Indications and Usage

Sevelawin-C is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis. The safety and efficacy of Sevelawin in CKD patients who are not on hemodialysis have not been studied. In hemodialysis patients, Sevelawin decreases the incidence of hypercalcemic episodes relative to patients on calcium treatment.

Contraindications

Sevelawin-C is contraindicated in patients with hypophosphatemia or bowel obstruction. Sevelawin-C is contraindicated in patients known to be hypersensitive to sevelamer hydrochloride or any of its constituents.

Precautions

General: The safety and efficacy of Sevelawin in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery have not been established. Consequently, caution should be exercised when Sevelawin is used in patients with these GI disorders.

Sevelawin does not contain calcium or alkali supplementation; serum calcium, bicarbonate, and chloride levels should be monitored.
In preclinical studies in rats and dogs, sevelamer hydrochloride reduced vitamin D, E, K, and folic acid levels at doses of 6-100 times the recommended human dose. In clinical trials, there was no evidence of reduction in serum levels of vitamins with the exception of a one year clinical trial in which Sevelawin treatment was associated with reduction of 25-hydroxyvitamin D (normal range 10 to 55 mcg/mL) from 39 ± 22 mcg/mL to 34 ± 22 mcg/mL (p<0.01). Most (approximately 75%) patients in Sevelawin clinical trials received vitamin supplements, which is typical of patients on hemodialysis.

Overdosage

Sevelawin has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelawin has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of Sevelawin in patients. Since Sevelawin is not absorbed, the risk of systemic toxicity is low.

Dosage and Administration

Patients Not Taking a Phosphate Binder. The recommended starting dose of Sevelawin is 800 to 1600 mg, which can be administered as two to four Sevelawin^® 400 mg Tablets with each meal based on serum phosphorus level.

The Recommended starting dose of Sevelawin-C 800mg is 2.4 g to 4.8 g per day with meal based on the serum phosphorus level. Table 4 provides recommended starting doses of Sevelawin-C 800 mg and Sevelawin 400 mg for patients not taking a phosphate binder.

Table 4. Starting Dose for Patients Not Taking a Phosphate Binder

SERUM PHOSPHORUS	SEVELAWIN-C 800 MG	SEVELAWIN 400 MG
> 5.5 and < 7.5 mg/dL	1 tablet three times daily with meals	2 tablets three times daily with meals
> 7.5 and < 9.0 mg/dL	2 tablets three times daily with meals	3 tablets three times daily with meals
> 9.0 mg/dL		4 tablets three times daily with meals