Rekovelle Adverse Reactions

Summary of safety profile: The most frequently reported adverse drug reactions (ADR) during treatment with REKOVELLE are headache, pelvic discomfort, ovarian hyperstimulation syndrome, pelvic pain, nausea, adnexa uteri pain and fatigue. None of these ADRs have been reported with an incidence rate of more than 5%. 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 as follows (Table 5) displays the adverse drug 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. (See Table 5.)

Click on icon to see table/diagram/image

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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.