Renal Resource Centre

MEDIA RELEASE

 

Genzyme Australasia is pleased to announce that
RENAGEL® is listed on the PBS from 1 December

 

A therapy anticipated to reduce death rates amongst people with Chronic Kidney Disease (CKD) is now reimbursed in Australia through the Pharmaceutical Benefits Scheme (PBS) – potentially life changing news for patients on dialysis[i] and the burgeoning number of local residents at risk.

Welcoming the Federal Government’s decision to list sevelamer hydrochloride (Renagel^®) on the PBS from 1 December 2007, Dr Tim Mathew, Medical Director, Kidney Health Australia, anticipates this may help to decrease the unacceptably high death rates currently associated with CKD complications.

“CKD is one of Australia’s fastest growing chronic diseases with almost six Australians beginning dialysis every day. Unfortunately the mortality on dialysis remains unacceptably high with over 10% of dialysis patients dying each year.”

In a healthy person, calcium and phosphorous found in food helps the body function and provides bone strength.  However, when the kidneys don’t work properly, a build-up of phosphorous and calcium can cause tissue to harden in the heart, arteries, joints and lungs, leading to problems such as heart attack and stroke[ii].

“While dialysis and diet are used to lower phosphorous levels, it is rarely enough to control the problem resulting in cardiovascular disease as the leading cause of death in patients with CKD[iii],” said Dr Mathew.

“Renagel is used for patients on dialysis and works like a sponge to soak up the phosphorus from foods so it is not absorbed into the blood. We anticipate it will also help CKD patients reach their treatment targets,” he said.

The number of Australians on kidney dialysis or receiving a kidney transplant has grown by 400 per cent in the last 25 years.[iv] However, given Australia’s low organ donation rates and lengthy waiting lists for kidney transplants,[v] dialysis is often the most common treatment for CKD.

Despite the high numbers of Australians currently diagnosed with CKD, a further one in three are at increased risk of developing kidney damage and don’t even know it,[vi] highlighting the growing extent of the problem in Australia.

“The high levels of CKD and Australians at risk of the disease are alarming when you consider how we are going to treat the disease into the future. Through the availability of treatments like Renagel we hope to help Australians with CKD live longer and with a better quality of life,” said Dr Mathew.

“Renagel is available on the PBS for Australians with CKD on dialysis, and is currently available in more than 35 countries and used by approximately 500,000 patients worldwide,” said Dan Brown, Managing Director, Genzyme Australasia.

On the PBS, the cost to patients will be $30.70 for a month’s treatment of RENAGEL, and $4.90 for pension cardholders.

PBS Listing : Authority required

Hyperphosphataemia in an adult with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where:

a) serum phosphate is greater than 1.6 mmol per L, or

b) the serum calcium times phosphate product is greater than 4.0.

Renagel® (sevelamer hydrochloride) is indicated for the management of hyperphosphataemia adult patients with stage 4 and 5 chronic kidney disease.
Renagel is contraindicated in patients with hypophosphataemia, and in patients with bowel obstruction.  Renagel should be used with caution in patients with gastrointestinal disorder i.e. swallowing disorders severe GI mobility disorders or major GI surgery.  Patients should swallow tablets whole, and not crush chew or break tablets. Renagel should be used with caution in combination with certain medications.
The most frequent adverse effects of Renagel are headache, infection, pain, diarrhoea, dyspepsia, vomiting, pruritis, rash and abdominal pain.  Serum calcium, bicarbonate and chloride levels should be monitored.
Please note that the list of benefits and side effects in the CMI not exhaustive, and patients should consult their doctors if they have any concerns about the information listed above or require further information. Genzyme® and Renagel® are registered trademarks of Genzyme Corporation.
The full text of the Consumer Medicine Information can be viewed at www.genzyme.com.au