Menogon
Menogon: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Menogon
ATX code: G03GA02
Active ingredient: menotropins
Producer: Ferring GmbH (Germany)
Description and photo update: 2018-26-10
Menogon is a follicle-stimulating drug.
Release form and composition
The dosage form of Menogon is a lyophilisate for preparing a solution for intramuscular (i / m) and subcutaneous (s / c) administration: a lyophilized mass from almost white to white with a yellowish tinge, complete with a solvent in the form of a transparent colorless solution (lyophilisate in ampoules from clear glass, 2 ml, complete with solvent in 1 ml clear glass ampoules, 5 sets in a plastic pallet, 1 or 2 pallets in a cardboard box).
1 ampoule with lyophilisate contains:
- active substances: follicle-stimulating hormone (FSH) - 75 IU (international units), luteinizing hormone (LH) - 75 IU;
- auxiliary components: lactose monohydrate, sodium hydroxide.
1 ampoule with a solvent (sodium chloride solution 0.9%) contains NaCl, diluted 10% hydrochloric acid, water for injection.
Pharmacological properties
Pharmacodynamics
The active substance of Menogon is hMG (human menopausal gonadotropin), which is obtained from the urine of postmenopausal women. The preparation contains the FSH and LH produced by the human pituitary gland in a 1: 1 ratio.
HMG has a hormonal effect (stimulates the process of maturation of sex cells and the synthesis of sex hormones) on the ovaries in women and on the testes in men.
FSH causes the growth of follicles in the ovaries and has a positive effect on their development. In addition, FSH activates the synthesis of estradiol in the granulosa cells of the follicular membrane through the formation of aromatic derivatives of androgens, which are formed during secretion under the influence of LH from theca cells.
In the testes, FSN causes the maturation of sustentocytes (Sertoli cells), which mostly affects cell division in the convoluted seminiferous tubules and the development of spermatozoa. The required high intratesticular androgen concentration is achieved by prior therapy with hCG (human chorionic gonadotropin).
When administered orally, hMG is not effective.
Pharmacokinetics
C max (maximum concentration) of FSH in the blood plasma occurs 6–48 hours after i / m and 6–36 hours after s / c administration.
The bioavailability of hMG is higher with subcutaneous administration than with intramuscular injection. After i / m administration of the drug at a dose of 300 IU C max FSH was 4.15 mIU / ml, T max (time to reach maximum concentration) - 18 hours; after subcutaneous administration - 5.62 mIU / ml and 12 hours, respectively.
The drug is excreted mainly in the urine. T 1/2 (half-life) is 56 hours with intramuscular administration and 51 hours with subcutaneous administration.
Indications for use
- women: anovulation (including polycystic ovary syndrome); controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies (for example, in vitro fertilization / embryo transfer, intracytoplasmic sperm injection);
- men: impaired spermatogenesis caused by hypogonadotropic hypogonadism.
Contraindications
Absolute:
- pregnancy, lactation period;
- cancer of the uterus, ovaries, breast;
- vaginal bleeding of unknown origin;
- the presence of cysts and / or an increase in the size of the ovaries not associated with Stein-Leventhal syndrome;
- primary ovarian dysfunction;
- genital anomalies incompatible with the normal course of pregnancy;
- uterine fibroids incompatible with pregnancy;
- prostate cancer;
- testicular cancer;
- primary testicular dysfunction;
- renal and / or hepatic impairment;
- age up to 18 years;
- increased individual sensitivity to the components of the lyophilisate / solvent.
Relative (using Menogon requires caution):
- the presence of risk factors for thromboembolic complications (individual or family predisposition, thrombophilia, obesity with a body mass index of more than 30 kg / m 2);
- diseases of the fallopian tubes in history.
If the patient has a history of hyperprolactinemia, thyroid and / or adrenal diseases, tumors of the hypothalamic-pituitary region, appropriate treatment should be carried out before starting hMG therapy.
Instructions for the use of Menogon: method and dosage
Menogone is administered intramuscularly or subcutaneously in the form of a solution, which should be prepared immediately before administration by dissolving the lyophilisate in the supplied solvent. It is not recommended to dilute more than 3 ampoules with lyophilisate in 1 ml of solvent.
Treatment of hMG should be carried out exclusively under the supervision of an attending physician with the appropriate specialization.
Since the ovaries react differently to the administration of gonadotropins, depending on this reaction, the dose of the drug in women is set individually. Menogone is used alone or in combination with gonadotropin-releasing hormone (GnRH) antagonists or agonists. Doses and duration of therapy depend on the treatment regimen used.
The doses of the drug described below are the same for both the i / m and the s / c route of administration.
