International non-patented name: Human Menopausal Gonadotrophin (HMG)

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Composition
Active ingredient: 75 IU of follicle-stimulating hormone (FSH) and 75 IU of luteinizing hormone in 1 vial
highly purified menotropin equivalent to the hormone (LH).
(human menopausal gonadotropin).
Solvent: 1 ampoule contains 1 ml of sterile and pyrogenic 0.9% isotonic sodium chloride solution.
Excipients: mannitol, disodium hydrogen phosphate, sucrose, phosphoric acid (% 85) A.T., k.m. For pH adjustment (sufficient amount).
     
Description
It is a white, sterile, pyrogenic, highly purified lyophilized powder. 
The solvent is a sterile, nonpyrogenic, colorless, transparent solution. 

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Pharmacotherapeutic group
Gonadotropins and other stimulators of ovulation.
Human menopausal gonadotropin.

ATC code: G03GA02

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pharmacological properties
Pharmacodynamics 
Human menopausal gonadotropin (HMG) - menotropin, is a highly purified hormonal preparation containing FSH and LH in a 1:1 ratio. It is obtained from the urine of postmenopausal women. 
The target organ of IMG hormonal effect are ovaries and testicles. FSH and LH are necessary for the formation and normal development of sex cells (gametes) in humans (folliculogenesis in women, spermatogenesis in men) and the synthesis of sex steroid hormones. 
Menotropin is used to stimulate these processes in cases of dysfunction of the gonads. It is also used to stimulate the development of multiple follicles within the framework of assisted reproductive technology programs (in vitro fertilization, embryo transfer). Due to the FSH component, it ensures maturation and development of follicles in the ovaries in women, which leads to an increase in the level of estrogen and the proliferation of the endometrium. 
In men, it induces the transformation of immature Sertroli cells into mature cells in the seminiferous tubule; It stimulates spermatogenesis by influencing the production of androgen-binding protein in Sertoli cells (mainly affects the maturation of seminiferous tubules and the development of spermatozoa). 
However, this requires a high concentration of intratesticular androgens, which requires prior treatment with human chorionic gonadotropin (HCG).
Menotropin is usually used in combination with human chorionic gonadotropin, which requires a high concentration of intraseminal androgens, which requires prior treatment with human chorionic gonadotropin (HCG). 
For the purpose of induction of ovulation or controlled hyperstimulation, the appointment of these drugs can be sequential, and in the case of stimulation of Leydig cells, it can be alternate.
Pharmacokinetics
Human menopausal gonadotropin is not effective when administered orally, so it must be administered intramuscularly or subcutaneously. The pharmacokinetics of IMQ were studied separately for each component after intramuscular or subcutaneous administration. Studies have shown that when menotropin is administered as a single dose of 300 IU, peak serum levels of FSH are reached approximately 19 hours after intramuscular administration and 22 hours after subcutaneous administration. After that, the serum level of FSH decreases with a half-life of 45 hours (intramuscular injection) and 40 hours (subcutaneous injection), respectively. Menotropin is excreted from the body mainly with urine. 

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Instructions for use 
In women 

• Follicle maturation in the treatment of anovulatory or oligoovulatory (including polycystic ovary syndrome), including infertility unresponsive to other treatment (clomiphene citrate) 

• Controlled ovarian hyperstimulation, including induction of multiple follicular development during assisted reproductive technology programs (eg, in vitro fertilization/embryo transfer (IVF/ET), gamete fallopian tube transfer (GIFT), and intracytoplasmic sperm injection (ICSI))

• Stimulation of spermatogenesis in men with androgen deficiency and infertility due to hypogonadotropic hypogonadism (congenital or acquired) (in combination with human chorionic gonadotropin)

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Contraindications 
In men and women

• Hypersensitivity to menotropin or any of the excipients contained in the preparation

• Organic lesions of the central nervous system (including tumors of the pituitary gland, hypothalamus)

In women

• Pregnancy and lactation period

• Ovarian cysts or enlarged ovaries not associated with polycystic ovary syndrome

• Vaginal bleeding and bloody discharge of unknown etiology (non-menstrual)

• Carcinoma of the ovaries, endometrium, or mammary glands 

• Primary (uncaused) ovarian failure 

• Developmental defects and deformations of female genital organs incompatible with normal pregnancy

