Renagel 400 mg film-coated tablets Sevelamer,Hydrochloride - United Kingdom[英国药品]

TOP

Renagel 400 mg film-coated tablets Sevelamer,Hydrochloride

2014-07-27 14:02:41 来源: 作者: 【大中小】浏览:342次评论:0条

For doctors

What is it and how is it used?

Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.

Adult patients whose kidneys have failed and who are receiving haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.

Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.

It may be necessary to use other medicines with Renagel, which could include calcium or vitamin D supplements, to control the development of renal bone disease.

What do you have to consider before using it?

Do not take Renagel if:

Take special care with Renagel
If any of the following applies to you, please consult your doctor before taking Renagel :

The safety and efficacy in children (below the age of 18 years) has not been established. Therefore Renagel is not recommended for use in this population.

Additional treatments:
Due to either your kidney condition or your dialysis treatment you may:

Changing treatment:
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.

Special note for patients on peritoneal dialysis
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis. This risk can be reduced by careful adherence to sterile techniques during bag changes. You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress,abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.

Taking other medicines
Please tell your doctor all if you are taking or have recently taken other medicines, including medicines obtained without a prescription.

Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).

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’s metabolism) may very rarely be observed in certain people taking levothyroxine (a thyroid hormone) and Renagel. Therefore your doctor may monitor the levels of TSH in your blood more closely.

Your doctor will check for interactions between Renagel and other medicines on a regular basis.

Taking Renagel with food and drink
You should take Renagel tablets with meals. However, you should adhere to your prescribed diet and liquid intake.
Do not chew. The tablets must be swallowed whole.

Pregnancy and breast-feeding
The safety of Renagel has not been established in pregnant or lactating women. Renagel should only be given to pregnant or lactating women if clearly needed.

Driving and using machines
No studies on the effects on the ability to drive and use machines has been performed. If you are affected, do not drive and do not use any tools or machines.

How is it used?

You should take Renagel as prescribed by your doctor. He/she will base the dose on your serum phosphate level. The recommended starting dose of Renagel for adults and the elderly (> 65 years) is two to four tablets with each meal 3 times a day.

Your doctor will check the levels of phosphate in your blood periodically and he/she may adjust the dose of Renagel when necessary (between 1 and 10 tablets of 400 mg per meal) to reach an adequate phosphate level.

In some cases where Renagel should be administered at the same time as another medicine. Your doctor may advise you to take this medicine 1 hour before or 3 hours after Renagel intake, or he/she may consider monitoring the blood levels of that medicine.

If you take more Renagel than you should
There are no reported overdoses in patients.
In the event of a possible overdose you should contact your doctor immediately.

If you forget to take Renagel
If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose .

What are possible side effects?

Like all medicines, Renagelcan cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking Renagel:
Very common (affects more than 1 user in 10): nausea, vomiting.
Common (affects 1 to 10 users in 100): diarrhoea, indigestion, abdominal pain, constipation, flatulence

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

Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, please inform your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not store above 25 °C. Keep the bottle tightly closed in order to protect from moisture.

Do not use Renagel after the expiry date stated on the carton and/or bottle after the letters “EXP”.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

↑ back to table of contents ↑

For doctors

What is it?

Renagel is a medicine that contains the active substance sevelamer hydrochloride. It is available as white, oval tablets (400 and 800 mg).

What is it used for?

Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adults on dialysis (a blood clearance technique used in patients with kidney disease). It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood). Renagel should be used with other treatments such as calcium or vitamin D supplements to control the development of bone disease. The medicine can only be obtained with a prescription.

How is it used?

The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day. The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l. Patients should take Renagel tablets whole with meals and stick to their prescribed diets.

How does it work?

Patients with long-term kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease. The active substance in Renagel, sevelamer hydrochloride, is a phosphate binder. When taken with meals, it attaches to phosphate from food within the gut, preventing it from being absorbed into the body. This helps to reduce the phosphate levels in the blood.

How has it been studied?

In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks. The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients. The second, which did not compare Renagel with any other medicines, included 172 patients. The longer study looked at the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.

In peritoneal dialysis, there has been one study comparing Renagel with calcium acetate in 143 patients over 12 weeks.
In all of the studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.

What benefits has it shown during the studies?

Renagel produced a significant decrease in serum phosphate in all of the studies.
In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate. Patients taking Renagel had a similar fall in phosphate levels in the second study. In the third, there was an average fall of 0.71 mmol/l over 44 weeks. In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).

What is the risk associated?

The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting. For the full list of all side effects reported with Renagel, see the Package Leaflet. Renagel should not be used in people who may be hypersensitive (allergic) to sevelamer or any of the other ingredients. Renagel must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Renagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Renagel was originally authorised under ‘Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 26 June 2006.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Renagel to Genzyme Europe B.V. on 28 January 2000. After ten years, the marketing authorisation was renewed for a further five years.

↑ back to table of contents ↑