Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Safety data are derived from spontaneous reports, published literature and PROMPT study (prospective single-arm, open-label study, 50 patients included in safety data set). Adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Table 1. Adverse drug reactions

System Organ Class       Frequency SOC / Preferred Term
Very common            Common                      Not known
(≥1/10)                (≥1/100, <1/10)
Blood and lymphatic                                                         Leukopenia, anaemia, system disorders                                                            thrombocytopenia Endocrine disorders      Adrenal insufficiency*
Metabolism and           Decreased appetite*       Hypokalaemia nutrition disorders
Nervous system           Headache*                 Sedation disorders                Dizziness*
Vascular disorders       Hypertension              Hypotension*
Gastroinstinal           Nausea*                   Vomiting* disorders                Abdominal pain*
Diarrhoea
Hepatobiliary                                                               Hepatic enzymes disorders                                                                   increased Skin and                 Hypersensitivity          Hirsutism**              Alopecia subcutaneous tissue      reactions including       Acne disorders                rash, pruritus and urticaria
Musculoskeletal and      Arthralgia           Myalgia connective tissue disorders
Infections and                                                         Pneumocystis Infestations                                                           jirovecii pneumonia General disorders and Asthenic conditions administration site      Peripheral oedema conditions
*Mainly during titration period/dose increase
**Reported cases occurred in the PROMPT study following treatment of 12 to 36 weeks duration 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/