The drug "Menopur": reviews and results, instructions for use and description. Instructions for use of Menopur and special instructions Menopur 75 instructions for use

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Installation

1 bottle of the drug contains follicle-stimulating hormone 75 IU and luteinizing hormone 75 IU.

Release form:

Lyophilisate for the preparation of solution for injection in a 2 ml bottle in a cardboard box; complete with solvent – sodium chloride solution 0.9% 1 ml. In this position, the drug is dispensed WITHOUT PACKAGING - 1 bottle with lyophilisate and 1 bottle with solvent.

Pharmachologic effect:

Menopur is a human menopausal gonadotropin (hMG) preparation, high degree cleaning. Belongs to the group of menothoropins, contains FSH and LH in a 1:1 ratio. The drug is obtained from the urine of postmenopausal women.

In women, the drug causes an increase in the level of estrogen in the blood and stimulates the growth and maturation of ovarian follicles and endometrial proliferation.

In men, the use of Menopur leads to an increase in the concentration of testosterone in the blood and stimulates spermatogenesis, affecting the Sertoli cells of the seminiferous tubules.

Indications for use:

For women:

infertility caused by hypothalamic-pituitary disorders (in order to stimulate the growth of one dominant follicle);
when carrying out assisted reproductive techniques for conception (stimulation of the growth of multiple follicles).

For men:

stimulation of spermatogenesis in azoospermia or oligoasthenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with therapy with human chorionic gonadotropin preparations, for example, Choragon).

Directions for use and dosage:

The drug is administered intramuscularly or subcutaneously. The injection solution is prepared immediately before administration using the supplied solvent.

For women:

For infertility caused by hypothalamic-pituitary disorders, in order to stimulate the growth of one dominant follicle.

The dosage regimen of the drug is determined individually. The optimal dose of the drug and duration of treatment are selected based on ultrasound of the ovaries, determination of the level of estrogen in the blood, as well as clinical observation. The maturation of the follicle is judged by the increase in the level of estrogen in the blood.

The initial dose of Menopur is 75-150 IU (1-2 bottles/day). If the ovaries do not respond, the dose is gradually increased until the level of estrogen in the blood increases or the follicles grow. The dose is left unchanged until the estrogen concentration reaches the preovulatory level. If estrogen levels rise rapidly at the beginning of stimulation, the dose of the drug should be reduced.

In order to induce ovulation, 5,000-10,000 IU of hCG is administered once 1-2 days after the last injection of Menopur.

For men:

To stimulate spermatogenesis, 1,000-3,000 IU of hCG is administered 3 times a week until testosterone levels in the blood normalize. Then, for several months, Menopur 75-150 IU (1-2 bottles) is administered 3 times a week.

Menopur contraindications:

diseases thyroid gland and adrenal glands;
tumors of the hypothalamic-pituitary region;
hyperprolactinemia;
persistent ovarian enlargement or cysts not associated with polycystic ovary syndrome;
developmental abnormalities of the genital organs or uterine fibroids incompatible with pregnancy;
vaginal bleeding unknown etiology;
cancer of the uterus, ovaries or mammary glands;
primary ovarian failure;
prostate cancer or other androgen-dependent tumors in men;
pregnancy;
lactation period;
hypersensitivity to menotropins (drugs containing LH and/or FSH) and other components of the drug.

Special instructions:

Before prescribing Menopur, it is recommended to carry out appropriate treatment in the presence of concomitant hypothyroidism, adrenal insufficiency, hyperprolactinemia, tumors of the hypothalamic-pituitary region, correction of hemoconcentration.

Before starting infertility treatment, the condition of the ovaries should be assessed (ultrasound and estradiol levels in the blood plasma). During the course of treatment, these studies should be carried out daily or every other day.

It should be taken into account that during the use of hMG drugs, the development of ovarian hyperstimulation is possible, which becomes clinically pronounced after the administration of hCG drugs for the purpose of ovulation and manifests itself in the formation of ovarian cysts big size. In this case, ascites and hydrothorax may occur, accompanied by oliguria, arterial hypotension and thromboembolic syndrome.

When the first signs of ovarian hyperstimulation appear (abdominal pain, palpable or ultrasound-detectable formations in the lower abdomen), treatment should be stopped immediately!

If ovarian hyperstimulation develops, hCG should not be administered for the purpose of ovulation.

When treated with hMG drugs, multiple pregnancies often develop.

In men with high levels of FSH in the blood (indicative of primary testicular failure), Menopur is usually ineffective.

Storage conditions:

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Menopur is a substance, a compound classified as a menotropin, with the active substance human menopausal gonadotropin, with a high degree of purification. It is used in the treatment of male and female infertility, which will be discussed further.

The active ingredient in Menopur is menotropin, containing follicle-stimulating and luteinizing hormones in a volume of 75 IU. Auxiliary connections - lactose and hydrochloric acid, sodium hydroxide. The solvent is 0.9% sodium chloride solution and diluted hydrochloric acid, water for injection.

