Table of contents:
- Release form and composition
- Pharmacological properties
- Indications for use
- Mimpara, instructions for use: method and dosage
- Side effects
- special instructions
- Application during pregnancy and lactation
- Pediatric use
- With impaired renal function
- For violations of liver function
- Use in the elderly
- Drug interactions
- Terms and conditions of storage
- Terms of dispensing from pharmacies
- Reviews about Mimpar
- Price for Mimpara in pharmacies
- Mimpara: prices in online pharmacies
Video: Mimpara - Instructions For Use, Price, Tablet Analogs, Reviews
2023 Author: Rachel Wainwright | [email protected]. Last modified: 2023-11-26 05:19
Mimpara: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Mimpara
ATX code: H05BX01
Active ingredient: cinacalcet (Cinacalcet)
Manufacturer: Pateon Inc. (Patheon Inc.) (Canada); Amgen Manufacturing Limited (Puerto Rico); DOBROLEK LLC (Russia); Amgen Europe, B. V. (Amgen Europe, BV) (Netherlands)
Description and photo update: 09.10.2019
Prices in pharmacies: from 6500 rubles.
Mimpara is an antiparathyroid drug.
Release form and composition
Dosage form of the drug - film-coated tablets: oval, light green shell, on one side there is a marking "AMG", on the other side the numbers corresponding to the dosage of tablets - "30", "60" or "90" 14 pcs. in blisters made of fluoropolymer film Aclar (Aklar) / polyvinyl chloride (PVC) / polyvinyl acetate (PVA) and aluminum foil, on which a protective color strip is applied with thermal ink; in a carton box, equipped with two transparent protective labels for the first opening control with a longitudinal colored stripe, there are 1, 2 or 6 blisters and instructions for use of Mimpara].
Composition for 1 film-coated tablet:
- active substance: cinacalcet hydrochloride - 33.06 / 66.12 / 99.18 mg (in terms of cinacalcet - 30/60/90 mg);
- auxiliary components: pregelatinized corn starch - 12.02 / 24.04 / 36.06 mg; MCC (microcrystalline cellulose) - 121.82 / 243.64 / 365.46 mg; povidone - 3.68 / 7.36 / 11.04 mg; crospovidone - 7.62 / 15.24 / 22.86 mg; colloidal silicon dioxide - 0.9 / 1.8 / 2.7 mg; magnesium stearate - 0.9 / 1.8 / 2.7 mg; carnauba wax - 0.018 / 0.036 / 0.054 mg;
- film shell: Opadrai II green (iron oxide yellow - 1.84%; aluminum varnish indigo carmine - 2.78%; triacetin - 8%; titanium dioxide - 19.38%; hypromellose 15cP - 28%; lactose monohydrate - 40%) - 7.2 / 14.4 / 21.6 mg; Opadry transparent (macrogol-400 - 9.1%; hypromellose 6cP - 90.9%) - 2.7 / 5.4 / 8.1 mg.
The active substance in Mimpara, cinacalcet, has a calcium mimetic effect, directly reducing the level of parathyroid hormone (PTH).
Calcium-sensitive receptors located on the surface of the main cells of the parathyroid glands are the main regulators of PTH secretion. Cinacalcet increases the sensitivity of these receptors to extracellular calcium, a decrease in PTH levels is accompanied by a decrease in serum calcium concentration.
The level of PTH correlates with the content of cinacalcet and soon after taking Mimpara begins to decrease, reaching a minimum value 2-6 hours after taking a dose, which corresponds to reaching the maximum concentration (C max) of cinacalcet. After that, within 12 hours from the moment of taking the drug, the concentration of PTH begins to increase as the content of cinacalcet decreases. Then the suppression of PTH remains at approximately the same level until the end of the daily interval, provided that the drug is taken once a day. In clinical studies of Mimpara, PTH concentration was measured at the end of the dosing interval.
The serum calcium concentration after reaching the stable phase remains at a constant level all the time between doses of Mimpara.
Secondary hyperparathyroidism (HPT)
Three double-blind, placebo-controlled clinical studies were conducted to study the pharmacological properties of cinacalcet in the treatment of HDPT, each lasting six months. They included 1136 patients with an uncontrolled form of IHPT with end-stage renal failure who were on dialysis.
At the start of the three studies, the mean intact PTH (iPTH) concentrations in the cinacalcet and placebo groups were 733 and 683 pg / ml (77.8 and 72.4 pmol / L), respectively. At the same time, 66% of patients took vitamin D before inclusion in the study, and phosphate-binding drugs - more than 90%.
