Sevelamer Carbonate

SEVELAMER CARBONATE- sevelamer carbonate powder, for suspension
Bionpharma Inc.

1 INDICATIONS AND USAGE

Sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Starting Dose fo r Adult Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer carbonate for oral suspension is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer carbonate for oral suspension for adult patients not taking a phosphate binder.

Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder
Serum Phosphorus Sevelamer Carbonate for Oral Suspension
> 5.5 and < 7.5 mg/dL 0.8 g three times daily with meals
≥ 7.5 mg/dL 1.6 g three times daily with meals

Dose Titration for Adult Patients Taking Sevelamer Carbonate for Oral Suspension. Titrate the sevelamer carbonate for oral suspension dose by 0.8 g three times per day with meals at two‑week intervals as necessary to achieve target serum phosphorus levels. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

Starting Dose for Pediatric Patients Not Taking a Phosphate Binder. The recommended starting dose for pediatric patients 6 years of age and older is 0.8 g to 1.6 g taken three times per day with meals based on the patient’s body surface area (BSA) category; see Table 2.

Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient’s Body Surface Area (m 2)
BSA (m 2) Starting Dose Per Meal/Snack Titration Increases/Decreases Per Dose
≥ 0.75 to < 1.2 0.8 g Titrate by 0.4 g
≥ 1.2 1.6 g Titrate by 0.8 g

Dose Titration for Pediatric Patients Taking Sevelamer Carbonate for Oral Suspension. Titrate the sevelamer carbonate for oral suspension dose as needed to achieve target levels at two-week intervals based on BSA category, as shown in Table 2.

Switching from Sevelamer Hydrochloride Tablets. For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.

Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams.

Switching from Calcium Acetate. Table 3 gives recommended starting doses of sevelamer carbonate for oral suspension based on a patient’s current calcium acetate dose.

Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Sevelamer Carbonate for Oral Suspension

Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Sevelamer Carbonate for Oral Suspension
Calcium Acetate 667 mg (Tablets per meal) Sevelamer Carbonate for Oral Suspension
1 tablet 0.8 g
2 tablets 1.6 g
3 tablets 2.4 g

2.2 Sevelamer Carbonate Powder Preparation Instructions

Sevelamer carbonate powder is available in 0.8 g packets. For dose increments of 0.4 g, use one half of a 0.8 g packet. Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4.

Table 4: Sevelamer Carbonate Powder Preparation Instructions
Amount of Sevelamer Carbonate Powder Minimum Amount of Water for Dose Preparation (either ounces, mL, or tablespoon)
Ounces mL Tablespoons
0.4 g 1 30 2
0.8 g 1 30 2
2.4 g 2 60 4

Instruct patients to stir the mixture vigorously (it does not dissolve), resuspend, if necessary, right before administration, and drink the entire preparation within 30 minutes.

As an alternative to water, the entire contents of the packet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal. Do not heat sevelamer carbonate powder (e.g., microwave) or add to heated foods or liquids.

3 DOSAGE FORMS AND STRENGTHS

Powder: 0.8 g and 2.4 g white to yellowish granular powder packaged in an opaque, foil-lined, heat-sealed packets

4 CONTRAINDICATIONS

Sevelamer carbonate is contraindicated in patients with bowel obstruction.

Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Events

Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the sevelamer carbonate clinical studies.

Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.

Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use [see Adverse Reactions ( 6.2)]. Inflammmatory disorder may resolve upon sevelamer carbonatesevelamer carbonate disconuation. Treatment with sevelamer carbonate should be re-evaluated in patients who develop severe gastrointestinal symptoms.

5.2 Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels

In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6 to 10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p < 0.01) with sevelamer hydrochloride treatment. Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.

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