LAMA + LABA inhaler Pregnancy: §4.6: 'There are no data on the use of Bevespi Aerosphere in pregnant women.' Very small amounts of glycopyrronium cross the placenta; in animal studies formoterol and glycopyrronium individually caused adverse effects in reproduction studies at very high doses/systemic exposures. 'Bevespi Aerosphere should only be used during pregnancy if the expected benefits outweigh the potential risks.' Breast-feeding: excretion in human milk is unknown (transfer into rat milk reported) — administer only if the expected benefit to the mother is greater than any possible risk to the infant.

Glycopyrronium with formoterol fumarate

Brand names: Bevespi Aerosphere

This pressurised metered-dose inhaler combines the long-acting muscarinic antagonist glycopyrronium with the long-acting beta2 agonist formoterol (e.g. Bevespi) as twice-daily dual bronchodilator maintenance therapy for COPD.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Two inhalations (two inhalations in the morning and two inhalations in the evening) of glycopyrronium 7.2 micrograms / formoterol fumarate dihydrate 5 micrograms per actuation

Route: Inhalation — pressurised metered dose inhaler (Bevespi Aerosphere); may be used with the Aerochamber Plus Flow-Vu spacer for patients who find it difficult to co-ordinate actuation with inspiration — source product: Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension

Frequency: Twice daily (morning and evening)

Max: §4.2 verbatim: 'Patients should be advised not to take more than 2 inhalations twice daily.'

SOURCE: eMC UK SPC, productName 'Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension' (https://www.medicines.org.uk/emc/product/12024/smpc), §4.2. VERBATIM: 'The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).' MISSED DOSE: 'If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.' ELDERLY: 'No dose adjustments are required in elderly patients.' HEPATIC IMPAIRMENT: usable at the recommended dose in mild to moderate impairment; no relevant data in severe hepatic impairment — use with caution and monitor for adverse reactions. PAEDIATRIC: no per-kg dose is stated, hence paedDose is null. §4.2 verbatim: 'There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD.' INDICATION LIMIT (§4.4): 'Bevespi Aerosphere should not be used to treat asthma' and it is not indicated for acute episodes of bronchospasm (not a rescue therapy). ADMINISTRATION: prime by shaking and actuating into the air four times before first use, or twice if unused for more than seven days, exposed to low temperatures or dropped; do not use if the drying agent has leaked out of its packet; actuation must be co-ordinated with inhalation for adequate lung deposition. SOURCE HYGIENE: the openFDA record in this bundle is 'Qbrexza' (glycopyrronium cloth, Journey Medical Corporation) — a TOPICAL product for primary axillary hyperhidrosis, a different route and indication with only one of the two components; none of its data has been used here. §4.5 was retrieved only in part (truncated at the fetch limit) and §4.4/§4.8 were also truncated.

Dose adjustments

Renal

§4.2: 'Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk.' §4.4 defines severe renal impairment as creatinine clearance < 30 mL/min. No dose reduction is specified.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or any of the excipients listed in section 6.1 (§4.3)
Should not be used to treat asthma (§4.4)
Not indicated for the treatment of acute episodes of bronchospasm, i.e. not a rescue therapy (§4.4)
Use with caution in severe cardiovascular disorders (ischaemic heart disease, tachyarrhythmias, severe heart failure), thyrotoxicosis and known or suspected QTc prolongation (§4.4)
Use with caution in symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma, because of anticholinergic activity (§4.4)

Side effects

Headache (1.9%), nausea (1.4%), muscle spasms (1.4%) and dizziness (1.3%) — the most common reactions in the clinical development programme (all common)
Anxiety, dry mouth, urinary tract infection and chest pain (common)
Tachycardia, palpitations and cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles) (uncommon)
Agitation, restlessness, insomnia, tremor, hyperglycaemia, urinary retention (uncommon)
Hypersensitivity reactions including rash and pruritus (uncommon); paradoxical bronchospasm was not observed at the recommended dose in clinical studies but if it occurs, stop treatment and consider other treatments (§4.4)

Interactions

§4.5: 'Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies.'
§4.5: 'Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms' — in vitro glycopyrronium is a substrate for the renal transporter OCT2 (the remainder of §4.5 was truncated at the fetch limit)
§4.4 (cross-referring to §4.5): caution with medicinal products known or suspected to prolong the QTc interval, and note that hypokalaemia caused by beta2-agonists may be potentiated by hypoxia and concomitant treatment in severe COPD
NOTE: §4.5 was only partially retrieved — clinician to review the full SPC section before publishing

Clinical monograph

How it works

Glycopyrronium blocks muscarinic receptors and formoterol stimulates beta2 adrenoceptors, producing complementary bronchodilation of airway smooth muscle through two mechanisms.

Prescribing in practice

It is a regular maintenance treatment and must never be used to relieve acute breathlessness, for which a separate short-acting reliever is required.
The antimuscarinic component warrants caution in closed-angle glaucoma, urinary retention and bladder outflow obstruction.
Beta2 agonist effects include tremor, palpitations and hypokalaemia, and it should not be combined with other long-acting bronchodilators of the same classes.

Monitoring

Monitor COPD control and inhaler technique, with attention to antimuscarinic effects, heart rate and palpitations.

Counselling the patient

Use regularly twice daily as maintenance, not for sudden symptoms.
Report eye pain, blurred vision or difficulty passing urine.
Mild tremor or a faster heartbeat can occur and usually settles.

Evidence & guidelines

A recognised long-acting muscarinic antagonist/long-acting beta2 agonist dual bronchodilator combination for COPD supported by trial data and consistent with NICE COPD guidance.

Reference: NICE NG115; GOLD; 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).

Curated clinical cross-links plus same-class fallbacks.

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