Generic Name: Renova
What is Renova?
However, some may be serious and need medical attention. If any of the following happen, tell your doctor immediately or go to the Accident and Emergency at your nearest hospital:Other side effects not listed above may occur in some patients. Tell your treating physician if you notice anything making you feel unwell when you are taking, or soon after you have finished taking Renagel.
Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well. If your treating physician tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over. AUSTR 101550Renagel 800 mg tablets are off-white, oval shaped tablets with "Renagel 800" printed on one side. AUSTR 101553Other ingredients: hypromellose, diacetylated monoglycerides, colloidal anhydrous silica and stearic acid.
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The change from baseline in CAC score was the primary end-point for the RIND study and a secondary end-point in the Treat to Goal study. The analysis showing all cause mortality is higher where CAC score is higher, provided no link between the surrogate and mortality. The resubmission presented new toxicity meta-analyses demonstrating fewer hypercalcaemic episodes and more dyspepsia episodes in sevelamer treated patients, but overall no differences in all adverse gastrointestinal events.
The resubmission described sevelamer as having significant advantages in effectiveness over calcium and having similar or less toxicity. The resubmission presented updated preliminary economic evaluations, which included costs of hospitalisations and dyspepsia. The PBAC considered that the most restrictive of the proposed restrictions would be most likely to identify the population in whom treatment with sevelamer could be cost-effective, ie treatment of hyperphosphataemia, in adult patients with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where: a serum phosphate is greater than 1.
The PBAC considered that there are some doubts about the validity of the DCOR and RIND mortality results. The DCOR results relied on acceptance of a pre-specified subgroup analysis where the primary analysis was not statistically significant and acceptance that heterogeneity of a subgroup result implies effect modification by age. In the RIND study mortality was a pre-specified secondary endpoint and there were differential drop-out rates. The coronary artery calcification results involve substantial missing data, and no empirical data have been presented to support the assumption that vascular calcification changes with observed with sevelamer translate into cardiovascular benefits.
The PBAC noted that the submission used the RIND study to validate the mortality difference in the less than 65 and over 65 sub-groups ie the mortality in RIND was being considered compatible with the over 65 sub-group in DCOR.
How should I take Renova?
Thus the risk of developing hypercalcemia is less with Renagel compared to calcium salts. Triglycerides, HDL cholesterol, and albumin did not change. Renagel is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease CKD on hemodialysis. The safety and efficacy of Renagel in CKD patients who are not on hemodialysis have not been studied.
In hemodialysis patients, Renagel decreases the incidence of hypercalcemic episodes relative to patients on calcium treatment. Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction.
What should I avoid while taking Renova?
Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Many of these side effects can be managed, and some may go away on their own over time.
Renova side effects
It differs from other phosphate binders because the drug binds itself with dietary phosphate and avoids its absorption when you take it along with meals. Renagel has the ability to act like a sponge and absorbs phosphorous that develop from the foods you eat. Marketed by Genzyme under the trade names Renvela and Renagel, the therapy is not meant for patients with bowel constriction or hypophosphatemia.
Renagel is basically available as 400 mg or 800 mg film coated tablets containing sevelamer hydrochloride on anhydrous basis. The inactive ingredients include stearic acid, colloidal silicon dioxide, diacetylated monoglyceride and hypromellose. Make sure to store the drug away from heat and moisture.
Common Renova ide effects may include:
Swallow the tablet whole.
Other drugs may interact with sevelamer, including prescription and over-the-counter medicines, vitamins, and herbal products.
In clinical trials, sevelamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Renagel should be used with other treatments such as calcium or vitamin-D supplements to control the development of bone disease.
This helps to ensure you are getting the right dose of Renagel. Do not use Renagel to treat any other complaints unless your treating physician tells you to. Do not stop taking your medicine or lower the dosage without checking with your treating physician. Check with your treating physician as soon as possible if you do not feel well or have any problems while taking Renagel, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Where can I get more information?
Package sizes are:1 bottle of 100 film-coated tablets1 bottle of 180 film-coated tabletsmultipacks containing 180 film-coated tablets 6 bottles of 30 tablets multipacks containing 360 film-coated tablets 2 bottles of 180 tablets multipacks containing 540 film-coated tablets 3 bottles of 180 tablets Not all pack sizes may be marketed.
Patients started on treatment three times per day with meals.