Menopur Multidose instructions for use

Take the first step

make an appointment with a doctor!

Most IVF protocols include a course of hormonal injections to stimulate the ovaries, prepare the woman’s body for embryo implantation, and maintain pregnancy after the procedure. As a rule, injections are performed by a doctor when the patient visits a medical facility or on an outpatient basis. However, this is not always convenient or possible - for example, if the woman works or is far from the clinic. Such injections can be performed independently, but the patient must clearly understand how to give injections during IVF so that they are as effective and safe as possible.

Compound

Pharmacodynamics

Menopur® is a highly purified human menopausal gonadotropin (HMG) preparation. The drug belongs to the group of menotropins, contains FSH and LH in a 1:1 ratio. obtained by extraction from the urine of postmenopausal women. Menopur® stimulates the growth and maturation of ovarian follicles, increases estrogen levels, and stimulates endometrial proliferation. Treatment with Menopur® is usually combined with the administration of human hCG (hCG) to induce final follicular maturation and the onset of ovulation.

Indications for Menopur®

Among women:

anovulation in polycystic ovary syndrome (if clomiphene therapy is ineffective);

controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies (ART).

For men:

stimulation of spermatogenesis in azoospermia or oligoasthenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with hCG drugs).

Operating principle

Menotropin is necessary for the timely and complete maturation of germ cells in women and men. For healthy folliculogenesis, as well as spermatogenesis, the ratio of folliculotropin and luteotropin must be equal, which is not always observed and leads to decreased fertility. In Menopur, the ratio between hormones is balanced, so the use of the product stimulates these processes.

In IVF protocols, the drug is prescribed to stimulate the formation of numerous follicles. It is usually combined with hCG (human chorionic gonadotropin).

There are two schemes for using drugs:

• Sequential - to induce ovulation or control hyperstimulation.
• Alternating - to stimulate spermatogenesis (Leydig cells).

Menotropin is a natural remedy that does not cause the formation of antibodies to it.

Contraindications

persistent enlargement of the ovaries, ovarian cysts (not caused by polycystic ovary syndrome);

abnormal development of the genital organs, uterine fibroids, incompatible with pregnancy;

metrorrhagia and other bleeding of unknown etiology;

ovarian, uterine and/or breast cancer;

prostate cancer, testicular tumor;

high concentration of FSH in primary ovarian failure;

pregnancy and lactation;

tumors of the hypothalamic-pituitary region;

androgen-dependent tumors;

hypersensitivity to the drug or its components.

If you have one of the listed diseases, you should definitely consult your doctor before taking the drug.

Carefully:

see "Special Instructions".

Menopur Multidose instructions for use

Composition: 1 bottle of lyophilisate contains: active substance: menotropins - 600 IU FSH + 600 IU LH or 1200 IU FSH + 1200 IU LH; excipients: lactose monohydrate 21.0 mg, polysorbate-20 0.005 mg, disodium hydrogen phosphate heptahydrate 0.268 mg, phosphoric acid solution 1 M qs, disodium hydrogen phosphate solution 0.5 M qs 1 syringe with solvent contains: metacresol 3.63 mg, water for injections up to 1.1 ml. Description Lyophilisate: white or almost white amorphous mass. Solvent: colorless transparent solution.

Pharmacotherapeutic group: follicle-stimulating agent.

ATX code: G03GA02

Pharmacological properties Pharmacodynamics Menopur® Multidose is a highly purified human menopausal gonadotropin (hMG) preparation. The drug belongs to the group of menotropins and contains follicle-stimulating (FSH) and luteinizing (LH) hormones in a 1:1 ratio. The drug is obtained by extracting FSH and LH from the urine of postmenopausal women. In women, the drug Menopur® Multidose stimulates the growth and maturation of ovarian follicles, increases the concentration of estrogen, and stimulates endometrial proliferation. In men, it stimulates spermatogenesis with azoospermia or oligoasthenospermia.

