Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see section 5.1).

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%).

Tabulated summary of adverse reactions
The following adverse reactions were identified in patients taking PREVYMIS in clinical trials. The adverse reactions are listed below 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).


Table 2: Adverse reactions identified with PREVYMIS
Frequency                                         Adverse reactions
Immune system disorders
Uncommon                                          hypersensitivity
Metabolism and nutrition disorders
Uncommon                                          decreased appetite
Nervous system disorders
Uncommon                                          dysgeusia, headache Ear and labyrinth disorders
Uncommon                                          vertigo
Gastrointestinal disorders
Common                                            nausea, diarrhoea, vomiting Uncommon                                          abdominal pain
Hepatobiliary disorders
Uncommon                                          alanine aminotransferase increased, aspartate aminotransferase increased
Musculoskeletal and connective tissue disorders
Uncommon                                          muscle spasms
Renal and urinary disorders
Uncommon                                          blood creatinine increased General disorders and administration site conditions
Uncommon                                          fatigue, oedema peripheral 

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/