ARX-SEVELAMER

What it is

ARX-SEVELAMER is a 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, and while the counter ions differ for the two salts, the polymer itself, the active moiety, is the same.

Approved indications

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

Dosing overview

ARX-SEVELAMER 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 must 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, and patients should swallow the tablets whole with water.

Key safety warnings

The safety and efficacy of sevelamer carbonate in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, severe constipation or major gastrointestinal tract surgery have not been established, and consequently caution should be exercised when sevelamer carbonate is used in patients with these gastrointestinal disorders. 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, and 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, with constipation as a possible preceding symptom, and patients who are constipated should be monitored carefully whilst being treated with sevelamer carbonate, with treatment re-evaluation in patients who develop severe constipation or other severe gastrointestinal symptoms. Sevelamer carbonate can bind fat-soluble vitamins contained in ingested food, and 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.

Contraindications

ARX-SEVELAMER is 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.

Regulatory history

ARX-SEVELAMER sevelamer carbonate 800 mg film-coated tablets were first listed on the ARTG on 9 November 2018.