Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of safety profile
The most frequently reported adverse reactions during treatment with REKOVELLE are OHSS headache, , , pelvic pain, nausea, 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 experienced in clinical trials by patients treated with REKOVELLE) using the algorithm-based dosing regimen. 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 discomforta

Reproductive system and breast     OHSS                           Vaginal haemorrhage disorders                          Pelvic painb                   Breast discomfortc 
General disorders and              Fatigue administration site conditions a
Abdominal discomfort includes abdominal pain/distention.
b
Pelvic pain includes pelvic discomfort and adnexa uteri pain.
c
Breast discomfort includes breast pain, breast swelling, breast tenderness and/or nipple pain.

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/