formoterol + glycopyrronium: clinical use

Prescribing considerations

• Confirm COPD and that maintenance LABA/LAMA treatment is appropriate; this product is not for asthma or rescue treatment.
• Assess inhaler technique and ability to coordinate a pressurised inhaler; consider the compatible spacer when needed.
• Use only after benefit–risk assessment in severe renal impairment or end-stage renal disease.
• Exercise caution in severe hepatic impairment because relevant clinical data are lacking.
• Review cardiovascular disease, thyrotoxicosis, QT prolongation, diabetes and susceptibility to hypokalaemia.

Contraindications and cautions

• Hypersensitivity to formoterol, glycopyrronium or any excipient.
• Caution is required with narrow-angle glaucoma, symptomatic prostatic hyperplasia or urinary retention.

Monitoring

• Inhaler technique, adherence, symptom response and adequacy of the acute-relief plan.
• Heart rate, rhythm and cardiovascular symptoms when clinically indicated.
• Potassium and glucose in patients with relevant risk factors or interacting treatment.
• Symptoms of urinary retention or narrow-angle glaucoma.
• Adverse reactions in severe renal or hepatic impairment.

Clinical pharmacology

Glycopyrronium produces bronchodilation through M3-receptor inhibition; formoterol activates beta2 receptors and increases cyclic AMP. Glycopyrronium is predominantly renally eliminated, while formoterol undergoes glucuronidation and O-demethylation.

Formulation and product differences

• This product is a pressurised inhalation suspension with an integrated dose indicator.
• It requires coordinated slow inhalation and actuation; compatibility has been demonstrated with the AeroChamber Plus Flow-Vu spacer.
• The actuator and canister are product-specific and should not be interchanged with other inhalers.
• The formulation contains norflurane, a phospholipid excipient and calcium chloride; it contains no inhaled corticosteroid.

Inhaled preparation

Route: Inhaled

Strengths: 7.2 micrograms + 5 micrograms