Active substanceFoliotropin alfaFoliotropin alfa
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  • GONAL-f®
    solution PC 
    Merck Serono Juorope Limited     United Kingdom
  • GONAL-f®
    lyophilizate PC 
  • Foliotrop®
    lyophilizate w / m PC 
    Al Gee Life Senses Ltd     The Republic of Korea
  • Dosage form: & nbsplIofilizate for the preparation of solution for intramuscular and subcutaneous administration
    Composition:
    1 bottle contains:
    Active substance: follitropin alfa-75 ME; Excipients: sucrose, trometamol, sodium hydroxide, hydrochloric acid.
    Solvent: sodium chloride, polysorbate-20, water for injection.

    Description:
    Lyophilized mass (lyophilizate) of white or almost white color.
    Solvent: Clear, colorless liquid.

    Pharmacotherapeutic group:Follicle stimulating agent
    ATX: & nbsp

    G.03.G.A   Gonadotropins

    G.03.G.A.05   Foliotropin alfa

    Pharmacodynamics:
    FOLLITROP® - recombinant human follicle-stimulating hormone (r-hFSH) - is a drug that stimulates the growth and development of follicles. The preparation is obtained by genetic engineering on the culture of Chinese hamster ovary cells. Has gonadotropic action: stimulates the growth and maturation of the follicle / follicles, promotes the development of several follicles during controlled ovarian hyperstimulation, including for assistive reproductive technologies.
    It has also been shown that in women with depressed secretion
    endogenous gonadotropins, follitropin alfa effectively stimulates the development of follicles and steroidogenesis, despite the inaccessible to measure a small level of luteinizing hormone (LH).

    Pharmacokinetics:
    When administered subcutaneously, the absolute bioavailability is approximately 70%. After repeated injections of FOLLITROP®, there is a triple cumulation of the drug in the blood compared to a single injection. The steady-state equilibrium concentration in the blood is reached within 3-4 days.
    After intravenous administration follitropin alfa is defined in extracellular fluids, with an initial half-life of approximately 2 hours from the body, whereas the final half-life is approximately 24 hours. The magnitude of the equilibrium volume of distribution is 10 liters, the total clearance is 0.6 liters / hour. One eighth of the administered dose of follitropin alfa is excreted by the kidneys.

    Indications:
    • Anovulation (including polycystic ovary syndrome) in women in the case of previous clomiphene therapy failure;
    • Controlled ovarian hyperstimulation in the programs of assisted reproductive technologies;
    • Ovarian stimulation in women with severe deficiency of follicle-stimulating and luteinizing hormones (in combination with a luteinizing hormone preparation).

    Contraindications:
    Hypersensitivity to the drug or excipients, hypothalamic-pituitary tumors.
    Pregnancy, voluminous neoplasms or ovarian cysts (not caused by the syndrome of polycystic ovaries), uterine bleeding of unclear etiology, ovarian cancer, uterine cancer, breast cancer.
    The drug should not be prescribed: with anomalies in the development of genital organs and uterine fibroids that are not compatible with pregnancy, primary ovarian failure, premature menopause.

    Carefully:
    In patients with porphyria, as well as in the presence of porphyria in relatives, careful monitoring is required during FOLLITROP® therapy. If the condition worsens or the first signs of this disease appear, it may be necessary to stop therapy.

    Pregnancy and lactation:
    During pregnancy and breastfeeding, FOLLITROP® is not prescribed.