Dosage form Menopura is a lyophilized powder used to prepare a solution for injection. The package contains a bottle of powder and solution for injection - 10 pcs each. everyone. The cost of a package of 10 ampoules varies from 11,076 rubles to 13,465 rubles, Moreover, in online pharmacies the cost will be slightly lower than in regular retail outlets. It is possible to buy ampoules individually, in this case the price of each 1 ampoule of Menopur 75 IU will be about 1800 rubles. The difference in price is obvious - buying packs of 10 ampoules is much more profitable.

There is also an ampoule Menopur-Multidose in a dosage of 200IU FSH + 1200IU LH - its price is from 22,900 to 28,900 rubles.

Pharmacological properties

The drug in women increases the level of the hormone estrogen in the body and stimulates the growth and development of follicles in the ovaries, plus the growth of the endometrium.
If the drug is prescribed to men, it increases the level of testosterone in the blood and stimulates the production of sperm, increasing their motility.

Indications for use

Regarding the indications for use of the drug, it is prescribed in the following cases:

female type of infertility caused by disorders in the hypothalamic-pituitary system.
to stimulate the growth and release of follicles in the reproductive sphere.
diagnosing azoospermia and oligoasthenospermia in men associated with hypogonadtropic hypodynamism.

But mostly this drug prescribed during the IVF procedure and in the course of infertility treatment, both in men and women, in order to increase the chances of fertilization.

Instructions for use

For women this drug to stimulate the growth and maturation of the dominant follicle — the dosage and duration of the course are determined by the doctor after an ultrasound and blood analysis. The initial dosage is 75 - 150 IU - this is 1-2 bottles per day; if there is no reaction from the ovaries, it is gradually increased.

In order to stimulate the process of egg maturation — 1-2 days after the first administration of the drug, the doctor administers the composition once in a volume of 5,000 to 10,000 IU.

To stimulate sperm production and development in men, from 1,000 to 3,000 IU are administered 3 times a week. This will help normalize the level of testosterone in the blood and after a week’s course it is worth administering the drug for 2-4 months, 75-100 IU.

Contraindications and side effects

Regarding existing contraindications, the drug is contraindicated during gestation and lactation, as well as in the following cases:

Diagnosis of hyperprolactinemia and diseases of the endocrine system.
In the case of the development of malignant oncology and a change in the size of the cyst or ovaries, not due to the course of polycystic disease.
During pregnancy and lactation.
Primary stage of ovarian hyperfunction.
For uterine types of bleeding and individual intolerance to the components of the drug.

Side effects of the drug appear in pain and bouts of vomiting. In addition, endocrine disorders are observed in the patient - enlargement of the ovaries in women and breast pain, breast enlargement, cyst formation.

Menopur can provoke allergic reactions - rashes all over the body and joint pain, anaphylactic shock and Quincke's edema develop, and body temperature rises. No less problematic is rapid weight gain and increased blood pressure.

Why is Menopur prescribed for IVF?

When carrying out IVF, stimulation of a woman’s reproductive system shows high therapeutic results - the main components of Menopur stimulate follicle growth and help improve the mucous membrane lining the uterus and activates the level of estrogen production in the body. It is often prescribed in combination with drugs containing hCG.

Before the very start of the IVF program, doctors recommend normalizing hormonal levels and therefore prescribe a combination of Menopur. Its dosage and duration of taking the drug depends on general condition patient, medical history - most often it is 75-150 IU. But reviews of the course completed are 98% positive.

Menopur: reviews and results

Today, the statistics are such that many women cannot conceive a child on their own naturally and therefore undergo the IVF procedure and thus increase their chances of becoming a mother. But this option will not give 100% results the first time - the procedure must be carried out several times and not every woman can pay for it many times, because it is not so cheap.

That is why doctors and pharmacists developed the hormonal stimulant Menopur - reviews from patients and doctors, positive results of therapy in 99 out of 100 cases are positive. The composition itself helps increase the chances of natural conception several times - it shows positive results after therapy. Feedback from patients is the most positive; the only thing that can be confusing in this case is the high chances of developing multiple pregnancy which may occur after using Menopur.

Of course, there are a considerable number of contraindications to the prescription of the composition, and therefore it is so important to take Menopur under strict supervision and according to a doctor’s indication, having undergone a course of diagnostics and examination. Taking this into account and with strict adherence to the dosage of the medicinal stimulant, side and unwanted manifestations will not be so terrible.

Real reviews from women about Menopur:

3.
, as well as HuMoG.

Taking into account a similar mechanism of action, doctors include Alterpur, Bravelle, as well as Pergoveris, Pregnil, as well as Ecostimulin, Elonva.

