SEVELAMER

What it is

ARX-SEVELAMER is a sevelamer carbonate film-coated tablet containing 800 mg of sevelamer carbonate. Sevelamer carbonate tablets contain sevelamer, a non-absorbed phosphate binding cross-linked polymer, free of metal and calcium. Sevelamer carbonate is an anion exchange resin with the same polymeric structure as sevelamer hydrochloride in which carbonate replaces chloride as the counter ion.

Approved indications

— Management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

Dosing overview

Sevelamer carbonate 800 mg tablets must be taken three times per day with meals at a dosage based on individual patient requirements to control phosphate levels. The recommended starting dose of sevelamer carbonate is 2.4 to 4.8 g per day based on clinical needs and phosphorus level. Serum phosphorus levels should be monitored and the dose of sevelamer carbonate titrated every 2–4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day. Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration. Patients should swallow the tablets whole with water.

Key safety warnings

Cases of serious inflammatory disorders of the gastrointestinal tract (including serious complications such as bleeding, perforation, ulceration, necrosis and colitis) with the presence of sevelamer crystals have been reported. Sevelamer carbonate should be re-evaluated in patients who develop severe gastrointestinal symptoms. In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate. Constipation may be a preceding symptom. Patients who are constipated should be monitored carefully while being treated with sevelamer carbonate. It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food. Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and these vitamins should be supplemented if necessary. Uncommon case reports of difficulty swallowing the sevelamer carbonate tablet have been reported. Many of these cases involved patients with contributing co-morbid conditions affecting the ability to swallow including swallowing disorders or oro-oesophageal abnormalities. Caution should be exercised when sevelamer carbonate tablets are used in these patients.

Contraindications

Sevelamer carbonate tablets are contraindicated in patients known to be hypersensitive to sevelamer carbonate or any of the other components of the tablet, with hypophosphataemia, or with bowel obstruction.

PBS listing

No source documents contain information about the current PBS listing status, pricing, or restriction type for this brand.

Regulatory history

ARX-SEVELAMER was first approved on 9 November 2018. ARTG registration 286651 lists SEVELAMER (LUPIN brand, sevelamer carbonate 800 mg film-coated tablet), sponsored by Dr Reddys Laboratories, first listed 2018-11-09. In November 2017, the PBAC recommended sevelamer carbonate as a new General Schedule and Section 100 (Highly Specialised Drugs Program) Authority Required listing for hyperphosphataemia in patients undergoing dialysis. In July 2022, the PBAC recommendation was revoked.