• Benign fibroids of the uterus incompatible with pregnancy (myoma) 

In men

• Primary (non-causal) failure of the testicles

Special instructions and precautions
Infergon has strong gonadotropic activity and may cause mild to severe side effects. For this reason, the drug should be used only under the supervision of a doctor with experience in the treatment of infertility. 
Safe and effective use of human menopausal gonadotropin should be performed under regular ultrasound monitoring of ovarian response and serum estradiol measurement. 
The response of patients to FSH injection may vary. To achieve the goal of treatment, the smallest effective dose of the drug that responds to the treatment should be used. The first injection of IMQ should be done directly under the supervision of a doctor.
Women
Before starting the treatment, couples should be diagnosed with infertility by appropriate methods and possible contraindications for pregnancy should be determined. 
Patients should be screened for hypothyroidism, adrenal insufficiency, hyperprolactinemia, and tumors of the pituitary or hypothalamus, and appropriate treatment should be prescribed. 
Ovarian growth and hyperstimulation may be observed if follicular development is stimulated as part of anovulatory infertility treatment or CRT programs. Such risks can be minimized by strictly following the prescribed dose and administration of the drug, as well as by monitoring the treatment.
Assessment of follicular development should only be performed by a physician with appropriate experience.
Ovarian Hyperstimulation Syndrome (OHSS)
It differs from the normal growth of the ovaries and can manifest as the degree of severity increases. Symptoms of YHSS include enlarged ovaries, elevated sex hormone levels, and increased vascular permeability. The last sign can lead to accumulation of fluid in the peritoneal, pleural and, in some cases, pericardial spaces. 
During severe YHSS, the following symptoms can be observed: abdominal pain, abdominal distention, ovarian hypertrophy, weight gain, shortness of breath, oliguria, nausea, vomiting, diarrhea. Hypovolemia, blood clotting, electrolyte imbalance, pleural exudate, hydrothorax, rapid breathing, thromboembolism can be detected during clinical examination. 
Ovarian overreaction to treatment with gonadotropins rarely leads to YHSS until ICS is administered to initiate ovulation. For this reason, during ovarian hyperstimulation, it is better not to inject ICS and the patient should be advised to refrain from sexual intercourse for at least 4 days and not to use non-hormonal contraceptives. YHSS can progress rapidly (within 24 hours to several days) with the development of severe symptoms. For this reason, the patient should be under medical supervision for 2 weeks after the injection of ICS. Ovarian hyperstimulation and the risk of multiple pregnancy can be minimized by following the recommended doses and administration of the drug, as well as by controlling the course of treatment. The risk of hyperstimulation during CRT can be reduced by aspiration of all follicles before ovulation. YHSS is more common in women with polycystic ovary syndrome (PYS); it usually develops after the end of hormonal treatment and reaches its maximum frequency after about 7-10 days. In most cases, it disappears spontaneously with the onset of menstruation. 
In case of severe YHSS, treatment with gonadotropins should be stopped (if not already done), the patient should be hospitalized and specific treatment should be started.
Multiple pregnancy
Multiple pregnancies increase the risk of complications for mother and baby. The risk of multiple pregnancy in patients undergoing induction of ovulation with the use of Infergon is higher compared to natural fertilization. Strict monitoring of ovarian response is recommended to minimize the risk of multiple pregnancy.
The risk of multiple pregnancy in patients undergoing CRT procedure mainly depends on the amount of transferred embryos, their quality and the patient's age. Before starting treatment, the patient should be informed about the potential risk of multiple pregnancy.
Premature birth, spontaneous abortions
Premature birth, spontaneous abortions are more common in patients undergoing CRT procedure or follicular growth stimulation for ovulation induction.
Ectopic pregnancy
Women with a history of fallopian tube disease are at risk of developing an ectopic pregnancy, regardless of pregnancy resulting from spontaneous fertilization or infertility treatment. Compared to cases in the general population (1-1.5%), the frequency of ectopic pregnancy after EKM was observed in 2-5%. 
Derivatives of organs of the reproductive system
Cases of benign and malignant tumors of the ovaries and other organs of the reproductive system are reported in women with several fertilization cycles. The increased risk of developing such tumors as a result of treatment with gonadotropins in infertile women is not known. 
Congenital developmental defects
The incidence of congenital malformations after CRT is slightly higher than after spontaneous fertilization. It is most likely due to differences in parental characteristics (eg maternal age, sperm characteristics) and multiple pregnancy.
Thromboembolism
In women at risk of developing thromboembolism, the risk may increase during treatment with gonadotropins, depending on the specific or hereditary nature of this pathology. The benefit of using gonadotropins in such women should be balanced against the possible risk. It should also be noted that pregnancy itself is a risk factor for thromboembolism. 
Men
Elevated endogenous levels of FSH indicate the presence of primary testicular disorders. Such patients do not respond to treatment with the use of XQ. In order to evaluate the patient's response to the treatment, the sperm should be analyzed every 4-6 months after starting the treatment.