This video will tell you how to properly prepare and administer a multidose of Menopur 1200 IU:

Active substance

Release form

lyophilisate for preparing a solution for intramuscular administration

Owner/Registrar

International Classification of Diseases (ICD-10)

E23.0 Hypopituitarism N46 Male infertility N97 Female infertility Z31.1 Artificial insemination

Pharmacological group

Menopausal human gonadotropin preparation (FSH:LH=1:1)

pharmachologic effect

Menopur ® is a highly purified human menopausal gonadotropin (hMG) preparation. Belongs to the group of menothoropins, contains FSH and LH in a 1:1 ratio. The drug is obtained from the urine of postmenopausal women.

In women, the drug causes an increase in the level of estrogen in the blood and stimulates the growth and maturation of ovarian follicles and endometrial proliferation.

In men, the use of Menopur leads to an increase in the concentration of testosterone in the blood and stimulates spermatogenesis, affecting the Sertoli cells of the seminiferous tubules.

Pharmacokinetics

C max FSH in blood plasma is achieved 6-24 hours after intramuscular administration of the drug Menopur ® . After this, the concentration of FSH in the blood gradually decreases. T 1/2 of menotropins - 4-12 hours.

For women

Infertility caused by hypothalamic-pituitary disorders (in order to stimulate the growth of one dominant follicle);

When carrying out assisted reproductive techniques for conception (stimulation of the growth of multiple follicles).

For men

Stimulation of spermatogenesis in azoospermia or oligoasthenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with therapy with human chorionic gonadotropin preparations, for example, Choragon).

Diseases of the thyroid gland and adrenal glands;

Tumors of the hypothalamic-pituitary region;

Hyperprolactinemia;

Persistent ovarian enlargement or cysts not associated with polycystic ovary syndrome;

Developmental abnormalities of the genital organs or uterine fibroids incompatible with pregnancy;

Vaginal bleeding of unknown etiology;

Cancer of the uterus, ovaries or mammary glands;

Primary ovarian failure;

Prostate cancer or other androgen-dependent tumors in men;

Pregnancy;

Lactation period;

Hypersensitivity to menotropins (drugs containing LH and/or FSH) and other components of the drug.

From the endocrine system: mastalgia, a sharp increase in estrogen excretion in the urine, moderate (uncomplicated) enlargement of the ovaries, formation of ovarian cysts; in men - gynecomastia.

Ovarian hyperstimulation syndrome: early signs- severe pain in the lower abdomen, nausea, vomiting, weight gain; hypovolemia, increased number of red blood cells in plasma (associated with a decrease in plasma volume), electrolyte imbalance, ascites, hemoperitoneum (presence of blood in the abdominal cavity), hydrothorax, thromboembolic syndrome.

From the digestive system: sometimes - nausea, vomiting, colicky pain.

Local reactions: redness, swelling, itching at the injection site.

Allergic reactions: arthralgia; rarely - hypersensitivity reactions (including skin rash, increased body temperature); very rarely with long-term use of the drug - the formation of antibodies (which leads to a decrease in the effectiveness of the therapy).

Other: oliguria, decreased blood pressure, increased body weight, multiple pregnancy.

Overdose

Currently, no cases of overdose of Menopur ® have been reported.

special instructions

Before prescribing Menopur ®, it is recommended to carry out appropriate treatment in the presence of concomitant hypothyroidism, adrenal insufficiency, hyperprolactinemia, tumors of the hypothalamic-pituitary region, correction of hemoconcentration.

It should be taken into account that during the use of hMG drugs, the development of ovarian hyperstimulation is possible, which becomes clinically pronounced after the administration of hCG drugs for the purpose of ovulation and manifests itself in the formation of large ovarian cysts. In this case, ascites and hydrothorax may occur, accompanied by oliguria, arterial hypotension and thromboembolic syndrome.

When the first signs of ovarian hyperstimulation appear (abdominal pain, palpable or ultrasound-detectable formations in the lower abdomen), treatment should be stopped immediately!

If ovarian hyperstimulation develops, hCG should not be administered for the purpose of ovulation.

When treated with hMG drugs, multiple pregnancies often develop.

In men with high levels of FSH in the blood (indicative of primary testicular failure), Menopur ® is usually ineffective.

Use during pregnancy and breastfeeding

Menopur ® is contraindicated for use during pregnancy and lactation.

During pregnancy, the manifestations of ovarian hyperstimulation syndrome worsen, their duration increases, and this condition can lead to a threat to the patient’s life.

Drug interactions

Menopur ® can be used in combination with Horagon (human human chorionic gonadotropin) in women - for the purpose of inducing ovulation, after stimulating the growth of follicles; in men - to stimulate spermatogenesis.

The drug is administered intramuscularly or subcutaneously. The injection solution is prepared immediately before administration using the supplied solvent.

