Luveris

Treatment with Luveris 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 Luveris therapy in association with FSH is to promote follicular development followed by final maturation after the administration of human chorionic gonadotropin (hCG).

Luveris should be given as a course of daily injections simultaneously with FSH. If the patient is amenorrhoeic and has low endogenous estrogen secretion, treatment can commence at any time. Luveris should be administered concomitantly with follitropin alfa.

e. one vial of Luveris) 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. In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa.

5 IU to 75 IU increments. 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 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 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.

). Special populations Elderly There is no relevant use of Luveris in the elderly population. Safety and efficacy of Luveris in elderly patients have not been established. Renal and 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 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.

Summary of the safety profile Luveris is used for the stimulation of follicular development in association with follitropin alfa. In this context, it is difficult to attribute adverse reactions to any one of the substances used. 9% of the injections, respectively.

No severe injection site reactions were reported. Ovarian hyperstimulation syndrome (OHSS) was observed in less than 6% of patients treated with Luveris. 4). In rare instances, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotropin therapy.

Although these adverse reactions were not observed, there is the possibility that they may also occur with Luveris. Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease. List of adverse reactions The following definitions apply to the frequency terminology used hereafter: 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), frequency not known (cannot be estimated from the available data).

The following adverse reactions may be observed after administration of Luveris. g. pain, erythema, haematoma, 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 Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.

In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency and hyperprolactinemia and appropriate specific treatment given. Porphyria In patients with porphyria or a family history of porphyria Luveris 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. 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.

Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, or enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites or marked ovarian enlargement.

Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, 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.

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 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