Generic Name: Renagel

What is Renagel?

You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid. Taking other medicinesPlease tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription. If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.

The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus medicines used in transplant patients may be reduced by Renagel. Your doctor will advise you if you are taking these medicines. Increased levels of thyroid stimulating hormone TSH, a substance in your blood which stimulates the thyroid gland to make thyroid hormone which helps control your body.

Therefore your doctor may monitor the levels of TSH in your blood more closely. You should take Renagel tablets with meals. However, you should adhere to your prescribed diet and liquid intake.

Two of the active-controlled studies are described here. One trial is a crossover trial with two 8-week periods comparing Renagel to calcium acetate and the other trial is a 52-week parallel design trial comparing Renagel tablets with calcium acetate and calcium carbonate. Patients started on Renagel Capsules or calcium acetate tablets three times per day with meals. Over each eight-week treatment period, at three separate time points the dose of either agent could be titrated up 1 capsule or tablet per meal 3 per day to control serum phosphorus.

Figure 1 illustrates that the proportion of patients achieving a given level of serum phosphorus lowering is comparable between the two treatment groups. Average daily consumption at the end of treatment was 4. Thus the risk of developing hypercalcemia is less with Renagel Capsules compared to calcium acetate. Neither LDL nor total cholesterol changed on calcium acetate treatment. Triglycerides, high-density lipoprotein HDL cholesterol, and albumin did not change on either treatment.

Similar reductions in serum phosphorus and LDL cholesterol were observed in an eight-week open-label, uncontrolled study of 172 end stage renal disease patients on hemodialysis. Calcium acetate and calcium carbonate produced comparable decreases in serum phosphorus. At week 52, using last-observation-carried-forward, Renagel and Calcium both significantly decreased mean serum phosphorus Table 2.

The major reason for dropout in the Renagel group was gastrointestinal adverse events. Figure 2, a plot of the phosphorus change from baseline for the completers, illustrates the durability of response for patients who are able to remain on treatment. Average daily consumption at the end of treatment was 6.

How should I take Renagel?

Furthermore, when administering an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, the drug should be administered 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. In a study designed to assess potential impairment of fertility, female rats were given dietary doses of 0. Male rats were given the same doses and treated for 28 days before mating.

What should I avoid while taking Renagel?

In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations. Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.

Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating.

The highest dose in this study was 4. In pregnant rats given dietary doses of 0. The effect of Renagel on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses of Renagel during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred.

Renagel side effects

What is the risk associated with Renagel. Why has Renagel been approved. What measures are being taken to ensure the safe and effective use of Renagel. Other information about RenagelThe European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000. Sevelamer hydrochloride belongs to the class of medications called phosphate binders. Phosphate is made up mostly of the mineral phosphorus, which is an important component of normal bone structure, cell metabolism, and cell function.

In the body, the kidneys help keep the amount of phosphorus in the blood at a relatively constant level.

Common Renagel ide effects may include:

  • Check with your doctor if you notice any symptom that worries you while you are taking this medication.

  • Over each eight-week treatment period, at three separate time points the dose of Renagel could be titrated up 1 capsule or tablet per meal 3 per day to control serum phosphorus, the dose of active-control could also be altered to attain phosphate control.

  • Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

  • In clinical use of Renagel, cases of itching, rash, abdominal pain, slow intestine motility movementblockages in the intestine, inflammation of abnormal small pouches called diverticula in the large intestine and perforation in the intestine wall have been reported.

Sevelamer hydrochloride Renagel is available as a tablet, in both 400 mg and 800 mg strengths. What is are the advantages and disadvantages of using sevelamer hydrochloride Renagel.

Sevelamer hydrochloride is a calcium-free, metal-free, nonabsorbed phosphate binder that has proven effective in controlling serum phosphorous levels in patients with chronic kidney disease. What are advantages and disadvantages of using sevelamer carbonate Renvela. Sevelamer carbonate is also available in powder packets for oral suspension.

Where can I get more information?

  • You may develop peritonitis infection of your abdominal fluid associated with your peritoneal dialysis.

  • What happens if I overdose Renagel, Renvela.