Salflumix Easyhaler

What it is

SALFLUMIX EASYHALER contains fluticasone propionate and salmeterol xinafoate. It is a powder for inhalation in a metered dose inhaler device. Two strengths are available: SALFLUMIX EASYHALER 250/50, which delivers 238 micrograms fluticasone propionate and 48 micrograms salmeterol per dose, and SALFLUMIX EASYHALER 500/50, which delivers 476 micrograms fluticasone propionate and 48 micrograms salmeterol per dose.

Approved indications

— Regular treatment of asthma, where the use of a combination product is appropriate. — Symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy.

Dosing overview

For asthma in adults and children over 12 years, the fluticasone propionate dose should be titrated to the lowest dose at which effective control of symptoms is maintained. The recommended dose range is 100/50 micrograms to 500/50 micrograms twice daily. SALFLUMIX EASYHALER is available as one inhalation of 250 micrograms fluticasone propionate and 50 micrograms salmeterol twice daily or one inhalation of 500 micrograms fluticasone propionate and 50 micrograms salmeterol twice daily. For COPD in adults, the recommended dose is 250/50 micrograms or 500/50 micrograms fluticasone propionate/salmeterol twice daily, with one inhalation 500/50 micrograms twice daily as standard or one inhalation 250/50 micrograms twice daily in patients at greater risk of inhaled corticosteroid adverse effects.

Key safety warnings

SALFLUMIX EASYHALER is not for relief of acute symptoms, for which a fast- and short-acting inhaled bronchodilator such as salbutamol is required. Patients should be advised to have their relief medication available at all times. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should be reviewed by a physician. There was an increased reporting of pneumonia in studies of patients with COPD receiving fluticasone propionate/salmeterol. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap. A drug interaction study has shown that ritonavir can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects. The concomitant use of salmeterol with strong CYP3A4 inhibitors (such as ketoconazole, atazanavir, ritonavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir) is not recommended due to the potential increased risk of cardiovascular adverse events.

Contraindications

SALFLUMIX EASYHALER is contraindicated in patients with a history of hypersensitivity to any ingredients of the preparation.

PBS listing

In November 2023, SALFLUMIX EASYHALER was recommended for listing on the PBS for asthma and chronic obstructive pulmonary disease as bioequivalent to Seretide Accuhaler on a cost-minimisation basis.

Regulatory history

SALFLUMIX EASYHALER 250/50 and 500/50 were first listed on the ARTG on 28 October 2022. In November 2023, the PBAC recommended new listing for both asthma and COPD indications.