Renvela 800 mg film-coated tablets Sevelamer Carbonate,Sevel - United Kingdom[英国药品]

TOP

Renvela 800 mg film-coated tablets Sevelamer Carbonate,Sevel

2014-07-12 17:34:43 来源: 作者: 【大中小】浏览:428次评论:0条

For doctors

What is it and how is it used?

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

Patients who have kidneys that do not work properly are not able to control the level of serum phosphorus 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 is 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.

What do you have to consider before using it?

Do not take Renvela if:
you have low levels of phosphate in your blood (your doctor will check this for you) you have bowel obstruction
you are allergic (hypersensitive) to the active substance or to any of the other ingredients of the product (see section 6).

Take special care with Renvela

If any of the following applies to you, please consult your doctor before taking Renvela swallowing problems problems with motility movement in your stomach and bowel being sick frequently active inflammation of the bowel have undergone major surgery on your stomach or bowel.

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

Additional treatments:
Due to either your kidney condition or your dialysis treatment you may:
develop low or high levels of calcium in your blood. Since Renvela does not contain calcium your doctor might prescribe additional calcium tablets.
have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.

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 if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Renvela 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 Renvela.

The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela. Your doctor will advise you if you are taking these medicines.

Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treatment low thyroid hormone levels) and Renvela. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.

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

Taking Renvela with food and drink
You must take Renvela tablets with meals.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend to become pregnant. It is unknown whether Renvela has any affect on unborn babies.

Tell your doctor if you wish to breast-feed your baby. It is unknown whether Renvela may pass through breast milk and affect your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

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 must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

The recommended starting dose of Renvela tablets for adults and the elderly (> 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.

The tablets must be swallowed whole. Do not crush, chew or break into pieces.

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

Your doctor will check the levels of phosphorus in your blood periodically and they may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

If you take more Renvela 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 Renvela
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, Renvelacan cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking Renvela:
Very common (affects more than 1 user in 10):
vomiting, constipation, upper abdominal pain, nausea

Common (affects 1 to 10 users in 100):
diarrhoea, abdominal pain, indigestion, flatulence

In clinical use, cases of itching, rash, slow intestine motility (movement)/blockages in the intestine, and perforation in the intestine wall have been reported.

Since constipation may be an early symptom of a blockage 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 use Renvela after the expiry date stated on the bottle and carton after the letters “EXP”.

Keep the bottle container tightly closed in order to protect from moisture.
This medicinal product does not require any special storage conditions.

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?

Renvela is a medicine that contains the active substance sevelamer carbonate. It is available as white tablets (800 mg) and as a powder (1.6 g and 2.4 g) to be made up into an oral suspension.

What is it used for?

Renvela is used to control hyperphosphataemia (high blood phosphate levels) in:

How is it used?

The recommended starting dose of Renvela depends on clinical need and the level of phosphate in the blood and ranges from 2.4 to 4.8 grams per day. Renvela must be taken three times a day with meals and patients should keep to their prescribed diets.
The dose of Renvela should be adjusted every two to four weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly. The tablets should be taken whole and the oral suspension should be taken within 30 minutes of being prepared.

How does it work?

Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart disease. The active substance in Renvela, sevelamer carbonate, is a phosphate binder. When taken with meals, the sevelamer molecules in sevelamer carbonate bind 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. Renvela is similar to another medicine, Renagel, which has been available in the European Union since 2000. Renagel contains sevelamer as the hydrochloride salt, and not the carbonate in Renvela.

How has it been studied?

The effects of Renvela were first tested in experimental models before being studied in humans . Two main studies compared Renvela with Renagel in 110 adults who were on dialysis. All patients had chronic kidney disease with hyperphosphataemia and had been on haemodialyis for at least three months. They had all previously taken oral phosphate binder treatment and most patients took vitamin D. The two studies were crossover studies: patients first received either Renvela (tablets or powder) or Renagel, and the treatments were then switched after four or eight weeks. The main measure of effectiveness was the average amount of phosphate in the blood during treatment.A third main study involving 49 patients studied Renvela in patients with hyperphosphataemia with a serum phosphorus level equal to or above 1.78 mmol/l and who were not on dialysis. Patients received Renvela for eight weeks. The main measure of effectiveness was how much the blood phosphate was reduced at the end of treatment.

What benefits has it shown during the studies?

Renvela was as effective as Renagel in reducing phosphate in patients with chronic kidney disease who were on dialysis. In two studies the average amount of phosphate in the blood during treatments with Renvela or Renagel was similar.
In the small study of patients not on dialysis who took Renvela, the average amount of phosphate in the blood was reduced by about a fifth, from 2.0 mmol/l to 1.6 mmol/l.

What is the risk associated?

The most common side effects with Renvela (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, upper abdominal (tummy) pain and constipation. For the full list of all side effects reported with Renvela, see the Package Leaflet.
Renvela should not be used in people who may be hypersensitive (allergic) to sevelamer carbonate or any of the other ingredients. Renvela 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) noted that the study of Renvela in patients not on dialysis was too small to provide enough evidence on its own to support the medicine’s use in these patients. Despite this, the Committee concluded that the medicine can be used in patients not on dialysis because they had the same underlying disease as those on dialysis.
The CHMP therefore decided that Renvela’s benefits are greater than its risks for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis and in adult patients with chronic kidney disease who are not on dialysis and who have a serum phosphorus level equal to or above 1.78 mmol/l. The Committee recommended that Renvela be given marketing authorisation.

How has it been studied?

The company that makes Renvela will make sure that educational materials are available in all Member States for patients and healthcare professionals. The programme will include information on the risk and prevention of peritonitis (inflammation of the lining of the abdomen) in patients undergoing peritoneal dialysis, arterio-venous fistula (an abnormal passageway between an artery and a vein) in patients undergoing haemodialysis, and vitamin deficiency in patients with chronic kidney disease.