Adverse reactions : תופעות לוואי

       4.8 Undesirable effects

Summary of the safety profile
The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4). The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).

In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50-200 mg t.i.d. for an average duration of 2.1 years. Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease. Adverse reactions were generally of mild to moderate severity and occurred with similar frequency across indications and dosages tested.

Tabulated list of adverse reactions

Adverse reactions from clinical trials and spontaneous reporting occurring in >1% of patients, are listed in the table below by system organ class and frequency (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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Blood and lymphatic system disorders
Common                         Thrombocytopenia

Metabolism and nutrition disorders
Very common                     Weight loss, decreased appetite
Psychiatric disorders
Common                               Depression, insomnia, libido decreased 
Nervous system disorders
Very common                          Tremor
Common                               Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness

Gastrointestinal disorders
Very common                          Diarrhoea, flatulence, abdominal pain Common                               Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia

Musculoskeletal and connective tissue disorders
Common                          Muscle spasms, muscle weakness

General disorders and administration site reactions
Common                           Fatigue, asthenia, chills and malaise 
Investigations
Common                               Nerve conduction studies abnormal 

Description of selected adverse reactions
Weight loss has been reported in 55 % % of patients. The greatest prevalence was observed between 6 and 12 months.


Zavesca has been studied in indications where certain events reported as adverse reactions such as neurological and neuropsychological symptoms/signs, cognitive dysfunction, and thrombocytopenia could also be due to the underlying conditions.


Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal products 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