Pharmacokinetics Absorption The maximum concentration of FSH in the blood plasma is achieved 7 hours after subcutaneous or intramuscular administration of the drug. Distribution The volume of distribution after repeated doses of 150 IU over 7 days is 8.9±3.5 IU/L for subcutaneous administration and 8.5±3.2 IU/L for intramuscular administration. Excretion Excreted mainly by the kidneys. The half-life of repeated doses is 30±11 hours for subcutaneous administration and 27±9 hours for intramuscular administration. Pharmacokinetics in patients with renal and hepatic impairment have not been studied.

Indications for use In women: • Anovulation (including polycystic ovary syndrome (PCOS) when clomiphene therapy is ineffective). • Controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies (BPT). In men: • stimulation of spermatogenesis with azoospermia or oligoasthenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with drugs of human chorionic gonadotropin (hCG)).

Contraindications Hypersensitivity to menotropins and other components of the drug; tumors of the pituitary gland or hypothalamus; decompensated hypothyroidism, adrenal insufficiency, hyperprolactinemia; children under 18 years of age. In women: • persistent enlargement of the ovaries, ovarian cysts (not caused by polycystic ovary syndrome); • abnormalities in the development of the genital organs, incompatible with pregnancy; • uterine fibroids, incompatible with pregnancy; • bleeding from the vagina of unknown etiology; • estrogen-dependent tumors (ovarian cancer, uterine cancer or breast cancer); • high concentration of FSH in primary ovarian failure; • pregnancy and breastfeeding period. In men: • androgen-dependent tumors (prostate cancer, testicular tumor). If you have one of the listed diseases, be sure to consult your doctor before taking the drug. Use caution if there are risk factors for thromboembolism, such as individual or family history, obesity (body mass index > 30 kg/m2) or thrombophilia.

Use during pregnancy and breastfeeding Menopur® Multidose is contraindicated during pregnancy and breastfeeding.

Method of administration and dosage The drug is used as monotherapy or in combination with other means of stimulating ovulation. The drug Menopur® Multidose is administered intramuscularly or subcutaneously with periodic change of injection site. The subcutaneous route of administration is preferable, as it ensures the greatest absorption of the drug. The doses of the drug described below are given according to FSH and are the same for both subcutaneous and intramuscular routes of administration. In women, the dose of the drug is set individually depending on the reaction of the ovaries. This requires monitoring the ovarian response to therapy in the form of ultrasound (ultrasound) alone, and preferably in combination with dynamic measurement of estradiol concentrations. Anovulation (including polycystic ovary syndrome (PCOS) when clomiphene therapy is ineffective) Treatment with Menopur® Multidose begins in the first 7 days of the menstrual cycle. The recommended initial dose is 75-150 IU/day for at least 7 days. In the absence of an ovarian response, the dose is gradually increased (no more than 1 time every 7 days) until an increase in the concentration of estrogen in the blood or follicular growth is registered. The recommended increasing dose is 37.5 IU, but not more than 75 IU. The maximum daily dose should not exceed 225 IU. If the therapeutic effect is not achieved within 4 weeks of treatment, injections of Menopur® Multidose are stopped, and then a new cycle is started with a higher dose of the drug. The patient is recommended to use barrier methods of contraception or abstain from sexual intercourse until menstruation occurs. If there is a therapeutic effect, the next day after the last injection of Menopur Multidose, 5,000-10,000 IU of hCG is administered once to induce ovulation. The patient is recommended to have sexual intercourse on the day of hCG administration and the day after administration. As an alternative method, intrauterine insemination is possible. In case of an excessive reaction, the administration of Menopur® Multidose should be stopped, the administration of hCG should be discontinued, and the patient is recommended to use barrier methods of contraception or abstain from sexual intercourse until the onset of menstruation. Controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies (BPT). For ART in combination with GnRH agonists, the use of Menopur® Multidose should be started approximately 2 weeks after the start of GnRH agonist therapy. The recommended starting dose of Menopur® Multidose is 150-225 IU/day daily for at least 5 days. If there is no response from the ovaries, the dose may be gradually increased. The recommended increasing dose is 150 IU. The maximum daily dose should not exceed 450 IU. If the therapeutic effect is not achieved within 20 days, further administration of Menopur® Multidose is not recommended. If the treatment regimen does not involve prior use of GnRH agonists, the use of Menopur® Multidose should begin on the 2-3rd day of the menstrual cycle. The dosage regimen is the same. After reaching the required number of mature follicles, 10,000 IU of hCG is administered once to induce the final maturation of the follicle and prepare the release of a full-fledged egg. The patient should be under close medical supervision for 2 weeks after hCG injection due to the possible development of ovarian hyperstimulation syndrome (OHSS). In case of an excessive reaction, the administration of Menopur® Multidose should be stopped, the administration of hCG should be discontinued, and the patient is recommended to use barrier methods of contraception or abstain from sexual intercourse until the onset of menstruation. For hypogonadotropic hypogonadism in men, the drug Menopur® Multidose is prescribed to stimulate spermatogenesis if previous therapy with hCG drugs caused only an androgenic reaction without signs of increased spermatogenesis. In this case, treatment continues by administering 2000 IU of hCG 2 times a week along with injections of Menopur® Multidose 75 IU 3 times a week. Treatment according to this regimen should be continued for at least 4 months; if ineffective, treatment is continued by administering hCG 2000 IU 2 times a week and Menopur® Multidose 150 IU 3 times a week. The status of spermatogenesis should be assessed monthly, and if there are no positive results within the next 3 months, treatment should be discontinued. For idiopathic normogonadotropic oligospermia, 5000 IU of hCG and 75-150 IU of Menopur® Multidose are administered weekly 3 times a week for 3 months. To stimulate spermatogenesis, 1000 - 3000 IU of hCG is administered 3 times a week until the concentration of testosterone in the blood normalizes. After this, 75-150 IU of Menopur® Multidose is administered 3 times a week for several months.