In the group of patients taking cinacalcet, there was a significant decrease in the concentration of iPTH, calcium-phosphorus product (Ca × P), and serum calcium and phosphorus, compared with the placebo group, in which patients received standard treatment. Decreased levels of iPTH and Ca × P were maintained throughout the 12 months of treatment. Cinacalcet contributed to their reduction, decreased serum calcium and phosphorus, regardless of the initial concentrations of IPTH or Ca × P, the prescribed dialysis regimen (peritoneal versus hemodialysis), the duration of the procedure, and whether or not vitamin D was used.
The decrease in PTH concentration was associated with a clinically insignificant decrease in the levels of such markers of bone metabolism as specific bone alkaline phosphatase (ALP), N-telopeptides, bone renewal, and bone fibrosis. According to the results of a retrospective analysis, collected using the Kaplan-Meier method based on the results of 6 and 12-month clinical studies of the data pool, the rates of bone fractures and parathyroidectomies in the cinacalcet group were lower than in the control group.
In preliminary studies of a group of patients with chronic kidney disease (CKD) and IHPT who are not on dialysis, it was found that cinacalcet decreased the concentration of PTH in the same way as in patients with end-stage renal disease (ESRD) and IHPT on dialysis … However, for patients with renal failure in the pre-dialysis stage, the goals of therapy, its safety and efficacy, as well as the optimal dosages have not been established. In addition, these studies have shown that in CKD patients who are not on dialysis and taking cinacalcet, the risk of developing hypocalcemia is greater than in end-stage renal disease in dialysis patients receiving cinacalcet. This may be due to lower initial calcium levels and / or residual renal function.
Parathyroid carcinoma and primary hyperparathyroidism (PHP)
In the course of the main study, 46 patients (29 people with a diagnosis of parathyroid carcinoma, 17 people with PPH, in whom parathyroidectomy is contraindicated / did not give results) took cinacalcet for a long time, up to 3 years (on average, with parathyroid carcinoma - 328 days and GWP - 347 days).
To achieve the main goal of reducing the serum calcium concentration in the blood by ≥ 1 mg / dL (≥ 0.25 mmol / L), a dosage regimen was used from 30 mg 2 times a day to 90 mg 4 times a day. In patients with carcinoma of the parathyroid glands, the average calcium level decreased from 14.1 mg / dL to 12.4 mg / dL (3.5-3.1 mmol / L), while in patients with PHP this indicator decreased from 12.7 mg / dl to 10.4 mg / dl (3.2-2.6 mmol / l). In 62% of patients (18 out of 29) with parathyroid carcinoma and 88% (15 out of 17) with PHP, a decrease in serum calcium concentration of at least 1 mg / dL (≥ 0.25 mmol / L) was achieved.
The main pharmacokinetic characteristics of cinacalcet are:
- absorption: the maximum plasma concentration (C max) after oral administration is achieved after 2-6 hours. The absolute bioavailability due to the use of the drug on an empty stomach, determined based on a comparison of the results of a number of studies, was ~ 20-25%. Taking Mimpara with food increases the bioavailability of cinacalcet by ~ 50–80%, regardless of the fat content in the diet. The increase in the area under the concentration-time curve (AUC) and C max occurs almost linearly, provided that the drug is taken once a day in the dose range of 30–180 mg. High daily doses (more than 200 mg) provide absorption saturation, most likely due to the poor solubility of the substance. Over time, the pharmacokinetic parameters of cinacalcet do not change;
- distribution: steady-state blood concentration (C ss) is achieved within seven days with minimal cumulation. There is a large volume of distribution (V d) - about 1000 liters, which indicates a wide distribution in tissues and organs. Approximately 97% of the substance binds to plasma proteins and is distributed at a minimum level in erythrocytes;
- metabolism: occurs mainly with the participation of cytochrome isoenzymes CYP3A4 and CYP1A2 (the role of CYP1A2 has not been confirmed by clinical methods). The main metabolites found in the blood are inactive. According to in vitro studies, cinacalcet is a potent inhibitor of CYP2D6, but at concentrations that were achieved in a clinical setting, it did not inhibit the activity of other cytochrome isoenzymes, such as CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and did not induce CYP2C192 isoenzymes, CYP3A4. Cinacalcet, labeled with a radioisotope method, after administration to healthy volunteers at a dose of 75 mg, underwent rapid and significant oxidation, followed by conjugation;
- excretion: a decrease in the concentration of cinacalcet occurs in 2 stages: the initial one with a half-life (T 1/2) of ~ 6 hours and the final, T 1/2 of which is from 30 to 40 hours. Metabolites are predominantly excreted through the urinary system - up to 80% of the dose, up to 15% is found in feces.
