Menopur Multidose, lyophilizate 1200 me fsg+1200 me lg

In women:

– Anovulation (including polycystic ovarian syndrome (PCOS) when clomiphene therapy is ineffective).

– Controlled ovarian hyperstimulation for the induction of multiple follicle growth in assisted reproductive technology (BPT).

In men:

– Stimulation of spermatogenesis in azoospermia or oligoasthenospermia due to primary or secondary hypogonadotropic hypogonadism (in combination with preparations of human chorionic gonadotropin (hCG).

Active ingredient

How to take, the dosage

The drug is used as monotherapy or in combination with other ovulation stimulants.

Menopur® Multidose is given by intramuscular or subcutaneous injection with periodic change of site of administration. The subcutaneous route of administration is preferred because it provides the greatest absorption of the drug. The doses of the drug described below are for FSH and are the same for both the subcutaneous and intramuscular routes of administration.

In women, the dose of the drug is set individually depending on the response of the ovaries. This requires monitoring the response of the ovaries to therapy in the form of an ultrasound examination (USG) alone, and preferably in combination with dynamic measurement of estradiol concentration.

Anovulation (including polycystic ovarian syndrome (PCOS) when clomiphene therapy has failed)

The treatment with Menopur® Multidose begins in the first 7 days of the menstrual cycle. The recommended starting dose is 75-150 IU/day for at least 7 days. If there is no ovarian reaction, the dose is gradually increased (no more than once every 7 days) until an increase in blood oestrogen concentration or follicle growth is recorded. The recommended booster dose is 37.5 IU, but no more than 75 IU. The maximum daily dose should not exceed 225 IU. If therapeutic effect is not achieved within 4 weeks of treatment, Menopur® Multidose injections are stopped and a new cycle is started with a higher dose. Patients are advised to use barrier methods of contraception or abstain from sexual intercourse until menstruation.

If there is a therapeutic effect the day after the last injection of Menopur Multidose, 5 000-10 000 IU of hCG are injected once for the induction of ovulation. Patients are advised to have sexual intercourse on the day of hCG injection and the day after the injection. Intrauterine insemination is an alternative method.

If there is an excessive reaction, Menopur® Multidose should be discontinued, the hCG infusion stopped, and the patient should use barrier contraception or abstain from sexual intercourse until her period starts.

Controlled ovarian hyperstimulation for the induction of multiple follicle growth in assisted reproductive technology (BPT).

Menopur® Multidose should be started about 2 weeks after starting GnRH agonist therapy for BPT in combination with GnRH agonists. The recommended starting dose of Menopur® Multidose is 150-225 IU/day daily for at least 5 days. If there is no ovarian response, the dose may be gradually increased. The recommended booster dose is 150 IU. The maximum daily dose should not exceed 450 IU. If no therapeutic effect is achieved within 20 days, further administration of Menopur® Multidose is not recommended.

If the treatment regimen does not presume prior use of GnRH agonists, Menopur® Multidose should be started on the 2nd or 3rd day of the menstrual cycle. The dosing regimen is the same.

When the desired number of mature follicles has been reached, 10,000 IU of hCG is administered once to induce final follicular maturation and to prepare the release of a complete egg. The patient should be closely monitored by a physician for two weeks after the hCG injection due to the possible development of ovarian hyperstimulation syndrome (OHSS).

If there is an excessive reaction, Menopur® Multidose should be stopped, the hCG injection stopped, and the patient should use a barrier method of contraception or abstain from sexual intercourse until her period is due.

In male hypogonadotropic hypogonadism Menopur® Multidose is indicated for spermatogenesis if previous therapy with hCG has caused only an androgen response without evidence of increased spermatogenesis. In this case, treatment is continued with 2000 IU of hCG twice weekly in combination with Menopur® Multidose injections 75 IU three times weekly. Treatment should be continued for at least 4 months on this regimen; if it fails, treatment should be continued with 2 IU of hCG twice weekly and Menopur® Multidose 150 IU three times weekly.

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 IU hCG weekly and 75-150 IU of Menopur® Multidose 3 times weekly for 3 months.

In order to stimulate spermatogenesis we administer 1000 to 3000 IU of hCG three times a week until normalization of the testosterone concentration in blood. After that 75 to 150 IU of Menopur® Multidose is given three times a week for several months.

Instructions for preparing the solution:

The solution for injection is prepared using the solvent provided. Menopur® Multidose must not be mixed with other medicines in the same syringe! The ready-to-use solution can be used for up to 28 days.

1. Remove the plastic cap from the lyophilizate bottle. Attach the solution preparation needle to the syringe with the solvent and remove the protective cap.

2. Slowly inject the solvent into the vial.

The vial has to be held vertically.

3. Gently stir the contents of the bottle in a circular motion until a clear solution is obtained. It usually dissolves in 1-2 minutes. Do not shake! Do not use the solution if there are undissolved particles or color changes!

4. draw the desired amount of solution into the syringe for injection.

5. Wipe the injection site with an alcohol wipe, remove any air bubbles from the syringe and inject the product.

Interaction

Special Instructions

The treatment must be performed under the supervision of a physician experienced in infertility treatment.