Instructions for preparing the solution: The injection solution is prepared using the supplied solvent. Mixing Menopur® Multidose with other medications in the same syringe is not allowed! The finished solution can be used for 28 days. 1. Remove the plastic cap from the lyophilisate bottle. Attach the needle for preparing the solution to the syringe with the solvent and remove the protective cap (Fig. 1, 2). 2. Slowly inject the solvent into the vial (Figure 3). KEEP THE BOTTLE VERTICALLY! 3. Gently stir the contents of the bottle in a circular motion until a clear solution is obtained (Fig. 4). Dissolution usually occurs in 1-2 minutes. Do not shake! Do not use the solution if undissolved particles or color changes appear! 4. Draw the required amount of solution into the syringe for injection (Fig. 5, 6). 5. Wipe the injection site with an alcohol wipe, remove air bubbles from the syringe and inject the drug

Side effects The most serious and common adverse reactions observed with Menopur® in clinical studies with an incidence of up to 10% were OHSS, abdominal pain, headache, injection site reactions and injection site pain. When using the drug Menopur® in clinical studies, gastrointestinal disorders associated with the development of OHSS were observed, such as flatulence, abdominal discomfort, nausea, vomiting and diarrhea. Thromboembolic complications and ovarian torsion were noted as rare complications of OHSS. Very rarely, allergic local or generalized reactions, including anaphylactic reactions, were observed. If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose Cases of overdose are unknown, however, in such situations, the development of OHSS should be expected, which becomes clinically pronounced after the administration of hCG drugs and is manifested by the formation of large ovarian cysts. At the first signs of hyperstimulation - abdominal pain, space-occupying formations in the lower abdomen palpated by a doctor or identified by ultrasound, nausea, vomiting, hemoconcentration, electrolyte imbalance - treatment with gonadotropins should be stopped immediately! Gynecological examination is carried out very carefully to avoid rupture of ovarian cysts; for the same purpose, it is recommended to avoid sexual intercourse. OHSS is regarded as moderately severe in cases where the following are observed: flatulence, nausea, vomiting, occasional diarrhea and an increase in the size of the ovaries to 5-10 cm (3-6 days after the administration of hCG). Treatment in these cases consists of bed rest and constant monitoring. The above symptoms in this case regress spontaneously after 2-3 weeks. OHSS is regarded as severe in cases where the following are observed: severe abdominal bloating, the appearance of ascites, hydrothorax or hydropericardium, an increase in ovarian size of more than 12 cm, a decrease in circulating blood volume, and the development of cardiovascular shock. Treatment in these cases consists of hospitalization, measures aimed at restoring circulating blood volume, correcting electrolyte disturbances and preventing the development of shock. Correction of water and electrolyte disturbances should be carried out with caution. It is necessary to maintain an acceptable, but slightly reduced compared to normal, circulating blood volume to prevent the transition of hemoconcentration to the acute phase. Diuretics are used only in the reverse development phase of this syndrome to eliminate hypervolemia that occurs due to the absorption of fluid from the cavities into the bloodstream. Fluid should not be removed from the abdominal, pleural or pericardial cavity unless absolutely indicated.

