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ICS/LAMA/LABA triple inhaler Pregnancy: SPC section 4.6: there are insufficient data from the use of Enerzair Breezhaler or its individual components (indacaterol, glycopyrronium and mometasone furoate) in pregnant women to determine whether there is a risk. In animal reproduction studies with pregnant mice, rats and rabbits, mometasone furoate caused increased foetal malformations and decreased foetal survival and growth. Like other beta-2 adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Verbatim: 'This medicinal product should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.' Breast-feeding: no information on the presence of the components in human milk; other inhaled corticosteroids similar to mometasone furoate are transferred into human milk; a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy. Fertility: animal data did not indicate a concern.

Mometasone with glycopyrronium and indacaterol

Brand names: Enerzair Breezhaler

This is a single inhaler combining the inhaled corticosteroid mometasone furoate, the long-acting muscarinic antagonist glycopyrronium and the long-acting beta-2 agonist indacaterol for maintenance treatment of asthma in adults not controlled on an ICS plus LABA. It is a once-daily inhaled triple therapy.

Adult dose

Dose: One capsule inhaled once daily, delivering indacaterol 114 micrograms / glycopyrronium 46 micrograms / mometasone furoate 136 micrograms
Route: Inhalation of the powder from the capsule, using only the Breezhaler inhaler provided with each new prescription. The capsules must not be swallowed and must only be removed from the blister immediately before use. After inhalation, patients should rinse their mouth with water without swallowing.
Frequency: Once daily, at the same time of day each day; it can be administered irrespective of the time of the day
Max: Maximum 114 micrograms / 46 micrograms / 136 micrograms once daily. SPC section 4.2 verbatim: 'The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily.' Also verbatim: 'Patients should be instructed not to take more than one dose in a day.'
VERBATIM (SPC section 4.2 Posology): 'The recommended dose is one capsule to be inhaled once daily. The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily. Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.' COMPONENT ORDER: the SPC states the strengths only as the string '114 mcg/46 mcg/136 mcg'; section 4.4 of the same SPC names the combination in the order 'indacaterol/glycopyrronium/mometasone furoate', which is the order used above. Confirm the per-component strengths against the product carton before prescribing. METHOD OF ADMINISTRATION (verbatim): 'For inhalation use only. The capsules must not be swallowed. The capsules must be administered only using the inhaler provided (see section 6.6) with each new prescription. Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. The capsules must only be removed from the blister immediately before use. After inhalation, patients should rinse their mouth with water without swallowing.' ELDERLY (verbatim): 'No dose adjustment is required in elderly patients (65 years of age or older).' NOT A RELIEVER (section 4.4, verbatim): 'This medicinal product should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.' Also verbatim: 'It is recommended that treatment with this medicinal product should not be stopped abruptly.' SCOPE: the fetched SPC gives a single fixed once-daily dose and no alternative regimen; no other indication is dosed in this bundle.

Dose adjustments

Renal

SPC section 4.2 verbatim: 'No dose adjustment is required in patients with mild to moderate renal impairment. Caution should be observed in patients with severe renal impairment or end-stage renal disease requiring dialysis (see sections 4.4 and 5.2).'

Hepatic

SPC section 4.2 verbatim: 'No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for the use of the medicinal product in patients with severe hepatic impairment, therefore it should be used in these patients only if the expected benefit outweighs the potential risk (see section 5.2).'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (SPC section 4.3 — the only contraindication stated in the fetched label)
  • Not a contraindication but an explicit section 4.4 restriction: must not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
  • Caution (section 4.4): cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders, thyrotoxicosis, and patients unusually responsive to beta-2 adrenergic agonists
  • Safety unknown (section 4.4 — excluded from the clinical development programme): unstable ischaemic heart disease, myocardial infarction in the last 12 months, NYHA class III/IV left ventricular failure, arrhythmia, uncontrolled hypertension, cerebrovascular disease, history of long QT syndrome, and patients treated with medicinal products known to prolong QTc

Side effects

  • Asthma (exacerbation) — very common (41.8% over 52 weeks in the IRIDIUM study)
  • Nasopharyngitis — very common (10.9%)
  • Upper respiratory tract infection — common (5.6%)
  • Headache — common (4.2%)
  • Candidiasis (oral candidiasis, oropharyngeal candidiasis) — common; rinse the mouth with water without swallowing after each inhalation
  • Urinary tract infection (grouped term: asymptomatic bacteriuria, bacteriuria, cystitis, urethritis, urinary tract infection, urinary tract infection viral) — common
  • Hypersensitivity (grouped term: drug eruption, drug hypersensitivity, hypersensitivity, rash, rash pruritic, urticaria) — common
  • Tachycardia (sinus, supraventricular or unspecified) — common
  • Oropharyngeal pain, cough and dysphonia — common
  • Gastroenteritis (grouped term including chronic gastritis, enteritis, gastritis, gastrointestinal inflammation) — common
  • Musculoskeletal pain (back pain, musculoskeletal chest pain, myalgia, neck pain) and muscle spasms — common
  • Pyrexia — common
  • Hyperglycaemia / blood glucose increased — uncommon
  • Cataract — uncommon
  • Dry mouth / dry throat — uncommon
  • Rash and pruritus — uncommon
  • Dysuria — uncommon
  • Section 4.4 warnings: immediate hypersensitivity reactions including angioedema (difficulty breathing or swallowing, swelling of tongue, lips and face), urticaria or skin rash — discontinue immediately; and paradoxical bronchospasm, which can be life-threatening — discontinue immediately
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Reliever use: increasing use of short-acting bronchodilators indicates deterioration of asthma control and warrants review by a physician and reassessment of therapy
  • Sudden and progressive deterioration in asthma symptoms is potentially life-threatening — urgent medical assessment
  • Pulse rate and blood pressure: beta-2 agonists may produce clinically significant cardiovascular effects; if such effects occur, treatment may need to be discontinued
  • Inhaler technique: patients who do not experience improvement in breathing should be asked whether they are swallowing rather than inhaling the capsule
  • Signs of allergic reaction (angioedema, urticaria, rash) and of paradoxical bronchospasm — discontinue immediately if either occurs
  • Oropharyngeal candidiasis: mouth-rinsing after each dose is required by the SPC
  • Note: the fetched SPC contains no dedicated laboratory-monitoring schedule; the items above are drawn from sections 4.2 and 4.4

Clinical monograph

How it works

Mometasone suppresses airway inflammation, indacaterol relaxes bronchial smooth muscle via beta-2 receptors and glycopyrronium produces additional bronchodilation by blocking muscarinic receptors.

Prescribing in practice

  • This is a maintenance preventer only and must not be used to relieve acute bronchospasm; patients still need a separate reliever inhaler.
  • Counsel on rinsing the mouth after use to reduce oral candidiasis and hoarseness from the corticosteroid component, and review inhaler technique.
  • Use the antimuscarinic component with care in significant cardiovascular disease, narrow-angle glaucoma or urinary retention.

Monitoring

Monitor asthma control, inhaler technique, and for oral candidiasis and antimuscarinic effects such as dry mouth or urinary symptoms.

Counselling the patient

  • This inhaler prevents attacks and is not for sudden breathlessness; keep your reliever to hand.
  • Rinse your mouth and spit out after each dose.
  • Use it once daily at the same time each day, even when you feel well.

Evidence & guidelines

Trials and the SPC support once-daily inhaled triple therapy for asthma uncontrolled on an inhaled corticosteroid and long-acting beta-2 agonist.

Reference: NICE NG80; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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