Sevelamer Hydrochloride
Sevelamer Hydrochloride Prescribing Information
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.
Serum Phosphorus | Sevelamer Hydrochloride Tablets 800 mg | Sevelamer Hydrochloride Tablets 400 mg |
| > 5.5 and < 7.5mg/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 | 2 tablets three times daily with meals | 4 tablets three times daily with meals |
Calcium Acetate 667 mg (Tablets per meal) | Sevelamer Hydrochloride Tablets 800 mg (Tablets per meal) | SevelamerHydrochloride Tablets 400 mg (Tablets per meal) |
| 1 tablet | 1 tablet | 2 tablets |
| 2 tablets | 2 tablets | 3 tablets |
| 3 tablets | 3 tablets | 5 tablets |
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 |
Tablets:
400 mg- White to off white, oval shaped biconvex film coated tablets imprinted with 'L024' in black ink on one side and plain on other side.
800 mg- White to off white, oval shaped biconvex film coated tablets imprinted with 'L025' in black ink on one side and plain on other side.
Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.
Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women
12.2 PharmacodynamicsIn addition to effects on serum phosphate levels, sevelamer hydrochloride has been shown to bind bile acids
In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred at 7 to 21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight).
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.
- Serious cases of dysphagia, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. ()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 ].Inflammatory disorders may resolve upon sevelamer hydrochloride discontinuation. Treatment with sevelamer hydrochloride should be re-evaluated in patients who develop severe gastrointestinal symptoms.