Interaction with other drugs The drug should not be mixed in the same syringe with other drugs! To induce ovulation, Menopur® Multidose can be prescribed in combination with hCG drugs. The simultaneous use of Menopur® Multidose with clomiphene can lead to increased follicular growth. Menopur® Multidose can be used in conjunction with GnRH agonists or antagonists to prevent premature ovulation peak. This may require increasing the dose of Menopur® Multidose.

Special instructions Treatment should be carried out under the supervision of a physician experienced in the treatment of infertility. The first injection of the drug should be performed under the direct supervision of a physician. Before prescribing Menopur® Multidose, the condition of the ovaries should be assessed using ultrasound or the concentration of estradiol in the blood. During the entire course of treatment, these studies should be carried out daily or every other day. Careful monitoring of the patient's condition is an integral part of the treatment. Before starting to use the drug Menopur® Multidose, it is recommended to conduct an examination to identify hypothyroidism, adrenal insufficiency, hyperprolactinemia, tumors of the pituitary gland or hypothalamus; as well as appropriate specific treatment. OHSS OHSS is a syndrome distinct from uncomplicated ovarian enlargement, the manifestations of which depend on the severity. It involves significant ovarian enlargement, high serum estrogen concentrations, and increased vascular permeability, which can lead to fluid accumulation in the peritoneal, pleural, and, rarely, pericardial cavity. In severe cases of OHSS, symptoms include abdominal pain, bloating, significant ovarian enlargement, weight gain, shortness of breath, oliguria, and gastrointestinal symptoms including nausea, vomiting, and diarrhea. On clinical examination, hypovolemia, hemoconcentration, electrolyte disturbances, ascites, hemoperitoneum, exudative pleurisy, hydrothorax, acute respiratory distress and thromboembolic complications are possible. Excessive ovarian response to gonadotropin administration rarely leads to the development of OHSS unless hCG is administered to stimulate ovulation. Therefore, in case of ovarian hyperstimulation, hCG should not be administered, and the patient should be warned to abstain from sexual intercourse or use barrier methods of contraception for at least 4 days. OHSS can progress rapidly (over 24 hours to several days) to become a serious medical complication, so patients should be monitored for at least 2 weeks after hCG administration. Compliance with the recommended doses of Menopur® Multidose, the administration regimen and careful monitoring of therapy can minimize the incidence of ovarian hyperstimulation and multiple pregnancies. When performing ART, aspiration of the contents of all follicles before ovulation can reduce the risk of developing OHSS. OHSS may be more severe and protracted as pregnancy progresses. Most often, OHSS develops after cessation of treatment with gonadotropins and reaches maximum severity within 7-10 days after the end of treatment. OHSS usually resolves spontaneously after the onset of menstruation. If severe OHSS develops, the patient is hospitalized and specific therapy is started. OHSS occurs with high frequency in patients with polycystic ovary syndrome. Multiple Pregnancies Multiple pregnancies are associated with an increased risk of adverse maternal and perinatal outcomes. When using menotropins, multiple pregnancies develop more often than with natural conception. In the case of in vitro fertilization (IVF), the likelihood of a multiple pregnancy depends on the number of embryos introduced, their quality and the age of the patient. The patient should be warned about the potential risk of multiple pregnancy before starting treatment. Complications of pregnancy The frequency of spontaneous abortions during pregnancy following treatment with Menopur® Multidose is higher than in healthy women. Ectopic pregnancy With a history of fallopian tube diseases, both during natural conception and during infertility treatment, women have a high risk of ectopic pregnancy. The prevalence of ectopic pregnancy after IVF is 2 to 5%, compared to 1 to 1.5% in the general population. Neoplasms of the reproductive system There have been reports of neoplasms of the ovaries and other organs of the reproductive system, both benign and malignant, in women who have undergone multiple drug regimens for the treatment of infertility. It has not yet been established whether treatment with gonadotropins increases the baseline risk of these tumors in infertile women. Congenital malformations The prevalence of congenital malformations of the fetus using ART is slightly higher than with natural conception. It is believed that this may be due to the individual characteristics of the parents (mother's age, sperm characteristics) and multiple pregnancies. Thromboembolic complications Women with known risk factors for thromboembolic complications, such as personal or family history, obesity (body mass index > 30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic complications during or after treatment with gonadotropins. In such cases, the benefit of their use must outweigh the risk. It should be borne in mind that pregnancy itself also increases the risk of thromboembolic complications. In men with high concentrations of FSH in the blood (indicative of primary hypogonadism), Menopur® Multidose is usually ineffective. Effect on the ability to drive vehicles and machines. Studies of the effect of menotropins on the ability to drive vehicles and machines have not been conducted. The drug Menopur® Multidose does not affect the ability to drive vehicles and machines.