Pharmacokinetic features in patients of various groups:
- advanced age: there were no clinically significant age-related differences in drug therapy;
- renal failure mild, moderate and severe; patients on hemodialysis / peritoneal dialysis: the pharmacokinetic profile of cinacalcet is comparable to that of healthy volunteers;
- liver failure: mild - does not significantly affect the pharmacokinetics of cinacalcet. Moderate and severe (in comparison with the group with normal liver function) - the average AUC values, respectively, are approximately 2 and 4 times higher; the average T 1/2 increases by 33% and 70%, respectively. Dysfunctions of the liver do not affect the degree of binding of a substance with plasma proteins. Due to the fact that for each patient the selection of doses is carried out on the basis of individual parameters of efficacy and safety, in case of liver failure, additional dose adjustment is not required;
- gender: women may have lower clearance of cinacalcet than men. Individual selection of doses does not require additional correction of the dosage regimen depending on the gender of the patient;
- pediatric patients: in children and adolescents under the age of 18, the pharmacokinetics of cinacalcet have not been studied;
- nicotine dependence: in smoking patients, the clearance of cinacalcet is higher than in nonsmokers, which may be associated with the induction of metabolism mediated by CYP1A2. When a patient quits / starts smoking during therapy, changes in the plasma concentration of cinacalcet may require dose adjustment.
Indications for use
- VHPT in patients with end-stage renal failure on dialysis - including as part of a combination treatment that includes drugs that bind phosphate and / or vitamin D;
- carcinoma of the parathyroid glands and PGP in patients for whom parathyroidectomy is contraindicated / ineffective - in order to reduce the severity of hypercalcemia.
- children and adolescents up to 18 years old;
- hereditary galactose intolerance, Lapp lactase deficiency, glucose / galactose malabsorption;
- Serum blood calcium concentration (adjusted for albumin) is less than the lower limit of the normal range;
- lactation period;
- hypersensitivity to cinacalcet and auxiliary components of the drug.
Relative contraindications (Mimpara tablets should be taken with caution): pregnancy; liver failure of moderate and severe severity; the presence of risk factors for lengthening the QT interval (diagnosed congenital syndrome of a long QT interval, taking medications that prolong the QT interval).
Mimpara, instructions for use: method and dosage
Mimpara tablets are intended for oral administration. They must be swallowed whole, without splitting or chewing, during meals or shortly after meals.
Secondary hyperparathyroidism (HPT)
For adults and elderly patients over 65, it is recommended to start taking Mimpara with a daily dose of 30 mg, the tablet should be taken once a day. Dose titration should be performed once every 2–4 weeks, until the maximum daily dose is reached - 180 mg, taken once a day. It should provide patients on dialysis with a target PTH concentration of 150 to 300 pg / ml (15.9–31.8 pmol / L), calculated from the concentration of iPTH. Determination of PTH concentration is carried out no earlier than 12 hours after taking Mimpara. Its assessment is carried out taking into account modern recommendations.
During therapy, PTH is determined 1–4 weeks after the start of the course or dose adjustment. Monitoring the level of PTH when taking a maintenance dose is performed once every 1–3 months. The concentration of PTH is allowed to be determined by the content of iPTG or biPTG (biointact PTH); taking Mimpara does not change the ratio between iPTG and biPTG.
During the dose titration period, frequent monitoring of serum calcium concentration is necessary, starting from 1 week after the start of the course or dose adjustment of Mimpara. Upon reaching the target concentration of PTH, the patient is transferred to a maintenance dose, and the level of calcium in the blood serum is assessed once a month. When the serum calcium concentration in the blood falls below the normal range, appropriate measures should be taken, including correction of concomitant treatment.
Parathyroid carcinoma and primary hyperparathyroidism (PHP)
For adults and elderly patients over 65, it is recommended to start taking Mimpara with a dose of 30 mg twice a day. Dose titration should be performed once every 2–4 weeks, increasing the dose as follows: twice a day, 30 mg; twice a day, 60 mg; twice a day, 90 mg; three to four times a day, 90 mg (as needed, to reduce serum calcium levels to the upper limit of the normal range or below). In clinical trials, the drug was used at a dose of 90 mg four times a day (maximum daily dose is 360 mg). Serum calcium concentration is determined 1 week after the start of the course and after each step of dose adjustment.