Women

At infertility caused by hypothalamic-pituitary disorders, in order to stimulate the growth of one dominant follicle

The initial dose of Menopur ® is 75-150 IU (1-2 bottles/day). If the ovaries do not respond, the dose is gradually increased until the level of estrogen in the blood increases or the follicles grow. The dose is left unchanged until the estrogen concentration reaches the preovulatory level. If estrogen levels rise rapidly at the beginning of stimulation, the dose of the drug should be reduced.

WITH the purpose of inducing ovulation 1-2 days after the last injection of Menopur, 5,000-10,000 IU of hCG is administered once.

For men

WITH to stimulate spermatogenesis 1,000-3,000 IU of hCG is administered 3 times a week until testosterone levels in the blood normalize. Then, for several months, the drug Menopur ® is administered 75-150 IU (1-2 bottles) 3 times a week.

Storage conditions and shelf life

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. Shelf life - 2 years.

Menopur is a follicle-stimulating drug that is used for male and female infertility, as well as to create conditions for fertilization using IVF. One bottle of medication contains a certain amount of hormone. The dosage depends on the indications and doctor's orders. It is administered by injection intramuscularly or subcutaneously. The manufacturer produces concentrates with indicators of 75, 600 and 1200 IU.

Menopur consists of purified human menopausal gonadotropin obtained from the urine of a postmenopausal woman. The content of both hormones in the medication is 1:1. After administration to a woman, the composition helps stimulate the production of the hormone estrogen, which in turn ensures the correct and complete maturation of the follicles. It also helps ensure the correct course of proliferative processes in endometrial tissue.

When administered to men, the same drug helps increase testosterone levels. As a result, spermatogenesis is stimulated. This happens due to the active effect of the composition on the cells of the seminiferous tubules.

The maximum concentration of the drug in the blood is achieved within an indefinite period. According to the instructions for Menopur, the maximum content of components can develop within 6-12 hours. It depends on the specific individual reaction and functioning of the body. Afterwards the concentration begins to gradually decrease. The half-life is approximately 4-12 hours. The metabolism of the drug has not been studied and has not been studied, but it is known that the composition is excreted by the body primarily through the kidneys, that is, with urine.

Important! The introduction of Menopur is associated with its own risks and features. The drug has many side effects and contraindications, and therefore before using it you should undergo a thorough diagnosis. During use, the condition of the patient or patient must be constantly monitored by medical personnel.

Indications for use

Instructions for use Menopur offers the following indications for use: medicine:

Female infertility, occurring against the background of disorders in the hypothalamic-pituitary system;
Stimulating follicle growth in reproductive techniques;
Azoospermia in men, which is associated with hypogonadtropic hypodynamism;
Oligoasthenospermia in men, which is associated with hypogonadtropic hypodynamism.

In general, Menopur is used for IVF, as well as in the treatment of male and female infertility to increase the chance of fertilization.

Mode of application

The drug is available in the form of a lyophysilate mass with a bottle of solvent. The drug is diluted immediately before administration. Injections are made subcutaneously or intramuscularly. Female infertility begins to be treated with a dosage of 75 IU. Use 1-2 bottles per day. Your doctor will tell you how to inject Menopur. The drug is used strictly under the supervision of medical staff to monitor the dynamics of the patient’s condition.

If the ovaries do not respond, the dosage is increased each time until the necessary response occurs in the form of follicle growth and an increase in estrogen levels. The dose does not change until the estrogen level reaches the threshold characteristic of the preovulatory method. With a sharp jump in estrogen concentration, the dosage is reduced.

Induction of ovulation using Menopur according to the instructions is carried out according to the usual scheme. After the end of the regimen, a few days later it is administered once in the form of a multidose in the amount of 5-10 thousand IU. It is important to understand that only a doctor who has relevant experience and knowledge in the treatment of pregnancy can administer the medication. That is, treatment of this type is usually carried out in specialized institutions.

To stimulate spermatogenesis in men, the drug Menopur is administered three times a week in the amount of 1-3 thousand IU. Therapy is continued until testosterone levels reach the required concentration. After this, the medicine is used with the same frequency, but at a dosage of 75-150 IU. The dynamics and condition of the patient are monitored over 3 months of Menopur therapy. If the desired effect is not achieved, then use of the drug is discontinued.

Important! The doctor may change the treatment regimen depending on the indications, data obtained and the achievement of a certain result. In other cases, the medicine is used according to classic scheme which is given above.

When treating infertility in a woman, sexual intercourse is recommended on the day of hCG administration or the next day. Wherein a necessary condition is the corresponding reaction of the ovaries. To stimulate ovarian growth, it should be prescribed approximately two weeks after the start of treatment with GnRH antagonists and Menopur. If an increase in dosage is required, then it is increased by no more than 150 IU at a time. Accordingly, the maximum dose per day is no more than 450 IU. Usually the medication is used for no more than 20 days. In this case, administration usually begins on day 2-3 menstrual cycle. In case of an adverse reaction, in addition to discontinuing the drug, the patient is expected to use barrier methods of contraception.