Release form Lyophilisate for preparing a solution for intramuscular and subcutaneous administration. 600 IU FSH + 600 IU LH or 1200 IU FSH + 1200 IU LH in type 1 colorless glass vials, sealed with a bromobutyl stopper with an aluminum roll and a flip-off cap. 1 ml of solvent in syringes for single use, colorless glass type 1 with a rubber cap-tip. 600 IU FSH + 600 IU LH 1 bottle with lyophilisate, 1 syringe with solvent, 1 needle for preparing a solution in individual packaging, 9 alcohol wipes in individual packaging, 9 syringes for disposable use with needles in individual packaging, with instructions for use in a cardboard box pack. 1200 IU FSH+ 1200 IU LH 1 bottle with lyophilisate, 2 syringes with solvent, 1 needle for preparing a solution in individual packaging, 18 alcohol wipes in individual packaging, 18 syringes for disposable use with needles in individual packaging, with instructions for use in a cardboard box pack.

Storage conditions At a temperature of 2-8 ° C. Do not freeze. Store the prepared solution for no more than 28 days at a temperature not exceeding 25° C. Keep out of the reach of children.

Shelf life: 3 years. Do not use after the expiration date.

Conditions of release By prescription.

Manufacturer Ferring GmbH, Witland 11, 24109 Kiel, Germany

Side effects

Common (>1/100 to <1/10)

From the genitourinary system:

ovarian hyperstimulation syndrome (OHSS), pain in the lower abdomen.

From the nervous system:

headache.

From the digestive system:

abdominal pain, nausea, flatulence.

General reactions and reactions at the injection site:

pain, swelling and irritation at the injection site.

Men may experience gynecomastia.

The most serious side effect is OHSS and associated complications: thromboembolic syndrome and ovarian torsion. If any of the side effects indicated in the instructions worsen, or any other side effects not specified in the instructions develop, you should inform your doctor.

Side effects of Menopur

from the gastrointestinal tract: sometimes there may be nausea and vomiting; from the endocrinological and gynecological status of women: treatment with hMG drugs can cause ovarian hyperstimulation, which manifests itself clinically after administration of hMG for the purpose of ovulation. This can lead to the formation of large ovarian cysts. In addition, with severe ovarian hyperstimulation, ascites, hydrothorax, oliguria, hypotension and thromboembolism may be detected; allergic and immunopathological reactions: hypersensitivity reactions rarely develop (fever, skin rashes), leading to the ineffectiveness of the therapy. Local reactions: swelling, pain or itching at the injection site.

