Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold 123mg.

Tabulated list of adverse reactions

Frequencies are defined as: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class.

Table 1: Adverse reactions with Galafold

System organ class                    Very common                      Common Psychiatric disorders                                                  Depression Nervous system disorders              Headache                         Paraesthesia Dizziness
Hypoaesthesia
Ear and labyrinth disorders                                            Vertigo Cardiac disorders                                                      Palpitations Respiratory, thoracic, and                                             Dyspnoea mediastinal disorders                                                  Epistaxis Gastrointestinal disorders                                             Diarrhoea Nausea
Abdominal pain
Constipation
Dry mouth
Defaecation urgency
Dyspepsia
Skin and subcutaneous tissue                                           Rash disorders                                                              Pruritus Musculoskeletal and                                                    Muscle spasms connective tissue disorders                                            Myalgia Torticollis
Pain in extremity
Renal and urinary disorders                                            Proteinuria General disorders and                                                  Fatigue administration site conditions                                         Pain Investigations                                                         Blood creatine phosphokinase increased
Weight increased

Adolescent population

The safety assessment in 21 adolescents (12 to < 18 years of age and weighing ≥ 45 kg) is based on 1-year safety data from the open label AT1001-020 trial in which subjects received the same dosage regimen as adults (see section 5.2). No age-specific differences in adverse reactions were observed between adolescent and adult subjects. The frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults based on these data.


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. 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/