Repata - Instructions For Use, Price, Reviews, Drug Analogues

Repata

Repata: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation

1. 10. Use in childhood
2. 11. In case of impaired renal function
3. 12. For violations of liver function
4. 13. Drug interactions
5. 14. Analogs
6. 15. Terms and conditions of storage
7. 16. Terms of dispensing from pharmacies
8. 17. Reviews
9. 18. Price in pharmacies

Latin name: Repatha

ATX code: C10AX13

Active ingredient: evolocumab (Evolocumab)

Manufacturer: Amgen Manufacturing, Limited (Puerto Rico)

Description and photo updated: 2019-11-12

Prices in pharmacies: from 14289 rubles.

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Repata is a drug that affects lipid metabolism.

Release form and composition

Dosage form - solution for subcutaneous (s / c) administration: liquid from colorless to yellowish, slightly opalescent or transparent, without mechanical impurities [in a cardboard box 1, 2 or 6 pre-filled syringe pens (PZSHR) collected from pre-filled syringes (PZH) made of glass containing 1 ml of solution, or 1 cell contour package, which contains 1 PZH made of glass, containing 1 ml of solution, as well as instructions for using Repata].

The composition of the solution contained in 1 PZSH or PZSHR (1 ml):

• active substance: evolocumab - 40 mg;
• auxiliary components: polysorbate 80 - 0.1 mg; glacial acetic acid - 1.2 mg; proline - 25 mg; sodium hydroxide - in the amount necessary to bring the pH to 5; water for injection - in the amount required to bring the volume of the solution to 1 ml.

Pharmacological properties

Pharmacodynamics

As a fully human monoclonal immunoglobulin G2 (IgG2), evolocumab inhibits subtilisin / kexin type 9 proprotein convertase (PCSK9). A substance with a high degree of affinity, selectively binds to PCSK9 and inhibits the binding of circulating PCSK9 to the low density lipoprotein (LDL) receptor on the surface of liver cells. Thus, it prevents PCSK9-mediated degradation of the LDL receptor. As a consequence, an increase in the expression of the LDL receptor in the liver leads to a decrease in serum LDL cholesterol.

The use of the drug for primary hyperlipidemia and mixed dyslipidemia reduces the content of lipoprotein (a) [Lp (a)], triglycerides, very low density lipoprotein cholesterol (VLDL), low density lipoprotein cholesterol (non-HDL), apolipoprotein B, total cholesterol, cholesterol LDL and unbound PCSK9, increases apolipoprotein A1 and high density lipoprotein (HDL) cholesterol, improving the total cholesterol / HDL cholesterol / apolipoprotein B / apolipoprotein A1 ratio.

A single SC administration of evolocumab at a dose of 140 or 420 mg after 4 hours leads to maximum suppression of circulating unbound PCSK9, which is accompanied by a decrease in LDL cholesterol, reaching the average nadir by 14 and 21 days, respectively. After the cancellation of Repata, changes in the content of serum lipoproteins and unbound PCSK9 are reversible. During the period of therapy, there was no compensatory increase in the production of LDL cholesterol and PCSK9. Also, after elimination of the drug, the concentration of LDL cholesterol and unbound PCSK9 does not increase, that is, there is no rebound syndrome.

In comparison with the placebo group, in patients receiving 140 mg of evolocumab every 14 days or 420 mg once a month, the maximum decrease in LDL cholesterol from the initial values reached -72 and -57%, respectively. The dosing regimens are equivalent in terms of mean LDL cholesterol reduction (mean at weeks 10 and 12).

A similar decrease in LDL cholesterol was observed when Repata was used both in monotherapy and as part of a combination treatment with other lipid-lowering agents. The effect on lowering LDL cholesterol is stable, the maximum duration of the course of use is currently 112 weeks.

The response to the use of evolocumab does not depend on external and internal factors (for example, such as pathology status, variability of laboratory parameters, combined use of other drugs and demographic characteristics).

Against the background of the use of Repata, like any other therapeutic proteins, immunogenicity can develop. It was determined by immunochemiluminescent binding in order to detect antibodies to the drug. If antibodies to evolocumab were detected in a patient during immunological screening, a biological analysis was additionally prescribed to determine whether these antibodies were neutralizing.