Directions for use and doses

V/m

or
s/c
. The subcutaneous route of administration is preferable because it ensures the greatest absorption of the drug. Treatment with the drug should only be carried out under the supervision of a physician with appropriate specialization and experience in the treatment of infertility.

Recommendations for preparing the solution:

the injection solution must be prepared immediately before administration using the supplied solvent. Sudden shaking should be avoided. The solution is not suitable for use if it contains undissolved particles or is opaque. The dose of the drug described below is the same for both subcutaneous and intramuscular routes of administration.

The dose should be adjusted individually depending on the response of the ovaries. This requires monitoring the ovarian response to therapy in the form of ultrasound alone, and preferably in combination with dynamic measurement of estradiol concentration.

In women, unless otherwise prescribed, the following treatment regimen is recommended:

Anovulation (including polycystic ovary syndrome):

The goal of treatment with Menopur® is the development of one mature follicle, from which an oocyte will emerge after administration of hCG drugs. Treatment usually begins in the first 7 days of the menstrual cycle with a dose of 75–150 IU (1–2 bottles of the drug) per day for a week. In the absence of an ovarian response, the dose is gradually increased by 37.5 IU no more than 1 time per week until an increase in estrogen levels in the blood or follicular growth is registered, but not more than 75 IU. The maximum daily dose should not exceed 225 IU. If a therapeutic response is not achieved within 4 weeks, treatment should be discontinued and a new cycle should be started with a higher initial dose. Patients are recommended to use barrier methods of contraception until the onset of their next menstruation. If an optimal response to therapy is achieved, a single injection of 5000–10,000 IU hCG should be given the day after the last dose of Menopur®. The patient is recommended to have sexual intercourse or undergo intrauterine insemination on the day of hCG administration and the day after administration.

To stimulate the growth of multiple follicles during ART

Menopur® should be prescribed approximately 2 weeks after the start of treatment with GnRH agonists. The recommended initial daily dose of Menopur® is 150–225 IU during the first 5 days of treatment. If there is no ovarian response, the dose may be gradually increased. Dose changes should not exceed 150 IU at a time. The maximum daily dose of Menopur® should not exceed 450 IU; in most cases, the drug should not be administered for more than 20 days. If the treatment regimen does not require prior use of GnRH agonists, administration of Menopur should begin on the 2nd or 3rd day of the menstrual cycle. The recommended method of administration and the same doses of the drug as described above. When an optimal response to the therapy is achieved, a single injection of 10,000 IU hCG should be given to induce the final maturation of the follicle and prepare the release of a full-fledged egg. Patients should be closely monitored for 2 weeks after hCG administration. If there is an excessive reaction to treatment with Menopur®, therapy should be discontinued, hCG administration should be discontinued and barrier methods of contraception should be used until the next menstruation.

In men

Unless otherwise prescribed, the following treatment regimen is recommended:

For hypogonadotropic hypogonadism to stimulate spermatogenesis

Menopur® is prescribed if previous therapy with hCG drugs caused only an androgenic reaction without signs of increased spermatogenesis. In this case, treatment continues by administering 2000 IU of hCG 2 times a week along with injections of Menopur® 75 IU 3 times a week. Treatment according to this regimen should be continued for at least 4 months; if ineffective, treatment is continued by administering hCG 2000 IU 2 times a week, and 150 IU Menopur® 3 times a week. The status of spermatogenesis should be assessed monthly, and if there are no positive results within the next 3 months, treatment should be discontinued.

For idiopathic normogonadotropic oligospermia

5000 IU of hCG and 75–150 IU of Menopur® are administered weekly 3 times a week for 3 months.

To stimulate spermatogenesis

1000–3000 IU of hCG is administered 3 times a week until the concentration of testosterone in the blood normalizes. After this, for several months, 75–150 IU of Menopur® 3 times a week.

