Menopur, lyophilizate 75 me fsg+75 me lg 10 pcs

Menopur is a gonadotropic.

Pharmacodynamics

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

Pharmacokinetics

Intake. C_max FSH in plasma is reached within 7 h after p/u or i/m administration.

Distribution. V_d after repeated doses of 150 ME for 7 days is 8.9±3.5 IU/L when administered p/q and 8.5±3.2 IU/L when administered v/m.

Metabolism. Not studied.

Exhaustion. FSH concentration in blood decreases gradually. T_1/2 is (30±11) h when administered by injection and (27±9) h when administered by injection. It is excreted mainly by the kidneys.

Indications

In women:

In men:

Active ingredient

Composition

Active substance:

Menotropins75 ME, which corresponds to 75 ME FSH, 75 ME LH;

Associates:

Lactose monohydrate, 20 mg;

Polysorbate-20, 0.1 mg;

Sodium hydroxide 0.0008-0.003 mg;

Hydrochloric acid 0-0.0005 mg;

A ampoule of solvent (0.9% sodium chloride solution):

Sodium chloride 9 mg,

hydrochloric acid 0.007 mg – 0.02 mg;

water for injection – up to 1 ml

How to take, the dosage

V/m or p/k. Subcutaneous method of administration is preferred because it provides the greatest absorption of the drug substance. Treatment with the drug should be carried out only under the supervision of a physician who has the appropriate specialization and experience in the treatment of infertility.

Recommendations for preparation of the solution: The solution for injection should be prepared immediately before injection using the solvent provided. Shaking the solution vigorously should be avoided. The solution is not suitable for use if it contains undissolved particles or is opaque. The dosage described below is the same for both subcutaneous and intramuscular routes of administration.

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

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

Anovulation (including polycystic ovarian syndrome):

The goal of treatment with Menopur® is to develop a single mature follicle from which an oocyte will emerge after hCG administration. Treatment is usually started in the first 7 days of the menstrual cycle with a dose of 75-150 ME (1-2 vials of the drug) per day for a week. In the absence of ovarian reaction, the dose is gradually increased by 37.5 ME no more than once a week until an increase in blood estrogen levels or follicle growth is recorded, but no more than 75 ME.

The maximum daily dose should not exceed 225 ME. If a therapeutic response is not achieved within 4 weeks, treatment should be discontinued and a new cycle should be started with higher starting doses. Patients are advised to use barrier methods of contraception until their next menstruation. If optimal response to therapy is achieved, a single injection of 5000-10000 ME hCG should be given the day after the last dose of Menopur®. The patient is advised to have sexual intercourse or an IUI on the day of hCG injection and the day after the injection.

In order to induce multiple follicle growth with HRT, Menopur® should be given approximately 2 weeks after starting treatment with a GnRH agonist. The recommended starting daily dose of Menopur® is 150-225 ME for the first 5 days of treatment. If there is no ovarian response, the dose may be gradually increased. Dose changes should not exceed 150 ME at a time. The maximum daily dose of Menopur® should not exceed 450 ME and in most cases should not be administered for more than 20 days. If there is no prior GnRH agonist regimen, Menopur® should be started on day 2 or 3 of the menstrual cycle.

The route of administration and the same doses of the drug as described above are recommended. When an optimal response to the ongoing therapy is achieved, a single injection of 10000 ME hCG should be given to induce final follicle maturation and prepare for the release of a complete egg. Patients should be closely monitored for 2 weeks after hCG administration. If there is an overreaction to Menopur® treatment, therapy should be discontinued, hCG should be stopped and barrier contraception should be used until the next menstruation.

In men, unless otherwise prescribed, the following regimen is recommended:

In hypogonadotropic hypogonadism for stimulation of spermatogenesis, Menopur® is indicated if prior therapy with hCG drugs has caused only an androgenic response without evidence of increased spermatogenesis. In this case, treatment is continued by administering 2,000 ME hCG twice weekly along with Menopur® injections of 75 ME three times weekly.

The treatment should be continued under this regimen for at least 4 months, and if it fails, treatment should be continued with 2,000 ME of hCG twice weekly and 150 ME of Menopur® three times a week. The state of spermatogenesis should be assessed monthly, and treatment should be discontinued if there are no positive results within the next 3 months.

In idiopathic normogonadotropic oligospermia, 5000 ME hCG weekly and 75-150 ME of Menopur® 3 times weekly for 3 months.

To stimulate spermatogenesis, 1000-3000 ME hCG is administered 3 times a week until blood testosterone concentrations normalize. After that, Menopur® is given 75-150 ME three times a week for several months.

Interaction

The drug should not be mixed with other drugs in the same syringe.

The combined use of Menopur® and clomiphene citrate may lead to increased follicular growth, although there are no clinical data on the combined use of these drugs.

When prescribing GnRH agonists to reduce pituitary intrinsic activity, Menopur® should be given at higher doses to achieve the desired follicular response.

Special Instructions

Before starting treatment, semen analysis of the sexual partner is recommended; treatment of hypothyroidism, insufficiency of the adrenal cortex, hyperprolactinemia, pituitary or hypothalamic tumors, if necessary. Gynecological examination in case of ovarian enlargement is performed very carefully to avoid rupture of ovarian cysts.

After stimulation of follicle maturation and ovulation, the possibility of a multiple pregnancy with natural conception increases. In the case of ART, the probability of a multiple pregnancy depends on the number of oocytes injected.

Particularly with a history of fallopian tube disease, the possibility of ectopic pregnancy should be kept in mind. Rates of early and spontaneous abortions after Menopur® treatment are higher compared to non-affected women, but they are comparable to rates of infertility of other etiologies.

The use of Menopur® has not been found to be associated with the occurrence or development of benign or malignant reproductive neoplasms.

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

Patients with a body mass index ≥30 kg/m2 are at increased risk of thromboembolic complications.

The treatment with menotropin drugs can lead to the development of SUI, which becomes clinically pronounced after the administration of hCG drugs and is manifested by the formation of large ovarian cysts. It is combined with the accumulation of fluid in the abdominal cavity (ascites), pleural cavity (hydrothorax), accompanied by a decrease in urine output (oliguria), a decrease in blood pressure (hypotension) and blood vessel occlusion (thromboembolic phenomenon). The most common occurrence of SUI is on day 7-10 after ovulation stimulated by hCG administration (less common with HRT).

At the first signs of SUI (abdominal pain, palpable or ultrasound-detectable masses in the lower abdomen), treatment should be stopped immediately!

The symptoms described above are exacerbated in the presence of pregnancy, and they increase in duration, which may be life-threatening for the patient.

In cases of CGY, you should not administer hCG to ovulate. In cases of HRT, the risk of SVF may be reduced if the contents of all follicles are aspirated before ovulation occurs.

In men with high FSH concentrations in the blood, menotropins are ineffective during treatment.

Menopur® does not adversely affect the ability to drive or operate machinery.

Contraindications

Side effects

Urogenital system disorders: ovarian hyperstimulation syndrome (OHS), lower abdominal pain.

Nervous system disorders: headache.

Gastrointestinal system: abdominal pain, nausea, flatulence.

General reactions and reactions at the injection site: pain, swelling and irritation at the injection site.

Overdose

Symptoms: cases of overdose are unknown, but in such situations, the development of SHF and thromboembolic complications should be expected.

Symptoms of SGBV are enlarged ovaries, lower abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, shortness of breath

Treatment: usually does not require additional treatment and resolves itself within 2-3 weeks. For more information, see Special Precautions.