Menopur® (Menopur)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMenotropinsMenotropins
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    • Dosage form: & nbspLyophilizate for solution for injection.
    Composition:1 bottle of lyophilizate contains:
    Active substances: Menotropin 75 ME, which corresponds to 75 ME FSH, 75 ME LH. Excipients: lactose monohydrate 20 mg, polysorbate-20 0.1 mg, sodium hydroxide 0.0008 mg-0.003 mg, hydrochloric acid 0 mg-0.0005 mg.
    1 ampoule solvent (0.9% solution of sodium chloride) contains: sodium chloride 9 mg, hydrochloric acid 0.007 mg - 0.02 mg, water for injection up to 1 ml.
    Description:lyophilizate: white or almost white lyophilized mass; solvent: colorless clear solution.
    Pharmacotherapeutic group:Follicle stimulating agent.
    ATX: & nbsp

    G.03.G.A.02   Gonadotropin-menopausal

    Pharmacodynamics:Menopur® is a preparation of human menopausal gonadotropin (MHC) of high purity. A drug. belongs to the group of menotropins, contains follicle-stimulating and luteinizing hormones in a ratio of 1: 1, obtained by extraction from the urine of women during the postmenopause. Menopur® stimulates the growth and maturation of ovarian follicles, increases the level of estrogen, stimulates the proliferation of the endometrium. Treatment with Menopur® is usually combined with the administration of human chorionic gonadotropin (hCG) preparations to induce the final maturation of follicles and the onset of ovulation.
    Pharmacokinetics:- suction: the maximum concentration of FSH (Cmax) in plasma is reached within 7 hours after subcutaneous or intramuscular injection.
    - distribution: the volume of distribution after repeated doses of 150 IU for 7 days is 8.9 ± 3.5 IU / L for subcutaneous administration and 8.5 ± 3.2 IU / L for intramuscular injection.
    - metabolism: not studied.
    - excretion: the concentration of FSH in the blood decreases gradually. The half-life is 30 ± 11 hours with subcutaneous and 27 ± 9 hours with intramuscular injection. It is excreted mainly by the kidneys.
    Indications:Among women:
    - anovulation in the syndrome of polycystic ovaries (with ineffective clomiphene therapy),
    - Controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technologies (ART).
    In men:
    - stimulation of spermatogenesis in azoospermia or oligoastenospermia caused by primary or secondary hypogonadotropic hypogonadism (in combination with preparations of human chorionic gonadotropin (hCG)).
    Contraindications:- Persistent increase in ovaries, ovarian cyst (not caused by polycystic ovary syndrome);
    - Anomalies in the development of genital organs, uterine fibroids, incompatible with pregnancy;
    - Metrorrhagia and other bleeding of unclear etiology;
    - cancer of the ovaries, uterus and / or breast;
    - prostate cancer, testicular tumor;
    - high concentration of FSH in primary ovarian failure;
    - pregnancy and lactation;
    - tumors of the hypothalamic-pituitary region;
    - androgen-dependent tumors;
    - hypersensitivity to the drug or its components.
    If you have any of these diseases, consult a doctor before taking the drug.
    Carefully:Cm. section "Special instructions".
    Pregnancy and lactation:Menopur® contraindicated in pregnant and lactating women.
    Dosing and Administration:Menopur® may be administered intramuscularly or subcutaneously.The subcutaneous route of administration is preferable, since it provides the greatest absorption of the drug substance. Treatment with the drug should be carried out only under the supervision of a doctor who has the appropriate specialization and experience in treating infertility.
    Recommendations for the preparation of the solution: the injection solution should be prepared immediately before administration, using the supplied solvent. Avoid sudden shaking. The solution is not suitable for use if it contains undissolved particles or it is opaque. The dose of the drug described below is the same for both the subcutaneous and intramuscular route of administration.