In ongoing clinical studies, in 0.1% of cases of using 1 dose of the drug [in 7 patients out of 4846 with mixed dyslipidemia and primary hypercholesterolemia and in none of 80 patients with homozygous familial hypercholesterolemia (GHCHS)], binding antibodies were detected (in 4 patients - transient antibodies). These patients were assigned an additional test for neutralizing antibodies. None of them had them. The presence of binding antibodies did not change the pharmacokinetic parameters of Repata, did not affect its safety and therapeutic response.

The results of clinical studies have shown that inhibition of PCSK9 activity by Repata leads to a decrease in serum LDL cholesterol and an improvement in other parameters of lipid metabolism. These results show the stable efficacy of the drug in improving lipid metabolism against the background of GOSHC, mixed dyslipidemia and primary hyperlipidemia (heterozygous familial / nonfamilial) in all populations and with any study design.

The use of 140 mg of the substance once every 14 days and 420 mg once a month are clinically equivalent in patients with mixed dyslipidemia and primary hypercholesterolemia in terms of an increase in the content of apolipoprotein A1 and HDL cholesterol, improving the ratio of total cholesterol / HDL cholesterol / apolipoprotein B / apolipoprotein; lowering lipoprotein (a), triglycerides, VLDL cholesterol, non-HDL cholesterol, apolipoprotein B, total cholesterol and LDL cholesterol.

The use of Repata allows to achieve a decrease in the LDL cholesterol content by about 55–75%, which remains during the entire period of a long-term course of therapy. The maximum response is usually achieved after 7-14 days after administration of the solution at a dosage of 140 mg once every 14 days and 420 mg once a month, respectively. In 80–85% of cases of using the drug in any dosage, there is a decrease in LDL cholesterol by more than 50% on average by 70–84 days of treatment.

Repat is superior to ezetimibe in reducing the concentration of non-HDL cholesterol, apolipoprotein B, LDL cholesterol, total cholesterol, lipoprotein (a) and the ratio of total cholesterol / HDL cholesterol / apolipoprotein B / apolipoprotein A1.

The use of the drug at a dose of 140 mg once every 14 days and 420 mg once a month was effective in all subgroups related to ezetimibe and placebo. At the same time, there were no significant differences between subgroups of patients defined by the following characteristics:

• floor;
• age;
• race;
• body mass index;
• region of origin;
• the degree of risk from the National Cholesterol Education Program;
• dose and intensity of statins;
• arterial hypertension;
• a family history of early coronary heart disease;
• baseline risk of coronary heart disease;
• glucose tolerance or intolerance (i.e. metabolic syndrome, type 2 diabetes, or neither);
• smoking status;
• initial concentration of triglycerides;
• initial concentration of LDL cholesterol;
• original unbound PCSK9.

In the conducted studies by the GOSHHS, the results of the general analysis of efficacy indicate a clinically significant decrease in the concentration of total cholesterol, apolipoprotein B, LDL cholesterol and non-HDL cholesterol by evolocumab in patients with this pathology.

Against the background of long-term use of the solution at a dosage of 140 mg once every 14 days and 420 mg once a month, there is a long-term therapeutic effect. This is confirmed by a decrease in the content of LDL cholesterol from 20 to 30% in patients with GOSHC who did not receive apheresis treatment, as well as in 15–20% of patients with GoSHC who received apheresis. In general, the safety and efficacy of evolocumab in patients of different groups aged 12 years and older, as well as in adults with GOSHC, does not differ.

Throughout all three periods of collecting a comprehensive array of data on the safety of use of Repaty, as well as between therapy regimens and patient subgroups, the ratio of the incidence of side effects is generally balanced.

Any safety concerns with respect to side effects reported for other lipid-lowering treatments (episodes of diabetes, muscle and liver complications) and phenomena that could theoretically be associated with inhibition of BCAA9 / increased expression of LDL receptors (episodes occurrence of hepatitis C) did not occur. Also, there were no signs indicating the likelihood of neurocognitive complications when using the solution. The results of studies with placebo controls or active controls for neurocognitive complications were similar.

