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Ovaleap is a brand name for Follitropin Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive 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…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with follitropin alfa should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should be individualised to optimise follicular development and to minimise the risk of unwanted ovarian hyperstimulation.
It is advised to adhere to the recommended starting doses indicated below. Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections. In menstruating women treatment should commence within the first 7 days of the menstrual cycle.
5 or 75 IU at 7- or preferably 14-day intervals if necessary, to obtain an adequate, but not excessive, response. In clinical practice, the starting dose is typically individualised based on the patient’s clinical characteristics, such as markers of ovarian reserve, age, body mass index, and, if applicable, previous ovarian response to ovarian stimulation.
Starting dose The starting dose can be adjusted in a stepwise manner (a) lower than 75 IU per day if an excessive ovarian response in terms of number of follicles is anticipated based on the patient’s clinical profile (age, body mass index, ovarian reserve); or (b) higher than 75 up to a maximum of 150 IU per day may be considered if a low ovarian response is anticipated.
The patient’s response should be closely monitored by measuring follicle size and number by ultrasound and/or estrogen secretion. Dose adjustments If a patient fails to respond adequately (either low or excessive ovarian response), continuation of that treatment cycle should be evaluated and managed according to the physician’s standard of care.
In cases of low response, the daily dose should not exceed 225 IU FSH. 4). Treatment should recommence in the next cycle at a dose lower than that of the previous cycle. Final follicular maturation When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5 000 IU up to 10 000 IU hCG should be administered 24 to 48 hours after the last follitropin alfa injection.
The patient is recommended to have coitus on the day of, and the day following, hCG administration. Alternatively intrauterine insemination may be performed. 4 Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other ART In the registration trials, a commonly used regimen for superovulation involved the administration of 150 to 225 IU of follitropin alfa daily, commencing on days 2 or 3 of the cycle.
g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. 4). 4). Tabulated list of adverse reactions The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. g. pain, erythema, haematoma, swelling and/or irritation at the site of injection) Investigations Common Weight gain Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Traceability In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. General Follitropin alfa is a potent gonadotropic substance capable of causing mild to severe adverse reactions and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
6 Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of follitropin alfa calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated 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 a first appearance of this condition may require cessation 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 evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment given. Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Adherence to recommended follitropin alfa dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events. For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
1; • tumours of the hypothalamus or pituitary gland; • ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin; • gynaecological haemorrhages of unknown origin; • ovarian, uterine or mammary carcinoma.
Ovaleap must not be used when an effective response cannot be obtained, such as: • primary ovarian failure; • malformations of sexual organs incompatible with pregnancy; • fibroid tumours of the uterus incompatible with pregnancy; • primary testicular insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In clinical practice, the starting dose is typically individualised based on the patient’s clinical characteristics, such as markers of ovarian reserve, age, body mass index, and, if applicable, previous ovarian response to ovarian stimulation.
Starting dose If a low ovarian response is anticipated, the starting dose may be adjusted in a stepwise manner to not higher than 450 IU daily. Conversely, if an excessive ovarian response is expected, the starting dose may be decreased below 150 IU.
The patient’s response should continue to be closely monitored by measuring follicle size and number by ultrasound and/or estrogen secretion until adequate follicular development has been achieved. Follitropin alfa can be given either alone, or, to prevent premature luteinisation, in combination with a gonadotropin-releasing hormone (GnRH) agonist or antagonist.
Dose adjustments If a patient fails to respond adequately (either low or excessive ovarian response), continuation of that treatment cycle should be evaluated and managed according to the physician’s standard of care. In cases of low response, the daily dose should not exceed 450 IU FSH.
Final follicular maturation When an optimal ovarian response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG is administered 24 to 48 hours after the last follitropin alfa injection to induce final follicular maturation.
Women with severe LH and FSH deficiency In LH and FSH deficient women, the objective of follitropin alfa therapy in association with a luteinising hormone (LH) preparation is to promote follicular development followed by final maturation after the administration of hCG.
Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa. If the patient is amenorrhoeic and has low endogenous estrogen secretion, treatment can commence at any time. A recommended regimen commences at 75 IU of lutropin alfa daily with 75 to 150 IU FSH.
Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and estrogen response. 5 to 75 IU increments. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG should be administered 24 to 48 hours after the last follitropin alfa and lutropin alfa injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Alternatively, intrauterine insemination or another medically assisted reproduction procedure may be performed based on the physician’s judgment of the clinical case. Luteal phase support may be considered since lack of substances with luteotropic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive […]
In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa. 5 to 75 IU increments. No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Comparison with historical data suggests that the ovulation rate obtained 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 more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment. In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
It comprises marked ovarian enlargement, high serum sex steroids and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities. The following symptomatology may be observed in severe cases of OHSS: 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 imbalances, ascites, haemoperitoneum, pleural effusions, 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, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in assisted reproductive technology (ART) cycles.
8). Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify 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 more protracted if pregnancy occurs.
Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days. OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7 to 10 days following treatment. Therefore, patients should be followed for at least 2 weeks after hCG administration. In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped if still ongoing and that the patient be hospitalised and appropriate therapy be started. 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. To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to […]