Renagel
Renagel - General Information
Renagel is a phosphate binding drug used to prevent hyperphosphataemia in patients with chronic renal failure. When taken with meals, sevelamer binds to dietary phosphate and prevents its absorption. It is marketed by Genzyme under the trade name Renagel.
Pharmacology of Renagel
Patients with end-stage renal disease (ESRD) retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg2/dL2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency. An increase in parathyroid hormone (PTH) levels is characteristic of patients with chronic renal failure. Increased levels of PTH can lead to osteitis fibrosa, a bone disease. A decrease in serum phosphorus may decrease serum PTH levels. Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Renagel taken with meals has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. In vitro studies have shown that the capsule and tablet formulations bind phosphate to a similar extent. Renagel treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.
Renagel for patients
The prescriber should inform patients to take Renagel (sevelamer) with meals and adhere to their prescribed diets. Instructions should be given on concomitant medications that should be dosed apart from Renagel. Because the contents of Renagel expand in water, tablets should be swallowed intact and should not be crushed, chewed, broken into pieces, or taken apart prior to administration.
Renagel Interactions
Renagel Capsules were studied in human drug-drug interaction studies with digoxin, warfarin, enalapril metoprolol and iron.
Digoxin: In 19 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2days, Renagel did not alter the pharmaco-kinetics of a single dose of digoxin.
Warfarin: In 14 healthy subjects receiving 6 Renagel capsules three times a day with meals for 2days, Renagel did not alter the pharmaco-kinetics of a single dose of warfarin.
Enalapril: In 28 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of enalapril.
Metoprolol: In 31 healthy subjects a single dose of 6 Renagel capsules did not alter the pharmacokinetics of a single dose of metoprolol.
Iron: In 23 healthy subjects, a single dose of 7 Renagel capsules did not alter the absorption of a single oral dose of iron as 200 mg exsiccated ferrous sulfate tablet.
However, when administering any other oral medication where a reduction in the bioavailability ofthat medication would have a clinically significant effect on safety or efficacy, the drug should beadministered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels of the drug. Patients taking anti-arrhythmic and anti-seizure medications were excluded from the clinical trials. Special precautions should be taken when prescribing Renagel to patients also taking these medications.
Renagel Contraindications
Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction. Renagel is contraindicated in patients known to be hypersensitive to sevelamer hydrochloride or any of its constituents.
Additional information about Renagel
Renagel Indication: For the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis.
Mechanism Of Action: Renagel prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Sevelamer
Synonyms: Not Available
Drug Category: Phosphate Binders
Drug Type: Small Molecule; Approved
Other Brand Names containing Sevelamer: Renagel;
Absorption: Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease.
Toxicity (Overdose): Sevelamer has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamer has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: Not Available
Dosage Forms of Renagel: Tablet Oral
Chemical IUPAC Name: 2-(chloromethyl)oxirane; prop-2-en-1-amine
Chemical Formula: C6H12ClNO
Sevelamer on Wikipedia: https://en.wikipedia.org/wiki/Sevelamer
Organisms Affected: Humans and other mammals