Upon reaching the target PTH concentration, the patient is transferred to a maintenance dose, and the serum calcium level is assessed at intervals of once every 2-3 months. At the end of the titration period to the maximum dose, serum calcium concentration is monitored periodically.
If it is impossible to achieve a clinically significant decrease in serum calcium concentration when using a maintenance dose, the question of completing drug therapy is raised.
According to the available data from placebo-controlled studies and uncontrolled studies, in patients who received cinacalcet for the treatment of HPT, parathyroid carcinoma and PGP, the most common adverse reactions were nausea and vomiting (mainly mild / moderate and transient). These reactions were also the most common reasons for discontinuation of therapy.
The list of unwanted side effects from systems and organs, which in placebo-controlled studies and uncontrolled studies, when analyzing causal relationships based on convincing evidence, were regarded as at least as possibly associated with the use of cinacalcet (very often - more than 1/10; often - more than 1/100 and less than 1/10; infrequently - more than 1/1000 and less than 1/100; rarely - more than 1/10 000 and less than 1/1000; very rarely - less than 1/10 000; frequency unknown - available data are not allow you to accurately assess the incidence of side effects):
- immune system: often - hypersensitivity reactions;
- metabolism and food intake: often - anorexia, decreased appetite;
- nervous system: often - convulsions, paresthesias, dizziness, headache;
- cardiovascular system: often - hypotension; frequency unknown - lengthening of the QT interval, ventricular arrhythmias as a result of hypocalcemia, worsening of the course of heart failure;
- respiratory system, chest and mediastinal organs: often - shortness of breath, upper respiratory tract infections, cough;
- gastrointestinal tract: very often - nausea / vomiting; often - abdominal pain, dyspepsia, diarrhea, pain in the upper abdomen, constipation;
- skin and subcutaneous tissue: often - rash;
- skeletal muscles and connective tissues: often - muscle spasm, myalgia, back pain;
- general disorders, reactions to taking Mimpara: often - asthenia;
- laboratory indicators: often - hypokalemia, hypocalcemia, decreased testosterone levels.
For patients on dialysis, doses titrated up to 300 mg, provided that they are taken once a day, are safe.
Hypocalcemia may become a symptom of an overdose of cinacalcet; if an overdose is suspected, it is necessary to control the calcium concentration for its timely detection.
Treatment: symptomatic and supportive. Hemodialysis is ineffective because cinacalcet has a high degree of binding to plasma proteins.
As a result of the use of Mimpara in routine practice, allergic reactions such as angioedema and urticaria were observed. But on the basis of the available data, it is impossible to estimate the frequency of their development.
In case of heart failure in patients taking cinacalcet, according to post-marketing observations, isolated idiosyncratic cases of a decrease in blood pressure by more than 20% from the initial one were recorded, with or without worsening of the course of heart failure. The relationship with the intake of Mimpara in these episodes cannot be completely excluded, since arterial hypotension may be a consequence of a decrease in serum calcium levels in the blood. According to clinical studies, in the group receiving cinacalcet, hypotension occurred in 7% of cases, in the placebo group - in 12%; heart failure was observed in both groups in 2% of patients.
Seizures in clinical studies were observed in patients receiving Mimpara in 1.4% of cases, and in the placebo group - in 0.4%. The reasons for such differences in the onset of seizures are poorly understood, but it is known that the seizure threshold decreases with a significant decrease in serum calcium concentration.
If serum calcium concentrations (corrected for albumin) are below the minimum normal range, cinacalcet should not be taken.
There have been observed life-threatening phenomena and deaths associated with hypocalcemia caused by taking Mimpara, including in children. Symptoms of hypocalcemia can be expressed by paresthesia, myalgia, spasms, tetany, and the development of seizures. In addition, a decrease in serum calcium levels contributes to a prolongation of the QT interval, as a result of which ventricular arrhythmias may develop. In routine practice, with hypocalcemia after the use of Mimpara, lengthening of the QT interval and ventricular arrhythmias were observed in some patients. It is impossible to estimate the incidence of such disorders based on the available data. Patients with other risk factors for prolonged QT interval, for example, those with a diagnosis of congenital long QT interval syndrome or taking medications that prolong the QT interval,should be careful while taking the drug.