Drug interactions

It is necessary to clarify how to dilute Menopur, as well as how to use it if other drugs are used to induce ovulation and stimulate spermatogenesis. This medicine goes well with Choragon. But during administration, mixing of injection solutions should not be allowed.

Simultaneous therapy with clomiphene citrate sharply increases the follicle response. If increasing the dosage of Menopur has led to undesirable side effects and overdose, then GRF antagonists are used.

Side effects

The medication has a number of side effects, and therefore is used strictly under the supervision of medical staff. Side effects include:

Nausea;
Ovarian hyperstimulation syndrome;
Ovarian enlargement;
Arthralgia;
Vomit;
Colic;
Oliguria;
Skin rash;
Gynecomastia in men;
Hypotension;
Increase in body weight;
Cyst formation;
Swelling of the injection area;
Thromboembolic syndrome;
Hemoperitoneum (bleeding in the peritoneum);
Redness of the injection area;
Multiple pregnancy;
Formation of antibodies to the composition of the drug.

Since the symptoms often manifest themselves quite intensely, you should carefully monitor the condition of the patient who is injected. medicinal product. Any deviation from the norm requires urgent adjustment or discontinuation of the medication.

Contraindications

Stimulation with Menopur also has its contraindications. Among them:

Hyperprolactemia;
Adrenal diseases;
Pathologies of the thyroid gland;
Tumors of the hypothalamus or pituitary gland;
Prostate cancer;
Lactation;
Persistent enlargement of the ovaries;
Hypersensitivity;
Cysts that are not associated with polycystic disease;
Anomalies in the development of the reproductive system that are incompatible with pregnancy;
Uterine fibroids incompatible with pregnancy;
Androgen-dependent tumors;
Vaginal bleeding whose causes have not been determined;
Uterine cancer;
Primary ovarian failure;
Pregnancy;
Oncology in the ovarian area;
Breast cancer.

It is worth noting that oncological pathologies are an absolute contraindication to the use of the drug. Not everyone understands why Menopur is prescribed. It primarily affects hormonal background patient or patient. And tumors often grow under such influence, significantly shortening a person’s life.

Also, the drug is not used if pregnancy is suspected. If the medication is used in therapy after fertilization, ovarian hyperstimulation syndrome appears, which worsens and lasts for a fairly long period of time. This condition is life-threatening for the patient.

special instructions

Before starting treatment with the drug, it is recommended to first undergo diagnostic testing for the presence of contraindications. if any are detected, then it is necessary to first undergo therapy to eliminate the pathologies. Only in this case, after some time has passed after the end of treatment, can you begin to use the medication to eliminate the consequences of infertility or to prepare for IVF.

Also, before using Menopur, the condition of the ovaries is assessed. First of all, an ultrasound is performed and the level of estradiol in the blood is determined. Throughout the entire course of injections, these studies are carried out daily or every other day.

Ovarian hyperstimulation may develop during the use of hMG drugs. It becomes most pronounced in clinical manifestation after the administration of drugs of this group for the purpose of ovulation. It manifests itself in the formation of ovarian cysts, which can reach a large size. In such cases, hydrothorax and ascites may additionally develop, which are accompanied by oliguria, arterial hypotension, and thromboembolic syndrome.

If the first signs of hyperstimulation appear, which are usually manifested by pain in the lower abdomen and formations in the same area, which are easily palpable or visible on ultrasound, therapy with this drug is stopped immediately. The drug of the hCG group is not administered in this condition for ovulation. When using Menopur, multiple pregnancies often develop.

If a man who is receiving medication has increased level FSH, this indicates the ineffectiveness of using the composition. As a rule, this indicator indicates primary testicular failure.

In general, no data on drug overdose have been reported. The instructions for use of Menopur also do not report these phenomena. But if the composition was administered in large quantities repeatedly, then the severe side effects mentioned above may develop. In this case, no treatment is required. The doctor adjusts the course or discontinues the drug. Symptoms go away on their own within a few weeks.

It is noted that ectopic pregnancy occurs most often in diseases fallopian tubes. Spontaneous and early abortions during treatment with Menopur occur more often than during natural pregnancy in healthy patients, but are equal in other types of infertility. The relationship between the drug and tumor growth has not been established.

Important! The incidence of congenital anomalies in newborns when using Menopur is higher than when conceiving naturally, but studies have shown that this is largely due to the individual characteristics of the parents - age, genetic predisposition, and so on.

How to store Menopur

How to store Menopur is indicated in the instructions. It is noted that the maximum temperature for storage is 25 degrees. In this case, the place should be dark and protected from children. It should also be taken into account that the drug cannot be kept in a diluted form due to the loss of its effectiveness and the rapid disintegration of the composition.

