Onriva75 mcg

Indacaterol maleate is a long-acting beta-2 agonist (LABA) bronchodilator indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important limitation of use: Indacaterol is not indicated for the treatment of asthma, and its safety and effectiveness in asthma have not been established in some regulatory approvals. It is also not indicated to treat acute deteriorations of COPD, and is not a rescue medicine for sudden breathing difficulty - a fast-acting inhaled bronchodilator should be used for that purpose.

Contains Onriva 75 mcg as the active ingredient, supplied as a dry powder for oral inhalation in capsules, commonly in 75 mcg strength (as approved in the US) or 150 mcg and 300 mcg strengths (as approved in many other countries), used only with the matching inhaler device.

Indacaterol is a once-daily, long-acting inhaled bronchodilator used specifically for the ongoing maintenance treatment of COPD, not for asthma or for relieving sudden breathing difficulty. It works by relaxing the muscles around the airways over a full 24-hour period, supporting once-daily dosing. As with all long-acting beta-2 agonists, it carries a boxed warning regarding an increased risk of asthma-related death when used in asthma without an inhaled corticosteroid, which is part of why it is not approved for asthma treatment; used correctly for its approved COPD indication, alongside a fast-acting inhaler for sudden symptoms, it is a well-established maintenance option.

Therapeutic Class: Bronchodilator (Long-acting Beta-2 Agonist, LABA)

Indacaterol has a long duration of bronchodilator action supporting once-daily dosing, with a half-life of approximately 40-56 hours. It is absorbed from the lungs after inhalation, is highly protein-bound (about 95%), and is metabolized mainly via hepatic CYP3A4, CYP2D6, and CYP1A1 enzymes, with the majority of a dose excreted in the urine.

• For oral inhalation only, using the specific inhaler device designed for this product - never swallow the capsules, as this will not produce the intended lung effect
• Take at approximately the same time each day, once daily only
• Do not exceed the recommended daily dose or use more than once every 24 hours
• Keep a fast-acting (rescue) inhaler available for sudden symptoms, since indacaterol is not intended to relieve acute breathing difficulty
• If a dose is missed, take the next dose at the regular scheduled time the following day; do not double up

The following should be assessed by a healthcare professional before combining with indacaterol:

• Other medicines containing a long-acting beta-2 agonist (LABA): should not be used concurrently, given the risk of clinically significant, potentially fatal, cardiovascular effects from excessive beta-agonist exposure.
• Beta-blockers: may block the bronchodilator effect of indacaterol and could produce severe bronchospasm in patients with COPD; if a beta-blocker is needed for another condition, a cardioselective agent may be considered, used with caution.
• Phenothiazines and other QT-prolonging medicines: combining with beta-agonists like indacaterol may increase the risk of cardiac conduction disturbances, including QT prolongation.
• Diuretics (non-potassium-sparing): ECG changes and/or low blood potassium associated with non-potassium-sparing diuretics may worsen with concomitant beta-agonist use; use with caution.
• Strong CYP3A4 or P-glycoprotein inhibitors: may increase indacaterol blood levels; monitor for increased side effects if combined.

Common side effects

• Cough
• Nasopharyngitis (common cold-type symptoms)
• Upper respiratory tract infection
• Headache
• Muscle spasms

Serious side effects (seek urgent medical attention)

• Life-threatening paradoxical bronchospasm: a sudden worsening of wheezing or breathing difficulty immediately after use - discontinue immediately and treat with an alternative fast-acting bronchodilator if this occurs.
• Cardiovascular effects: increased heart rate, palpitations, chest pain, or high blood pressure, particularly with excessive use or when combined with other LABA-containing medicines - do not exceed the recommended dose.
• Immediate hypersensitivity reactions: rash, hives, swelling of the face or throat, difficulty breathing - discontinue immediately if these occur.
• Signs of worsening COPD despite treatment - increasing use of a rescue inhaler, or decreasing effectiveness of a rescue inhaler, should be reported to a doctor promptly, since it may indicate deteriorating disease control.

Pregnancy

Data on indacaterol use in human pregnancy are limited; it should be used during pregnancy only if the treating doctor determines the benefit outweighs the potential risk, given the class-wide considerations associated with beta-agonist use during pregnancy, such as potential effects on uterine contractions at high systemic exposure.

Breastfeeding

It is not known whether indacaterol passes into human milk; use during breastfeeding should be discussed with a healthcare professional.

• Not for asthma: this medicine is not indicated for asthma, and use of a LABA alone (without an inhaled corticosteroid) in asthma carries an increased risk of asthma-related death, a class-wide LABA warning.
• Not a rescue medicine: do not use for acute symptoms or acute COPD deterioration; keep a fast-acting bronchodilator available for this purpose.
• Do not exceed the recommended dose: excessive use or combining with other LABA-containing products can cause clinically significant, potentially fatal, cardiovascular effects.
• Use with caution in patients with cardiovascular disease, seizure disorders, hyperthyroidism, or diabetes, given the class effects of beta-agonists on heart rate, blood pressure, and blood glucose.
• Use with caution in patients with existing QT prolongation, or those on other QT-prolonging medicines.

Overdose is likely to result in exaggerated beta-agonist effects, including excessive stimulation of the cardiovascular system (increased heart rate, palpitations, arrhythmias, raised or lowered blood pressure), tremor, headache, nervousness, muscle cramps, dry mouth, and, potentially, hypokalemia or hyperglycemia. Suspected significant overdose requires prompt medical evaluation, particularly for cardiac monitoring; treatment is generally supportive, provided in a medical facility, with a cardioselective beta-blocker considered under close medical supervision if severe cardiovascular effects occur, given the risk of associated bronchospasm.

Store the capsules at room temperature, in their original blister packaging, protected from moisture, and only remove a capsule from the blister immediately before use. Do not store capsules in the inhaler device.

• Hepatic impairment: No dose adjustment recommended for mild to moderate impairment; data are not available for severe impairment, so use with caution.
• Renal impairment: No specific dose adjustment is generally established; use with general caution given the class effects of beta-agonists.
• Children: Safety and effectiveness have not been established in patients younger than 18 years, and it is not indicated for use in this age group.

Indacaterol is used as ongoing, long-term maintenance therapy for COPD, for as long as it provides symptom benefit and is well tolerated, as part of the patient's overall COPD management plan, with regular review by the treating doctor.

Drug Class: Long-acting beta-2 adrenergic agonist

Indacaterol stimulates beta-2 adrenergic receptors on airway smooth muscle, causing the muscles surrounding the airways to relax over a sustained, 24-hour period. This widens (dilates) the airways, improving airflow and easing symptoms such as breathlessness in patients with COPD, supporting once-daily use as a maintenance treatment rather than for immediate symptom relief.

Safety and effectiveness of indacaterol have not been established in patients younger than 18 years, and it is not indicated for use in children.