PAVTIDE

What it is

PAVTIDE contains fluticasone propionate and salmeterol xinafoate. It is available as an ACCUHALER (powder for inhalation) and a metered dose inhaler (MDI). The ACCUHALER contains 100, 250 or 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol per dose. The MDI delivers 50, 125 or 250 micrograms of fluticasone propionate and 25 micrograms of salmeterol per actuation. Salmeterol provides symptomatic relief, while fluticasone propionate improves lung function and prevents exacerbations.

Approved indications

— Regular treatment of asthma, including in patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids, patients symptomatic on current inhaled corticosteroid therapy, and initiation of maintenance therapy in patients with moderate persistent asthma not adequately controlled on reliever medication. — Symptomatic treatment of patients with severe COPD (FEV1 less than 50 per cent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy.

Dosing overview

The dose of fluticasone propionate should be titrated to the lowest dose at which effective control of symptoms is maintained. There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.

Key safety warnings

PAVTIDE is not for relief of acute symptoms, for which a fast- and short-acting inhaled bronchodilator such as salbutamol is required, and patients should be advised to have their relief medication available at all times. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should be reviewed by a physician, with consideration given to increasing corticosteroid therapy. There was an increased reporting of pneumonia in studies of patients with COPD receiving fluticasone propionate/salmeterol, and physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap. Cardiovascular effects, such as increases in systolic blood pressure and heart rate, may occasionally be seen with sympathomimetic drugs, especially at higher than therapeutic doses, and PAVTIDE should be used with caution in patients with pre-existing cardiovascular disease. A transient decrease in serum potassium may occur with sympathomimetic drugs at higher therapeutic doses, and therefore PAVTIDE should be used with caution in patients predisposed to low levels of serum potassium. Ritonavir, a highly potent cytochrome P450 3A4 inhibitor, can greatly increase fluticasone propionate plasma concentrations, and 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 should be avoided unless the potential benefit outweighs the risk. Concomitant use of systemic ketoconazole increases exposure to salmeterol, which may lead to prolongation in the QTc interval; due to the potential increased risk of cardiovascular adverse events, concomitant use of salmeterol with strong CYP3A4 inhibitors is not recommended.

Contraindications

PAVTIDE is contraindicated in patients with a history of hypersensitivity to any ingredients of the preparation. PAVTIDE ACCUHALER is contraindicated in patients with severe milk-protein allergy.

PBS listing

No source document provides information about PBS listing for PAVTIDE.

Regulatory history

PAVTIDE was first listed on the Australian Register of Therapeutic Goods on 7 May 2014, with six registered variants: ACCUHALER 100/50, 250/50 and 500/50 micrograms, and MDI 50/25, 125/25 and 250/25 micrograms.