The number and types of side effects in all conducted studies were similar, both with monotherapy with Repata, and with its combined use with other drugs (with statins in combination with ezetimibe or without it) or with statin intolerance.

No new signals regarding the safety of prescribing a substance, in a comparative study of data on side effects that appeared in the course of studies of patients with GOSHC and data on adverse events that occurred in studies of primary hyperlipidemia (heterozygous familial / nonfamilial) and mixed dyslipidemia were not identified.

Pharmacokinetics

After subcutaneous administration, the pharmacokinetics of evolocumab is non-linear.

The main pharmacokinetic characteristics of the substance:

• absorption: after a single subcutaneous injection at a dose of 140 or 420 mg to healthy volunteers, the median maximum serum concentration was achieved over a period of 3 to 4 days with a calculated absolute bioavailability of 72%. After the introduction of 140 mg of the solution, the average value of the maximum concentration (C _max) is 18.6 (7.3) μg per 1 ml. The final area under the concentration-time curve (AUC _last) - 188 (98.6) days × μg / ml. Similar values of C _max and AUC _last after injection of 420 mg of the drug were, respectively, 59 (17.2) μg per 1 ml / 924 (346) days × μg per 1 ml, respectively;
• distribution: after intravenous (iv) administration of the drug in a single dose of 420 mg, the average calculated volume of distribution in the equilibrium state is 3.3 (0.5) l. This suggests its limited distribution in tissues;
• metabolism: after intravenous administration of Repata in a single dose of 420 mg, the calculated mean systemic clearance is 12 (2) ml per hour. Repeated s / c administration of the drug for 84 days in clinical trials led to a dose-proportional increase in exposure for dosage regimens of 140 mg and more. Approximately double and triple cumulation was observed at a minimum serum concentration of 7.21 (6.6) when the solution was administered at a dose of 140 mg every 14 days or 420 mg once a month - 11.2 (10.8). By day 84 of dosing, the minimum serum concentration reached an equilibrium state. The estimated effective half-life of the drug ranged from 11 to 17 days. No time-related changes in serum concentrations were observed over 112 weeks;
• Elimination: Since evolocumab is a fully human monoclonal IgG2 antibody, its clearance is due to specific binding and complexation with the target ligand PCSK9, as well as standard pathways for IgG clearance in the reticuloendothelial system. Through these pathways of catabolism, the drug is broken down to small amino acids and peptides. With the combined use of Repata with statins, an increase in clearance of almost 20% is noted, which is partly due to an increase in PCSK9 content caused by the second. This increase does not have a negative effect on the pharmacodynamics of the substance in relation to lipids. The conducted pharmacokinetic analysis in populations of significant differences in serum concentrations of the drug in patients with familial and nonfamilial hypercholesterolemia,and also in combination treatment with statins was not identified.

Correction of the dosage regimen depending on the gender, age and race of patients, according to the results of pharmacokinetic analysis in populations, is not required.

The pharmacokinetics of evolocumab depends on the patient's body weight, however, weight does not significantly affect its hypolipidemic effect. On this basis, depending on the body weight, the dosage regimen is not adjusted.

According to a pharmacokinetic analysis in populations based on pooled data from clinical trials, there were no differences in the pharmacokinetics of Repata in mild / moderate renal impairment compared with normal renal function.

Evaluation of the effect of impaired liver function on therapy with Repata was carried out as follows: the solution was administered as a single subcutaneous injection at a dose of 140 mg to 8 healthy volunteers, 8 patients with moderate impairment and 8 patients with mild impairment of liver function. Compared with healthy subjects, the exposure to the drug was reduced by 40–50%, but the baseline PCSK9 content, as well as the time / degree of its neutralization, remained similar in all three groups. Thus, there was a similar effect on the reduction of LDL cholesterol.