The first injection of the drug must be done under the direct supervision of a physician.

The ovaries should be evaluated with an ultrasound scan or blood estradiol concentrations before Menopur® Multidose is prescribed. These tests should be performed daily or every other day for the duration of treatment. Close monitoring of the patient’s condition is an integral part of the treatment.

We recommend screening for hypothyroidism, adrenal insufficiency, hyperprolactinemia, pituitary or hypothalamic tumors; and appropriate specific treatment before starting Menopur® Multidose.

SGYA

SGYA is a syndrome distinct from uncomplicated ovarian enlargement, whose manifestations vary in severity. It includes significant ovarian enlargement, high serum estrogen concentrations, and increased vascular permeability, which may lead to fluid accumulation in the abdominal, pleural and, less frequently, pericardial cavities. In severe cases of SUI, the following symptoms are observed: abdominal pain, abdominal bloating, significant ovarian enlargement, weight gain, shortness of breath, oliguria, and gastrointestinal symptoms, including nausea, vomiting, and diarrhea. On clinical examination, hypovolemia, hemoconcentration, electrolyte disturbances, ascites, hemoperitoneum, exudative pleurisy, hydrothorax, acute respiratory distress, and thromboembolic complications may occur.

The overreaction of the ovaries to gonadotropin administration rarely results in SVF unless hCG is administered to stimulate ovulation. Therefore, in cases of ovarian hyperstimulation, hCG should not be administered, and the patient should be warned to abstain from intercourse or use barrier methods of contraception for at least 4 days. HCG can progress rapidly (within 24 hours to days), becoming a serious medical complication, so patients should be monitored for at least 2 weeks after hCG administration. Adherence to the recommended doses of Menopur® Multidose, the administration regimen, and close monitoring of therapy can minimize cases of ovarian hyperstimulation and multiple pregnancies. For ART, aspiration of all follicle contents prior to ovulation may reduce the risk of IUF.

SGF can be more severe and prolonged in the development of pregnancy. Most commonly, SGY develops after discontinuation of gonadotropin treatment and peaks in severity within 7-10 days of the end of treatment. Typically, SGN resolves spontaneously after the onset of menstruation.

If severe SVF develops, the patient is hospitalized and specific therapy is started.

HFH occurs with high frequency in patients with polycystic ovarian syndrome.

Multiple pregnancies

Multiple pregnancies have an increased risk of adverse maternal and perinatal outcomes. Multiple pregnancies are more common with the use of menotropins than with natural conception. In the case of in vitro fertilization (IVF), the likelihood of a multiple pregnancy depends on the number of embryos injected, their quality and the age of the patient. The patient should be warned about the potential risk of multiple pregnancies before starting treatment.

Pregnancy complications

The rate of spontaneous abortions in pregnancies after treatment with Menopur® Multidose is higher than in healthy women.

Ectopic pregnancy

Women with a history of fallopian tube disease, whether they conceive naturally or are treated for infertility, have a high risk of ectopic pregnancy. The prevalence of ectopic pregnancy after IVF is 2 to 5% compared with 1 to 1.5% in the general population.

Reproductive system neoplasms

There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It has not yet been determined whether gonadotropin treatment increases the baseline risk of these tumors in women with infertility.

Congenital malformations

The prevalence of congenital fetal malformations with ART is slightly higher than with natural conception. This is thought to be due to the individual characteristics of the parents (age of the mother, characteristics of the sperm) and multiple pregnancies.

Thromboembolic complications

Women with known risk factors for thromboembolic complications, such as individual or familial predisposition, obesity (body mass index > 30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic complications during or after gonadotropin treatment. In such cases, the benefits of their use should outweigh the risks. Note that pregnancy itself also increases the risk of thromboembolic complications.

In men with high FSH concentrations in the blood (indicative of primary hypogonadism) Menopur® Multidose is generally ineffective.

Influence on driving and operating ability

There have been no studies of the effect of menotropins on driving and operating ability. Menopur® Multidose has no effect on driving and operating machinery.

Contraindications

Hypersensitivity to menotropins and other components of the drug; pituitary or hypothalamic tumors; decompensated hypothyroidism, adrenal insufficiency, hyperprolactinemia; children under 18 years of age.

In women:

– persistent ovarian enlargement, ovarian cysts (not caused by polycystic ovary syndrome);

– Genital abnormalities incompatible with pregnancy;

– uterine fibroids incompatible with pregnancy;

– vaginal bleeding of unknown etiology;

– estrogen-dependent tumors (ovarian cancer, uterine cancer, or breast cancer);

– high FSH concentrations in primary ovarian failure;

– pregnancy and breastfeeding.

In men:

– androgen-dependent tumors (prostate cancer, testicular tumor).

If you have any of the above conditions, be sure to consult your doctor before taking the drug.

With caution if you have risk factors for thromboembolism, such as individual or familial predisposition, obesity (body mass index > 30 kg/m2), or thrombophilia.

Side effects

Overdose