Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions during treatment with Elonva in clinical trials (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 women 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                Not known                    Hypersensitivity reactions, disorders                                                 both local and generalised,
including rash*
Psychiatric disorders        Uncommon                     Mood swings Nervous system               Common                       Headache disorders
Uncommon                     Dizziness
Vascular disorders           Uncommon                     Hot flush
Gastrointestinal             Common                       Nausea disorders
Uncommon                     Abdominal distension,
vomiting, diarrhoea,
constipation
Musculoskeletal and          Uncommon                     Back pain connective tissue disorders

Pregnancy, puerperium        Uncommon                     Abortion spontaneous and perinatal conditions

Reproductive system          Common                       OHSS, pelvic pain, pelvic and breast disorders                                      discomfort, breast tenderness
Uncommon                     Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain
General disorders and        Common                       Fatigue administration site conditions
Uncommon                     Injection site haematoma,
injection site pain,
irritability
Investigations               Uncommon                     Alanine aminotransferase increased, aspartate
aminotransferase increased
Injury, poisoning and          Uncommon                        Procedural pain procedural complications

*Adverse reactions were identified through post-marketing surveillance.
Description of selected adverse reactions

In addition, ectopic pregnancy and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.

In rare instances, thromboembolism has been associated with Elonva therapy as with other gonadotropins.

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