Sucroferric oxyhydroxide (P-TOL® chewable
tablets, 250 and 500 mg) is a
phosphate binder for oral use; it is composed of polynuclear
iron (III)-oxyhydroxide,
sucrose, and starches, and is currently indicated for alleviating
hyperphosphatemia in patients with
chronic kidney disease (CKD) on dialysis. The results of non-clinical pharmacological studies have suggested that P-TOL consistently decreases serum
phosphorus levels in the aqueous environment at pH levels similar to those in the gastrointestinal tract, thereby suppressing the progression of
secondary hyperparathyroidism, aberrant calcification, and abnormal bone metabolism associated with
hyperphosphatemia. Since the diameter of the P-TOL
tablet exceeds 15 mm, it is manufactured with a doughnut-shape to minimize
choking hazards. From the results of
pharmaceutical studies, it was indicated that the P-TOL
tablets promptly disintegrated in the gastrointestinal tract and excessive
iron uptake from this product is unlikely to occur. In clinical studies, P-TOL (one
tablet/dose, t.i.d.) decreased serum
phosphorus levels during treatment Week 1 and allowed stable, long-term control of serum
phosphorus levels. Furthermore, P-TOL was expected to reduce the
tablet burden on patients and to improve medication adherence. The most common adverse reaction was
diarrhea. However, in most cases, the symptoms were mild and
oral administration of P-TOL could be continued. Although
iron-related parameters tended to increase,
iron uptake from this product was low, and the risk of
iron overload was considered to be low. These findings confirm the efficacy and safety of P-TOL in CKD patients with
hyperphosphatemia. Therefore,
sucroferric oxyhydroxide therapy is a potentially useful treatment option for
hyperphosphatemia.