November 2021 new listing wrap-up

Budesonide with glycopyrronium and formoterol fixed-dose combination (FDC) inhaler (Breztri Aerosphere) is now listed on the PBS General Schedule (Section 85) as Authority Required (Streamlined) for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD).^1,2

The restrictions for the medicine require that the patient must have:¹

• experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months. The patient must have significant symptoms despite regular bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or
• been stabilised on a combination of a LAMA, LABA and an ICS for this condition.

The medicine should not be used:¹

• as treatment for asthma in the absence of a COPD diagnosis
• for the initiation of bronchodilator therapy in COPD
• as reliever therapy for asthma
• at a different dose interval/frequency as recommended in the approved Product Information
• in combination with an ICS + LABA, LABA + LAMA, or LAMA, LABA or ICS monotherapy.

What is it?

The medicine is a triple therapy FDC inhaler that includes:³

• budesonide: an ICS that produces a rapid and dose-dependent anti-inflammatory action in the airways
• glycopyrronium: a LAMA that induces bronchodilation, particularly in central airways, by blocking the effect of acetylcholine on airway smooth muscle cells
• formoterol: a LABA that activates adenylate cyclase and induces direct relaxation of peripheral airway smooth muscle cells.

The recommended dose is two actuations (puffs) twice daily. Each actuation provides budesonide 160 µg, glycopyrronium 7.2 µg and formoterol 5 µg.³

Who is it for?

Budesonide with glycopyrronium and formoterol FDC inhaler is a maintenance treatment to prevent exacerbations and relieve symptoms in adults (aged 18 years and over) with moderate or severe COPD who have not had an adequate response to dual therapy (ICS + LABA or LABA + LAMA). The medicine is not indicated for initiation therapy for COPD exacerbation nor for the treatment of asthma.^3-5

Safety issues

Serious adverse effects include paradoxical bronchospasm, cardiovascular effects (tachycardia, palpitations) and allergic reaction.^3,6 The ICS in the medicine may also increase the risk of pneumonia.^6,7

Less serious, usually mild and short-lived adverse effects include headache, urinary tract infection, muscle spasms, oral candidiasis, anxiety, insomnia, cough/hoarse voice and nausea.^3,6

Glaucoma, increased intraocular pressure and cataracts can occur with long-term use of an ICS or use of a LAMA. Referral to an ophthalmologist should be considered for patients who develop ocular symptoms such as blurred vision, or who use budesonide with glycopyrronium and formoterol FDC inhaler long term.³

What else should health professionals know?

Budesonide with glycopyrronium and formoterol FDC inhaler is the third triple therapy FDC inhaler to be listed on the PBS. Fluticasone furoate with umeclidinium and vilanterol (Trelegy Ellipta) was listed on 1 March 2020 and beclometasone with glycopyrronium and formoterol (Trimbow) on 1 June 2021.^8,9

Triple therapy delivered in a single inhaler may be environmentally more sustainable, convenient for patients and improve adherence compared with the use of multiple inhalers, but it is similar (non-inferior) in terms of clinical efficacy.^1,4,5

Poor inhaler technique is associated with reduced symptom control.¹⁰ It is essential to provide instructions and demonstrate correct inhaler technique to patients, and re-check at each visit that they are continuing to use their inhaler correctly.^5,10

For more information see NPS MedicineWise In my practice: inhaler technique – it's a repeat prescription.