Onbrez Breezhaler150 mcg

Onbrez Breezhaler is an inhaled, long-acting beta2-adrenergic agonist (LABA) indicated for the following use:

Established / FDA-Approved Indication

• Chronic Obstructive Pulmonary Disease (COPD): Onbrez Breezhaler is indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Important Labeling Distinctions

• Onbrez Breezhaler is NOT indicated for the treatment of asthma. Safety and efficacy of Onbrez Breezhaler in asthma have not been established, and LABA monotherapy is associated with an increased risk of asthma-related death (see Precautions and Warnings).
• Onbrez Breezhaler is NOT a rescue medication and must not be used to treat acute deteriorations of COPD or acute episodes of bronchospasm.

Each hard capsule for oral inhalation contains Indacaterol Maleate equivalent to a labeled dose of indacaterol base (commonly available internationally as 150 mcg or 300 mcg strengths), along with lactose monohydrate as a carrier/excipient. The capsule is intended for use only with its accompanying single-dose dry powder inhaler device and must not be swallowed.

Onbrez Breezhaler is the maleate salt of indacaterol, an ultra-long-acting beta2-adrenergic receptor agonist (LABA) developed for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is formulated as a dry powder inside hard capsules that are inserted into a dedicated single-dose inhaler device immediately before use; the powder is inhaled directly into the lungs.

Onbrez Breezhaler provides sustained bronchodilation for a full 24 hours, allowing convenient once-daily dosing, unlike older short-acting bronchodilators that require multiple daily doses.

Onbrez Breezhaler belongs to the therapeutic class of long-acting beta2-adrenergic agonists (LABA), used as inhaled bronchodilators in the maintenance management of chronic obstructive pulmonary disease.

Indacaterol Maleate acts as a selective agonist at beta2-adrenergic receptors present on airway smooth muscle. Binding of Indacaterol Maleate to these receptors activates adenylate cyclase, increasing intracellular cyclic AMP (cAMP). Elevated cAMP activates protein kinase A, which lowers intracellular calcium and relaxes bronchial smooth muscle, producing bronchodilation.

Onset of bronchodilation with Indacaterol Maleate occurs within about 5 minutes of inhalation, and the effect is sustained for 24 hours, supporting once-daily dosing. Indacaterol Maleate shows high intrinsic efficacy at the beta2-receptor, with relatively lower activity at beta1-receptors, though cardiovascular beta1-mediated effects (e.g., increased heart rate) can still occur, particularly at higher doses.

Onbrez Breezhaler capsules are for oral inhalation only and must never be swallowed. To administer:

• Remove one capsule from the blister immediately before use; do not store capsules outside the blister.
• Open the inhaler device, place the capsule in the chamber, and close the device until it clicks.
• Press both side buttons once, fully, at the same time, then release, to pierce the capsule.
• Breathe out fully (away from the device), then place the mouthpiece in the mouth, tilt the head slightly back, and inhale rapidly and deeply through the device; hold the breath for as long as comfortable (up to 10 seconds).
• Check the capsule for remaining powder; if powder remains, repeat the inhalation step.
• Discard the empty capsule after use; do not use the device to inhale any other medication.

Onbrez Breezhaler has the following clinically significant drug interactions:

• Other long-acting beta2-agonists (LABAs): Concomitant use with other LABA-containing medicines should be avoided because of the risk of additive sympathomimetic and cardiovascular effects; Onbrez Breezhaler should not be combined with other LABA-containing products.
• Beta-adrenergic blockers: Beta-blockers (especially non-selective agents) may block the pulmonary and cardiovascular effects of Onbrez Breezhaler and should generally be avoided in patients using Onbrez Breezhaler; if required for compelling medical reasons, a cardioselective beta-blocker may be considered with caution.
• Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: These agents (and drugs known to prolong the QT interval) may potentiate the effect of Onbrez Breezhaler on the cardiovascular system and should be used with caution.
• Non-potassium-sparing diuretics (e.g., loop or thiazide diuretics): Concurrent use may enhance ECG changes and/or hypokalemia associated with beta2-agonist therapy; use with caution and monitor potassium and ECG where clinically indicated.
• Other sympathomimetic agents: Concomitant use of other sympathomimetic medicines may potentiate adverse cardiovascular effects of Onbrez Breezhaler.

The most commonly reported adverse effects with Onbrez Breezhaler include:

• Nasopharyngitis (common cold-like symptoms)
• Cough
• Headache
• Nausea
• Musculoskeletal pain (including back pain)
• Hypertension
• Sinusitis and upper respiratory tract infection

Less common but clinically important cardiovascular effects, consistent with the beta2-agonist class, include tachycardia, palpitations, and tremor. Rarely, paradoxical bronchospasm can occur (see Precautions and Warnings).