    The dose should be selected individually depending on the response of the ovaries. For this purpose, it is necessary to monitor the ovarian response to the therapy in the form of an ultrasound study separately, and preferably, in combination with a dynamic measurement. the concentration of estradiol.
    In women, unless otherwise prescribed, the following treatment regimen is recommended:
    - Anovulation (including polycystic ovary syndrome):
    The purpose of treatment with Menopur® is the development of a mature follicle, from which, after the administration of HCG preparations, the oocyte will be released.
    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 ovarian response, the dose is gradually increased by 37.5 IU no more frequently than 1 time per week before the registration of an increase in estrogen levels in the blood or the growth of follicles, but no more than 75 ME. The maximum daily dose should not exceed 225 IU. If the therapeutic response is not reached within 4 weeks, discontinue treatment and start a new cycle with higher initial doses. Patients are advised to use barrier methods of contraception before the next menstrual period.
    If the optimal response to the therapy is achieved, a single injection of 5000 to 10,000 IU hCG should be made the day after the last dose of Menopur®. The patient is recommended to have sex or an intrauterine insemination procedure on the day of HCG administration and the day after the introduction.
    - To stimulate the growth of multiple follicles during assisted reproductive technologies (ART) Menopur® should be prescribed approximately 2 weeks after the start of treatment with agonists gonadotropin-releasing hormone (GnRH). The recommended initial daily dose of Menopur® is 150-225 IU during the first 5 days of treatment.
    In the absence of ovarian response, 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 ME, in most cases should not be administered more than 20 days.
    If the treatment regimen does not presuppose the use of GnRH agonists, the administration of Menopur® should be started on the 2nd or 3rd day of the menstrual cycle. The method of administration and the same doses of the preparation as described above are recommended. When an optimal response to the therapy is achieved, a single injection of 10,000 IU hCG should be made to induce the final ripening of the follicle and prepare the exit of the full egg. Patients should be monitored carefully within two weeks after the administration of hCG. When overreaction to treatment with Menopur® Therapy should be discontinued, the hCG should be discontinued and barrier methods of contraception should be used before the next menstrual period.
    In men, unless otherwise prescribed, the following treatment regimen is recommended:
    at hypogonadotropic hypogonadism for stimulation of spermatogenesis preparation Menopur® is prescribed if previous therapy with HCG preparations caused only an androgenic reaction without signs of increased spermatogenesis.
    In this case, the treatment is continued by the introduction of 2000 IU hCG 2 times a week along with injections of Menopur® 75 IU 3 times a week. Treatment for this regimen should be continued for at least 4 months, if ineffective, the treatment is continued by injecting a 2,000 IU hCG drug 2 times a week and 150 IU of Menopur® 3 times a week.
    The state of spermatogenesis should be assessed on a monthly basis, and if there are no positive results within the next 3 months, treatment should be discontinued.
    With idiopathic normogonadotropic oligospermia, 5000 ME HCH and 75-150 ME of Menopur® 3 times a week for 3 months, for stimulation of spermatogenesis, 1000-3000 IU hCG is administered 3 times a week to normalize testosterone concentration in the blood. After that, for several months 3 times a week for 75-150 ME of Menopur preparation®.
    Side effects:

    Often (from> 1/100 to <1/10)

    From the urine-reproductive system

    Ovarian hyperstimulation syndrome (OCS), abdominal pain.

