Menopur 75ME lyof powder for solution + solvent N 10

Packaging, release form

Menopur is available in bottles with powder and ampoules with a solvent (saline solution, sterile water).

Three formats of FSH and LH dosages in a bottle are available:

• 75 IU (international units).
• 600 IU.
• 1200 IU.

Auxiliary components:

• lactose;
• sodium hydroxide;
• polysorbate 20;
• hydrochloric acid.

You can purchase a package of Menopur containing 5 or 10 bottles with 2 mg of dry substance and, accordingly, ampoules with 1 ml of injection water. In a drug with a dosage of 600 IU and 1200 IU, instead of ampoules, there may be syringes with a ready-made solvent.

Compound

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.

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

Menopur is indicated for the treatment of infertility using reproductive technologies, most often IVF or ICSI.

Designated for the following purposes:

• stimulation of follicular growth in women with ovarian failure (hypogonadotropic, normogonadotropic);
• stimulation of sperm production and formation in case of insufficient or normal production of steroids.

The drug can be used for:

• decreased fertility after improper hormonal stimulation of the gonads;
• anovulatory cycles;
• insufficiency of the corpus luteum when other medications are ineffective;
• hypogonadism caused by the administration of GnRH agonists in women with polycystic syndrome;
• some disorders of spermatogenesis;
• for controlled hyperstimulation.

The drug is prescribed exclusively by a doctor and used under medical supervision. Individually, the gynecologist selects the dosage, regimen, and duration of therapy. You cannot adjust the assignments yourself.

Synonyms of nosological groups

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

Contraindications

Menopur is not used for:

• various tumors of the reproductive organs;
• fibroids;
• breast cancer;
• neoplasms of the pituitary gland;
• growth of ovarian cysts not associated with polycystic disease;
• congenital defects of the genital organs;
• gestational period;
• lactation;
• early menopause;
• prostate or testicular cancer in men.

Due to its low effectiveness, the drug is not used for conditions in which pregnancy is impossible: uterine fibroids, abnormalities of the reproductive organs.

Possible side effects:

• abdominal pain;
• bloating;
• dyspeptic disorders (vomiting, loose stools);
• weight gain;
• dyspnea;
• skin rash;
• decrease in the amount of urine.

It is extremely rare that signs of hyperstimulation occur with an overdose of the drug.

Instructions for administering the drug "Menopur"

Daily dose of Menopur for IVF

the standard is 75 IU or 150 IU. Treatment occurs under the control of estrogen levels over time. For this purpose, ultrasound and/or clinical blood tests are used.

If there is no increase in hormone levels, the dosage is increased until the levels begin to increase and reach the preovulatory level, after which the drug is stopped. With a rapid increase in estrogen, the dose is reduced. To further stimulate ovulation, hCG 5000–10,000 IU is administered. Over the next 9 days, 3 consecutive injections of hCG 5000 IU are given. The use of choriotropin helps prevent the development of corpus luteum insufficiency.

At the IVF stage, follicular growth is stimulated with the help of Menotropin alone, 75–300 IU daily. Or in combination with gonadotropin-releasing factor agonists or clofimene. Before puncture of the follicle, an injection of hCG is given.

Men are given Menotropin 75 IU every day or 2-3 injections per week in combination with human chorionic gonadotropin 1000-2000 IU. The duration of the course aimed at improving spermatogenesis is up to three months. During treatment, hormone replacement therapy (testosterone) is discontinued. If the process of sperm formation has improved, then the patient is given maintenance doses of hCG.

The injection is given subcutaneously in the abdominal area. You need to mix the solvent with the powder in one bottle. Fill the syringe with the resulting clear solution and inject into the skin fold. Press the puncture with a swab containing alcohol. It is advisable to change the injection site daily. Usually the first injection is given by a health worker in a clinic, the rest - at home independently after thorough medical instructions.

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.

The development of side effects when taking Menopur

In most cases, side effects occur after discontinuation of the drug and manifest themselves in the form of headache, nausea, flatulence, and pain at the injection site. Men often experience enlarged mammary glands. Among all the side effects, the most dangerous and undesirable is ovarian hyperstimulation syndrome, which will manifest itself not only by an increase in the size of the ovaries, but also by abdominal pain, nausea, vomiting and loose stools. The most severe complications will include symptoms of hydrothorax (fluid in the chest), ascites (in the abdomen), and bleeding disorders.