Interaction with other drugs 
The interaction with other drugs has not been studied. Despite the lack of clinical experience, it is believed that the use of menotropin together with other preparations for stimulation of ovulation (eg, human chorionic gonadotropin, clomiphene citrate) may enhance the follicular response. 
Higher doses of Infergon may be necessary to achieve the required follicular response when using HN-RH agonists for pituitary desensitization.
Infergon should not be mixed or added to other drugs in the same injection.

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Use during pregnancy and lactation
Consult your doctor before starting to use the drug.
It should not be used during pregnancy and lactation. If you discover that you are pregnant during treatment, inform your doctor immediately.

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 use in pediatrics
The drug is not intended for use in children.

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Effects on the ability to drive vehicles and other potentially dangerous mechanisms
Does not affect.

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Method of use and dosage
Always use this medication as directed by your doctor.
Intended for adult use only.
It is administered as an intramuscular or subcutaneous injection. The dosage of the drug and the duration of treatment are determined individually depending on the clinic of the disease, as well as the patient's age and physical criteria. The dosing regimen shown below applies to both subcutaneous and intramuscular administration. 
Infergon should be used under the supervision of a doctor with experience in the treatment of infertility problems. The first injection should be done under the supervision of a doctor.

Preparation of solution 
It is important that your hands, the tools you use and the place you put them are clean. So wash your hands first. 
The powder in the vial should be dissolved in the sodium chloride solution in the ampoule and used immediately. Up to 5 vials of Infergon can be dissolved in 1 ml of sodium chloride solution. Any unused portion should be discarded.
The usual recommended starting dose is 75 IU to 150 IU. This dose may be gradually increased by your doctor depending on your response to the medication. The duration of treatment is determined individually by the doctor. In women, the total treatment period can be extended up to 4-5 weeks. In men, it should be used for at least 3 months.
In women
•    Anovulation or oligo-ovulation (including polycystic ovary syndrome)
The main goal of the treatment with Infergon is to develop a single mature Graafian follicle and then release the egg from this follicle by applying human chorionic gonadotropin. 
Treatment with Infergon should be started during the first 7 days of the menstrual cycle. Usually, the starting dose of Infergon is 75-150 IU. The patient's further treatment regimen is adjusted depending on the results of clinical control (estradiol level in the blood and evaluation of the growth and maturation of follicles by ultrasound examination). If the ovaries do not respond to treatment, the dose of the drug should be increased by 75 IU every 7 days starting from the second week until the follicle matures. The maximum daily dose of the drug should not exceed 225 IU. If the ovaries do not respond after 4 weeks of treatment, the drug should be discontinued. 
A new course of treatment should be started with higher doses of the drug. 
When an adequate response is obtained (dominant follicle size greater than 18 mm), IXQ is administered intramuscularly as a single injection at a dose of 5000-10000 IU 24-48 hours after the last injection of Infergo to induce ovulation. Ovulation usually occurs after 34-36 hours. The patient should be advised to have intercourse every day from the day of injection of XQ until ovulation occurs. Alternatively, intrauterine insemination (IUI) can be performed. The patient should be under strict medical supervision for 2 weeks after the injection of XQ. 
If an overreaction to the injection of Infergon is observed, the course of treatment should be stopped and ICS should not be injected. The patient should use non-hormonal contraceptives or refrain from intercourse until the start of the next menstrual bleeding. 
Treatment can be started with a lower dose in the next menstrual cycle and repeated in the same way.
Controlled ovarian hyperstimulation for in vitro cultivation of multiple follicles within assisted reproductive technology programs 
According to the superovulation protocol, the recommended daily dose of Infergon is 150-225 IU. Injections start on the 2nd or 3rd day of menstruation and continue until sufficient maturation of the follicle is achieved. The patient's further treatment regimen is adjusted depending on the results of clinical control (estradiol level in the blood and assessment of follicle growth and maturation by ultrasound examination). The maximum daily dose of the drug should not exceed 450 IU. Adequate maturation of follicles is usually observed on the 10th day of treatment (5-20 days). The duration of treatment should not exceed 20 days. In order to induce ovulation if an adequate response is obtained, 24-48 hours after the last injection of Infergon, IXQ is administered intramuscularly in a dose of 5000-10000 IU as a single injection. The patient should be advised to have intercourse every day from the day of injection of XQ until ovulation occurs. Alternatively, intrauterine insemination (IUI) can be performed. The patient should be under strict medical supervision for 2 weeks after the injection of XQ. If an overreaction to the injection of Infego is observed, the course of treatment should be stopped and IXG should not be injected. The patient should use non-hormonal contraceptives or refrain from sexual intercourse until the start of the next menstrual bleeding.
In men   
Stimulation of spermatogenesis in men with hypogonadotropic hypogonadism (infertility due to androgen deficiency)  
Infergon is prescribed in a dose of 75 IU or 150 IU 2-3 times a week. These injections should be administered with an appropriate dose of HCG (human chorionic gonadotropin) to increase testosterone levels and stimulate spermatogenesis. The combined treatment should be continued until the results of spermatogenesis improve (not less than 3-4 months). Current clinical experience shows that sometimes an 18-month course of treatment is required to achieve spermatogenesis.In order to evaluate the patient's response to the treatment, the sperm should be analyzed every 4-6 months after starting the treatment.