The recommended Menogon treatment regimens, depending on the indications:
- anovulation (including polycystic ovary syndrome): start treatment with the drug within the first 7 days of the menstrual cycle. The initial dose is 75-150 IU / day and is administered for the first 7 days. Then, based on the results of monitoring the response of the ovaries to the therapy on the basis of ultrasound (ultrasound) and determining the plasma concentration of estradiol, a further treatment regimen is selected. The dose should be increased no more than once every seven days. The recommended increasing dose is 37.5 IU (one injection), subsequently each increase should not exceed 75 IU. The maximum daily dose should be no more than 225 IU. If within 4 weeks of treatment the therapeutic effect is not achieved, the administration of the drug is temporarily stopped, then a new cycle of therapy is started with a higher dose of gonadotropins. When an adequate response of the ovaries is obtained, on the next day after the last injection of Menogon, 5000–10000 IU of hCG is injected once to induce ovulation. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse, or as an alternative option, intrauterine insemination is possible. For at least 2 weeks after the administration of hCG, the patient should be under constant monitoring. In case of an excessive ovarian reaction to Menogon's injections, the course of treatment should be discontinued and the administration of hCG should be canceled. A woman should use barrier contraceptives before menstruation;or as an alternative, intrauterine insemination is possible. For at least 2 weeks after the administration of hCG, the patient should be under constant monitoring. In case of an excessive ovarian reaction to Menogon's injections, the course of treatment should be discontinued and the administration of hCG should be canceled. A woman should use barrier contraceptives before menstruation;or as an alternative, intrauterine insemination is possible. For at least 2 weeks after the administration of hCG, the patient should be under constant monitoring. In case of an excessive ovarian reaction to Menogon's injections, the course of treatment should be discontinued and the administration of hCG should be canceled. A woman should use barrier contraceptives before menstruation;
- controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies: Menogon treatment is recommended to start 2 weeks after the start of the use of GnRH agonists. According to the protocol for the use of GnRH antagonists on the principle of feedback, treatment of hMG begins on the 2nd or 3rd day of the menstrual cycle. The initial dose is 150-225 IU / day and is administered for 5 or more days. After monitoring the ovarian response based on the results of ultrasound and determining the plasma concentration of estradiol, a further treatment regimen is selected. The increasing dose should be no more than 150 IU. The maximum daily dose should not exceed 450 IU. The total duration of therapy is no more than 20 days. When an adequate ovarian response is achieved after the last injection of Menogon, a single dose of 10,000 IU hCG is injected to induce the final maturation of follicles and the release of the oocyte. After the introduction of hCG, the patient should be under constant monitoring for at least 2 weeks. With an excessive ovarian reaction to Menogon's injections, the course of therapy should be discontinued and the administration of hCG should be canceled. The patient is recommended to use barrier contraceptives before the onset of menstruation;
- hypogonadotropic hypogonadism: to stimulate spermatogenesis in men, Menogon is recommended to be administered at a dose of 75–150 IU three times a week together with hCG injections at a dose of 1500 IU, if the previous treatment with hCG preparations (injections of 1500–5000 IU hCG 3 times a week) for 4-6 months led to the normalization of plasma testosterone concentration. It is recommended to continue therapy according to this scheme for 4 months or more until spermatogenesis improves. In the absence of a therapeutic effect, the combination therapy can be continued until a positive therapy result is obtained. Studies have shown that improvement in spermatogenesis occurs after 18 months or more of treatment.
Side effects
Side effects from systems and organs and their frequency in accordance with a special classification [very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1 / 100), rare (≥1 / 10,000 to <1/1000), very rare (<1/10,000, including individual reports), frequency unknown (cannot be estimated due to insufficient data)]:
- gastrointestinal tract: often - nausea, vomiting, abdominal pain;
- nervous system: often - headache;
- immune system: very rarely - hypersensitivity reactions, the formation of antibodies;
- skin and subcutaneous tissue: often - skin rash;
- genitals and mammary gland: often - OHSS (ovarian hyperstimulation syndrome) *, breast tenderness, very rarely (in men) - gynecomastia, acne, weight gain;
- general disorders and disorders at the injection site: very often - reactions and pain at the injection site **, often - flu-like symptoms, rarely - an increase in body temperature;
- allergic reactions: very rarely - anaphylactic shock.
* in OHSS, cases of ovarian torsion and thromboembolic disorders have been reported.
** According to clinical studies of local tolerance, reactions at the injection site were observed in 55-60% of patients, but were assessed as serious in about 12% of cases. Reactions occurred mainly with subcutaneous administration of Menogon. With i / m injections, reactions at the injection site were observed in approximately 13% of patients.
The risk of spontaneous abortion with a pregnancy resulting from gonadotropin therapy is higher than with a normal pregnancy.
In case of aggravation of these side effects or the occurrence of any other adverse reactions, it is necessary to inform the attending physician about it.
