Sevelamer Hydrochloride/Carbonate

Indications

Sevelamer Hydrochloride/Carbonate is used for: Hyperphosphataemia

Adult Dose

End-Stage Renal Disease Hemodialysis; hyperphosphatemia Initial dose Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals Maintenance dose Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal Dosing considerations Titrate dose; increase by 400-800 mg per meal at 2-week intervals; no more than 4 g Switching From Ca-Acetate Substitute 800 mg for 667 mg of Ca-acetate Substitute 1600 for1334 mg of Ca-acetate Substitute 2400 mg for 2001 mg Ca-acetate

Child Dose

Safety and efficacy not established

Renal Dose

Administration

Should be taken with food.

Contra Indications

Hypophosphatemia or bowel obstruction.

Precautions

Patients w/ dysphagia, swallowing disorders, severe GI motility disorders, active inflammatory bowel disease or major GI tract surgery. Pregnancy and lactation. Monitoring Parameters Monitor serum levels of phosphate, Ca, Cl and bicarbonate. Vitamin supplementation due to reduction in vit D, E, K and folic acid absorption. Monitor for signs and symptoms of peritonitis in patients undergoing peritoneal dialysis. Lactation: Not absorbed systemically; not excreted in breast milk

Pregnancy-Lactation

Pregnancy: Not absorbed systemically following oral administration and maternal use not expected to result in fetal exposure to the drug May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation Lactation: Not absorbed systemically by mother following oral administration; breastfeeding is not expected to result in exposure of child to drug May decrease serum levels of fat soluble vitamins and folic acid in pregnant women; consider supplementation

Interactions

May decrease absorption of ciprofloxacin, ciclosporin, mycophenolate, tacrolimus and levothyroxine. Sevelamer should be given 3 hr before or 1 hr after taking other drugs to minimise potential pharmacokinetic interaction.

Adverse Effects

Side effects of Sevelamer Hydrochloride/Carbonate : >10% Vomiting (22%), Nausea (20%), Diarrhea (19%), Dyspepsia (16%), Nasopharyngitis (14%), Limb pain (13%), Pruritus (13%), Arthralgia (12%), Bronchitis (11%), Dyspnea (10%), Hypertension (10%) 1-10% Abdominal pain (9%), Constipation (8%), Flatulence (8%), Peritonitis (during peritoneal dialysis: 8%), Hypercalcemia (5-7%) Frequency Not Defined Back pain, Cough, Headache, Pyrexia, Upper respiratory infection, Pruritus, Rash, Intestinal perforation, Fecal impaction, Intestinal obstruction.

Mechanism of Action

Sevelamer, a polymeric compound, acts by binding to phosphate molecules in the gut, limiting its absorption and thus lowering serum phosphate levels w/o altering Ca, Al, or bicarbonate levels.