    Dosing and Administration:
    Enter subcutaneously or intramuscularly.
    The dry substance is dissolved in the applied solvent immediately before use. In 1 ml of solvent dissolve the contents of not more than three vials of the preparation, which allows to reduce the injected volume of injection.
    With anovulation (including polycystic ovary syndrome) in women in the case of previous treatment with clomiphene (with a saved menstrual cycle or with a violation of its periodicity).
    Treatment begins in the first 7 days of the cycle. Stimulation is performed under the supervision of ultrasound (measure the size of the follicles) and / or the concentration of estrogens in the blood. The stimulation starts with a daily dose of 75-150 IU, increasing by 37.5 ME-75 ME, 2 times at intervals of 7 or (which is preferable) 14 days before the desired effect is achieved. The maximum dose of one injection should not exceed 225 IU. If there is no positive dynamics after 4 weeks, treatment is stopped. In the next cycle, stimulation should begin with a higher dose.
    After the optimal size of the follicles is reached, after 24-48 hours after the last injection of FOLLITROPA®, 250 μg of recombinant human chorioradotropin (p-hCG) or 5000-10 000 IU hCG of human chorionic
    gonadotropin (hCG).On the day of injection of hCG and the next day, the patient is recommended to have sexual intercourse.
    In case of excessive ovarian response to stimulation, hCG administration should be abolished. In the next cycle, a lower dose of Pholllotrop® is prescribed compared to the previous dose.
    When conducting controlled ovarian hyperstimulation for assisted reproductive technologies.
    FOLLITROP® is prescribed daily for 150-225 ME, starting from 2 ^ 3 days of the cycle. The daily dose may vary, but usually does not exceed 450 IU. Treatment is continued until the follicles reach adequate size according to ultrasound (an average of 5-20 days).
    24-48 hours after the last injection of FOLLITROP®, 250 μg of r-hCG or 5000-10 000 IU hCG are administered once to induce the final maturation of the follicles.
    To suppress the endogenous release of LH and maintain it at a low level, analogues of gonadotropin-releasing hormone are used. For ovarian stimulation in women with severe deficiency of follicle-stimulating and luteinizing hormones.
    The dose and scheme of treatment is selected by the doctor individually.
    Typically, FOLLITROP® is administered daily subcutaneously in the techene for up to 5 weeks at the same time as luteinizing hormone.Treatment with FOLLITROP® is started at a dose of 75-150 IU simultaneously with lutropin alfa in a dose of 75 IU. If necessary, the dose of FOLLITROP® can be increased by 37.5 ME-75 ME, 2 times every 7-14 days.
    In the absence of an adequate response to stimulation for 5 weeks, therapy should be discontinued and restarted in a new cycle at a higher dose.
    After reaching the optimum size of the follicle of the follicles, 250 μg p-hCG or 5000-10 000 IU hCG are injected once 24-48 hours after the last injection of FOLLITROP® and lutropin alfa. On the day of injection of hCG and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination can be performed.
    In case of excessive ovarian response to stimulation, treatment should be discontinued and the administration of hCG should be canceled. In the next cycle, a lower dose of Pholllotrop® is prescribed compared to the previous dose.

    Side effects:
    When using the drug FOLLITROP®, it is possible to develop side effects, which, depending on the frequency of appearance, are regarded as very frequent (more than 1/10), frequent (more than 1/100 and less than 1/10), infrequent (more than 1/1000 and less than 1 / 100), rare (more than 1/10000 and less than 1/1000), very rare (less than 1/10000, including single messages).
    When used in women, there are:
    Local reactions: often mild / moderate at the injection site (pain, redness, bruising, swelling).
    Central nervous system: infrequently - a headache.
    Reproductive system and mammary glands: often - ovarian cysts; infrequent - ovarian hyperstimulation syndrome (SWS) of mild or moderate severity, rarely severe HSH, torsion of ovarian cyst (as complication of OHV), ovarian apoplexy * ectopic pregnancy (in women with a history of fallopian tube disease), multiple pregnancy . Special instructions).
    The mild form of SWS is accompanied by pains in the lower abdomen, nausea, vomiting, weight gain, increased ovaries, including the formation of cysts. With moderate to severe HSH, shortness of breath, oliguria, ascites, hydrothorax, pleural effusion, accumulation of fluid in the pericardial cavity are also noted. Possible acute pulmonary insufficiency, thromboembolism. Gastrointestinal tract: infrequently - abdominal pain, nausea, vomiting, diarrhea, colic, eructation.
    Vascular system: very rarely - increased blood coagulability (thromboembolism), pulmonary embolism, ischemic stroke, myocardial infarction.
    Respiratory organs: very rarely in patients with bronchial asthma - worsening of the course or exacerbation of the disease.
    Immune system: very rarely - mild systemic allergic reactions (reddening of the skin, rash, swelling of the face, urticaria, shortness of breath), development of severe allergic reactions, including anaphylaxis.
    Other: fever, arthralgia.
    If serious side effects or effects not described above occur, you should inform your doctor.

