Puregon · 4.6 Fertility, pregnancy and lactation · 1

HOS-083128 · has-adverse-reaction-information · PDF-Seite 7

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta). Cases of anaphylactic reactions (including those requiring hospitalisation) have been reported in the post-marketing setting. Treatment of females: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse 7 reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement. The table below lists the adverse reactions with follitropin beta reported in clinical trials and post- marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from available data). SOC Frequency Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Gastrointestinal disorders Common Abdominal distension Abdominal pain Uncommon Abdominal discomfort Constipation Diarrhoea Nausea Reproductive system and breast Common OHSS disorders Pelvic pain Uncommon Breast complaints1 Metrorrhagia Ovarian cyst Ovarian enlargement Ovari

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HOS-083124 · has-contraindication-information · PDF-Seite 4

For males and females • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Primary gonadal failure. 4 Additionally for females • Undiagnosed vaginal bleeding. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS). • Malformations of the reproductive organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy.

HOS-083123 · has-indication-information · PDF-Seite 2

In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In adult males: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism. 2

HOS-083126 · has-interaction-information · PDF-Seite 7

Concomitant use of Puregon and clomifene citrate may enhance the follicular response. After pituitary desensitisation induced by a GnRH agonist, a higher dose of Puregon may be necessary to achieve an adequate follicular response.

HOS-083127 · has-pregnancy-information · PDF-Seite 7

Fertility Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes. In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of administration, see section 4.2. Pregnancy The use of Puregon during pregnancy is not indicated. In case of inadvertent exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH. However, to date, no particular malformative effect has been reported. No teratogenic effect has been observed in animal studies. Breast-feeding There is no information available from clinical or animal studies on the excretion of follitropin beta in milk. It is unlikely that follitropin beta is excreted in human milk due to its high molecular weight. If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.

HOS-083125 · has-warning-information · PDF-Seite 5

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. Antibiotic hypersensitivity reactions • Puregon may contain traces of streptomycin and/or neomycin. These antibiotics may cause hypersensitivity reactions in susceptible persons. Infertility evaluation before starting treatment • Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, patients should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. In females Ovarian Hyperstimulation Syndrome (OHSS) OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS. OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and by pregnancy (endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration. Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Puregon. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended. Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART). Adherence to the recommended Puregon dose and treatment r

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