Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most common adverse reactions associated with MACRILEN reported in Study 052 (see section 5.1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%). Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need.

Tabulated list of adverse reactions

Adverse reactions reported in Study 052 are listed below by MedDRA body system organ class and by 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); not known (cannot be estimated from available data).

MedDRA organ class                         Common                                      Uncommon                             Not known Dysgeusia (bitter/metallic taste)          Somnolence
Nervous system disorders                Dizziness                                  Tremor Headache
Vertigo
Ear and labyrinth disorders


Palpitations                          ECG QT prolonged
Cardiac disorders
Sinus bradycardia                     ECG T wave abnormal
Nausea                                     Abdominal pain
Gastrointestinal disorders
Diarrhoea
Feeling cold
General disorders and administration
Fatigue                                    Hunger site conditions
Feeling hot                                Thirst
Description of selected adverse reactions

Cardiac electrophysiology
During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions. These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).

The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study of a supra-therapeutic dose of macimorelin (2 mg/kg) and in a single-ascending dose study, which included three dose levels of macimorelin (0.5 mg/kg, 1 mg/kg and 2 mg/kg). Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1). The mechanism for the observed QTcF prolongation is unknown.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions 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://sideeffects.health.gov.il