Features of dilution of the drug

Sometimes it may be necessary to administer a large dose of the drug or just several bottles at once. What is necessary and important to remember for this. So, the drug is diluted immediately before the administration itself. If you cannot carry out the manipulations yourself, then it is better to have it done by medical professionals. Having drawn the solvent into the syringe, it is injected into the bottle; after dissolving, the drug is drawn into the syringe and placed in the second bottle. And so on until the entire required dose has been collected.

Correct dilution of the drug

special instructions

Before starting treatment, it is recommended to perform a semen analysis of the sexual partner; if necessary, treat hypothyroidism, adrenal insufficiency, hyperprolactinemia, tumors of the pituitary gland or hypothalamus. Gynecological examination during ovarian enlargement is carried out very carefully to avoid rupture of ovarian cysts.

After stimulating follicle maturation and ovulation, the possibility of multiple pregnancies during natural conception increases. In the case of ART, the likelihood of a multiple pregnancy depends on the number of oocytes injected.

The possibility of ectopic pregnancy should be borne in mind, especially with a history of fallopian tube diseases. The frequency of early and spontaneous abortions during pregnancy occurring after treatment with Menopur® is higher than in healthy patients, but comparable to that for infertility of other etiologies.

No connection has been established between the use of Menopur® and the occurrence or development of benign or malignant neoplasms of the reproductive organs.

The incidence of congenital malformations in newborns during ART is slightly higher than during natural conception. However, this is more likely to be related to the individual characteristics of the parents (age, sperm characteristics, etc.) than to Menopur®.

It should be remembered that patients with a body mass index ≥30 kg/m2 have an increased risk of developing thromboembolic complications.

Treatment with menotropin drugs can lead to the development of OHSS, which becomes clinically pronounced after the administration of hCG drugs and manifests itself in the formation of large ovarian cysts. This is combined with the accumulation of fluid in the abdominal cavity (ascites), pleural cavity (hydrothorax), accompanied by a decrease in the volume of urine excreted (oliguria), a decrease in blood pressure (hypotension) and blockage of blood vessels (thromboembolic phenomenon). Most often, OHSS occurs on the 7-10th day after ovulation, stimulated by the administration of hCG (less often during ART).

At the first signs of OHSS (abdominal pain, space-occupying formations in the lower abdomen palpable by a doctor or detected by ultrasound), treatment should be stopped immediately!

In the presence of pregnancy, the above-described phenomena become aggravated and their duration increases, which can threaten the patient’s life.

In cases of OHSS development, hCG should not be administered for the purpose of ovulation. During ART, the risk of OHSS can be reduced if the contents of all follicles are aspirated before ovulation.

During the treatment period, menotropins are ineffective in men with high concentrations of FSH in the blood.

Menopur® does not have a negative effect on the ability to drive a car or use other machinery.

Menopur overdose, symptoms and treatment

Ovarian hyperstimulation syndrome may develop. Treatment is symptomatic. With a mild degree of hyperstimulation (grade I), accompanied by a slight enlargement of the ovaries (ovarian size 5–7 cm), increased secretion of steroid hormones and abdominal pain, there is no need to carry out special measures. The patient should be informed about the cause of this condition and monitored. In the second degree of hyperstimulation with the formation of ovarian cysts (ovarian size 8–10 cm), occurring with abdominal pain, nausea and vomiting, a thorough clinical examination should be carried out, and in the case of a high hemoglobin level, it may be necessary to replace the circulating blood volume by intravenous infusion. In case of III degree of hyperstimulation with the formation of large ovarian cysts (ovarian size 10 cm), manifested by ascites, hydrothorax, bloating, abdominal pain, dyspnea, retention of electrolytes in the body, increased hemoglobin levels and blood viscosity, platelet aggregation with the risk of thromboembolic complications, it is necessary urgent hospitalization.

Synonyms of nosological groups

Category ICD-10 Synonyms of diseases according to ICD-10