Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of safety profile
The most frequently reported adverse reactions during treatment with REKOVELLE are headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain and fatigue. The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials.
Tabulated list of adverse reactions
The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the pivotal clinical trials according to MedDRA system organ class and frequency as follows: common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 2 Adverse reactions in pivotal clinical trials
Common                          Uncommon
System Organ Class               (≥1/100 to <1/10)               (≥1/1,000 to <1/100) Psychiatric disorders                                            Mood swings 
Nervous system disorders           Headache                      Somnolence Dizziness

Gastrointestinal disorders         Nausea                        Diarrhoea Vomiting
Constipation
Abdominal discomfort

Reproductive system and breast     OHSS                          Vaginal haemorrhage disorders                          Pelvic pain                   Breast pain Adnexa uteri pain             Breast tenderness
Pelvic discomfort
General disorders and              Fatigue administration site conditions

Description of selected adverse reactions
OHSS is an intrinsic risk of the ovarian stimulation. Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea. Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment (see section 4.4).

Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).

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/