Renagel


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sevelamer

(se-vel-a-mer) ,

Renagel

(trade name),

Renvela

(trade name)

Classification

Therapeutic: electrolyte modifiers
Pharmacologic: phosphate binders
Pregnancy Category: C

Indications

Reduction of serum phosphate levels in patients with hyperphosphatemia associated with end-stage renal disease.

Action

A polymer that binds phosphate in the GI tract, preventing its absorption.

Therapeutic effects

Decreased serum phosphate levels and reduction in the consequences of hyperphosphatemia (ectopic calcification, secondary hyperparathyroidism with osteitis fibrosa).

Pharmacokinetics

Absorption: Not absorbed; action is local (in GI tract).
Distribution: Unknown.
Metabolism and Excretion: Eliminated in feces.
Half-life: Unknown.

Time/action profile (↓ in serum phosphate levels)

ROUTEONSETPEAKDURATION
PO5 days2 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Hypophosphatemia;Bowel obstruction.
Use Cautiously in: Dysphagia, swallowing disorders, severe GI motility disorders, or major GI tract surgery; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Gastrointestinal

  • bowel obstruction/perforation (life-threatening)
  • esophageal obstruction (tablet) (life-threatening)
  • diarrhea (most frequent)
  • dyspepsia (most frequent)
  • vomiting (most frequent)
  • choking (tablet)
  • constipation
  • dysphagia (tablet)
  • flatulence
  • nausea

Interactions

Drug-Drug interaction

May ↓ absorption of other drugs and ↓ effectiveness, especially drugs whose efficacy is dependent on tightly controlled blood levels.↓ absorption of ciprofloxacin.

Route/Dosage

Oral (Adults) 800–1600 mg with each meal; may titrate by 800 mg every 2 wk to achieve target serum phosphorus levels.

Availability

Tablets: 400 mg, 800 mg
Powder for oral suspension: 800 mg/packet, 2400 mg/packet

Nursing implications

Nursing assessment

  • Assess patient for GI side effects periodically during therapy.
  • Lab Test Considerations: Monitor serum phosphorous, calcium, bicarbonate, and chloride levels periodically during therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Do not confuse Renagel with Renvela.
  • Doses of concurrent medications, especially antiarrhythmics, should be spaced at least 1 hr before or 3 hr after sevelamer.
  • Oral: Administer with meals. Do not break, chew, or crush tablets; contents expand in water.
    • Place contents of powder packet in a cup and mix thoroughly with at least 1 ounce of water for the 0.8-g dose or 2 ounces of water for the 2.4-g dose packet. Stir mixture vigorously (it does not dissolve) and drink entire preparation within 30 min or resuspend the preparation right before drinking.

Patient/Family Teaching

  • Instruct patient to take sevelamer with meals as directed and to adhere to prescribed diet.
  • Caution patient to space concurrent medications at least 1 hr before or 3 hr after sevelamer.
  • Advise patient to notify health care professional if GI effects are severe or prolonged.

Evaluation/Desired Outcomes

  • Decrease in serum phosphorous concentration to ≤6 mg/dL. Dose adjustment is based on serum phosphorous concentrations.

sevelamer

A phosphate chelator used to reduce phosphorus in patients with end-stage renal disease and in chronic renal failure patients not requiring dialysis. It also reduces uric acid levels, and may be of use in patients with hyperuricaemia, uric acid nephrolithiasis and gout.

Adverse effects
Blood pressure lability (hypo- or hypertension), nausea, vomiting, dyspepsia, diarrhoea, constipation.

Renagel®

Sevelamer, see there.
References in periodicals archive ?
Welchol: Daiichi Sankyo Inc, Tokyo, Japan; Colestid: Pfizer Inc, New York, New York; LoCholest: Warner Chilcott Inc, Rockaway, New Jersey; Prevalite: Upsher-Smith Laboratories, Maple Grove, Minnesota; Questran: Par Pharmaceutical, Woodcliff Lake, New Jersey; Kayexalate: Concordia International Corp, Oakville, Ontario, Canada; and Renvela and Renagel: Sanofi SA, Paris, France.
In a more recent prospective, randomized, and open label study, 59 hemodialysis patients were randomized to sevelamer hydrochloride (n = 30, Renagel 1600 mg three times a day) or calcium acetate (n = 29, Royen 500 mg three times a day) for twelve weeks [49].
Renvela is a next generation version of Renagel, a calcium-free metal free, non-absorbed phosphate binder, and has the added benefit of a carbonate filter.
for allegedly infringing a patent used for its Renagel kidney medicine.
Whitesides' innovation was Renagel, a drug that binds the harmful phosphates eliminating the harmful metallic accumulation.
Renvela is being developed as a next generation phosphate binder to replace Renagel (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States.
According to the severity of secondary hyperparathyroidism, each patient being treated for secondary hyper parathyroidism was given oral active vitamin D3 calcitriol (Rocaltrol; Roche Laboratories Inc., Nutley, NJ), calcium carbonate capsule, and sevelamer (Renagel; Genzyme Europe BV, Naarden, The Netherlands) tablets at various doses.
Two polymer products have been brought to market, Renagel (sevelamer hydrochloride), a calcium-free, metal-free phosphate binder for patients with end-stage renal disease, and WelChol (colesevelum hydrocholoride), a cholesterol-lowering agent.
Genzyme's new formulation of Renagel, a dialysis drug, didn't generate the revenues that were expected.
Indeed, the estimated savings in Medicare Parts A and B expenditures attained through the use of sevelamer (RenaGel) in his case-control study amounted to $17,328 per treated patient per year, compared with conventional management, according to Dr.
Genzyme says Renvela is a next generation version of Renagel, a calcium-free, metal-free, non-absorbed phosphate binder, and has the added benefit of a carbonate buffer.
Poly[allylamine hydrochloride] (RenaGel): A noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure.