Bemfola · 4.4 Special warnings and precautions for use · 1

HOS-096456 · 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 ovarian hyperstimulation syndrome (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). 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). Treatment in women 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 mediastinal disorders Very rare: Exacerbation or aggravation of asthma Gastrointestinal disorders Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common: Ovarian cysts Common: Mild or moderate OHSS (including associated symptomatology) Uncommon: Severe OHSS (including associated symptomatology) (see section 4.4) Rare: Complication of severe OHSS General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection) Treatment in men Immune system disorders Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock 9 Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma Skin and subcutaneous tissue disorders Common: Acne Reproductive system and breast disorders Common: Gynaecomastia, varicocele General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection) Investigations Common:

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HOS-096452 · has-contraindication-information · PDF-Seite 5

• 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 unrelated to polycystic ovarian disease and of unknown origin; • gynaecological haemorrhages of unknown origin; • ovarian, uterine or mammary carcinoma. Follitropin alfa must not be used when an effective response cannot be obtained, such as in cases of: • primary ovarian failure; • malformations of sexual organs incompatible with pregnancy; • fibroid tumours of the uterus incompatible with pregnancy; • primary testicular insufficiency.

HOS-096451 · has-indication-information · PDF-Seite 2

In adult women 2 • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene 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. • Follitropin alfa in association with a luteinising hormone (LH) preparation is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. In adult men • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.

HOS-096454 · has-interaction-information · PDF-Seite 8

Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomiphene 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-096455 · has-pregnancy-information · PDF-Seite 8

Pregnancy There is no indication for use of follitropin alfa during pregnancy. Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/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 Follitropin alfa is not indicated during breast-feeding. Fertility Follitropin alfa is indicated for use in infertility (see section 4.1). 8

HOS-096453 · has-warning-information · PDF-Seite 5

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. General recommendations Follitropin alfa is a potent gonadotrophic 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 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 the 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 inter-patient 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 the 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 follitropin alfa/LH versus human menopausal gonadotropin

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