There are limited data on the use of Onbrez Breezhaler in pregnant women. As with other beta2-agonists, Onbrez Breezhaler may inhibit uterine contractions (tocolytic effect) if used during labor. Onbrez Breezhaler should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, and only under medical supervision.

It is not known whether Onbrez Breezhaler is excreted in human breast milk. Because many drugs are excreted in breast milk, caution should be exercised, and Onbrez Breezhaler should be used during breastfeeding only if clearly needed, after consulting a physician, weighing the benefits of treatment against any potential risk to the infant.

Boxed Warning: Asthma-Related Death (LABA Class Warning)

Long-acting beta2-adrenergic agonists (LABAs), the class of medicine that includes Onbrez Breezhaler, increase the risk of asthma-related death. Onbrez Breezhaler is not indicated for the treatment of asthma. Data are not available to determine whether the risk of asthma-related death is increased in patients with COPD who use Onbrez Breezhaler.

Not for Acute Symptoms

Onbrez Breezhaler is not a rescue medicine and must not be used to treat acute symptoms of COPD or acute bronchospasm; a short-acting bronchodilator should be used for acute relief, and patients should be instructed to seek medical attention if rescue treatment becomes less effective or is needed more often than usual.

Cardiovascular Effects

Beta2-agonists such as Onbrez Breezhaler can produce clinically significant cardiovascular effects, including increases in heart rate, blood pressure, and ECG changes; Onbrez Breezhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Other Precautions

• Paradoxical bronchospasm: Discontinue Onbrez Breezhaler immediately if paradoxical bronchospasm occurs and institute alternative therapy.
• Convulsive disorders: Use with caution, as with other sympathomimetic agents.
• Thyrotoxicosis: Use with caution due to potential for increased sympathomimetic effects.
• Diabetes mellitus: Beta2-agonists may transiently raise blood glucose; monitor as clinically indicated.
• Hypokalemia: Beta2-agonist therapy may produce significant hypokalemia in some patients, potentiated by concomitant use with diuretics (see Interactions).

Overdose of Onbrez Breezhaler is likely to produce exaggerated beta2-agonist effects, such as tachycardia, palpitations, tremor, headache, nausea, hypokalemia, hyperglycemia, and increased blood pressure or, rarely, hypotension. Cardiac arrhythmias may occur.

There is no specific antidote for Onbrez Breezhaler overdose. If overdose is suspected, discontinue Onbrez Breezhaler immediately and seek immediate medical attention or contact a poison control center. Supportive treatment and monitoring of cardiac status (ECG) and serum potassium should be instituted by a physician as clinically indicated; cardioselective beta-blockers may be considered by a physician with caution, given the risk of inducing bronchospasm.

Store at room temperature (below 30°C), away from light and moisture. Keep capsules in the blister until immediately before use, and keep out of reach of children. Do not refrigerate or freeze.

• Elderly: No overall differences in safety or efficacy have been observed between elderly and younger adult patients; no dose adjustment is required based on age alone.
• Renal impairment: No dose adjustment needed in mild-to-severe renal impairment; use with caution in severe renal impairment or end-stage renal disease due to limited data (see Dosage and Administration).
• Hepatic impairment: No dose adjustment needed in mild-to-moderate hepatic impairment; use with caution in severe hepatic impairment, which has not been studied (see Dosage and Administration).
• Pediatric patients: Safety and efficacy of Onbrez Breezhaler have not been established in patients under 18 years of age; it is not indicated for use in children or adolescents.
• Pregnancy and lactation: See Pregnancy and Lactation section.

Onbrez Breezhaler is intended for long-term, continuous, once-daily maintenance treatment of COPD and should be taken regularly every day as prescribed, even when the patient feels well, to maintain control of airflow obstruction. It is not intended for short-term or as-needed use. Patients should not stop Onbrez Breezhaler without consulting their physician, and any perceived reduction in effectiveness or worsening of symptoms should be reported to a physician promptly rather than increasing the dose or frequency on their own.

Bronchodilator; Long-acting beta2-adrenergic agonist (LABA); Anti-COPD inhaled therapy

Indacaterol Maleate selectively stimulates beta2-adrenergic receptors in bronchial smooth muscle, activating adenylate cyclase to raise intracellular cAMP, which relaxes airway smooth muscle and produces sustained bronchodilation lasting 24 hours (see Pharmacology for full mechanism).

C

The safety and efficacy of Onbrez Breezhaler in pediatric patients (below 18 years of age) have not been established. Onbrez Breezhaler is not indicated for use in children or adolescents, and it must not be used as a substitute for appropriate pediatric asthma or COPD-directed therapy. Use in this population should only occur under specialist medical guidance if ever considered off-label, which is not generally recommended.