VELPHORO

What it is

Velphoro is a chewable tablet containing 500 mg iron, equivalent to 2500 mg sucroferric oxyhydroxide. Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water and the phosphate ions throughout the physiological pH range of the gastrointestinal tract, and serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.

Approved indications

— Control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.

Dosing overview

The recommended starting dose of Velphoro is 1,500 mg iron per day (3 tablets). Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2–4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. In clinical practice, patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 to 2,000 mg iron per day (3 to 4 tablets). The maximum recommended dose is 3,000 mg iron (6 tablets) per day. Tablets must be taken with meals, chewed and not swallowed whole.

Key safety warnings

Velphoro can cause discoloured (black) stool, which may visually mask gastrointestinal (GI) bleeding. However, Velphoro does not affect guaiac based (Hemoccult) or immunological based (iColo Rectal and Hexagon Obti) faecal occult blood tests. One tablet of Velphoro is equivalent to approximately 1.4 g of carbohydrates, and patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. In vitro studies showed significant drug interaction (adsorption by Velphoro) with alendronate, doxycycline and levothyroxine, and it is recommended that these drugs should be administrated at least 1 hour before or at least 2 hours after intake of Velphoro. Diarrhoea occurred in 11.6% of patients in clinical trials; in the 55 weeks long term studies, the majority of these treatment-related diarrhoea adverse events were mild and transient, occurred early during treatment initiation and led to treatment discontinuation in only 3.1% of the patients.

Contraindications

Velphoro is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Velphoro is contraindicated in patients with haemochromatosis and any other iron accumulation disorders.

PBS listing

Velphoro chewable tablet (2.5 g, equivalent to 500 mg iron) is listed on the PBS as 4 items with streamlined restriction and an ex-manufacturer price of A$340.00.

Regulatory history

Velphoro was first approved on 27 November 2014. It is registered on the ARTG in two pack formats: a blister pack and a bottle containing chewable tablets, both first listed 2014-11-27.