    From the nervous system

    headache

    From the digestive system

    abdominal pain, nausea, flatulence

    General reactions and reactions at the site of administration

    Pain, swelling and irritation at the injection site
    Men can have gynecomastia. The most serious side effect is ovarian hyperstimulation syndrome and complications associated with it: thromboembolic syndrome and ovarian twisting.
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:Cases of overdose are unknown, however, in such situations, development of HNS and thromboembolic complications should be expected. Symptoms of CHD - ovarian enlargement, abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, dyspnea - usually do not require additional treatment and go on independently for 2-3 weeks. For details, see "Special instructions".
    Interaction:The drug should not be mixed in the same syringe with other medicines!
    Joint use of Menopur® and clomiphene citrate may lead to increased follicular growth, although there is no clinical evidence for the combined use of these drugs. When appointing GnRH agonists to reduce their own pituitary activity, you should appoint Menopur® in higher doses to achieve the desired response of follicles.
    Special instructions:Before the start of treatment, it is recommended to perform an analysis of the sperm of the sexual partner; if necessary, to treat hypothyroidism, insufficiency of the adrenal cortex, hyperprolactinaemia, pituitary tumors or hypothalamus. Gynecological examination with an increase in the ovaries is carried out very carefully to avoid rupture of the ovarian cysts.
    After stimulation of maturation of follicles and ovulation, the possibility of multiple pregnancy during natural conception increases. In the case of ART, the likelihood of multiple pregnancies depends on the number of oocytes administered.
    It should be borne in mind the possibility of an ectopic pregnancy,especially in diseases of the fallopian tubes in the anamnesis. Frequency of early and spontaneous abortions in pregnancy after treatment with Menopur®, higher than in healthy patients, but comparable to that of infertility of another etiology.
    The relationship between the use of Menopur® and the emergence or development of benign or malignant neoplasms of reproductive organs.
    The frequency of congenital anomalies in neonates during ART is slightly higher than in conception by natural means. However, this is more likely due to the individual characteristics of the parents (age, sperm characteristics, etc.) than with the drug Menopur®.
    It should be remembered that in patients with a body mass index> 30 kg /m2 the risk of thromboembolic complications increases.
    Treatment with drugs of menotropins can lead to the development of the ovarian hyperstimulation syndrome (OSS), which becomes clinically pronounced after the administration of HCG preparations and is manifested in the formation of large ovarian cysts. This is combined with the accumulation of fluid in the abdominal cavity (ascites), pleural cavity (hydrothorax),is accompanied by a decrease in the volume of excreted urine (oliguria), a decrease in blood pressure (hypotension), and clotting of blood vessels (thromboembolic phenomenon). Most often, CHD occurs on the 7-10th day after ovulation, stimulated by the introduction of hCG, (less often - during ART).
    At the first signs of OHV (abdominal pain, palpated by a doctor or ultrasound-defined volume formations in the lower abdomen), treatment should be stopped immediately!
    In the presence of pregnancy, the above-described phenomena become aggravated, and their duration increases, which can threaten the life of the patient.
    In cases of development of HNS, it is not necessary to administer a drug of HCH for the purpose of ovulation. When carrying out ART, the risk of an OHR may be reduced if aspirates the contents of all follicles before ovulation.
    In the period of treatment in men with a high concentration in the blood of FSH menotropins ineffective.
    Menopur® does not adversely affect the ability to drive and other mechanisms.
    Form release / dosage:Lyophilizate for solution for injection.
    Packaging:Vial with lyophilizate: 75 I of the lyophilizate into a vial of colorless glass type 1, sealed with a rubber stopper with aluminum rolling and a flip-off type cover.
    Ampoule with solvent: 1 ml of solution into ampoules of colorless glass type 1 with possible color coding as a color point and / or one or several rings.
    5 vials of lyophilizate and 5 ampoules of the solvent into the contour cell package. One or two packagings with instructions for use in a cardboard box.
    Storage conditions:At a temperature of no higher than 25 ° C.
    Do not freeze.
    The finished solution should not be stored for more than 28 days at a temperature of no higher than 25 ° C. Unused solution must be disposed of.
    Keep out of the reach of children.
    Shelf life:Lyophilizate: 2 years.
    Solvent: 3 years.
    Do not use after the expiration date stated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015764 / 01
    Date of registration:19.05.2009 / 11.09.2012
    Expiration Date:Unlimited
    The owner of the registration certificate: Ferring GmbH Ferring GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFERRING PHARMACEUTICALS LLCFERRING PHARMACEUTICALS LLCRussia
    Information update date: & nbsp2016-08-24
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