TRIMBOW

What it is

TRIMBOW is a pressurised metered dose inhaler. It contains beclometasone dipropionate and formoterol fumarate dihydrate. Two strengths are available: TRIMBOW 100/6, which delivers 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate per metered dose, and TRIMBOW 200/6, which delivers 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate per metered dose. The inhaler is provided with a dose counter.

Approved indications

— Treatment of asthma in adults 18 years and older where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate, including patients not adequately controlled with inhaled corticosteroids and as-needed inhaled rapid-acting beta2-agonist, or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. — Symptomatic treatment of adults with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators (TRIMBOW 100/6 only).

Dosing overview

For asthma, TRIMBOW offers two treatment approaches. Maintenance therapy: TRIMBOW 100/6 or TRIMBOW 200/6 is taken as regular maintenance treatment with a separate as-needed rapid-acting bronchodilator. Maintenance and reliever therapy: TRIMBOW 100/6 is taken as regular maintenance treatment and as needed in response to asthma symptoms. For TRIMBOW 100/6 maintenance therapy, the dose is one or two inhalations twice daily with a maximum daily dose of 4 inhalations. For TRIMBOW 200/6 maintenance therapy, the dose is two inhalations twice daily with a maximum daily dose of 4 inhalations. For TRIMBOW 100/6 maintenance and reliever therapy, the recommended maintenance dose is 1 inhalation twice daily, with 1 additional inhalation taken as needed in response to symptoms, not more than 6 inhalations on any single occasion, and a maximum daily dose of 8 inhalations. For COPD (TRIMBOW 100/6 only), the dose is two inhalations twice daily.

Key safety warnings

TRIMBOW should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, acute myocardial infarction, ischaemic heart disease, congestive heart failure, occlusive vascular diseases, arterial hypertension and aneurysm. Caution is advised when treating patients with known or suspected prolongation of the QTc interval, as formoterol itself may induce prolongation of the QTc interval. Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment. Paradoxical bronchospasm may occur with an immediate increase in wheezing and rapidness of breath after dosing and should be treated immediately with a fast-acting inhaled bronchodilator; TRIMBOW should be discontinued immediately if this occurs. Systemic effects may occur with inhaled corticosteroids, particularly at high doses prescribed for long periods, including Cushing's syndrome, adrenal suppression, decrease in bone mineral density, growth retardation, cataract and glaucoma. An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Patients should be advised to rinse the mouth or gargle with water or brush the teeth after inhaling to minimise the risk of oropharyngeal candida infection.

Contraindications

TRIMBOW is contraindicated in patients with hypersensitivity to beclometasone dipropionate, formoterol fumarate dihydrate or any of the excipients.

Regulatory history

TRIMBOW 100/6/10 was first listed on the ARTG on 24 June 2020, and TRIMBOW 200/6/10 was first listed on 26 May 2022.