Indications for use

• primary hyperlipidemia (heterozygous familial and non-familial) and mixed dyslipidemia (according to Fredrickson's classification - type IIa, IIb, IV) in adults as an addition to the diet to lower LDL cholesterol, total cholesterol, apolipoprotein B, non-HDL cholesterol, triglycerides, LDL cholesterol, cholesterol, lipoprotein (a) and the ratio of total cholesterol / HDL cholesterol / apolipoprotein B / apolipoprotein A1, as well as to increase HDL cholesterol and apolipoprotein A1: simultaneously with statin, in combination with statin and other lipid-lowering treatment (for example, ezetimibe therapy), or simultaneously with other lipid-lowering treatment in patients with statin intolerance, as well as monotherapy or combined with other lipid-lowering treatment in patients whose statin prescription, from a clinical point of view,considered impractical;
• GOSHS: Repatu is prescribed to adolescents aged 12 years and older, as well as adults with GOSHS (according to Fredrickson's classification - type IIa) in order to reduce the concentration of non-HDL cholesterol, total cholesterol, apolipoprotein B and LDL cholesterol (in combination with other lipid-lowering treatment, for example, with statins, LDL apheresis).

Contraindications

Absolute:

• pregnancy;
• period of breastfeeding;
• children's age: in the treatment of mixed dyslipidemia and primary hyperlipidemia (heterozygous familial / non-familial) - under 18 years of age; with GOSHS - under 12 years old;
• individual intolerance to the components of the drug.

Relative (Repata is prescribed under medical supervision):

• type 1 diabetes mellitus;
• severe hepatic impairment (according to the Child-Pugh classification - class C);
• uncontrolled arterial hypertension [diastolic arterial pressure (BP) at rest> 110 mm Hg. Art., systolic blood pressure> 180 mm Hg. Art.];
• Severe arrhythmia (eg, medically uncontrolled supraventricular tachycardia, atrial fibrillation with rapid ventricular response, paroxysmal ventricular tachycardia);
• unstable angina;
• an increase in the activity of creatine phosphokinase (in comparison with the upper limit of the norm - more than 3 times);
• chronic heart failure (left ventricular ejection fraction <30% or according to NYHA classification - III and IV functional classes);
• uncontrolled dysfunction of the thyroid gland (change in the level of thyroid-stimulating hormone> 1.5 times higher and lower than normal).

Currently, the available clinical data on patients with these disorders / pathologies are limited. The decision to use Repata in such cases should be based on an individual assessment of the intended therapeutic benefit with potential risks.

Repata, instructions for use: method and dosage

Repat's solution is administered s / c. Before starting its use, the patient should switch to an appropriate cholesterol-lowering diet and observe it throughout the course of treatment.

Recommended dosage regimen:

• mixed dyslipidemia and primary hyperlipidemia: adults - 1 s.c. injection of 140 mg of the drug every 14 days or 420 mg once a month. These doses are clinically equivalent. One PZSHR or one PZSh contains 1 dose (140 mg) for a dosage regimen of 1 time per 14 days. In order to deliver a dose of 420 mg with a dosing regimen once a month for half an hour, three PZShR or three PZSh are sequentially administered;
• ГоСГХС: children over 12 years old and adults - 1 s / c injection of 420 mg of the drug once every 14 days or once a month. For patients receiving apheresis, Repata can be administered every 14 days in accordance with the apheresis schedule. In order to deliver a dose of 420 mg with a dosage regimen of 1 time per 14 days or 1 time per month, three PZSHR or three PZSh are injected sequentially for half an hour.

Correction of the Repaty dosage regimen for patients with impaired renal function, elderly patients, as well as against a background of mild / moderate liver dysfunction (according to the Child-Pugh classification - class A and B, no more than 9 points) is not required. Patients with severe liver dysfunctions (according to the Child-Pugh classification - class C) were not included in clinical studies.

The safety and efficacy of using Repata in children with mixed dyslipidemia and primary hyperlipidemia has not been studied. 14 adolescents aged 12 years and older were included in the GOSHHS studies. There were no differences in the safety and efficacy of the solution in these adolescents compared with adults.

Before injecting the solution, it is important to check it for discoloration or inclusions. If the liquid has become cloudy or discolored, contains cloudy or colored inclusions, it cannot be used. Do not shake the medicine.

In order to avoid discomfort at the injection site, it is necessary to warm the solution to 25 ° C (room temperature) before performing it, and then slowly introduce the entire contents of the PZShR / PZSh. Then PZSh / PZShR with liquid residues should be thrown away. Any amounts of unused solution or materials must be disposed of according to local regulations.

