Prevymis Adverse Reactions

Summary of the safety profile: The safety assessment of PREVYMIS was based on two Phase 3 clinical trials.
In P001, 565 HSCT recipients received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see Pharmacology: Pharmacodynamics under Actions).
The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting (1.9%). The most frequently reported adverse reactions that led to discontinuation of PREVYMIS were: nausea (1.6%), vomiting (0.8%), and abdominal pain (0.5%).
In P040, 218 HSCT recipients received PREVYMIS or placebo from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT and were followed for safety through Week 48 post-HSCT (see Pharmacology: Pharmacodynamics under Actions). The adverse reactions reported were consistent with the safety profile of PREVYMIS as characterised in study P001.
Tabulated summary of adverse reactions: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials. The adverse reactions are listed as follows by body system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000). (See Table 4.)

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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. Healthcare professionals are asked to report any suspected adverse reactions.