.

Help patients remember the 12 detailed steps in the Instructions for Use by learning the 3 i’s for using ARCAPTA NEOHALER. You can also watch the brief video below. Before patients use the ARCAPTA NEOHALER, they should refer to the full Prescribing Information, including BOXED WARNING, and Medication Guide.

Pull off cap

Step 1. Pull off cap

Open inhaler

Step 2. Open Inhaler

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

Prepare capsule

Step 3. Prepare capsule

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

Take one blister and peel away the protective backing to expose the foil.

Remove an ARCAPTA capsule

Step 4. Remove an ARCAPTA capsule

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

With dry hands, remove one capsule from the blister by pushing the ARCAPTA capsule through the foil.

Do not swallow ARCAPTA capsule.

Insert capsule

Step 5. Insert capsule

Place the capsule into the capsule chamber.

Do not place a capsule directly into the mouthpiece.

Close the inhaler

Step 6. Close the inhaler

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

Pierce the capsule

Step 7. Pierce the capsule

Hold the inhaler upright.

Press both buttons fully one time. You should hear a ‘click’ as the capsule is being pierced.

Do not press the piercing buttons more than one time.

Release the buttons fully

Step 8. Release the buttons fully

Breathe out

Step 9. Breathe out

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

Never blow into the mouthpiece.

Inhale the medicine

Step 10. Inhale the medicine

Before breathing in, place the mouthpiece in your mouth and close your lips around the mouthpiece. Hold the inhaler with the buttons to the left and right (not up and down).

Breathe in rapidly and steadily, as deeply as you can. Do not press the piercing buttons.

Note the whirring noise from the inhaler

Note

As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise.

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

Hold breath

Step 11. Hold breath

Continue to hold your breath as long as comfortably possible while removing the inhaler from your mouth. Then breathe out.

Remove capsule

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 11. Most people are able to empty the capsule in one or two 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 the full dose.

Step 12. Remove capsule

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

Do not store the capsules in the NEOHALER device.


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

A video guide to using the ARCAPTA NEOHALER.

A video guide to using the ARCAPTA 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, the active ingredient in ARCAPTA NEOHALER.

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



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

ARCAPTA NEOHALER should not be initiated in patients with acutely deteriorating COPD 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. 

ARCAPTA 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 ARCAPTA NEOHALER should not use another medicine containing a LABA for any reason.

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

As with other inhaled beta2-adrenergic agonists, ARCAPTA NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, ARCAPTA NEOHALER should be discontinued immediately and alternative therapy instituted.

ARCAPTA NEOHALER, like with 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. ARCAPTA 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, ARCAPTA NEOHALER 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, ARCAPTA NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

ARCAPTA 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.

In 6 clinical trials, 48% of ARCAPTA NEOHALER patients reported adverse reactions compared with 43% of placebo patients. The most common adverse events reported in ≥2% of patients taking ARCAPTA NEOHALER, and occurring more frequently than in patients taking placebo, were cough (6.5% vs 4.5%), nasopharyngitis (5.3% vs 2.7%), headache (5.1% vs 2.5%), nausea (2.4% vs 0.9%), and oropharyngeal pain (2.2% vs 0.7%).

The most common serious adverse reactions were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups.

ARCAPTA capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA 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 ARCAPTA NEOHALER.
 

Indication

ARCAPTA® NEOHALER® (indacaterol) is a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

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