ganirelix

HOS-084116 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using recFSH for ovarian stimulation. The adverse reactions with Orgalutran using corifollitropin alfa for ovarian stimulation are expected to be similar. Tabulated list of adverse reactions The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100). The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance. System organ class Frequency Adverse reaction Immune system disorders Very rare Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria)1 Worsening of a pre-existing eczema2 Nervous system disorders Uncommon Headache Gastrointestinal disorders Uncommon Nausea General disorders and Very common Local skin reaction at the site of injection administration site (predominantly redness, with or without conditions swelling)3 Uncommon Malaise 1 Cases have been reported, as early as with the first dose, among patients administered Orgalutran. 2 Reported in one subject after the first Orgalutran dose. 3 In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration. Description of selected adverse reactions Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see section 4.4), ectopic pregnancy and spontaneous abortion. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of

Auszug; vollständigen Abschnitt im Original lesen.

HOS-084112 · has-contraindication-information · PDF-Seite 3

− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue. − Moderate or severe impairment of renal or hepatic function. − Pregnancy or breast-feeding.

HOS-084111 · has-indication-information · PDF-Seite 2

Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.

HOS-084114 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.

HOS-084115 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no adequate data from the use of ganirelix in pregnant women. In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3). The relevance of these data for humans is unknown. Breast-feeding It is not known whether ganirelix is excreted in breast milk. The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see section 4.3). 4 Fertility Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation. For posology and method of administration, see section 4.2.

HOS-084113 · has-warning-information · PDF-Seite 3

Hypersensitivity reaction Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local), have been reported with Orgalutran, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria (see section 4.8). If a hypersensitivity 3 reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions. Ovarian hyperstimulation syndrome (OHSS) Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin. Ectopic pregnancy Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. Congenital malformations The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations. In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist. Women weighing less than 50 kg or more than 90 kg The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see sections 5.1 and 5.2). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.