Sevelamer

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Available since: 2019-09-19

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Clinical Pharmacology

Medication for the treatment of hyperphosphatemia. Allylamine carbonate polymer not absorbed in the gastrointestinal tract. Binding of phosphates in the digestive tract, reduces their concentration in serum. The drug does not contain Ca and therefore does not cause hypercalcemia, observed during the use of other

phosphate excreting drugs that contain Ca2 +. The effect on the concentration of phosphorus in the blood is maintained when taking the drug for 1 year.

Indications

Hyperphosphatemia in chronic renal failure in patients on hemodialysis or peritoneal dialysis, as part of complex therapy, including Ca preparations, colecalciferol or its analogues.

CELAMEREX® is indicated for hyperphosphatemia in adult patients on hemodialysis. CELAMEREX® should be used as part of a combination therapy aimed at preventing bone damage due to kidney disease and including calcium supplements, 1,25-hydroxyvitamin D3 or one of its analogues.

Composition

1 tablet, film coated, contains carbonate as the active substance of Sevelamer, in terms of dry substance 800 mg.

Excipients: lactose monohydrate - 286.25 mg, colloidal silicon dioxide - 5.50 mg, zinc stearate - 8.25 mg.

The composition of the shell: macrogol and polyvinyl alcohol copolymer - 19.80 mg, talc - 13.20 mg.

Sevelamer is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Selamerex			pills
Renagel	Jenzyme Europe B.V	USA	gel

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Dosage and Administration

Is ingested during the meal. pills should be swallowed whole, without chewing.

For patients who do not receive phosphate binding drugs, the dose should be individually adjusted based on the measurement of serum phosphate concentrations:

Serum phosphate concentrations in non-phosphate binders	Initial dose of the drug Selamereks^®
1.76-2.42 mmol / l (5.5-7.5 mg / ml)	800 mg 3 times / day
> 2.42 mmol / l (> 7.5 mg / ml)	1600 mg 3 times / day

For patients receiving phosphate binding drugs (Ca²⁺): prescribed in equivalent doses in terms of 1 mg of drugs containing Ca²⁺(on the basis) which the patient accepted earlier.

The dose varies from 800 to 4000 mg, the maximum daily dose is 7 g. The dose is selected taking into account the concentration of phosphate in the blood serum (the required reduction to 1.76 mmol / l (5.5 mg / dl) and below).

Phosphate concentrations are monitored every 2–3 weeks until stabilization is achieved.

Selamerex^® should be taken with meals and at the same time adhere to the established diet.

Adverse reactions

The frequency of side effects noted when taking Sevelamer is in accordance with the classification of the World Health Organization (WHO): very often (more than 1/10), often (more than 1/100 and less than 1/10).

On the part of the digestive system: very often - nausea, vomiting, abdominal pain, constipation, diarrhea, dyspepsia; often - flatulence.

From the side of the central nervous system: very often - a headache.

Since the cardiovascular system: very often - increase or decrease in blood pressure.

On the part of the skin: very often - itching; often - rash.

Other: very often - pain of different localization; often - pharyngitis.

In clinical practice, intestinal obstruction is very rarely observed. Side effects are more common in patients with end-stage chronic renal failure.

Carefully:

Inflammatory diseases of the gastrointestinal tract, impaired motility of the gastrointestinal tract (including constipation), surgical operations on the gastrointestinal tract (in history), dysphagia, difficulty swallowing, simultaneous use with antiarrhythmic and antiepileptic drugs, pregnancy, period breastfeeding.

Drug interactions

Reduces the bioavailability of ciprofloxacin by 50%. Medicines for which a reduction in bioavailability may be of clinical importance should be applied 1 h before or 3 h after taking SELAMEREX®.

The effects of cyclosporine, mycophenolate mofetil, and tacrolimus may be diminished when taking CELAMEREX®.

A thyroid hormone deficiency can occasionally develop in some people taking SELAMEREX® with levothyroxine.

Pregnancy and Lactation

For pregnant women, the safety of Sevelamer has not been established. In animal studies, there was no evidence that Sevelamer caused embryotoxicity. The drug should be prescribed to pregnant women only if there is a clear need and after conducting a thorough analysis of the balance of risks and benefits for the mother and the fetus.

For nursing mothers, the safety of Sevelamer has not been established. The drug should be prescribed to lactating women only if there is a clear need and after conducting a thorough analysis of the balance of risks and benefits for mother and child.

Special instructions

If you forgot to take one dose of medicine, skip it. Take the next dose at your regular mealtime. Do not take a double dose, do not try to fill in the missed.

With the use of the drug SELAMEREX®, there may be a lack of vitamins A, D, E, K, folic acid in the blood. Therefore, it is possible additional appointment of these vitamins.

If you are taking medication to treat cardiac arrhythmias or epilepsy, you should consult with your doctor about taking CELAMEREX®.

Influence on ability to drive motor transport and control mechanisms:

Effects on the ability to drive vehicles and other mechanisms that require increased concentration of attention, were not identified.