A doctor knows how to dilute Menopur. The product is diluted immediately before use. In this case, it is necessary to avoid shaking the bottle. The drug is considered unsuitable for use if the solution is not transparent or if it contains undissolved particles. Dosages are the same for subcutaneous or intramuscular administration. The type of injection is determined by the doctor. The dosage is selected by the doctor based on the reaction of the ovaries, which is monitored using ultrasound and determining the level of estradiol.

The shelf life of the medicine is no more than two years. After this time, it is unsafe to use. The drug is dispensed strictly according to prescription and is used under the supervision of the attending physician after appropriate examination and treatment of concomitant pathologies. Using the medication without a doctor's prescription is strictly prohibited.

INN: Menotropins

Manufacturer: Ferring GmbH

Anatomical-therapeutic-chemical classification: Human menopausal gonadotropin

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 013725

Registration period: 14.08.2014 - 14.08.2019

Instructions

Tradename

International nonproprietary name

Dosage form

Lyophilized powder for the preparation of solution for injection (75 IU FSH and 75 IU LH) complete with solvent

Compound

One bottle contains

active substance - menotropin (highly purified human menopausal gonadotropin, hMG), which corresponds to 75 IU of FSH (follicle-stimulating hormone) and 75 IU of LH (luteinizing hormone,

Excipients: lactose monohydrate, polysorbate 20, sodium hydroxide, hydrochloric acid.

Solvent: sodium chloride solution, hydrochloric acid, water for injection.

Description

Lyophilized mass in the form of a white or almost white lump

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Gonadotropins and other ovulation stimulants. Gonadotropins. Menopausal gonadotropin.

ATX code G03GA02

Pharmacological properties

Pharmacokinetics

The maximum level of follicle-stimulating hormone (FSH) in the blood plasma is achieved 6-24 hours after intramuscular administration of the drug. After this, the concentration of FSH in the blood gradually decreases. The half-life of gonadotropins is 4-12 hours.

Pharmacodynamics

Menopur is a highly purified menopausal human gonadotropin preparation. The drug contains follicle-stimulating and luteinizing hormones in a 1:1 ratio, 75 IU each of FSH and LH, which are produced by the human pituitary gland. The active substance is obtained from the urine of postmenopausal women. Menopur in women causes an increase in the level of estrogen in the blood, the growth and maturation of ovarian follicles.

Indications for use

Female infertility due to anovulation (including polycystic ovary syndrome) in women who do not respond to treatment with clomiphene citrate

Controlled ovarian hyperstimulation to induce multiple follicular growth during assisted reproductive technologies (ART), such as fertilization in vitro, as well as intraplasmic sperm injection

Directions for use and doses

Menopur is intended for subcutaneous or intramuscular use. The powder is dissolved immediately before administration using the solvent that is included. Up to 3 bottles of Menopur powder can be diluted in 1 ml of solvent. The solution should not be used if it contains particles and is not clear.

Dosage regimens are identical for subcutaneous and intramuscular administration.

The individual response of the ovaries to exogenous gonadotropins varies greatly, which does not allow the use of standardized dosing regimens. Despite this, doses are selected individually depending on the response of the ovaries to treatment. Menopur can be used either alone or in combination with gonadotropin-releasing factor (its agonist or antagonist to control ovarian hyperstimulation). The recommended dosage and duration of treatment depend on the individualized treatment regimen.

Anovulation (including polycystic ovary syndrome): the goal of treatment with Menopur is the formation of a single Graafian follicle from which an oocyte will be released as a result of the action of human chorionic gonadotropin hormone (HCG).

The use of Menopur should be started during the first 7 days of the menstrual cycle. The recommended starting dose is 75-150 IU per day for 7 days. Based on routine clinical monitoring (including ovarian ultrasound alone or with monitoring of estradiol levels), further dosing should be individualized depending on response. Adjust the dose no more than once every 7 days. The recommended one-time dose increase is 37.5 IU, and should not exceed 75 IU. The maximum daily dose should not exceed 225 IU. If there is no result within 4 weeks, the course of treatment should be stopped, and further treatment should be started in doses higher than those used in the interrupted cycle.

After achieving optimal results, a single dose of hCG should be administered in an amount of 5,000 to 10,000 IU the next day after the last dose of Menopur. On the day of HCG administration and the next day, it is recommended to have sexual intercourse. An alternative method is to perform artificial intrauterine insemination. In case of an increased reaction to Menopur, treatment should be discontinued and patients should abstain from sexual intercourse or use barrier methods of contraception until the start of the next monthly cycle.

Controlled ovarian hyperstimulation to induce multiple follicle formation during assisted reproductive technology (ART) programs:

Sample protocol for using Menopur with gonadotropin-releasing factor agonists.

In clinical trials involving gonadotropin releasing factor regulation, treatment with Menopur should be started approximately 2 weeks after the start of agonist treatment. The recommended starting dose of Menopur is 150-225 IU per day for at least the first 5 days of treatment. Based on clinical observations (including ultrasound alone or in combination with estradiol levels), further dosing should be individualized, but not to exceed 150 IU at each dose adjustment. The maximum daily dose should not exceed 450 IU and, in most cases, treatment duration of more than 20 days is not recommended.

