Adverse reactions : תופעות לוואי

4.8 Undesirable effects
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 (≥1/1000 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 administration site                                  injection (predominantly redness, with conditions                                           or without 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 the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il