What is the active ingredient in Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen?

Follitropinum alfa (Follitropinum alfa)

What pharmaceutical form is Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen available in?

Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen: Roztwór do wstrzykiwań 225 j.m./0,375 ml (podskórna)

Is Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen OTC or prescription only?

Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen requires a doctor's prescription.

What are the side effects of Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen?

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 an inherent risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely (see section 4.4). List of a

Who should NOT take Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen?

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 haemorrhage of unknown origin, Carcinoma of the ovary, uterus or breast. Follitropin alfa must not be used when an effective response cannot be obtained, such as: Primary ovarian failure, Malformation of the sexual organs in

Does Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen interact with other medications?

Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concomitant use of a GnRH agonist or antagonist to induce pituitary desensitisation may necessitate an increase in the dose of follitropin alfa to achieve an adequate ovarian response. No other clinically significant drug interaction has been reported during follitropin alfa therapy.

Can Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen be used during pregnancy?

Pregnancy There is no indication for use of follitropin alfa during pregnancy. Data from a limited number of exposed pregnancies (fewer than 300 pregnancy outcomes) do not indicate any malformations or foetal/neonatal toxicity of follitropin alfa. No teratogenic effects have been observed in animal studies (see section 5.3). In case of exposure during pregnancy, there are insufficient clinical data to exclude a teratogenic effect of follitropin alfa. Breast-feeding Follitropin

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

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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 European Medicines Agency website https://www.ema.europa.eu. Mechanism of action Follicle-stimulating hormone (FSH) and luteinising hormone (LH) are secreted from the anterior pituitary gland 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 after r-hFSH administration, while the increase in E2 levels takes longer and can be observed from the fourth day of treatment. The 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 reached approximately 10 days after 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 endogenous serum LH levels < 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 Differences between the 2 groups were statistically significant (p < 0.05) for all listed criteria. 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 of the administered medicinal product and the batch number should be clearly recorded in the patient's medical records in order to improve the 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 ovarian response by ultrasound, either alone or preferably in combination with measurement of serum oestradiol levels. There may be a degree of variability in the response to FSH administration between individual patients, with a poor response in some patients and an excessive response in others. The lowest effective dose in relation to the treatment objective should be used 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 appearance of this condition may require discontinuation of treatment. Treatment in women Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be investigated for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia and appropriate specific treatment given. Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or as part of ART procedures, may experience ovarian enlargement or develop hyperstimulation. Adherence to the recommended dose of follitropin alfa, dosing regimen and careful monitoring of therapy will minimise the incidence of such events. For accurate interpretation of the indices of follicular development and maturation, the physician needs to be experienced in the interpretation of the relevant tests. In clinical trials, an increased sensitivity of the ovaries to follitropin alfa was shown when co-administered with lutropin alfa. If an FSH dose increase is deemed appropriate, dose adjustment should preferably be at 7 to 14-day intervals, preferably in increments of 37.5 to 75 IU. No direct comparisons of follitropin alfa/LH with human menopausal gonadotrophin (hMG) have been performed. Comparison with historical data suggests that the ovulation rate achieved with follitropin alfa/LH is similar to that obtained with hMG. Ovarian hyperstimulation syndrome (OHSS) A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is seen more frequently in women with polycystic ovarian syndrome and usually regresses without treatment. In contrast to uncomplicated ovarian enlargement, OHSS is a condition that can manifest with increasing degrees of severity. OHSS involves 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 the development of OHSS include young age, low body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol levels, previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in assisted reproductive technology (ART) cycles. Adherence to the recommended dose of follitropin alfa and dosing regimen can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8). Monitoring of stimulation cycles by ultrasound examination and measurement of oestradiol levels is recommended for early identification of risk factors. There is evidence suggesting that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient 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 become a serious medical condition. OHSS most commonly occurs after hormonal treatment has been discontinued and reaches its maximum approximately seven to ten days after treatment. Therefore, patients should be followed 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 and gonadotrophin treatment is still ongoing, it is recommended to discontinue treatment, hospitalise the patient and start appropriate therapy. 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, the risk of multiple pregnancy is mainly related to the number of embryos transferred, their quality and the age of the patient. The patient should be advised 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 following natural conception. Ectopic pregnancy Women with a history of tubal disease are at 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. Congenital malformations The prevalence of congenital malformations after ART may be slightly higher compared with 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 levels of endogenous FSH indicate primary testicular failure. These patients do not respond to follitropin alfa/hCG therapy. Follitropin alfa should not be used when an effective response cannot be obtained. Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response. Sodium content This medicine contains less than 1 mmol 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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