Menopur lyophilizate solution for injection 75 IU + solvent vials, 10 pcs.

Composition

Active ingredient:

menotropins 75 ME, which corresponds to 75IU FSH,75IU LH;

Auxiliary substances:

lactose monohydrate-20 mg;

polysorbate-20-0.1 mg;

sodium hydroxide 0.0008-0.003 mg;

hydrochloric acid 0-0,0005 mg;

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

Pharmacological action

Menopur – gonadotropic.

Pharmacodynamics

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

Pharmacokinetics

Suction. _{Cmax of}FSH in plasma is reached within 7 hours after subcutaneous or intramuscular administration.

Distribution. VD after repeated doses of 150 IU for 7 days is 8.9±3.5 IU / l with subcutaneous administration and 8.5±3.2 IU / L with intravenous administration.

Metabolism. Not studied.

Output. The concentration of FSH in the blood decreases gradually. T_1/2 is (30±11) h for subcutaneous administration and (27± 9) h for intravenous administration. It is mainly excreted by the kidneys.

Indications

For 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 oligoastenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with hCG preparations).

Contraindications

• persistent ovarian enlargement, ovarian cysts (not due to polycystic ovarian syndrome);
• malformations of the reproductive organs, myoma of the uterus incompatible with pregnancy;
• metrorrhagia and other bleeding of unknown etiology;
• cancer of the ovaries, uterus and/or breast cancer;
• prostate cancer, testicular cancer;
• high concentration of FSH in primary ovarian failure;
• pregnancy and lactation;
• tumors of the hypothalamic-pituitary region;
• androgenization tumor;
• hypersensitivity to the drug or its components.

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

Side effects

From the genitourinary system: ovarian hyperstimulation syndrome (OHSS), lower abdominal pain.

Nervous system disorders: headache.

From the digestive system: abdominal pain, nausea, flatulence.

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

Interaction

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

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

When prescribing agonists GnRH to reduce the pituitary gland’s own activity should be prescribed Menopur® in higher doses to achieve the desired response of the follicles.

How to take, course of administration and dosage

In / m or p / K. The subcutaneous method of administration is preferable, because it provides the greatest absorption of the drug substance. Treatment with the drug should only be carried out under the supervision of a doctor who has the appropriate specialization and experience in infertility treatment.

Recommendations for preparing the solution: the solution for injection should 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 administration.

The dose should be selected individually, depending on the ovarian response. To do this, it is necessary to monitor the ovarian response to the therapy performed 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 to develop one mature follicle, from which an oocyte will emerge after administration of hCG preparations. Treatment usually begins in the first 7 days of the menstrual cycle with a dose of 75-150 IU (1-2 vials of the drug) per day for a week. In the absence of an ovarian reaction, the dose is gradually increased by 37.5 IU no more than once a week until an increase in the level of estrogens in the blood or follicle growth is recorded, but not more than 75 IU.

The maximum daily dose should not exceed 225 IU. If the therapeutic response is not achieved within 4 weeks, treatment should be discontinued and a new cycle should be started with higher initial doses. Patients are advised to use barrier methods of contraception before the next menstrual period. If optimal response is achieved, a single injection of 5000-10000 IU hCG should be given on the day following the last dose of Menopur®. The patient is recommended to have sex or perform an intrauterine fertilization procedure on the day of hCG administration and the next 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 for the first 5 days of treatment. In the absence of an ovarian reaction, the dose may gradually increase. The dose change 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 involve the preliminary use of agonists GnRH, 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 that were 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 for the release of a full-fledged egg. Patients should be carefully monitored for 2 weeks after hCG administration. If there is an overreaction to treatment with Menopur®, therapy should be discontinued, hCG should not be administered, and barrier methods of contraception should be used until the next menstruation occurs.

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

In hypogonadotropic hypogonadism, Menopur®is prescribed to stimulate spermatogenesis if previous therapy with hCG caused only an androgenic reaction without signs of increased spermatogenesis. In this case, treatment is continued by administration of 2000 IU hCG 2 times a week together with injections of Menopur® 75 IU 3 times a week.

Treatment according to this scheme should be continued for at least 4 months, if ineffective, treatment is continued by injecting hCG at 2000 IU 2 times a week, and 150 IU of Menopur® 3 times a week. The state of spermatogenesis should be evaluated monthly, and if there are no positive results within the next 3 months, treatment should be discontinued.

In 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 that, for several months,75-150 IU of Menopur®3 times a week.

Overdose

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

Symptoms of OHSS include ovarian enlargement, lower abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, and shortness of breath

Treatment: they usually do not require additional treatment and pass independently within 2-3 weeks. For more information, see the “Special Instructions”section.

Special instructions

Before starting treatment, it is recommended to analyze the sperm of the sexual partner; if necessary, treat hypothyroidism, adrenal insufficiency, hyperprolactinemia, pituitary or hypothalamic tumors. Gynecological examination with enlarged ovaries 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 probability of multiple pregnancies depends on the number of injected oocytes.

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

No association 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 when conceived naturally. However, this is more likely due to the individual characteristics of the parents (age, sperm characteristics, etc. ) than to the drug 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 menotropins can lead to the development of OHSS, which becomes clinically pronounced after the introduction 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 released (oliguria), a decrease in blood pressure (hypotension) and blockage of blood vessels (thromboembolic phenomenon). Most often, OHSS occurs on the 7th-10th day after ovulation, stimulated by the introduction of hCG, (less often – during ART).

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

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

In cases of OHSS, HCG should not be administered for the purpose of ovulation. When performing ART, the risk of OHSS can be reduced if the contents of all follicles are aspirated before ovulation occurs.

Menotropins are ineffective during treatment in men with high blood concentrations of FSH.

Menopur® does not adversely affect the ability to drive a car or other mechanisms.

Form of production

Lyophilizate for the preparation of a solution for intramuscular administration

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Menotropins

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as directed by your doctor

Indications

Infertility Treatment

Weight

Weight: 124 gr.