Luveris · 4.8 Undesirable effects · 1

HOS-084200 · has-adverse-reaction-information · PDF-Seite 6

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. In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4% and 0.9% 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. No severe OHSS was reported (see section 4.4). 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. 6 Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Nervous system disorders Common: Headache Vascular disorders Very rare: Thromboembolism, usually associated with severe OHSS Gastrointestinal disorders Common: Abdominal pain, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Common: Mild or moderate OHSS (including associated symptomatology), ovarian cyst, breast pain, pelvic pain General disorders and administration site conditions: Common: Injection site reaction (e.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.

HOS-084196 · has-contraindication-information · PDF-Seite 3

Luveris is contraindicated in patients with: • hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • 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

HOS-084195 · has-indication-information · PDF-Seite 2

Luveris in association with a follicle stimulating hormone (FSH) preparation is indicated for the stimulation of follicular development in adult women with severe luteinising hormone (LH) and FSH deficiency.

HOS-084198 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. 5 Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.

HOS-084199 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is no indication for the use of Luveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of Luveris has been observed in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Luveris. Breast-feeding Luveris is not indicated during breast-feeding. Fertility Luveris is indicated for the stimulation of follicular development, in association with FSH (see section 4.1).

HOS-084197 · has-warning-information · PDF-Seite 3

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. 3 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. Adherence to recommended Luveris and FSH dosage and regimen of administration can minimise the

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