Leitlinien & Arzneimittelsicherheit

HOS-095464 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile The most frequently reported adverse reactions during treatment with Elonva in clinical trials in women (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also section 4.4), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%). Tabulated list of adverse reactions The table below displays the main adverse reactions in adults treated with Elonva in clinical trials and post-marketing surveillance according to system organ class and frequency; 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 available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System organ class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reactions, both local and generalised, including rash* Psychiatric disorders Uncommon Mood swings Nervous system disorders Common Headache Uncommon Dizziness Vascular disorders Uncommon Hot flush Gastrointestinal disorders Common Nausea Uncommon Abdominal distension, vomiting, diarrhoea, constipation Musculoskeletal and Uncommon Back pain connective tissue disorders Pregnancy, puerperium and Uncommon Abortion spontaneous perinatal conditions Reproductive system and Common OHSS, pelvic pain, pelvic breast disorders discomfort, breast tenderness Uncommon Ovarian torsion, adnexa uteri pain, premature ovulation,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095460 · 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 ovary, breast, uterus, pituitary or hypothalamus.  Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.  Primary ovarian failure.  Ovarian cysts or enlarged ovaries.  Fibroid tumours of the uterus incompatible with pregnancy.  Malformations of the reproductive organs incompatible with pregnancy.  Risk factors for OHSS: o A history of Ovarian Hyperstimulation Syndrome (OHSS). o A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination. o A basal antral follicle count > 20. o Polycystic ovarian syndrome (PCOS).

HOS-095459 · has-indication-information · PDF-Seite 2

Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG).

HOS-095462 · has-interaction-information · PDF-Seite 7

No interaction studies with Elonva and other medicines have been performed. Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicinal products are anticipated. Elonva may cause a false positive hCG pregnancy test if the test is administered during the ovarian stimulation portion of the ART cycle. This may be due to cross-reactivity of hCG pregnancy tests with the carboxy-terminal peptide of the beta subunit of Elonva.

HOS-095463 · has-pregnancy-information · PDF-Seite 7

Pregnancy In case of inadvertent exposure to Elonva during pregnancy, clinical data are not sufficient to exclude an adverse outcome of pregnancy. In animal studies reproductive toxicity has been observed (see section 5.3). The use of Elonva during pregnancy is not indicated. Breast-feeding The use of Elonva during breast-feeding is not indicated. Fertility Elonva is indicated for use in infertility in women: In women Elonva is used in the treatment of Controlled Ovarian Stimulation in combination with GnRH in ART programs (see section 4.1). Elonva is indicated for treatment of HH in adolescent males: In adolescent males (14 years and older), Elonva is used in treatment of hypogonadotropic hypogonadism in combination with hCG (see section 4.1). However, whether this treatment has effect on fertility is unknown.

HOS-095461 · 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. 4 Infertility evaluation before starting treatment Before starting treatment, the couple’s infertility should be assessed as appropriate. In particular, women should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Elonva. Dosing during the stimulation cycle Elonva is intended for single subcutaneous injection only. Additional injections of Elonva should not be given within the same treatment cycle. (See also section 4.2.) After administration of Elonva, no additional FSH-containing product should be administered prior to stimulation day 8 (see also section 4.2). Renal insufficiency In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2). Therefore, the use of Elonva in these patients is not recommended. Not recommended with a GnRH agonist protocol in women undergoing ART There are limited data on the use of Elonva in combination with a GnRH agonist. Results of a small uncontrolled study suggest a higher ovarian response than in combination with a GnRH antagonist. Therefore, the use of Elonva is not recommended in combination with a GnRH agonist (see also section 4.2). Not recommended in adolescent males previously treated with GnRH, gonadotropins, or testosterone treatment. There are no data available in patients previously treated with GnRH, gonadotropins (e.g., hCG, FSH) and androgens (e.g., testosterone, etc.) except for diagnostic testing purposes. 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 associ

Auszug; vollständigen Abschnitt im Original lesen.