Since cinacalcet helps to reduce the concentration of calcium in the blood serum, careful monitoring is required for the appearance and development of hypocalcemia. Serum calcium levels are checked within 1 week from the start of therapy or dose adjustment of Mimpara. Once the maintenance dose has been determined, this check is done about once a month. In the case of a decrease in serum calcium in the range of 7.5-8.4 mg / dL (1.875-2.1 mmol / L) or if symptoms of hypocalcemia develop, phosphate-binding calcium-containing drugs, vitamin D and / or Correct dialysate calcium with phosphate binders. But if it is not possible to eliminate hypocalcemia, it is necessary to reduce the dose or cancel the reception of Mimpara. Patients with serum calcium levels less than 7.5 mg / dL (1,875 mmol / L), with preserved symptoms of hypocalcemia, if it is impossible to increase the dose of vitamin D, therapy is suspended until the level of calcium in the blood serum reaches 8 mg / dL (2 mmol / L) and / or until the symptoms of hypocalcemia pass. In the future, treatment is resumed using the next lowest dose of Mimpara.
During the clinical study EVOLVE (Evaluation Of Cinacalcet Therapy to Lower CardioVascular Events - a study of the use of cinacalcet to reduce the incidence of cardiovascular complications) in patients with CKD who are on dialysis and who took Mimpara, the concentration of calcium in the blood serum fell below 7.5 mg / dL (1.875 mmol / L) at least once in 29% of patients from registration observations lasting 6 months and in 21% and 33%, respectively, during the first 6 months and in general.
In patients with chronic suppression of the PTH level below ~ 1.5 of VGN (upper limit of normal), according to the results of the analysis of iPTH, the development of adynamic bone disease is possible. If the PTH content decreases below the recommended range, the dose of Mimpara and / or vitamin D should be reduced or therapy should be discontinued.
In the EVOLVE study of 3883 dialysis patients, neoplasms were reported in the Mimpara and placebo groups, respectively, in 2.9 and 2.5 study participants per 100 patient-years. At the same time, it was not possible to establish a direct causal relationship with the use of the drug.
With ESRD, testosterone concentrations in patients often fall below normal. Thus, according to a clinical study of dialysis patients with ESRD, a decrease in the concentration of free testosterone after 6 months from the start of therapy in the group taking Mimpara was on average in 31.3% of patients, in the placebo group - in 16.3%. A further decrease in the concentration of total and free testosterone in the open extended phase of this study over the 3-year period of taking Mimpara was not revealed. The clinical significance of a decrease in serum testosterone levels has not been established.
Mimpara tablets contain lactose as an auxiliary component, depending on the dosage, the lactose content is: 1 tablet 30 mg - 2.74 mg of lactose; 1 tablet 60 mg - 5.47 mg lactose; 1 tablet 90 mg - 8.21 mg lactose. The use of Mimpara is contraindicated in patients with rare hereditary diseases - congenital glucose intolerance, Lapp lactase deficiency, impaired absorption of glucose-galactose.
Influence on the ability to drive vehicles and complex mechanisms
The effect of cinacalcet on the patient's cognitive function has not been studied. But you should take into account some undesirable side reactions that are possible when taking Mimpara, which can negatively affect the speed of psychomotor reactions and the ability to concentrate.
Application during pregnancy and lactation
There are no data from clinical studies of the use of cinacalcet in pregnant women. In preclinical studies in rabbits, it was found that the substance penetrates the hematoplacental barrier. Experiments on animals did not reveal a direct negative effect on the course of pregnancy, labor, or postnatal development of pups. Embryotoxic and teratogenic effects on the fetus were also not detected during experiments on pregnant female rats and rabbits, with the exception of a decrease in the weight of rat embryos when toxic doses of the drug were used in pregnant females. During pregnancy, Mimparu is recommended to be used only if necessary, when the potential benefit to the mother significantly outweighs the possible risks to the fetus / newborn.
To date, the possibility of penetration of cinacalcet into human breast milk has not been studied. It is known that the substance is excreted in the breast milk of lactating rats, while there is a high ratio of its concentration in milk and plasma. After a careful assessment of the need for therapy for the mother and the risks to the health of the baby, breastfeeding should be discontinued or Mimpara should be discontinued.
There are no data from clinical studies that would indicate the effect of cinacalcet on human fertility. In the course of experiments carried out on animals, such an effect was also not detected.
It is contraindicated to use Mimpara in pediatrics, since there is insufficient data on the effectiveness and safety of its use for the treatment of children and adolescents. In a clinical study, a fatal case was reported in a pediatric patient with severe hypocalcemia.