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Side effects
As with all medicines, unwanted side effects may occur in people who are sensitive to any of the ingredients in the preparation.
Human menopausal gonadotropin is usually well tolerated by the body. 
Additional reactions are classified according to organ systems and frequency of occurrence as follows: very often (≥1/10); often (≥1/100 to <1/10); sometimes (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10000); with an unknown frequency (the available data are insufficient to determine the frequency of occurrence).
In women 
Very often:local reactions such as headache, ovarian cyst, injection site pain, redness, swelling and/or irritation.
Often:nausea, vomiting, diarrhea, foam, abdominal pain, ovarian hyperstimulation syndrome (OHSS).
Rare:ovarian torsion.
Very rare: systemic allergic reactions such as thromboembolism, erythema, rash or facial swelling.

In men  
Often:acne, gynecomastia, weight gain.  
Consult your doctor if unwanted effects occur. 
If you experience any side effects not listed in this package insert, tell your doctor. 

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Overdose
Treatment with human menopausal gonadotropin can lead to ovarian hyperstimulation, which in most cases is clinically significant only when ICS is administered to initiate ovulation. Mild hyperstimulation (degree I) accompanied by slight growth of ovaries (5-7 cm), increased secretion of steroid hormones and abdominal problems does not require specific treatment. The patient should be informed about this and should be under strict medical supervision. Ovarian cyst (ovary size 8-10 cm), abdominal symptoms, hyperstimulation accompanied by nausea and vomiting (II degree) clinical monitoring and symptomatic treatment and, if necessary, injection of blood substitutes with high hemoconcentration v/d is indicated. Treatment is carried out in the case of large ovarian cysts (ovary size >10 cm), ascites, hydrothorax, abdominal tension, shortness of breath, slowness of electrolytes in the body, blood clotting, risk of thromboembolism, and severe hyperstimulation (grade III) accompanied by an increase in platelet aggregation.  

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Release form
Lyophilized powder for preparation of intramuscular injection solution 75 BV, in vial. 
1 ml of sterile and pyrogenic 0.9% isotonic sodium chloride solution in an ampoule. 
1 vial of powder and 1 ampoule of solvent are packed in a cardboard box with a leaflet.

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Store condition
It should be stored at a temperature of 2-8ºС, protected from light and out of the reach of children. Do not freeze. The solution should be used immediately after preparation. Any unused portion should be discarded.

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

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Condition of release from pharmacy
It is released on the basis of a prescription.

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Producer
BSV BioScience GmbH, Germany.

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Licensee 
Tempus  LLC distributor company.