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Arcapta Neohaler

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Arcapta Neohaler

Arcapta Neohaler Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Arcapta Neohaler indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta Neohaler is not indicated for the treatment of asthma and increases the risk of asthma-related death. Common side effects from the use of Arcapta Neohaler are cough, headache, and nausea.

Arcapta capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Arcapta capsules are only for inhalation and should only be used with the Neohaler device. The recommended dosage of Arcapta Neohaler is the once-daily inhalation of the contents of one 75 mcg Arcapta capsule using the Neohaler inhaler. Patients should be cautioned against the use of Arcapta Neohaler along with the use of diuretics, xanthine derivates, beta-blockers, and steroids.

There are no adequate and well-controlled studies with Arcapta Neohaler in pregnant women. Arcapta Neohaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Arcapta Neohaler, indacaterol, is excreted in human milk. Because many drugs are excreted in human milk and because indacaterol has been detected in the milk of lactating rats, caution should be exercised when Arcapta Neohaler is administered to nursing women.

Our Arcapta Neohaler Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Arcapta Neohaler in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using indacaterol and call your doctor at once if you have any of these serious side effects:

  • chest pain, tremors, fast heart rate, pounding heartbeats or fluttering in your chest;
  • new or worsening cough, fever, trouble breathing;
  • swelling of your ankles or feet;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • feeling suddenly short of breath;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • worsening of your condition.

Less serious side effects may include:

  • throat pain;
  • nausea;
  • headache;
  • muscle pain or spasm; or
  • cold symptoms such as stuffy nose, sinus pain, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Arcapta Neohaler (Indacaterol Inhalation Powder) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Arcapta Neohaler FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Long-acting beta2-adrenergic agonists, such as ARCAPTA NEOHALER, increase the risk of asthma-related death. ARCAPTA NEOHALER is not indicated for the treatment of asthma [See BOXED WARNING and WARNING AND PRECAUTIONS].

Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The ARCAPTA NEOHALER safety database reflects exposure of 2516 patients to ARCAPTA NEOHALER at doses of 75 mcg or greater for at least 12 weeks in six confirmatory randomized, double-blind, placebo and active-controlled clinical trials. In these trials, 449 patients were exposed to the recommended dose of 75 mcg for up to 3 months, and 144, 583 and 425 COPD patients were exposed to a dose of 150, 300 or 600 mcg for one year, respectively. Overall, patients had a mean pre-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 54%. The mean age of patients was 64 years, with 47% of patients aged 65 years or older, and the majority (88%) was Caucasian.

In these six clinical trials, 48% of patients treated with any dose of ARCAPTA NEOHALER reported an adverse reaction compared with 43% of patients treated with placebo. The proportion of patients who discontinued treatment due to adverse reaction was 5% for ARCAPTA NEOHALER-treated patients and 5% for placebo-treated patients. The most common adverse reactions that lead to discontinuation of ARCAPTA NEOHALER were COPD and dyspnea.

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

Table 1 displays adverse drug reactions reported by at least 2% of patients (and higher than placebo) during a 3 month exposure at the recommended 75 mcg once daily dose. Adverse drug reactions are listed according to MedDRA (version 13.0) system organ class and sorted in descending order of frequency.

Table 1: Number and frequency of adverse drug reactions greater than 2% (and higher than placebo) in COPD patients exposed to ARCAPTA NEOHALER 75 mcg for up to 3 months in multiple dose, controlled trials

  Indacaterol 75 mcg once daily
n=449 n (%)
Placebo
n=445 n (%)
Respiratory, thoracic and mediastinal disorders
  Cough 29 (6.5) 20 (4.5)
  Oropharyngeal pain 10 (2.2) 3 (0.7)
Infections and infestations
  Nasopharyngitis 24 (5.3) 12 (2.7)
Nervous system disorders
  Headache 23 (5.1) 11 (2.5)
Gastrointestinal disorders
-   Nausea 11 (2.4) 4 (0.9)

In these trials the overall frequency of all cardiovascular adverse reactions was 2.5% for ARCAPTA NEOHALER 75 mcg and 1.6% for placebo during a 3 month exposure. There were no frequently occurring specific cardiovascular adverse reactions for ARCAPTA NEOHALER 75 mcg (frequency at least 1% and greater than placebo).

Additional adverse drug reactions reported in greater than 2% (and higher than on placebo) in patients dosed with 150, 300 or 600 mcg for up to 12 months were as follows:

Cough experienced post-inhalation

In the clinical trials, health care providers observed during clinic visits that an average of 24% of patients experienced a cough on at least 20% of visits following inhalation of the recommended 75 mcg dose of ARCAPTA NEOHALER compared to 7% of patients receiving placebo. The cough usually occurred within 15 seconds following inhalation and lasted for no more than 15 seconds. Cough following inhalation in clinical trials was not associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy.

Clinical Trials Experience in Asthma

In a 6-month randomized, active controlled asthma safety trial, 805 adult patients with moderate to severe persistent asthma were treated with ARCAPTA NEOHALER 300 mcg (n=268), ARCAPTA NEOHALER 600 mcg (n=268), and salmeterol (n=269), all concomitant with inhaled corticosteroids, which were not co-randomized. Of these patients, there were 2 respiratory-related deaths in the ARCAPTA NEOHALER 300 mcg dose group. There were no deaths in the ARCAPTA NEOHALER 600 mcg dose group or in the salmeterol active control group. Serious adverse reactions related to asthma exacerbation were reported for 2 patients in the indacaterol 300 mcg group, 3 patients in the indacaterol 600 mcg group, and no patients in the salmeterol active control group.

In addition, a two-week dose-ranging trial was conducted in 511 adult patients with mild persistent asthma taking inhaled corticosteroids. No deaths, intubations, or serious adverse reactions related to asthma exacerbation were reported in this trial.

Postmarketing Experience

The following adverse reactions have been identified during worldwide post-approval use of indacaterol, the active ingredient in ARCAPTA NEOHALER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are: tachycardia/heart rate increase/palpitations, pruritus/rash and dizziness.

Read the entire FDA prescribing information for Arcapta Neohaler (Indacaterol Inhalation Powder) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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