Recommendations for self-administered SC administration of Repat solution

In order to protect against light exposure, PZShR and PZSh should be stored in their original packaging in a refrigerator at a temperature of 2 to 8 ° C.

It is recommended to inject on your own after a nurse, attending physician or pharmacist teaches the patient to inject the solution.

Inside the orange / gray cap PZShR / PZSh there is a protective cap for the needle, consisting of natural rubber obtained from latex. Therefore, it is important to inform your doctor if you are allergic to latex.

Repata should be kept out of the reach of children.

The drug should not be frozen, shaken, or removed from the orange / gray cap until the patient is ready for injection. It is forbidden to use PZShR / PZSh, which have been frozen, fallen on a hard surface (as their parts may be damaged) and after the expiration date.

If you have any questions, you should contact your doctor for advice.

Before the introduction of 1 PZShR, carefully removed from the package, and the remaining unused devices are placed back into the refrigerator. To remove 1 PZSh, open the package and take out the blister from it. The blister is placed in the hand, turned over and the syringe is removed by gently pressing in the middle. If it was not possible to get the PZSh, they carefully re-press the blister. Do not remove the syringe from the packaging by the gray protective cap or piston rod, as this may damage it. It is important to always hold the device by the cylinder.

Within half an hour (at least), the drug is warmed to room temperature so that the injection is safe. Do not use any heat source for this purpose, including microwave oven, hot water or direct sunlight. It is also unacceptable to shake the solution and remove the orange / gray cap until the patient is ready to administer Repata.

After the solution is warmed up, the PZShR / PZSh are inspected: check the expiration date of their expiration date and make sure that the liquid visible in the window is colorless or slightly yellow, transparent. The name of the medicinal product - REPATA - should be indicated on the PZH label.

The pen / syringe should not be used if the expiration date has passed, the orange / gray cap is loose or missing, the device has been dropped, any part of it appears broken or damaged, the solution becomes cloudy or discolored, or contains colored particles or flakes. In such cases, it is necessary to use a new device and consult a doctor.

When the PZShR / PZSh is ready for use, everything necessary for the injection is prepared. The patient should thoroughly wash his hands with soap and place on a well-lit, clean surface 1 device, alcohol wipes, a gauze pad or cotton swab, a patch and a container for disposing of pricks.

The injection site must be prepared and disinfected with an alcohol wipe, and the skin must be allowed to dry. Repatha can be injected into the thigh, abdomen (with the exception of the five centimeter area around the navel) and the outer surface of the upper arm (if someone is helping the patient to give the injection). The injection site of evolocumab should not be touched. Each time it should fall on a different site. If the injection is to be given to the same site, it is important to ensure that the drug is injected at a different site.

Areas of skin with redness, inflammation, bruising or induration cannot be used for Repatha. It is recommended to avoid areas with stretch marks or scars.

Immediately before administration, the orange / gray cap is removed from the PZShR / PZSh and immediately placed in a sharps container. The presence of a drop of liquid on the tip of the needle, and for a pen and on the yellow protective device, is considered normal. It is forbidden to bend, unscrew or twist the cap, put it back in place after removal. Do not touch the yellow protective device on the orange cap with your fingers.

If any air space / air bubbles are found in the syringe, hold it with the needle up and gently click the barrel until the air moves to the top of the syringe. Then, by pressing on the piston rod, air is gently and slowly released. It is important not to allow the solution to pour out and not to touch the syringe needle with your hands.

In order to create a solid surface, the selected site for administration of the drug by means of the PZSR is stretched with fingers and clamped, creating an area of 5 cm; through PZSh - only clamp. It should be borne in mind that during the introduction of Repata from a syringe pen, the skin should be kept stretched or compressed, and from the syringe - compressed.

PZShR without an orange cap is applied to the skin perpendicularly (at an angle of 90 degrees) and the syringe is pressed firmly into the skin until it stops moving. When the patient is ready for the injection (not earlier), he presses the gray start button. After a click is heard, he continues to press the pen into the skin, and then removes it. The entire injection can take 15 seconds.

