Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile

During the HELIOS-A 18-month treatment period, the most frequently occurring adverse reactions reported in Amvuttra-treated patients were pain in extremity (15%) and arthralgia (11%).

Tabulated list of adverse reactions

The adverse reactions are presented as MedDRA preferred terms and under the MedDRA System Organ Class (SOC). The frequency of the adverse reactions is expressed according to the following categories:
•     Very common (≥1/10)
•     Common (≥1/100 to <1/10)
•     Uncommon (≥1/1,000 to <1/100) 
Table 1: Adverse reactions reported for Amvuttra

System Organ Class                         Adverse reaction                      Frequency Respiratory, thoracic, and mediastinal     Dyspnoeaa                             Common disorders
Musculoskeletal and connective tissue      Arthralgia                            Very common disorders                                  Pain in extremity                     Very common General disorders and administration       Injection site reactionb              Common site conditions
Investigations                             Blood alkaline phosphatase            Common increased



System Organ Class                          Adverse reaction                  Frequency a
Includes dyspnoea, dyspnoea exertional and dyspnoea paroxysmal nocturnal b
Reported symptoms included bruising, erythema, pain, pruritus, and warmth. Injection site reactions were mild, transient, and did not lead to treatment discontinuation 
Description of selected adverse reactions

Immunogenicity
During the HELIOS-A 18-month treatment period, 4 (3.3%) Amvuttra-treated patients developed anti- drug antibodies (ADA). ADA titres were low and transient with no evidence of an effect on clinical efficacy, safety, or pharmacokinetic or pharmacodynamic profiles of vutrisiran.

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/