In regimens that do not involve regulation (inhibition), treatment with Menopur should begin on the 2-3rd day of the menstrual cycle. The recommended dosage value and regimen are the same as those proposed for the above protocols using hCG agonists for regulation.

Having achieved the optimal response of the body, patients are given a single dose of 5000 to 1000 IU of hCG to induce the final maturation of the follicle and prepare for the release of the oocyte.

Patients should be closely monitored for at least 2 weeks after administration of hCG. In case of an increased reaction to Menopur, treatment should be discontinued and patients should abstain from sexual intercourse or use barrier methods of contraception until the start of the next monthly cycle.

Side effects

During treatment with Menopur in clinical studies Adverse reactions frequently reported: abdominal pain, headache, reactions and pain at the injection site, with a frequency of 10%. The table shows the most common adverse reactions by organs and systems obtained in clinical trials.

According to clinical trials, typical gastrointestinal symptoms associated with OHSS were discomfort and bloating, nausea, and vomiting. A rare complication of OHSS is venous thromboembolic disorders and ovarian torsion.

Allergic reactions have been reported with the use of gonadotropin preparations: local skin reactions and general reactions, including anaphylaxis.

Rarely, hypersensitivity reactions (fever, skin rash), swelling, pain or itching at the injection site develop.

In isolated cases, with prolonged use of the drug, the formation of antibodies is possible, which leads to the ineffectiveness of the therapy.

Treatment with hMG drugs can cause ovarian stimulation, which becomes clinically apparent after administration of hCG (hCG) for the purpose of ovulation. This can lead to the formation of ovarian cysts large sizes. In addition, with severe ovarian hyperstimulation, ascites, hydrothorax, oliguria, hypotension and thromboembolic phenomena can be observed.

Flu-like symptoms may develop.

Treatment with hMG in the natural cycle can lead to multiple pregnancies. Pregnancies resulting from infertility treatment with gonadotropins more often end in abortions compared to normal pregnancies.

Contraindications

Pituitary or hypothalamic tumor

Carcinoma of the ovary, uterus, or breast

For gynecological bleeding of unknown etiology

Cysts or enlarged ovaries not associated with polycystic ovary syndrome

Hypersensitivity to the components of the drug

In the cases described below, a positive treatment result is not expected, therefore Menopur should not be prescribed for:

Primary ovarian failure

Anomalies of the genital organs incompatible with pregnancy

Fibrous neoplasms of the uterus, incompatible with pregnancy.

Drug interactions

Despite the lack of clinical experience, it is expected that the simultaneous use of Menopur with clomiphene may enhance the follicular maturation response. At joint use with gonadotropin-releasing factor agonists for the purpose of pituitary desensitization, high doses of Menopur may be necessary to achieve the desired ovarian response.

special instructions

Menopur is a potent gonadotropic drug that can cause side effects of varying severity; it should be used exclusively under the supervision of a physician knowledgeable in the treatment of infertility.

Gonadotropin therapy requires a certain amount of time from doctors and requires careful and regular monitoring of the ovarian response to treatment, including ultrasound, preferably in combination with determining the level of estradiol in the blood plasma.

There is significant variation between patients when receiving menotropin, some of whom may have a very poor response to treatment. The minimum dose appropriate for the treatment goal should be used.

The first injection of Menopur should be done under the supervision of a doctor.

Before starting treatment, it is necessary to conduct research into the causes of infertility in both partners, as well as conduct a medical examination regarding possible contraindications. In particular, patients must be examined for the presence of hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, pituitary or hypothalamic tumor, and appropriate treatment prescribed for such pathological conditions.

Patients who undergo follicular growth stimulation, either as part of treatment for infertility due to anovulation or as part of an assisted reproductive technology (ART) program, may experience an increase in ovarian size or develop ovarian hyperstimulation syndrome. Adhering to the recommended dosage regimen of Menopur and carefully monitoring the ovarian response to treatment will help minimize the risk of developing these side effects. Rapid assessment of follicle maturation indicators requires the physician to have appropriate experience and interpretation of such tests.

Ovarian hyperstimulation syndrome (OHSS)

OHSS is a condition different from uncomplicated ovarian enlargement. OHSS is a syndrome that appears on its own, and the severity of symptoms can increase.

The syndrome manifests itself in a significant increase in the size of the ovaries, an increase in the level of sex steroid hormones, as well as increased permeability of blood vessels, which can lead to the accumulation of fluid in the abdominal, pleural and, in exceptional cases, in the pericardial cavity.

