Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Undesirable effects reported by patients suffering from acromegaly 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).
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 induration).
The profile of undesirable effects is similar for other indications.


System organ       Very common          Common              Uncommon       Post-marketing class              (≥1/10)              (≥1/100 to          (≥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 disorders                               bradycardia*
Vascular                                                    Hot flushes* disorders
Gastrointestinal   Diarrhoea, loose     Nausea,             Faeces         Pancreatitis disorders          stools*, abdominal   vomiting,           discoloured* pain                 constipation,
flatulence,
abdominal distension,
abdominal discomfort,
dyspepsia,
steatorrhoea**
Hepatobiliary       Cholelithiasis       Biliary dilatation* disorders
Musculoskeletal                          Musculoskeletal and connective                           pain**, myalgia** tissue disorders
Skin and                                 Alopecia,
subcutaneous                             hypotrichosis* tissue disorders
General                                  Asthenia,
disorders and                            fatigue, injection administration                           site reactions site conditions                          (pain, mass,
induration,
nodule, pruritus)
Investigations                           ALAT                  ASAT increased*, increased*,           blood alkaline
ASAT                  phosphatase abnormal*,            increased*, blood
ALAT                  bilirubin abnormal*,            abnormal*, blood blood bilirubin       sodium increased*,           decreased* blood glucose increased*,
glycosylated haemoglobin increased*,
weight decreased,
pancreatic enzymes decreased**
Immune system                                                                      Allergic reactions disorders                                                                          (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 reaction after authorization 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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il