Leitlinien & Arzneimittelsicherheit

HOS-216268 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection). Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see section 4.4). Thromboembolism may occur very rarely (see section 4.4). Tabulated list of adverse reactions The adverse reactions are ranked under heading of frequency using the following convention: 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Treatment in women Table 1: Adverse reactions in women System organ class Frequency Adverse reaction Immune system disorders Very rare Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock Nervous system disorders Very common Headache Vascular disorders Very rare Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and Very rare Exacerbation or aggravation of mediastinal disorders asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast Very common Ovarian cysts disorders Common Mild or moderate OHSS (incl

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HOS-216264 · has-contraindication-information · PDF-Seite 5

• Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1; • tumours of the hypothalamus or 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. Ovaleap must not be used when an effective response cannot be obtained, such as: • primary ovarian failure; • malformations of sexual organs incompatible with pregnancy; • fibroid tumours of the uterus incompatible with pregnancy; • primary testicular insufficiency.

HOS-216263 · has-indication-information · PDF-Seite 2

In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. • Ovaleap in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. 2 In adult men • Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.

HOS-216266 · has-interaction-information · PDF-Seite 8

Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response. No other clinically significant medicinal product interaction has been reported during follitropin alfa therapy.

HOS-216267 · has-pregnancy-information · PDF-Seite 8

Pregnancy There is no indication for use of Ovaleap during pregnancy. Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of follitropin alfa. No teratogenic effect has been observed in animal studies (see section 5.3). In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of follitropin alfa. Breast-feeding Ovaleap is not indicated during breast-feeding. Fertility Ovaleap is indicated for use in infertility (see section 4.1).

HOS-216265 · has-warning-information · PDF-Seite 5

Traceability In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file. General Follitropin alfa is 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. 5 Gonadotropin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of follitropin alfa calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients and exaggerated response in others. The lowest effective dose in relation to the treatment objective should be used in both men and women. Porphyria Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa. Deterioration or a first appearance of this condition may require cessation of treatment. Treatment in women 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, adrenocortical deficiency, hyperprolactinemia and appropriate specific treatment given. Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation. Adherence to recommended follitropin alfa dose and regimen of administration and careful monitoring of therapy will minimise the incidence of such events. For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests. In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7 to 14 day intervals and preferably with 37.5 to 75 IU increments. No direct comparison of fo

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