Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects reported by patients suffering from acromegaly and GEP-NETs treated with lanreotide in clinical trials are listed under the corresponding body organ systems according to the following classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).

The most commonly expected adverse drug reactions following treatment with lanreotide are gastrointestinal disorders (most commonly reported are diarrhoea and abdominal pain, usually mild or moderate and transient), cholelithiasis (often asymptomatic) and injection site reactions (pain, nodules and indurations).

The profile of undesirable effects is similar for all indications.

System organ         Very             Common (≥1/100          Uncommon       Post-marketing class                common           to <1/10)               (≥1/1,000 to   safety (≥1/10)                                  <1/100)        experience (frequency not known)
Metabolism and                        Hypoglycaemia,
nutrition                             decreased disorders                             appetite**,
hyperglycaemia,
diabetes mellitus

Psychiatric                                                   Insomnia* disorders
Nervous system                        Dizziness,
disorders                             headache,
lethargy**
Cardiac                               Sinus bradycardia* disorders
Vascular                                                      Hot flushes* disorders
Gastrointestinal     Diarrhoea,       Nausea, vomiting,       Faeces disorders            loose stools*,   constipation,           discoloured*   Pancreatitis abdominal        flatulence,                            exocrine pain             abdominal                              insufficiency, distension,                            Pancreatitis abdominal discomfort*,
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dyspepsia,
steatorrhoea**

Hepatobiliary      Cholelithiasis   Biliary dilatation*                    Cholecystitis, disorders                                                                  cholangitis Musculoskeletal                     Musculoskeletal and connective                      pain**,
tissue disorders                    myalgia**
Skin and                            Alopecia,
subcutaneous                        hypotrichosis* tissue disorders
General                             Asthenia, fatigue,
disorders and                       injection site administration                      reactions (pain,
site conditions                     mass, induration,
nodule, pruritus)
Investigations                      ALAT increased*,        ASAT
ASAT abnormal*,         increased*,
ALAT abnormal*,         blood blood bilirubin         alkaline increased*, blood       phosphatase glucose                 increased*,
increased*,             blood glycosylated            bilirubin haemoglobin             abnormal*,
increased*, weight      blood sodium decreased,              decreased* pancreatic enzymes decreased**
Immune system                                                              Allergic disorders                                                                  reactions (including angioedema,
anaphylaxis,
hypersensitivity)
* based on a pool of studies conducted in acromegalic patients
** based on a pool of studies conducted in patients with GEP-NETs

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/