In adult women Anovulation (including polycystic ovarian syndrome) in women who have not responded to treatment with clomifene citrate. Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART), such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. Follitropin alf

Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen: Roztwór do wstrzykiwań 300 j.m./0,50 ml

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the injection site). Mild or moderate ovarian hyperstimulation syndrome (OHSS) has been reported commonly and should be considered as an inherent risk of the stimulation procedure. Severe

hypersensitivity to the active substance or to any of the excipients listed in section 6.1, tumours of the hypothalamus or pituitary gland, ovarian enlargement or ovarian cysts not related to polycystic ovarian syndrome and of unknown origin, gynaecological bleeding of unknown origin, ovarian, uterine or breast carcinoma, Follitropin alfa must not be used in conditions where an e

Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen

Q: Warnings?

Traceability The name and batch number of the administered product should be clearly recorded in the patient's medical records to improve traceability of biological medicinal products. General recommendations Follitropin alfa is a potent gonadotrophic substance capable of causing mild to severe adverse reactions and should only be used by a physician who is thoroughly familiar with infertility pro

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Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins, ATC code: G03GA05. Bemfola is a biosimilar medicinal product.‍‍‍‍‍‍‍ Detailed information is available on the website of the European Medicines Agency https://www.ema.europa.eu. Mechanism of action Follicle-stimulating hormone (FSH) and luteinising hormone (LH) are secreted from the anterior pituitary in response to GnRH and play complementary roles in follicular development and ovulation. FSH stimulates the development of ovarian follicles, while LH is involved in follicular development, steroidogenesis and maturation. Pharmacodynamic effects Following administration of r-hFSH, inhibin and oestradiol (E2) levels increase with subsequent induction of follicular development. The increase in serum inhibin levels is rapid and can be observed as early as the third day following r-hFSH administration, while the increase in E2 levels takes longer and can be observed from the fourth day of treatment onwards. Total follicular volume begins to increase after approximately 4 to 5 days of daily r-hFSH administration and, depending on the patient's response, the maximum effect is achieved after approximately 10 days from the start of r-hFSH administration. Clinical efficacy and safety in women In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/l as measured in a central laboratory. However, it should be taken into account that there are differences between LH measurements performed in different laboratories. In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table below) and in ovulation induction, follitropin alfa was more effective than urinary FSH in terms of a lower total dose and shorter treatment duration required to trigger follicular maturation. In ART, treatment with follitropin alfa at a lower total dose and shorter treatment duration compared with urinary FSH resulted in a higher number of oocytes retrieved. Table: Results of study GF 8407 (randomised, parallel-group study comparing the efficacy and safety of follitropin alfa with urinary FSH in assisted reproduction techniques) follitropin alfa (n = 130) urinary FSH (n = 116) Number of oocytes retrieved 11.0 ± 5.9 8.8 ± 4.8 Number of days of FSH stimulation required 11.7 ± 1.9 14.5 ± 3.3 Total FSH dose required (number of FSH 75 IU ampoules) 27.6 ± 10.2 40.7 ± 13.6 Need for dose increase (%) 56.2 85.3 The differences between the 2 groups were statistically significant (p < 0.05) for all the criteria listed. Clinical efficacy and safety in men In men with FSH deficiency, follitropin alfa administered concomitantly with hCG for at least 4 months induces spermatogenesis.

