Rekovelle Adverse Reactions

Summary of safety profile: The most frequently reported adverse drug reactions (ADR) during treatment with REKOVELLE are ovarian hyperstimulation syndrome (OHSS), headache, pelvic pain, nausea and fatigue. OHSS occurred in approximately 6% of all patients and severe OHSS was reported in less than 0.9%. The frequency of these adverse reactions might decrease with repeated treatment cycles, as this has been observed in clinical trials.
ADRs from clinical trials: The table as follows (Table 3) displays the adverse drug 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. (See Table 3.)

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ADRs from post-marketing sources: Post-marketing data is in line with adverse drug reactions reported in clinical trials presented in Table 3.
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.