With impaired renal function
It is contraindicated to take Mimpara in patients diagnosed with CKD who are not on dialysis. Preliminary studies have shown that they have an increased risk of developing hypocalcemia with serum calcium concentrations less than 8.4 mg / dL (2.1 mmol / L) compared to patients on dialysis. This may be due to a lower initial calcium level and / or the presence of residual renal function.
For violations of liver function
The level of cinacalcet in the blood plasma of patients with moderate and severe hepatic insufficiency according to the Child-Pugh classification can be 2–4 times higher than normal values. In this case, Mimpara should be taken with caution, ensuring careful monitoring of the concentration of the substance during dose titration and while continuing therapy.
Adjustment of the initial dose in patients with hepatic impairment is not required.
Use in the elderly
There were no clinically significant differences in the pharmacokinetics of cinacalcet associated with elderly patients.
The effect of other drugs on the pharmacokinetics of cinacalcet:
- potent inhibitors (voriconazole, itraconazole, ketoconazole, telithromycin, ritonavir) or inducers (rifampicin) of the cytochrome CYP3A4 isoenzyme: since cinacalcet is partially metabolized by this enzyme, their combined use may require a dose adjustment of Mimpara. So the simultaneous intake of a powerful inhibitor of CYP3A4 - ketoconazole 200 mg 2 times a day leads to an increase in the concentration of cinacalcet ~ 2 times;
- inhibitors of the cytochrome CYP1A2 isoenzyme (ciprofloxacin, fluvoxamine): their effect on plasma concentrations of cinacalcet has not been studied, but the beginning or discontinuation of concomitant use of potent CYP1A2 inhibitors with Mimpara may require correction of the dosage regimen;
- smoking (stimulant of CYP1A2 activity): in smokers, the clearance of cinacalcet is 36-38% higher than in nonsmokers, and therefore dose adjustment may be required if the patient starts or quits smoking during Mimpara therapy;
- calcium carbonate (single use at a dose of 1500 mg): the pharmacokinetics of cinacalcet does not change;
- sevelamer (2400 mg 3 times a day): does not affect the pharmacokinetics of cinacalcet;
- pantoprazole (80 mg once a day): does not alter the pharmacokinetics of cinacalcet.
The effect of cinacalcet on the pharmacokinetic characteristics of other drugs:
- drugs metabolized by the CYP2D6 isoenzyme with a narrow therapeutic range / variable pharmacokinetics (such as propafenone, nortriptyline, metoprolol, flecainide, desipramine, clomipramine): since cinacalcet is a potent inhibitor of CYP2D6, when used in combination with these drugs, they may need to be properly adjusted;
- desipramine (50 mg once a day): taking with cinacalcet at a dose of 90 mg once a day significantly (up to 3.6 times) increased the level of sensitivity to desipramine (90% confidence interval from 3 to 4.4) in active metabolizers CYP2D6;
- warfarin: after repeated oral administration of Mimpara, the pharmacokinetics and pharmacodynamics of warfarin did not change significantly (prothrombin time and the activity of blood clotting factor VII were measured). The absence of the effect of cinacalcet on the pharmacokinetics of R- and S-warfarin, as well as the absence of autoinduction of enzymes after repeated use of the drug, indicates that cinacalcet is not an inducer of CYP3A4, CYP2C9, CYP1A2 in humans;
- midazolam (substrate of CYP3A4 and CYP3A5) (orally at a dose of 2 mg): simultaneous use with cinacalcet at a dose of 90 mg does not change its pharmacokinetics, which indirectly indicates the absence of the effect of cinacalcet on the pharmacokinetics of drugs metabolized by CYP3A5A4 isoenzymes, for example, CYP3A5A4 isoenzymes and for example, including cyclosporine and tacrolimus.
The analogues of Mimpara are Rotocaltset, Parsabiv, Zemplar, Tsinakalset-Vista.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life - 4 years or 5 years (depending on the manufacturer).
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Mimpar
On specialized forums and sites, reviews about Mimpar are extremely rare. It is very difficult to draw conclusions on the safety and efficacy of an antiparathyroid drug based on their monitoring. One of the patients describes that after a month of Mimpara therapy, when taken in a dose of 30 mg once a day, his PTH level decreased from 1100 to 250 pg / ml. But he warns of the importance of controlling calcium levels in the body.
The disadvantages are the high cost of Mimpara.
Price for Mimpara in pharmacies
Estimated price of Mimpara, film-coated tablets, 30 mg, for 28 pcs. (2 blisters of 14 pcs. In a cardboard box) - 8,300-11,913 rubles.
Mimpara: prices in online pharmacies
Mimpara 30 mg film-coated tablets 28 pcs.
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!
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