⚠️ Warnings

Traceability The name and batch number of the administered product should be clearly recorded in the patient's medical records to improve traceability of biological medicinal products. General recommendations Follitropin alfa is a potent gonadotrophic substance capable of causing mild to severe adverse reactions and should only be used by a physician who is thoroughly familiar with infertility problems and their management. Gonadotrophin therapy requires a certain time commitment from the physician and supportive healthcare staff, as well as the availability of appropriate monitoring facilities.‍‍‍‍‍‍‍ Safe and effective use of follitropin alfa in women requires regular monitoring of the ovarian response by ultrasound, either alone or preferably in combination with measurement of serum oestradiol levels. Individual patient response to FSH administration may be variable, with a poor response in some patients and an excessive response in others. The lowest effective dose should be used relative to the treatment objective in both men and women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa. Deterioration or first manifestation of this condition may necessitate discontinuation of treatment. Treatment in women Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy should be evaluated. In particular, patients should be investigated for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, and appropriate specific treatment should be provided. In patients undergoing stimulation of follicular growth, either as treatment for anovulatory infertility or as part of ART procedures, ovarian enlargement or hyperstimulation may develop. Adherence to the recommended follitropin alfa dose, administration regimen and careful monitoring of therapy minimises the incidence of such cases. For accurate interpretation of follicular development and maturation indices, the physician should be experienced in the interpretation of the relevant tests. In clinical trials, increased ovarian sensitivity to follitropin alfa was shown when administered in combination with lutropin alfa. If an FSH dose increase is considered appropriate, the dose should preferably be adjusted at 7 to 14-day intervals and preferably by 37.5 to 75 IU increments. No direct comparison of follitropin alfa/LH with human menopausal gonadotrophin (hMG) has been performed. Comparison with historical data suggests that the ovulation rate achieved with follitropin alfa/LH is similar to that achieved with hMG. Ovarian hyperstimulation syndrome (OHSS) A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It occurs more frequently in women with polycystic ovarian syndrome and usually resolves without treatment. In contrast to uncomplicated ovarian enlargement, OHSS is a condition that can manifest with increasing degrees of severity. It includes marked ovarian enlargement, high serum sex steroid levels and increased vascular permeability which can result in accumulation of fluid in the peritoneal, pleural and, rarely, pericardial cavities. In severe cases of OHSS, the following symptoms may be observed: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalance, ascites, haemoperitoneum, pleural effusion, hydrothorax or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction. Independent risk factors for developing OHSS include young age, low body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol levels and previous episodes of OHSS, a large number of developing ovarian follicles and a large number of oocytes retrieved in assisted reproductive technology (ART) cycles. Adherence to the recommended follitropin alfa dose and administration regimen can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8). Monitoring of stimulation cycles by ultrasound examination as well as oestradiol measurements is recommended for early identification of risk factors. There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and have a more protracted course if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG should not be administered and the patient should be advised to abstain from sexual intercourse or to use barrier contraception for at least 4 days. OHSS may progress rapidly (within 24 hours) or over several days and may develop into a serious medical condition. It most commonly occurs after hormonal treatment has been discontinued and reaches its maximum at approximately seven to ten days after treatment. Therefore, patients should be followed up for at least two weeks after hCG administration. In ART, the incidence of hyperstimulation may be reduced by aspiration of all follicles prior to ovulation. Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended that gonadotrophin treatment, if still ongoing, should be discontinued, the patient hospitalised and appropriate treatment initiated. Multiple pregnancy In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception. The majority of multiple conceptions are twins. Multiple pregnancy, especially of high order, carries an increased risk of adverse maternal and perinatal outcomes. Careful monitoring of ovarian response is recommended to minimise the risk of multiple pregnancy. In patients undergoing ART procedures, the risk of multiple pregnancy is related mainly to the number of embryos transferred, their quality and the age of the patient. The patient should be informed of the potential risk of multiple births before starting treatment. Miscarriage The rate of spontaneous or induced miscarriage is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than after natural conception. Ectopic pregnancy In women with a history of tubal disease, there is a risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments. A higher prevalence of ectopic pregnancy after ART has been reported compared with the general population. Reproductive system neoplasms Neoplasms of the ovaries and other reproductive organs, both benign and malignant, have been observed in women who have undergone multiple treatment regimens for infertility treatment. It is not yet established whether treatment with gonadotrophins increases the risk of these tumours in infertile women or not. Congenital malformations The prevalence of congenital malformations after ART may be slightly higher than after natural conception. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies. Thromboembolic events In women with recent or ongoing thromboembolic disease or in women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotrophins may further increase the risk of worsening or occurrence of such events. In these women, the benefits of gonadotrophin administration need to be weighed against the risks. It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events. Treatment in men Elevated endogenous FSH levels indicate primary testicular failure. Such patients are unresponsive to follitropin alfa/hCG therapy. Follitropin alfa should not be used when an effective response cannot be achieved. Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response. Sodium content This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially sodium-free.

Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen

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