Renagel

Reangel is a drug used in hyperphosphatemia and -caliemia. It contains polyalylamine hydrochloride (phosphate-binding polymer) and Sevelamer; the drug is not absorbed, it does not contain calcium and metals. Instead, it includes polyamines, which are separated from the main polymer chain by carbon molecules. Some of these amines are protonated inside the intestines, and also interact with phosphate molecules through hydrogen and ionic bonds.

The synthesis of phosphate inside the gastrointestinal tract, carried out by sevelamer, leads to a decrease in serum phosphate values.

[1]

Indications Renaglia

It is used for hyperphosphatemia in persons undergoing peritoneal dialysis or hemodialysis.

[2]

Release form

The release of the drug element is implemented in tablets - 180 pieces inside a plastic jar.

[3], [4]

Pharmacodynamics

During clinical tests, the effectiveness of the component camelama while reducing serum phosphorus values in people who are on peritoneal dialysis or hemodialysis.

Sevelamer reduces the number of episodes of hypercalcemia compared with phosphate-binding drugs based on Ca (probably due to the fact that it does not contain calcium). Testing that lasted for 12 months showed that the effect of the drug at the level of phosphates with Ca remains at least for the duration of the specified term.

The component is capable of synthesizing bile acids in both in vitro and in vivo tests during studies in experimental animal models. Synthesis of bile acids occurs using ion exchange resins (a method used to reduce blood cholesterol levels). In clinical tests, Sevelamer resulted in a 15-31% decrease in LDL-, as well as total cholesterol. This effect was noted after 14 days of therapy and persisted with prolonged treatment. The levels of albumin and triglycerides with HDL-cholesterol remained the same.

In clinical testing performed with the participation of persons on hemodialysis, the use of only sevelamer did not affect the serum levels of intact parathyroid hormone. The testing that lasted 3 months involved people who received peritoneal dialysis sessions, but this effect manifested itself in the form of a decrease in the level of intact parathyroid hormone in comparison with those using calcium acetate.

During therapy in individuals with a secondary stage of hyperparathyroidism, Renagel is used in combination with other medicines, including calcium drugs and D3 1,25-dihydroxyvitamin or one of its analogues. This is necessary to reduce the performance of intact parathyroid hormone.

A clinical test that lasted for 12 months showed that the drug did not lead to the development of a negative effect on mineralization or bone mass (compared to Ca carbonate).

[5], [6], [7], [8]

Dosing and administration

The drug is administered in combination with other drugs - this is necessary to prevent the appearance of osteodystrophy of the kidneys.

Renagel is taken internally, along with food - tablets do not need to be chewed, they are swallowed whole. Also required to follow the diet prescribed by the doctor.

First, it is recommended to use 2.4 or 4.8 g of substance per day (when selecting a portion, clinical needs and phosphorus indicators inside blood serum are taken into account). The drug is applied 3 times a day, with food.

For serum values of phosphate (in persons who do not use phosphate-binding drugs), which are 1.76-2.42 mmol / l (or 5.5-7.5 mg / dL), it is required to use 1-well pill 0.8 g 3 - once a day. If the indicated values are> 2.42 mmol / L (or> 7.5 mg / dL), 2 such tablets are required 3 times per day.

People who have previously used phosphate-binding drugs, the drug is administered in a ratio of g / g (equal proportions), while monitoring the serum indicators of phosphorus - to ensure the use of optimal daily portion.

The serum phosphate level is required to constantly monitor and adjust the dosage of the drug to reduce this level to 1.76 mmol / L (or 5.5 mg / dL) or less. Serum phosphate values are first checked at 2-3 week intervals (until a stable figure is obtained), and later - regularly.

Portions can vary between 1-5 tablets per 1 meal. In clinical tests that lasted 12 months, during the chronic stage, the average daily dosage of Sevelamer was 7 g.

[10], [11], [12],

Use Renaglia during pregnancy

There is no information regarding the safety of using drugs during pregnancy. Tests involving animals did not show development of embryotoxicity with administration of Sevelamer. Renagel is used in pregnant women only if there are strict indications and after careful assessment of the risk-benefit ratio.

The safety of using the drug during lactation has also not been studied. Therefore, it is used in the specified period only after assessing the possible consequences and benefits, according to vital signs.

Contraindications

The main contraindications:

• severe intolerance associated with sevelamer or other elements of the drug;
• gyphophosphatemia;
• intestinal obstruction.

Side effects Renaglia

Among the side symptoms associated with the work of the digestive organs: mostly vomiting or nausea. Also often observed bloating, obstipatsiya, dyspepsia, diarrhea or pain in the upper abdominal area.

During the post-marketing period, a rash, itching, bowel obstruction, abdominal pain, intestinal perforation, or blockage (full or partial) were noted.

[9]

Interactions with other drugs

With interaction tests in which volunteers participated, the drug reduced the bioavailability of ciprofloxacin by about 50%. The study of this combination was carried out with the introduction of a single dose. Therefore, the drug should not be used with ciprofloxacin.

In the post-marketing period, there was rarely an increase in TSH values in people who combined the drug with levothyroxine. In this regard, it is necessary to closely monitor the TSH indicators in individuals who take together these drugs.

In the case of sharing of Renagel with mofetil mycophenolate, cyclosporine and tacrolimus, the individuals who underwent organ transplantation decreased the indices of these drugs, but without clinical complications (for example, transplant organ rejection). The likelihood of an interaction cannot be ruled out, due to which it is necessary to closely monitor the blood values of these drugs during joint therapy and after stopping their use.

When using any medication that may have a clinical impact on efficacy and safety, a decrease in the level of bioavailability may require such a drug to be taken at least 60 minutes before or 3 hours after using Renagel. Otherwise, the doctor must monitor the blood indicators of such drugs.

[13],

Storage conditions

Renagel should be kept in a place inaccessible to small children. Temperatures are a maximum of 25ºC.

[14], [15]

Shelf life

Renagel is allowed to apply for a 36-month term since the sale of the drug.

Application for children

Therapeutic efficacy and safety of the use of the drug in pediatrics have not been studied, because of what Renagel is not prescribed for this category of patients.

[16], [17], [18], [19]

Analogs

Analogues of the drug are substances Renwell, Calcium Acetate, as well as Selamereks with Sevelamer.

[20], [21], [22], [23], [24]