Onbrez breezhaler® [Indacaterol]

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Dosage and Administration

Adverse reactions

When using the drug in therapeutic doses, the following adverse events were most often noted: nasopharyngitis, cough, upper respiratory tract infections and muscle spasms. Most of the above adverse events were mild or moderate severity, the incidence of these adverse events decreased with further use.
Below are the undesirable effects observed with the use of the drug in doses of 150 and 300 mg 1 time / day. in patients with COPD. Undesirable reactions are distributed according to the frequency of occurrence. The following criteria were used to estimate the frequency: very often (≥1 / 10); often (≥1 / 100,

Infections and invasions: often - nasopharyngitis, upper respiratory tract infections, sinusitis.
On the part of the respiratory system: often - cough, sore throat, rhinorrhea.
On the part of the musculoskeletal system: often - muscle spasm, myalgia, bone pain.
On the part of the nervous system: infrequently - dizziness, paresthesia.
Since the cardiovascular system: often - IHD; infrequently - atrial fibrillation.
On the part of the digestive system: often - dry mouth.
Metabolic disorders: often - hyperglycemia / newly diagnosed diabetes mellitus.
General disorders: often - peripheral edema, pain in the chest (non-cardiogenic); infrequently - discomfort in the chest.
When using the drug in a dose of 600 mcg 1 time / day., The safety profile did not significantly differ from that during inhalation of therapeutic doses (150 and 300 mcg 1 time / day.). Additional adverse events were anemia and tremor. Muscle cramps and nasopharyngitis were also detected more frequently. In patients with COPD with inhalation at recommended doses, the drug does not have a clinically significant systemic β2-adrenomimetic effect. The average heart rate changed by no more than 1 beats / min. The incidence of tachycardia (noted in rare cases), a significant lengthening of the QTc interval (> 450 ms for men and> 470 ms for women) and hypokalemia was similar to placebo.
Plasma glucose concentrations were similar to those in the placebo group.
In clinical studies, within 15 seconds after inhalation of the drug in patients (in 17-20% of cases), sporadic cough development was observed with a duration of about 5 seconds. The occurrence of cough after inhalation of Onbrez Breezhaler slightly worried patients and did not require discontinuation of treatment with the drug (since cough is a symptom of COPD, and only in 6.6% of cases did patients cough with the use of the drug).There was no association between the cough observed immediately after the inhalation of the drug and the development of bronchospasm, exacerbation of COPD, worsening of the course of COPD and a decrease in the effectiveness of the drug.

Contraindications

- age up to 18 years (efficacy and safety have not been established);
- pregnancy;
- breastfeeding period;
- Hypersensitivity to any of the components of the drug.

Drug interactions

Drugs that extend the QT interval
As with the use of other β2-adrenoreceptor agonists, prolongation of the QT interval is possible during drug therapy. Since this effect of indacaterol on the length of the QT interval can be potentiated by other drugs, Onbrez® Brizhaler® should be used with caution in patients receiving MAO inhibitors, tricyclic antidepressants, or other drugs that prolong the QT interval. Lengthening the QT interval increases the risk of developing ventricular arrhythmias.
Sympathomimetic drugs
The simultaneous use of indacaterol with sympathomimetics (both separately and as part of combination therapy) may increase the risk of developing adverse events.
The drug should not be used simultaneously with other long-acting β2-adrenoreceptor agonists or with drugs that include long-acting β2-adrenoreceptor agonists.
Hypokalemia
Concurrent use with methylxanthine derivatives, GCS, or potassium-infusing diuretics may enhance the potential hypokalemia caused by β2-adrenoreceptor agonists.
Β2-adrenoreceptor blockers
Since β2-adrenoreceptor blockers can weaken the effect or inhibit the action of β2-adrenoreceptor agonists, Onbrez® Bryzhaler® should not be used simultaneously with β2-adrenoreceptor blockers (including eye drops).
If necessary, the use of both classes of drugs, it is preferable to use cardioselective blockers of β2-adrenergic receptors, however, they must be used with caution.
Interaction at the level of isoenzyme CYP3A4 and membrane transporter P-glycoprotein
The interaction of indacaterol with specific inhibitors of the isoenzyme CYP3A4 and P-glycoprotein, such as ketoconazole, erythromycin and verapamil, has been studied.
The simultaneous use of indacaterol with verapamil resulted in a 1.4–2 fold increase in AUC and a 1.5 fold increase in Cmax. When indacaterol was administered with erythromycin, the AUC increased 1.4–1.6 times and Cmax increased 1.2 times. Combination therapy with indacaterol and ketoconazole caused a 2-fold and 1.4-fold increase in AUC and Cmax, respectively. This increase in exposure due to drug interactions did not change the safety profile.
When using indacaterol with other drugs, no drug interactions were observed. In vitro studies have shown that indacaterol has little potential for interaction with drugs at the metabolic level of enzymes or at the level of membrane transporters with systemic exposure achieved when prescribing therapeutic doses.

Special instructions

Overdosage

• Brand name: Onbrez breezhaler
• Active ingredient: Indacaterol
• Dosage form: Capsules with powder for inhalation.
• Manufacturer: Novartis
• Country of Origin: Switzerland