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 ?
Enrollment is also complete in a study comparing a powder form of sevelamer carbonate dosed once a day to Renagel tablets dosed three times a day.
Renvela offers the benefits of Renagel but has the added benefit of a carbonate buffer.
The program covers commonly prescribed bone disease medications, including Fosrenol, Hectorol, Phoslo, Renagel, Sensipar, and Semplar.
In the US market, the conversion from Renagel to Renvela has already been quite strong with over 90% of Nephrologists now prescribing the product and sevelamer share division favoring Renvela over Renagel.
The three- year trial involving more than 2,100 patients compared the difference in mortality and morbidity outcomes for patients receiving Renagel (sevelamer hydrochloride) with those using calcium-based phosphate binders.
Within the sevelamer franchise, patient conversion to Renvela stands at about 27% and about half of the Renvela patients had been switched from Renagel.
Bone Care's Hectorol line of vitamin D2 prohormone product, is used to treat secondary hyperparathyroidism in patients on dialysis, where it can be taken in tandem with Genzyme's Renagel and other phosphate binders.
In both the dialysis and CKD markets, Nephrologists project increases in the use of Renvela and Shire's Fosrenol primarily at the expense of PhosLo and Renagel.
Genzyme's primary drug in the kidney transplant area is Renagel (sevelamer hydrochloride), a phosphate binder for patients with end stage renal disease undergoing hemodialysis.
Calcium based phosphate binders are the most frequently prescribed binders in both dialysis and CKD, however, there is a high prevalence of combination binder therapy typically involving a calcium based agent combined with Genzyme's Renagel.
Familiarity with Genzyme's Renagel is high, as are perceptions of its performance on the most important phosphate binder attributes, but use of the product tends to be limited to second line therapy.
While sevelamer volume grew by 4 percent year over year, Renagel pricing in Brazil and conversion to Renvela in the United States resulted in a decrease in revenue.