Renafos

Oval, white to off-white film coated tablets without scoring line.
The tablets are debossed with 'SVL' on one side.
Each film coated tablet contains 800 mg sevelamer carbonate.
Excipients/Inactive Ingredients: Tablet core: Lactose monohydrate, Colloidal silicone dioxide, Zinc stearate.
Film coating: Combination opadry film-coating system 06A29148.

Pharmacotherapeutic group: Treatment of hyperphosphataemia. ATC code: V03AE02.
Pharmacology: Pharmacodynamics: Mechanism of action: Sevelamer carbonate contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach. These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.
By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum. Regular monitoring of serum phosphorus levels is always necessary during phosphate binder administration.
Sevelamer binds bile acids and may interfere with the absorption of fat-soluble vitamins such as A, D, E and K.
Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone.
Pharmacokinetics: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract.

Sevelamer carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥1.78 mmol/l.
Sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

Posology: Starting dose: The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Sevelamer carbonate must be taken three times per day with meals. (See Table 1.)


Click on icon to see table/diagram/image


For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), sevelamer carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily dose.
Titration and maintenance: Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Patients taking sevelamer carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of sevelamer carbonate has not been established in children below the age of 18 years.
Sevelamer is not recommended in children below the age of 18 years.
Method of administration: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.

No cases of overdose has been occurred. Sevelamer hydrochloride which contain the same active moiety as sevelamer carbonate has no undesirable effects.
In chronic kidney disease patients, the maximum average daily dose is 14.4 grams of sevelamer carbonate in a single daily dose.

Hypersensitivity to the active substance or to any of the excipients listed in Description.
Hypophosphataemia.
Bowel obstruction.

The safety and efficacy of sevelamer carbonate has not been known in children below the age of 18 years.
The safety and efficacy of sevelamer carbonate have not been known in adult patients with chronic kidney disease not on dialysis with serum phosphorus <1.78 mmol/l.
Therefore sevelamer carbonate is currently not recommended for use in these patients.
The safety and efficacy of sevelamer carbonate have not been known in patients with the following disorders: Dysphagia; Swallowing disorders; Severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion; Active inflammatory bowel disease; Major gastrointestinal tract surgery.
Therefore caution should be exercised when sevelamer is used in these patients.
Intestinal obstruction and ileus/subileus: Constipation may be a proceeding symptom. Patients who are constipated should be monitored carefully while being treated with sevelamer.
The treatment should be reevaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Fat-soluble vitamins: Patients with chronic kidney disease may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary intake and the severity of their disease.
It cannot be excluded that sevelamer carbonate can bind fat-soluble vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E and K status should be assessed regularly. It is recommended that vitamin supplements be given if necessary. It is recommended that chronic kidney disease patients not on dialysis are given vitamin D supplements (approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken apart from their dose of sevelamer carbonate. In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Folate deficiency: There is possibility of folate deficiency during long-term sevelamer carbonate treatment.
Hypocalcaemia/hypercalcaemia: Patients with chronic kidney disease may develop hypocalcaemia or hypercalcaemia. Sevelamer carbonate does not contain any calcium. Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Metabolic acidosis: Patients with chronic kidney disease are predisposed to developing metabolic acidosis. Monitoring of serum bicarbonate levels is therefore recommended.
Peritonitis: Peritonitis is a known complication in patients receiving peritoneal dialysis. Patients on peritoneal dialysis should be closely monitored to ensure the correct use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Swallowing and choking difficulties: Caution should be exercised when sevelamer carbonate is used in patients with difficulty swallowing.
Anti-arrhythmic and anti-seizure medicinal products: Caution should be exercised when prescribing sevelamer carbonate to patients also taking anti-arrhythmias and anti-seizure medicinal products (see "Interactions").
Hypothyroidism: Closer monitoring of patients with hypothyroidism coadministered with sevelamer carbonate and levothyroxine is recommended (see "Interactions").
Long-term chronic treatment: The potential absorption and accumulation of sevelamer during long-term chronic treatment (>one year) cannot be totally excluded (see "Pharmacology: Pharmacokinetics under Actions").
Hyperparathyroidism: Sevelamer carbonate is not indicated for the control of hyperparathyroidism. In patients with secondary hyperparathyroidism, sevelamer carbonate should be used within the context of a multiple therapeutic approach, which could include calcium as supplement. 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Effects on Ability to Drive and Use Machines: Sevelamer has no or negligible influence on the ability to drive and use machines.

Pregnancy: Sevelamer carbonate should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Breast-feeding: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate should be made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonate therapy to the woman.
Fertility: There are no effect of sevelamer on fertility in humans.

The most frequently occurring undesirable effects related to Sevelamer were all in the gastrointestinal disorder system organ class. (See Table 2.)


Click on icon to see table/diagram/image

Decreased the bioavailability of ciprofloxacin. Sevelamer carbonate should not be taken simultaneously with ciprofloxacin.
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been occurred in transplant patients when coadministered with sevelamer hydrochloride (i.e. graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate, mofetil and tacrolimus should be considered during the use of combination and after its withdrawal.
Hypothyroidism has been occurred in patients with co-administered sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving sevelamer carbonate and levothyroxine.
Caution should be exercised when prescribing sevelamer carbonate to patients also taking anti-arrhythmic and antiseizure medicinal products.
Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril, or metoprolol.
Sevelamer carbonate is not absorbed and may affect the bioavailability of other medicinal products. The medicinal product should be administered at least one hour before or three hours after Sevelamer carbonate or the physician should consider monitoring blood levels.

Incompatibilities: Not applicable.

Store below 30°C.
Keep the bottle tightly closed in order to protect from moisture.
Shelf Life: 3 years.

Antidotes & Detoxifying Agents

V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.

K