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Pergoveris is a brand name for Follitropin Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility disorders. Posology In LH and FSH deficient women, the objective of Pergoveris therapy is to promote follicular development followed by final maturation after the administration of human chorionic gonadotropin (hCG).
Pergoveris should be given as a course of daily injections. If the patient is amenorrhoeic and has low endogenous oestrogen secretion, treatment can commence at any time. A recommended regimen commences with one vial of Pergoveris daily.
1). Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and oestrogen response. 5 to 75 IU increments using a licensed follitropin alfa preparation. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
3 When an optimal response is obtained, a single injection of 250 micrograms of r-hCG or 5 000 IU to 10 000 IU hCG should be administered 24 to 48 hours after the last Pergoveris injection. 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 luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive response is obtained, treatment should be stopped and hCG withheld. 4). Special populations Elderly There is no relevant indication for the use of Pergoveris in the elderly population. Safety and efficacy of this medicinal product in elderly patients have not been established.
Renal and hepatic impairment Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established. Paediatric population There is no relevant use of this medicinal product in the paediatric population.
Method of administration Pergoveris is intended for subcutaneous administration. The first injection should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided.
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). 7 Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency.
The frequency categories used are: 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), not known (cannot be estimated from the available data). g.
pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection) 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 name and the batch number of the administered product should be clearly recorded. 4 General recommendations Pergoveris contains potent gonadotropic substances 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.
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 should be given.
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 Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
In these patients, Pergoveris may increase the risk of an acute attack. Deterioration or a first appearance of this condition may require cessation of treatment. 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.
1 • tumours of the hypothalamus and 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 Pergoveris 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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Follitropin Alfa in European Union.
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Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice. 6.
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, and thromboembolic events. 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 oestradiol level (> 900 pg/mL or > 3 300 pmol/L in anovulation), previous episodes of OHSS and large number of developing ovarian follicles (3 follicles of ≥ 14 mm in diameter in anovulation).
Adherence to recommended Pergoveris and FSH dosage and regimen of administration can minimise the risk of ovarian hyperstimulation. Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
5 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 OHSS occur such as serum oestradiol level > 5 500 pg/mL or > 20 200 pmol/L and/or ≥ 40 follicles in total, 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 seven to ten days following treatment.
Usually, OHSS resolves spontaneously with the onset of menses. Therefore patients should be followed for at least two weeks after hCG administration. If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing. The patient should be hospitalised and specific therapy for OHSS started.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease. When a risk of OHSS is assumed, treatment discontinuation should be considered. Ovarian torsion Ovarian torsion has been reported after treatment with other gonadotropins.
This may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovarian syndrome. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multiple pregnancy In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception. The majority of multiple conceptions are twins. Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended. The patients should be advised of the potential risk of multiple births before starting treatment. When risk of multiple pregnancies is assumed, treatment discontinuation should be considered.
Pregnancy loss The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than in the normal population. 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 […]