PZSh is inserted into the skin at an angle of 45–90 degrees, while pressing the piston rod is prohibited. Then continuously and slowly push the piston rod until the syringe is empty. At the end of the injection, the finger is removed from the rod and the syringe is carefully removed from the skin.

After removing the PZShR, the needle will close automatically. The orange / gray cap and the used device are discarded in a sharps container. The patient should be informed by the attending physician about the correct disposal of the drug.

It is important to keep the device and the piercing container out of the reach of children. Do not reuse the pen / syringe, put back the orange / gray cap, touch the yellow protective device PZShR and dispose of the drug in household waste.

In cases of the appearance of blood, the injection site is pressed with a cotton swab or gauze cloth, if necessary, sealed with a plaster. Do not rub the injection site.

Side effects

Against the background of Repata therapy in recommended doses in registration studies, the development of nasopharyngitis (7.4%), upper respiratory tract infections (4.6%), back pain (4.4%), arthralgia (3.9%) was most often noted., influenza (3.2%) and reactions at the injection site (2.2%). The safety profile in the population of patients with GOSHC was consistent with that demonstrated in the groups with mixed dyslipidemia and primary hypercholesterolemia.

Possible adverse reactions [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01%, including isolated messages - very rare]:

• infectious and parasitic diseases: often - nasopharyngitis, influenza, upper respiratory tract infections;
• immune system: often - skin rash; infrequently - urticaria;
• gastrointestinal tract: often - nausea;
• musculoskeletal system and connective tissue: often - arthralgia, back pain;
• general disorders and disorders at the injection site of the solution: often - reactions at the injection site (edema, pain, bleeding, erythema, hematoma).

There is limited experience with evolocumab in children. 14 patients with GOSHC, aged 12 to 18 years, took part in ongoing clinical trials. There were no differences in the safety of Repata between adolescents and adults with GOSGHS. The efficacy and safety of the drug in children with mixed dyslipidemia and primary hypercholesterolemia have not been established.

In double-blind clinical trials, 7656 (41.3%) patients out of 18,546 participants were over 65 years old, and 1500 (8.1%) were over 75 years old. There were no differences in efficacy or safety between them and younger patients.

In 48 (0.3%) of 17,992 patients who used at least 1 dose of Repata, binding antibodies were detected in clinical studies. None of them showed neutralizing antibodies. Patients whose serum tested positive for the presence of binding antibodies underwent additional testing for the presence of neutralizing antibodies to the drug. The safety, clinical response and pharmacokinetic parameters of evolocumab were independent of the presence of antibodies to it.

Overdose

In conducted studies on animals with an exposure dose of evolocumab 300 times exceeding 420 mg once a month, prescribed to patients, intoxication and the development of side effects were not observed.

There is no specific treatment. In the event of a potential overdose, symptomatic therapy is recommended, including supportive treatment (if necessary).

special instructions

Before using Repata, the probable secondary causes of mixed dyslipidemia or hyperlipidemia (for example, nephrotic syndrome, hypothyroidism or diabetes mellitus) should be assessed and measures should be taken to adequately control the associated pathologies.

Against the background of moderate hepatic impairment, a decrease in exposure to evolocumab was noted, which probably could be the reason for a decrease in the effect on LDL cholesterol.

Patients with the following diseases / disorders were not included in Repaty's clinical studies:

