Rekovelle Adverse Reactions

The most frequently reported adverse drug 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.
ADRs from clinical trials: The table as follows (Table 7) displays the adverse reactions experienced in clinical trials by patients treated with REKOVELLE using the algorithm-based dosing regimen. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. (See Table 7.)

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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.
Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see Pharmacology: Pharmacodynamics under Actions).