Arcapta Neohaler

• Synthetic sympathomimetic amine.1 10

• Relatively selective, long-acting β2-agonist.1 14 15 16 17

• Selectivity similar to that of formoterol; indacaterol has more than 24- or 20-fold greater agonist activity at β2-adrenergic receptors compared with β1- or β3-adrenergic receptors, respectively; clinical importance unknown.1 16

• Activates adenyl cyclase and stimulates production of cyclic adenosine-3′,5′-monophosphate (cAMP).1 14 16 Increased concentrations of cAMP relax bronchial smooth muscle.1 14 16

• Appears to inhibit IgE-dependent release of mediators (e.g., histamine) from human lung mast cells.15

• Does not appear to antagonize bronchorelaxant effect of short-acting, inhaled β2-agonists.16

• Tolerance not observed with long-term administration;16 17 improvement in lung function (as measured by FEV1) observed after 4 weeks of treatment consistently maintained over 12 weeks in clinical studies.1

• Provide a copy of the manufacturer's patient information (medication guide) to all patients each time the drug is dispensed.1 2 Importance of instructing patients to read the medication guide prior to initiation of therapy and each time the prescription is refilled.2 11 12

• Importance of informing patients that long-acting β2-adrenergic agonists (e.g., indacaterol) increase the risk of asthma-related death and that indacaterol is not indicated for the treatment of asthma.1 11 12

• Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the inhalation delivery system (Neohaler).1

• Importance of advising patients using indacaterol not to swallow the dry-powder capsules or to use them with any capsule inhaler other than the Neohaler device.1 Importance of advising patients not to use this inhaler with any other capsules.1 Importance of advising patients to use the new inhaler device provided with each new prescription.1

• Importance of adherence to dosing schedules, including not altering the dose or frequency of use unless otherwise instructed by a clinician.1 2

• Importance of advising patients that if a dose is missed, to take the dose as soon as it is remembered; importance of not taking more than one dose in a 24-hour period.1 2

• Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-adrenergic agonist as treatment for acute COPD symptoms.1

• Importance of discontinuing regular use of short-acting, inhaled β2-agonists when initiating indacaterol and using short-acting, inhaled β2-agonists to relieve acute symptoms.1

• Importance of not using indacaterol to relieve acute symptoms or exacerbations of COPD.1

• Importance of contacting a clinician immediately if symptoms worsen, the short-acting inhaled β2-agonist becomes less effective or more inhalations than usual are required, or clinically important decrease in lung function occurs.1

• Importance of advising patients receiving indacaterol not to use additional doses of the drug or other inhaled, long-acting β2-adrenergic agonists because excessive use of sympathomimetic agents may result in substantial cardiovascular effects or death.1

• Importance of patients not discontinuing therapy without medical supervision, since symptoms may recur after discontinuance.1

• Importance of informing patients of adverse effects associated with β2-adrenergic agonists (e.g., palpitations, chest pain, rapid heart rate, tremor, nervousness).1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, vitamins, and herbal supplements, as well as any concomitant illnesses (e.g., cardiac disorders, hypertension, seizures, thyroid disorders, diabetes mellitus, allergies to drugs or food).1 2

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In the U.S.

• Arcapta Neohaler

Available Dosage Forms:

• Capsule

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

If you will be using this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk to your doctor or get medical care right away:

• Your symptoms do not improve after using this medicine within a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana™), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist™), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine; dry mouth; increased thirst; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; seizures; shortness of breath; uneven heartbeat; or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Arm, back, or jaw pain
• chest pain or discomfort
• chest tightness or heaviness
• cough
• dizziness
• fainting
• fast or irregular heartbeat
• fever or chills
• nausea
• shortness of breath
• sneezing
• sore throat
• sweating
• tightness in the chest
• troubled breathing
• wheezing

• Abdominal or stomach pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• body aches or pain
• dry mouth
• ear congestion
• fainting
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• loss of consciousness
• loss of voice
• rapid weight gain
• runny or stuffy nose
• stomachache
• sweating
• tingling of the hands or feet
• unexplained weight loss
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

• Fast, irregular, pounding, or racing heartbeat or pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Muscle or bone pain
• muscle spasm
• pain or tenderness around the eyes and cheekbones

• Itching skin
• rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to indacaterol or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking or will be taking another drug like this one.

This is not a list of all drugs or health problems that interact with Arcapta Neohaler.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Arcapta Neohaler. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), this medicine may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• Do not take more of Arcapta Neohaler or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Arcapta Neohaler while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Inhalation powder:

75 mcg: hard gelatin capsule with black product code “IDL 75” above a bar printed on one side of the capsule and the logo “” printed on the other side.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. [see Warnings and Precautions (5.1)]. Arcapta Neohaler is not indicated for the treatment of asthma.

Arcapta Neohaler is contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients. [see Warnings and Precautions (5.4)].

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© Arcapta Neohaler Patient Information is supplied by Cerner Multum, Inc. and Arcapta Neohaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.