    Overdose:
    At present, cases of overdose of FOLLITROP® have not been reported. Apparently, one should expect the development of the syndrome of ovarian hyperstimulation (see section "Special instructions").

    Interaction:
    When combining FOLLITROP® with other stimulant drugs (hCG, clomiphene) the response of the ovaries increases; against the background of desensitization of the pituitary gland by analogues of gonadotropin-
    releasing the hormone - decreases (an increase in the dose of the drug may be required). The incompatibility of the drug FOLLITROP® with other drugs is not available. FOLLITROP® should not be mixed with other drugs in the same syringe, except lutropin alfa.

    Special instructions:
    Since the drug can cause various adverse reactions, FOLLITROP® should only be used by specialists who have experience with assistive reproductive technologies. The beginning of therapy should be preceded by examination of a sterile couple, in particular, studies should be conducted to exclude hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, hypothalamic-pituitary tumors, and, if necessary, prescribe appropriate therapy. It is necessary to assess the patency of the fallopian tubes for the purpose of choosing the method of assisted reproductive technologies. It is necessary to exclude the obstruction of fallopian tubes if the patient does not participate in the program of in vitro fertilization.
    In the treatment of FOLLITROPOM®, the evaluation of the ovarian condition by ultrasound (US) is required, either alone or in conjunction with the determination of the concentration of estradiol in the blood plasma.
    Minimum effective doses should be used.
    With the appointment of hCG, the probability of a syndrome of ovarian hyperstimulation and superovulation increases.Therefore, with excessive ovarian response to stimulation, hCG is not prescribed, and patients are advised to refrain from coit for at least 4 days or use barrier methods of contraception. The probability of the occurrence of ovarian hyperstimulation syndrome in patients undergoing controlled ovarian hyperstimulation for assisted reproductive technologies is reduced by aspiration of all follicles.
    The risk of multiple pregnancy with ancillary reproductive technologies depends on the number of embryos transferred, more often there are pregnancies of twins. After the induction of ovulation, the frequency of multiple pregnancies and childbirth increases in comparison with the natural conception.
    The frequency of interruption of pregnancy after induction of ovulation and programs of assisted reproductive technologies is slightly higher than in the population, but comparable to those of women suffering from other forms of infertility.
    The probability of ectopic pregnancy after the application of assisted reproductive technologies is 2 to 5%, compared to 1 -1.5% in the general population.
    It is necessary to inform the doctor about all types of allergic reactions that the patient has, as well as about all drugs used before starting treatment with FOLLITROP®.
    FOLLITROP® contains 30 mg of sucrose, which corresponds to 0.03 bread units.
    In the case of the appointment of FOLLITROP® together with lutropine alpha, they can be mixed in a single syringe.

    Effect on the ability to drive transp. cf. and fur:
    The drug does not affect the ability to drive a car and control other mechanisms.

    Form release / dosage:lyophilizate for the preparation of a solution for intramuscular and subcutaneous administration of 75 IU

    Solvent per ml
    Packaging:
    Lyophilizate, for the preparation of a solution for subcutaneous and intramuscular administration of 75 IU in a bottle of transparent, colorless neutral glass with a volume of 3 ml, closed with a rubber stopper, an aluminum cap and a plastic lid with the control of the first opening.
    Solvent 1 ml in a bottle of neutral glass with a volume of 3 ml with the control of the first opening.
    One vial with lyophilizate and one vial with solvent is packaged in a plastic contour mesh package, which is placed in a cardboard box together with an instruction for use.

    Storage conditions:
    List B
    In a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    3 years.
    Shelf life of the solvent is 3 years.
    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008834/09
    Date of registration:05.11.2009
    The owner of the registration certificate:Al Gee Life Senses LtdAl Gee Life Senses Ltd The Republic of Korea
    Manufacturer: & nbsp
    LG LIFE SCIENCES, Ltd. The Republic of Korea
    Representation: & nbspMIR-FARM LLC MIR-FARM LLC Russia
    Information update date: & nbsp26.10.2015
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