Presentation and Status in Health Basket
Posology: In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG). Luveris should be given as a course of daily injections simultaneously with FSH. Since these patients are amenorrhoeic and have
low endogenous oestrogen secretion, treatment can commence at any time.
Luveris should be administered concomitantly with follitropin alfa.
Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and oestrogen response. A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-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 of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Luveris and FSH injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Alternatively, intrauterine insemination (IUI) may be performed.
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.
Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Older people: There is no relevant indication for the use of Luveris in the elderly population. Safety and effectiveness of Luveris in elderly patients have not been established.
Renal or hepatic impairment: Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment have not been established.
Paediatric population: There is no relevant indication for the use of Luveris in the paediatric population.
Method of administration: Luveris is intended for subcutaneous use. The first injection of Luveris should be performed under direct medical supervision. The powder should be reconstituted, immediately prior to use, with the solvent provided. Self-administration of this medicinal product should only be
performed by patients who are well-motivated, adequately trained and with access to expert advice.
In association with a follicile stimulating hormone (FSH), the preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials those patients were defined by endogenous serum LH level < 1.2 IU/L.
– hypersensitivity to active substances or to any of the excipients.
– 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
Luveris must not be used when a condition exists which would make a normal pregnancy impossible, such as:
– primary ovarian failure
– malformations of sexual organs incompatible with pregnancy
– fibroid tumours of the uterus incompatible with pregnancy
Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Intended for subcutaneous administration. The powder should be reconstituted, immediately prior to use, with the solvent provided. This product should not be used when an effective response cannot be obtained, such as ovarian failure, malformation of the sexual organs incompatible with pregnancy or fibroid tumours of the uterus incompatible with pregnancy. Patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. Patients undergoing stimulation of follicular growth are at a increased risk of developing hyperstimulation. Ovarian hyperstimulation syndrome (OHSS). Careful monitoring of ovarian response, based on ultrasound, is recommended prior to and during stimulation therapy, incidence of multiple pregnancies and birth is increased, ultrasound scans as well as estradiol measurements are recommended.
See prescribing information for full details.
Mild and moderate injection site reactions. Ovarian hyperstimulation syndrome was observed in less than 6% of patients treated. Ectopic pregnancy, injection site reaction, headache, somnolence, nausea, breast, abdominal and pelvic pain, ovarian cyst.
Should not be administered as a mixture with other medicdbinal products in the same injection, except follitropin alfa.