In severe cases of OHSS, symptoms may include abdominal pain, bloating, significant ovarian enlargement, weight gain, shortness of breath, oliguria, and gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Clinical examination may reveal hypovolemia, electrolyte imbalance, ascites, hemoperitoneum, pleural effusion, hydrothorax, acute pulmonary distress syndrome, and episodes of thromboembolism.

Increased ovarian response to gonadotropin treatment rarely leads to OHSS, unless hCG is used to stimulate ovulation. Therefore, in cases of OHSS, one should refrain from using stimulation with hCG, and also recommend that patients abstain from sexual intercourse or use barrier methods of contraception for at least 4 days. OHSS can have a rapid onset (days to days) and is serious side effect Therefore, patients should be under medical supervision for at least 2 weeks after the administration of hCG.

Compliance with the recommended dosage regimen of Menopur and careful monitoring during treatment will minimize the risk of ovarian hyperstimulation and multiple pregnancies. During an assisted reproductive technology (ART) program, aspiration of all follicles before ovulation will help reduce the risk of overstimulation.

OHSS can become severe and long-lasting in the event of pregnancy. Typically, OHSS goes away on its own with the onset of menstruation.

In severe cases of OHSS, gonadotropin administration should be stopped and the patient should be hospitalized for special treatment.

The syndrome often develops in patients with polycystic ovary syndrome.

Multiple pregnancy

Multiple pregnancy, especially with large quantities fetuses, carries an increased risk of complications for both the mother and the fetus during the perinatal period.

In patients who ovulate as a result of treatment with gonadotropin hormones, cases of multiple pregnancy are more frequent compared to pregnancies resulting from natural fertilization. To minimize the risk of multiple pregnancy, it is necessary to carefully monitor the reaction of a woman's ovaries.

In patients after ART, the risk of multiple pregnancy is associated mainly with the number of embryos transferred, their quality and the age of the patient.

Before starting treatment, patients should be warned about the possibility of multiple pregnancies.

Miscarriage

The incidence of miscarriage due to termination of pregnancy or spontaneous abortion is higher in women undergoing stimulation of follicular maturation or undergoing assisted reproductive technology (ART) programs than in the case of natural conception.

Ectopic pregnancy

Women with fallopian tube diseases are at greater risk of developing ectopic pregnancy than in cases of healthy conception or infertility treatment. The incidence of ectopic pregnancy after in vitro fertilization is 2-5% compared to 1-1.5% in the population.

Neoplasms of the reproductive organs

In women who have repeatedly received drug treatment regarding infertility, the development of both benign and malignant neoplasms of the ovaries and other organs of the reproductive system has been reported. To date, the connection between treatment with gonadotropin and the tendency to tumors in women with infertility has not yet been clarified.

Congenital malformations

Prevalence birth defects development in women after ART may slightly exceed the number of defects during natural conception. It is believed that this may be the result individual characteristics parents (maternal age, sperm characteristics, etc.) and multiple pregnancies.

Thromboembolic disorders

Women at increased risk of developing thromboembolic conditions, despite a hereditary predisposition, significant obesity (body mass index > 30 kg/m2) or thrombophilia may develop venous or arterial thromboembolic disorders both during and after cessation of gonadotropin treatment. It should be noted that pregnancy itself also carries an increased risk of thromboembolic complications.

The use of Menopur may lead to positive result doping test.

The use of Menopur as a doping can worsen your health.

The drug contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactase malabsorption syndrome.

Use during pregnancy or breastfeeding

Menopur is contraindicated during pregnancy and breastfeeding.

Children

Not prescribed for children.

Features of the effect of the drug on the ability to drive vehicle and potentially dangerous mechanisms

Does not affect.

Overdose

Symptoms: possible development of ovarian hyperstimulation syndrome. Treatment is symptomatic.

In case of mild hyperstimulation (grade I), which is accompanied by a slight enlargement of the ovaries (ovarian size 5-7 cm), excessive secretion steroid hormones and abdominal pain, there is no need to take special precautions. It is necessary to inform the patient about the causes of this condition and closely monitor her.

With degree II hyperstimulation with the formation of ovarian cysts (ovarian size 8-10 cm), which is accompanied by abdominal pain, nausea and vomiting, it is necessary to conduct a thorough clinical examination, and in case high level hemoglobin may need to be replaced with circulating blood using intravenous infusions.

With degree of hyperstimulation III with the formation of large ovarian cysts (ovarian size more than 10 cm), which is accompanied by ascites, hydrothorax, bloating, abdominal pain, dyspnea, salt retention in the body, increased hemoglobin levels, increased blood viscosity, platelet aggregation with the risk of thromboembolic complications require urgent hospitalization.

Release form and packaging

75 IU of follicle-stimulating hormone and 75 IU of luteinizing hormone in colorless glass bottles with a rubber stopper, crimped with aluminum caps, with a blue plastic safety cap.

1 ml of solvent in colorless glass ampoules made of type I glass, with a colored control point.

Self-adhesive labels are placed on bottles and ampoules.

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