Adverse reactions : תופעות לוואי

4.8   Undesirable effects
 a)    Summary of the safety profile
Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism 
Based on available data from patients receiving cinacalcet in placebo controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting. Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Discontinuation of therapy as a result of undesirable effects was mainly due to nausea and vomiting.
b)    Tabulated list of adverse reactions

Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: 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).
Incidence of adverse reactions from controlled clinical studies and post-marketing experience are: 
MedDRA system organ class              Subject incidence              Adverse reaction *
Immune system disorders                Common                         Hypersensitivity reactions Metabolism and nutrition               Common                         Anorexia disorders                              Common                         Decreased appetite Nervous system disorders               Common                         Seizures† Common                         Dizziness
Common                         Paraesthesia
Common                         Headache
*
Cardiac disorders                      Not known                      Worsening heart failure† *
Not known                      QT prolongation and ventricular arrhythmia secondary to hypocalcaemia†
Vascular disorders                     Common                         Hypotension Respiratory, thoracic and              Common                         Upper respiratory infection mediastinal disorders                  Common                         Dyspnoea Common                         Cough
Gastrointestinal disorders             Very common                    Nausea Very common                    Vomiting
Common                         Dyspepsia
Common                         Diarrhoea
Common                         Abdominal pain
Common                         Abdominal pain – upper
Common                         Constipation
Skin and subcutaneous tissue           Common                         Rash disorders
Musculoskeletal and connective         Common                         Myalgia tissue disorders                       Common                         Muscle spasms Common                         Back pain
General disorders and                  Common                         Asthenia administration site conditions
Investigations                         Common                           Hypocalcaemia† Common                           Hyperkalaemia

Common                           Reduced testosterone levels†
† see section 4.4
* see section c
 c)       Description of selected adverse reactions
Hypersensitivity reactions

Hypersensitivity reactions including angioedema and urticaria have been identified during post- marketing use of cinacalcet. The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.

Hypotension and/or worsening heart failure

There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the frequencies of which cannot be estimated from available data.

QT prolongation and ventricular arrhythmia secondary to hypocalcaemia 
QT prolongation and ventricular arrhythmia secondary to hypocalcaemia have been identified during post-marketing use of cinacalcet, the frequencies of which cannot be estimated from available data (see section 4.4).
 d)        Paediatric population

Cinacalcet Teva is not indicated for use in paediatric patients. The safety and efficacy of cinacalcet in the paediatric population have not been established. A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 4.4).

Reporting of suspected adverse reactions
Reporting of 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 event should be reported to the Ministry of Health according to the National Regulations, by using an online form, which is available at: https://sideeffects.health.gov.il