No

Phosphate Binder

Reduction of serum phosphorous in patients with end-stage renal disease

C

It is not known whether sevelamer is excreted in human milk. Because sevelamer may cause a reduction in the absorption of some vitamins, it should be used with caution in pregnant and/or nursing women.

Hypersensitivity to sevelamer or any component of the formulation, hypophosphatemia, or bowel obstruction

Use with caution in patients with gastrointestinal disorders including dysphagia, swallowing disorders, severe gastrointestinal motility disorders, or major gastrointestinal surgery. May cause reductions in vitamin D, E, K, and folic acid absorption. Long-term studies of carcinogenic potential have not been completed. Capsules should not be taken apart or chewed.

>10%:

Cardiovascular: Hypotension (11%), thrombosis (10%)

Central nervous system: Headache (10%)

Endocrine and metabolic: Decreased absorption of vitamins D, E, K and folic acid

Gastrointestinal: Diarrhea (16%), dyspepsia (5% to 11%), vomiting (12%)

Neuromuscular and skeletal: Pain (13%)

Miscellaneous: Infection (15%)

1% to 10%:

Cardiovascular: Hypertension (9%)

Gastrointestinal: Nausea (7%), flatulence (4%), diarrhea (4%), constipation (2%)

Respiratory: Cough (4%)

Sevelamer is not absorbed systemically. There are no reports of overdosage in patients.

No formal drug interaction studies have been undertaken. Sevelamer may bind to some drugs in the gastrointestinal tract and decrease their absorption. When changes in absorption of oral medications may have significant clinical consequences (such as antiarrhythmic and antiseizure medications), these medications should be taken at least 1 hour before or 3 hours after a dose of sevelamer.

Store at controlled room temperature

Sevalamer (a polymeric compound) binds phosphate within the intestinal lumen, limiting absorption and decreasing serum phosphate concentrations without altering calcium, aluminum, or bicarbonate concentrations

Absorption: Not absorbed systemically

Elimination: Feces

Adults: Oral: 2-4 capsules 3 times/day with meals; the initial dose may be based on serum phosphorous:

>6.0 mg/dL and <7.5 mg/dL: 2 capsules 3 times/day

>7.5 mg/dL and <9.0 mg/dL: 3 capsules 3 times/day

greater than or equal to 9.0 mg/dL: 4 capsules 3 times/day

Dosage should be adjusted based on serum phosphorous concentration, with a goal of lowering to <6.0 mg/dL; maximum daily dose studied was 30 capsules/day.

Must be administered with meals

Serum phosphorus

None noted

None noted

No information available to require special precautions

No effects or complications reported

Take as directed, with meals. Do not break or chew capsule. You may experience headache or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); upset stomach, nausea, or vomiting (frequent small meals, frequent mouth care, or sucking hard candy may help); diarrhea (yogurt or buttermilk may help); hypotension (use caution when rising from sitting or lying position or when climbing stairs or bending over); or mild neuromuscular pain or stiffness (mild analgesic may help). Report persistent adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Capsule: 403 mg