Overdose
During Menogon therapy (after the administration of hCG to induce ovulation), OHSS of varying severity may occur:
- OHSS degree I (mild): accompanied by such symptoms as a slight (up to 5-7 cm) increase in the size of the ovaries, an increase in the concentration of sex hormones and abdominal pain. No treatment required. The patient should be informed of the complication and kept under close supervision;
- OHSS degree II: accompanied by the formation of ovarian cysts up to 8-10 cm, abdominal symptoms, nausea and / or vomiting. Hospitalization and symptomatic therapy are required, including, in case of an increase in hemoglobin level, intravenous infusion of solutions that maintain the volume of circulating blood (BCC);
- OHSS grade III: ovarian cysts more than 10 cm in size are formed, symptoms such as ascites, abdominal enlargement and pain, sodium retention, hydrothorax, shortness of breath, increased hemoglobin levels in the blood, increased blood viscosity, accompanied by the process of platelet adhesion with a risk of thromboembolism. Mandatory hospitalization and symptomatic therapy are required.
special instructions
Avoid shaking the prepared solution. If particles appear in the solution or if it becomes cloudy, the drug cannot be used.
Menogon treatment should be carried out exclusively under the supervision of a specialist who has experience in infertility therapy. Also, the use of gonadotropins requires appropriate equipment and the participation of qualified medical personnel. In the course of treatment, regular monitoring of the functional state of the ovaries is necessary (through ultrasound and determination of the concentration of estradiol in the blood plasma).
It is recommended to use gonadotropins in the lowest effective doses that meet the goals of therapy.
The first injection of the drug is carried out under the direct supervision of the attending physician.
Some features of the use of Menogon in women:
- With regard to preparation for treatment: before starting therapy, it is necessary to diagnose infertility in the woman and her partner and establish possible contraindications to pregnancy. It is also recommended to conduct an examination for the presence of adrenal cortex insufficiency, hypothyroidism, tumors of the hypothalamic-pituitary region, hyperprolactinemia and, if necessary, prescribe appropriate treatment.
- Regarding the development of OHSS: in case of OHSS, before the introduction of hCG, do not inject hCG and warn the patient about the need to abstain from sexual intercourse or use barrier contraceptives for at least 4 days. Since OHSS can progress rapidly (from 24 hours to several days), patients should be monitored after hCG administration for at least two weeks. In case of pregnancy, OHSS can be more severe and prolonged. OHSS usually develops after discontinuation of gonadotropin therapy, reaching a maximum within 7–10 days. After the onset of menstruation, OHSS usually resolves spontaneously. With polycystic ovary syndrome, the likelihood of OHSS is increased.
- Regarding the development of multiple pregnancies: with menotropin therapy, the risk of multiple pregnancies is higher than with natural conception. To minimize it, careful monitoring of the ovarian response is necessary. In the case of using assisted reproductive technologies, the likelihood of developing multiple pregnancies depends on the patient's age, the number of injected embryos and their quality. The patient should be warned about the potential risk of multiple pregnancy before starting therapy.
- With regard to pregnancy complications: the risk of miscarriage and premature birth is higher in patients treated with gonadotropins than in healthy women. In patients after menotropin therapy, the likelihood of an ectopic pregnancy is approximately 2-3 times higher than in the general population.
- With regard to thromboembolic complications: during or after gonadotropin therapy, patients with risk factors (predisposition, obesity, thrombophilia) have an increased risk of arterial or venous thromboembolic complications. In such cases, the benefit / risk ratio should be assessed. It should be borne in mind that pregnancy itself also increases the risk of developing such complications.
- With regard to congenital malformations: the frequency of congenital malformations of the fetus after the use of assisted reproductive technologies is slightly higher than with natural conception. Perhaps this is due to multiple pregnancies and the individual characteristics of the parents - the characteristics of the sperm, the age of the mother.
The use of Menogon in men with a high concentration of FSH in the blood is impractical. To determine the effectiveness of treatment, it is recommended to carry out a semen analysis 4–6 months after the start of therapy.
Doping tests can show positive results with Menogon treatment.
It is impossible to use the drug as a doping due to the likely health hazard.
The finished solution contains a small amount of sodium - less than 23 mg (1 mmol) per dose.
Application during pregnancy and lactation
The use of Menogon is contraindicated during pregnancy and during breastfeeding.
Pediatric use
There are no indications for the use of Menogon in children and adolescents under 18 years of age.
With impaired renal function
Clinical studies in patients with impaired renal function have not been conducted, therefore, the drug is not recommended to be prescribed to patients with renal diseases.
For violations of liver function
According to the instructions, Menogon is contraindicated in patients with hepatic insufficiency due to lack of clinical experience.
Drug interactions
The interaction of the drug with other drugs has not been studied.
Menogone should not be mixed in the same syringe with other medications.
The combined use of hMG with clomiphene can increase the stimulation of follicular growth.
When used simultaneously with GnRH agonists, an increase in the dose of hMG may be required to achieve an optimal ovarian response.
Analogs
Analogues of Menogon are: Menopausal Gonadotropin, Menopur, Merional and others.
Terms and conditions of storage
Store in a dark place at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of the reach of children.
Shelf life is 3 years. Store the prepared solution for no more than 28 days.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Menogone
At this time, users did not leave reviews about Menogone, by which one could judge any qualities of the drug.
The price of Menogon in pharmacies
The approximate price of Menogon is about 10,000 rubles for a pack of 10 sets.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
