Rekovelle · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-097455 · has-adverse-reaction-information · PDF-Seite 7

Summary of safety profile The most frequently reported adverse reactions during treatment with REKOVELLE are OHSS, headache, pelvic pain, nausea and fatigue. The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials. Tabulated list of adverse reactions The table below (Table 2) displays the adverse reactions experienced in clinical trials by patients treated with REKOVELLE using the algorithm-based dosing regimen. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2 Adverse reactions in pivotal clinical trials Common Uncommon System Organ Class (≥1/100 to <1/10) (≥1/1,000 to <1/100) Psychiatric disorders Mood swings Nervous system disorders Headache Somnolence Dizziness Gastrointestinal disorders Nausea Diarrhoea Vomiting Constipation Abdominal discomforta Reproductive system and OHSS Vaginal haemorrhage breast disorders Pelvic painb Breast discomfortc General disorders and Fatigue administration site conditions a Abdominal discomfort includes abdominal pain/distention. b Pelvic pain includes pelvic discomfort and adnexa uteri pain. c Breast discomfort includes breast pain, breast swelling, breast tenderness and/or nipple pain. Description of selected adverse reactions OHSS is an intrinsic risk of the ovarian stimulation. Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea. Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment (see section 4.4). Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benef

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HOS-097451 · has-contraindication-information · PDF-Seite 4

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • tumours of the hypothalamus or pituitary gland • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome • gynaecological haemorrhages of unknown aetiology (see section 4.4) • ovarian, uterine or mammary carcinoma (see section 4.4) In the following situations, treatment outcome is unlikely to be favourable, and therefore REKOVELLE should not be administered: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy

HOS-097450 · has-indication-information · PDF-Seite 2

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

HOS-097453 · has-interaction-information · PDF-Seite 6

No interaction studies have been performed with REKOVELLE. Clinically significant interactions with other medicinal products have neither been reported during REKOVELLE therapy, nor are expected.

HOS-097454 · has-pregnancy-information · PDF-Seite 6

Pregnancy REKOVELLE is not indicated during pregnancy. No teratogenic risk has been reported, following controlled ovarian stimulation, in clinical use with gonadotropins. There are no data from the inadvertent exposure to REKOVELLE in pregnant women. Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3). Breast-feeding REKOVELLE is not indicated during breastfeeding. Fertility REKOVELLE is indicated for use in infertility (see section 4.1).

HOS-097452 · has-warning-information · PDF-Seite 4

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. REKOVELLE contains a potent gonadotropic substance 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. Gonadotropin therapy requires time commitment by physicians and supportive healthcare professionals, as well as the availability of appropriate monitoring facilities. Safe and effective use of REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with measurement of serum estradiol levels, on a regular basis. The dose of REKOVELLE is individualised for each patient to obtain an ovarian response with favourable safety/efficacy profile. There may be a degree of interpatient variability in response to FSH administration, with poor response to FSH in some patients and exaggerated response in others. 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 and hyperprolactinemia, and the appropriate specific treatment should be given. Use of results obtained with other assays than the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter and LUMIPULSE G AMH from Fujirebio for REKOVELLE dose determination is not recommended, as there currently is no standardisation of available AMH assays. 4 Patients undergoing stimulation of follicular growth may experience ovarian enlargement and may be at risk of developing OHSS. Adherence to the REKOVELLE dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events. Ovarian Hyperstimulation Syndrome (OHSS) A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in patients 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 an

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