Sevelamer Hydrochloride

SEVELAMER HYDROCHLORIDE- sevelamer hydrochloride tablet, film coated
Glenmark Pharmaceuticals Inc., USA

1. INDICATIONS AND USAGE

Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.

2. DOSAGE AND ADMINISTRATION

Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, which can be administered as one or two 800 mg sevelamer hydrochloride tablets or two to four 400 mg sevelamer hydrochloride tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer hydrochloride tablets for patients not taking a phosphate binder.

Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate Binder

Serum Phosphorus

Sevelamer Hydrochloride Tablets 800 mg

Sevelamer Hydrochloride Tablets 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 mg/dL

2 tablets three times daily with meals

3 tablets three times daily with meals

≥9 mg/dL

2 tablets three times daily with meals

4 tablets three times daily with meals

Patients Switching from Calcium Acetate. In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride tablets and calcium acetate. Table 2 gives recommended starting doses of sevelamer hydrochloride tablets based on a patient’s current calcium acetate dose.

Table 2: Starting Dose for Dialysis Patients Switching From Calcium Acetate to Sevelamer Hydrochloride Tablets

Calcium Acetate 667 mg (Tablets per meal)

Sevelamer Hydrochloride Tablets 800 mg

(Tablets per meal)

Sevelamer Hydrochloride

Tablets 400 mg

(Tablets per meal)

1 tablet

1 tablet

2 tablets

2 tablets

2 tablets

3 tablets

3 tablets

3 tablets

5 tablets

Dose Titration for All Patients Taking Sevelamer Hydrochloride Tablets. Adjust dosage based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dL or less. Increase or decrease by one tablet per meal at two-week intervals as necessary. Table 3 gives a dose titration guideline. The average dose in a Phase 3 trial designed to lower serum phosphorus to 5 mg/dL or less was approximately three sevelamer hydrochloride 800 mg tablets per meal. The maximum average daily sevelamer hydrochloride tablets dose studied was 13 g.

Table 3: Dose Titration Guideline

Serum Phosphorus

Sevelamer Hydrochloride Tablets Dose

>5.5 mg/dL

Increase 1 tablet per meal at 2-week intervals

3.5 to 5.5 mg/dL

Maintain current dose

<3.5 mg/dL

Decrease 1 tablet per meal

3. DOSAGE FORMS AND STRENGTHS

400 mg Tablets: off-white to pale yellow, oval shaped, biconvex film-coated tablets, imprinted with ‘G446’ on one side and plain on the other side.

800 mg Tablets: off-white to pale yellow, modified capsule shaped, biconvex film-coated tablets, imprinted with ‘G447’ on one side and plain on the other side.

4. CONTRAINDICATIONS

Sevelamer hydrochloride is contraindicated in patients with bowel obstruction.

Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to 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 hydrochloride clinical studies.

Dysphagia and esophageal tablet retention have been reported in association with use of sevelamer tablets, 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)]. Inflammatory disorders may resolve upon sevelamer hydrochloride discontinuation. Treatment with sevelamer hydrochloride should be re-evaluated in patients who develop severe gastrointestinal symptoms.

5.2 Monitor Serum Chemistries

Bicarbonate and chloride levels should be monitored.

5.3 Monitor for Reduced Vitamins D, E, K (clotting factors) and Folic Acid Levels

In preclinical studies in rats and dogs, sevelamer hydrochloride 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 received vitamin supplements, which is typical of patients on dialysis.

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