Indacaterol

Indacaterol is a prescription medication used long-term to prevent breathing difficulties (wheezing, cough, chest tightness and shortness of breath) caused by chronic obstructive pulmonary disease (COPD). Indacaterol belongs to a group of medications called long acting beta agonists (LABA). It works by helping the muscles in your lungs to stay relaxed, opening up the airways, making it easier to breathe.

Indacaterol is a prescription medication used in adults to prevent symptoms of chronic obstructive pulmonary disease (COPD) such as wheezing, cough, chest tightness and shortness of breath. COPD is a lung disease that includes both chronic bronchitis and emphysema.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Indacaterol may be found in some form under the following brand names:

• Arcapta

Indacaterol can cause serious side effects. See “Drug Precautions” section.

Common side effects include:

• runny nose
• cough
• sore throat
• headache
• nausea

Tell your healthcare provider about any side effect that bothers you or that does not go away. 

These are not all the side effects with indacaterol. Ask your healthcare provider or pharmacist for more information.

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

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• diuretics such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril), metolazone (Zaroxolyn) and others
• beta blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol XL), propranolol (Inderal) and others
• antidepressants such as notriptyline (Pamelor), and MAO inhibitors
• other long-acting beta agonists such as formoterol (Foradil, Perforomist), salmeterol (Serevent) and others
• oral steroids such as prednisone (Deltasone), dexamethasone (Decadron, Dexone) methylprednisolone (Medrol) and others
• QT-prolonging medications 

This is not a complete list of indacaterol drug interactions. Ask your healthcare provider or pharmacist for more information.

Indacaterol can cause serious side effects, including:

• serious allergic reactions including rash, hives, swelling of the tongue, lips and face, difficulties in breathing or swallowing. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
• sudden shortness of breath that may be life-threatening
• fast or irregular heartbeat (palpitations)
• increased blood pressure
• chest pain
• low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• high blood sugar

People with asthma who take long-acting beta2 adrenergic-agonist (LABA) medicines, such as indacaterol, have an increased risk of death from asthma problems.

It is not known if LABA medicines, such as indacaterol, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).

• Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems.

Do not use indacaterol if you:

• have asthma
• have had an allergic reaction to indacaterol 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of indacaterol there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all of your health conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• are pregnant or planning to become pregnant or breastfeeding
• are allergic to indacaterol or any other medicines or food products

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Indacaterol and certain other medicines may interact with each other. This may cause serious side effects.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Indacaterol falls into category C. There are no well-done studies that have been done in humans with indacaterol. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

It is not known if indacaterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using indacaterol.

• Use indacaterol 1 time each day at the same time of the day. 
• If you miss a dose of indacaterol, take it as soon as you remember. Do not take more than one dose in 24 hours. 
• Do not swallow indacaterol capsules. Indacaterol capsules should always be used with the Neohaler inhaler only.
• Always use the new Neohaler inhaler that is provided with each new prescription.
• Indacaterol 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 one prescribed for you.
• Do not stop using indacaterol 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.
• Do not use indacaterol:
  • more often than prescribed
  • more medicine than prescribed for you
  • with other LABA medicines
• Call your health care provider or get emergency medical care right away if:
  • your breathing problems worsen with indacaterol
  • you need to use your rescue medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving your symptoms

The recommended indacaterol dose for the treatment of chronic obstructive pulmonary disease (COPD) is one 75 mcg capsule inhaled into the lungs using the Neohaler device once daily.

If you take too much indacaterol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store indacaterol (inhaler and blister-packaged capsules) in a dry place 59° F to 86° F (15°C to 30°C).  Protect indacaterol (inhaler and blister-packaged capsules) from moisture. 
• Do not remove indacaterol capsules from their foil package until just before use.
• Keep indacaterol capsules out of the light.
• Do not store indacaterol capsules in the Neohaler inhaler.
• Keep indacaterol and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (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 LABA, including indacaterol, the active ingredient in indacaterol inhaler. The safety and efficacy of indacaterol inhaler in patients with asthma have not been established. Indacaterol inhaler is not indicated for the treatment of asthma.