Because the drug can cause various adverse reactions, GONAL-f® should only be prescribed by a physician-a specialist directly dealing with infertility problems. The beginning of therapy should be preceded by examination of a barren couple, in particular,studies should be conducted to exclude hypothyroidism, adrenocortical insufficiency, hyperprolactinaemia, hypothalamic-pituitary tumors, and, if necessary, prescribe appropriate therapy.
It is necessary to assess the patency of the fallopian tubes in order to choose the method of assisted reproductive technology. It is necessary to exclude obstruction of the fallopian tubes if the patient does not participate in the program of in vitro fertilization.
In patients with porphyria, as well as in the presence of porphyria from relatives, careful monitoring is required during therapy with GONAL-f®. If the condition worsens or the first signs of this disease appear, it may be necessary to stop therapy.
When treating with GONAL-f®, evaluation of the ovarian condition by ultrasound (ultrasound) is required both separately and in combination with the determination of estradiol in blood plasma. Reaction to administration
follicle-stimulating hormone may differ in different patients, therefore, minimum effective doses should be used in both women and men.
The drug GONAL-f® contains less than 1 mmol (23 mg) of sodium in 1 dose, that is, it is not a significant source of sodium. Ovarian hyperstimulation syndrome (OSS)
OCS must be differentiated from uncomplicated ovarian enlargement. Clinical symptoms of HNS can be manifested with increasing severity. Characteristic significant increase in the size of the ovaries, a high level of sex hormones, increased vascular permeability, leading to accumulation of fluid in the abdominal, pleural and, rarely, pericardial cavities.
The following symptoms are most typical for severe CHD: pain and feeling of raspiraniya in the abdomen, a pronounced increase in the size of the ovaries, weight gain, shortness of breath, oliguria, gastrointestinal symptoms (nausea, vomiting, diarrhea); hypovolaemia, hemoconcentration, electrolyte balance disorder, ascites, hemoperitonium, pleural effusion, hydrothorax, acute respiratory distress syndrome may occur. In very rare cases, severe SWC may be complicated by ovarian torsion and cases of thromboembolism, such as pulmonary embolism, ischemic stroke, or myocardial infarction.
In order to minimize the risk of CHD and multiple pregnancies, it is recommended that to regularly use ultrasound and evaluate the concentration of estradiol in blood plasma for early identification of risk factors. Independent risk factors for the development of OHSS are polycystic ovaries or a high concentration of estradiol in the blood plasma. With anovulation, the risk of advanced CHD increases with a concentration of estradiol> 900 pg / ml (3300 pmol / l) and the presence of more than 3 follicles with a diameter of 14 mm or more. In ART, the risk of developing CHD increases with an estradiol concentration> 3000 pg / ml (11000 pmol / L) or the presence of 20 or more follicles with a diameter of 12 mm or more.
Strict adherence to the recommended dosage of GONAL-f®, as well as careful monitoring of therapy, minimizes the risk of developing CHD and multiple pregnancies.
There is reason to believe that hCG plays a key role in the emergence of OHSS. At the onset of pregnancy, the severity of CHD may worsen, and its duration may increase. When the estradiol level> 5500 pg / ml (20200 pmol / l) or when 40 or more follicles are present, abstinence should be made of the use of hCG. The patient is recommended to abstain from coitus for 4 days or use barrier methods of contraception.
SHG can quickly progress (from days to several days) to severe state. Most OCG occurs after cessation of hormonal therapy and reaches its maximum after 7-10 days, so after the introduction of HCG, it is necessary to observe for at least two weeks.
The probability of the occurrence of ovarian hyperstimulation syndrome in patients undergoing controlled ovarian hyperstimulation for ART is reduced by aspiration of all follicles.
HSH of mild or moderate severity passes spontaneously. In the development of severe CHD, gonadotropin therapy, if it continues, should be discontinued. The patient should be hospitalized and prescribed a specific treatment for CHD.
Multiple pregnancy The frequency of multiple pregnancy and childbirth with induction of ovulation is higher, compared with natural conception. The most common option for multiple pregnancies is twins. Multiple pregnancy, especially in the case of a large number of embryos, increases the risk of an adverse outcome for the mother and fetus. To minimize the risk of multiple pregnancies, careful monitoring of the ovarian response is necessary.In ART, the risk of multiple pregnancies is mainly related to the number of embryos transferred, their viability and the age of the patient.
Unintention of pregnancy
The frequency of miscarriage or spontaneous abortions (miscarriages) after induction of ovulation and ART programs is higher than in the general population. Ectopic pregnancy Patients with maternal tube disease have a history of increased risk of ectopic pregnancy. The probability of ectopic pregnancy after the use of assisted reproductive technologies is higher than in the general population.
Neoplasms of the organs of the reproductive system There are reports of benign and malignant neoplasms of the ovary and other reproductive organs in women after repeated induction of courses of infertility treatment with various medications. At present, the relationship between gonadotropin therapy and an increased risk of neoplasm with infertility has not been established.
Congenital malformations of development
The frequency of congenital anomalies after the application of ART programs can be slightly higher than with natural pregnancy and childbirth.Nevertheless, it is not known whether this is due to the peculiarity of the parents (for example, the age of the mother, the quality of the sperm) and the multiple pregnancy or directly with ART.
Thromboembolic complications In patients with recent or current thromboembolic disease, and with a possible risk of their occurrence, the use of gonadotropins may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy should be correlated with the possible risk. It should be noted that pregnancy itself carries an increased risk of thromboembolic disorders.
Treatment of men Increased concentration of follicle-stimulating hormone in the blood serum of men may indicate primary testicular failure. In this case, treatment with r-hFSH / hCG is ineffective and GONAL-f® should not be prescribed.
After 4-6 months after the start of the course of therapy, it is recommended that spermogram monitoring be performed. Patients should be aware of the above risks before starting therapy.
It is necessary to inform the doctor about all types of allergic reactions that are present in the patient, as well as about all drugs used before starting treatment with the drug GONAL-f®.It is necessary to mark the date of the first application on the pen with the drug.
PAfter first use, the drug may not be stored. more than 28 days at a temperature of no higher than 25 ° C. Do not use the drug after this period.
Within the shelf life of the drug can be stored at a temperature of no higher than 25 ° C to 3 months. After 3 months, it should be destroyed, if it was not used. Re-placing in the refrigerator is not allowed.