• severe hepatic impairment (according to the Child-Pugh classification - class C);
• activity of creatine phosphokinase, exceeding 3 times the upper limit of the norm. However, clinical studies have not found safety signals in the form of increased creatine phosphokinase activity or muscle side effects;
• uncontrolled dysfunction of the thyroid gland (thyroid-stimulating hormone more than 1.5 times higher and lower than the norm) until adequate control of the pathology is achieved. During the studies, the side effects of hyper- or hypothyroidism were reported with approximately the same frequency among all treatment groups - less than 0.3%;
• unstable angina. long-term data on the safety of evolocumab administration from open-ended studies showed that the likelihood of major cardiovascular events and hospitalizations for unstable angina and heart failure did not increase;
• severe heart rhythm disturbances. A separate assessment of cardiac side effects showed that reports of their occurrence were rare, and the frequency of new abnormalities in electrocardiograms was comparable between the evolocumab and control groups. Similar results were obtained in a separate analysis of adverse reactions potentially associated with increased repolarization. The analysis did not reveal any effect of the drug on the QT / QTc interval;
• uncontrolled arterial hypertension (systolic blood pressure> 180 mm Hg. or diastolic blood pressure> 110 mm Hg at rest). Analysis of the mean changes from baseline values of systolic and diastolic blood pressure did not reveal any significant differences in the groups of evolocumab or control groups;
• chronic heart failure (NYHA classification - III and IV functional class). During clinical studies, the frequency of mentions of the development of chronic heart failure, adverse events of heart failure was approximately the same among all treatment groups and was less than 0.3%. Long-term safety data from open-phase studies showed that the likelihood of major cardiovascular events and hospitalizations for unstable angina pectoris and heart failure did not increase;
• type 1 diabetes mellitus or decompensated type 2 diabetes mellitus (HbA1c> 8.5%). A separate assessment of adverse reactions showed that changes in fasting glucose and glycosylated hemoglobin parameters were comparable in all study groups. No clinically significant differences were found in the safety analysis in the subgroup of patients with type 2 diabetes mellitus.

In cases of the combined use of Repata with other lipid-lowering drugs (for example, statins, ezetimibe), it is important to take into account the existing contraindications and special instructions given in the instructions for using these drugs.

Since the cap for the PZSh and PZShR needle consists of natural rubber obtained from latex, it is important for the patient to inform the attending physician about the presence of a latex allergy, if any.

Application during pregnancy and lactation

Data on drug use during pregnancy are limited. No direct / indirect interactions in the form of reproductive toxicity have been reported in animal studies. Repata for pregnant women can be prescribed only in cases where the predicted therapeutic benefit to the mother significantly outweighs the potential risks to the fetus.

It has not been established whether evolocumab has the ability to pass into breast milk. Potential risks to newborn / breastfed infants cannot be ruled out. The decision to discontinue therapy or discontinue lactation should be based on an assessment of the possible benefits of continuing treatment for the mother with the perceived risk of adversely affecting the newborn.

There are no data on the effect of evolocumab on human fertility. Conducted animal studies did not reveal any effects on fertility endpoints with AUC values significantly higher than those in patients using Repatu at a dose of 420 mg once a month.

Pediatric use

With mixed dyslipidemia and primary hypercholesterolemia, the use of Repata is contraindicated in patients under the age of 18; with GOSHHS - under 12 years old, since the effectiveness and safety of its use in patients of these age groups has not been established

With impaired renal function

In severe renal failure, Repatu is prescribed with caution.

For violations of liver function

Repata is used with caution in patients with severe hepatic impairment (class C according to the Child-Pugh classification).

Drug interactions

The interaction of evolocumab with other drugs has not been studied. The pharmacological interaction between it and statins has been evaluated in clinical research programs. When using the combination, there was an approximately 20% increase in substance clearance. The increased clearance is due to an increase in the concentration of PCSK9 mediated by statins, which did not affect the pharmacodynamic effect of evolocumab in relation to lipids. In cases where the combination is used, statin doses are not adjusted.

No studies have been conducted on the pharmacokinetic and pharmacodynamic interactions between Repata and hypolipidemic agents other than statins and ezetimibe.

Due to the lack of compatibility studies, the drug should not be mixed with other drugs.

Analogs

The analogues of Repaty are Tulip, Torvakard, Liprimar, Atoris.

Terms and conditions of storage

Store in a place protected from light and moisture, at temperatures up to 8 ° C, do not shake. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Repat

According to reviews, Repata is a safe and effective drug used in the treatment of mixed dyslipidemia, primary hyperlipidemia and GoSGHS.

Price for Repatu in pharmacies

The approximate price for Repatu (in a package 1 syringe pen containing 1 ml of solution) is 14,500 rubles.

Repata: prices in online pharmacies

Drug name Price Pharmacy

Repata 140 mg / ml solution for subcutaneous administration 1 ml 1 pc. RUB 14,289 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!