Adverse reactions : תופעות לוואי

4.8         Undesirable effects

Summary of the safety profile

The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.

Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%), see section 4.4.

Tabulated list of adverse reactions

Table 1 summarises adverse reactions observed in the HELP study that included 84 subjects with HAE, who received at least one dose of TAKHZYRO.

The frequency of adverse reactions listed in Table 1 is defined using the following convention: 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).

Table 1: Adverse reactions reported with lanadelumab

System organ class                          Adverse drug reaction                     Frequency 
Immune system disorders                     Hypersensitivity*                         Common 
Nervous system disorders                    Dizziness                                 Common 
Skin and subcutaneous tissue disorders      Rash maculo-papular                       Common 
Musculoskeletal and connective tissue
Myalgia                                   Common disorders

General disorders and administration
Injection site reactions**                Very common site conditions
Alanine aminotransferase increased        Common
Investigations
Aspartate aminotransferase increased      Common
*Hypersensitivity includes: pruritus, discomfort and tingling of tongue.
**Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.

Safety data available from the HELP study extension are consistent with the safety data from the HELP study (described in Table 1).
Paediatric population

The safety of TAKHZYRO 300 mg/2 ml was evaluated in a subgroup of 23 subjects 12 to less than 18 years of age in the HELP and HELP study extension. In the SPRING study, the safety of TAKHZYRO was also evaluated at 150 mg/1 ml in 21 subjects 2 to less than 12 years of age (see section 5.1). No subject below the age of 3.5 years was receiving lanadelumab in the study. No new adverse reactions were identified. Safety and tolerability results for paediatric subjects were consistent with overall study results for all subjects.



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/