Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile

The safety of paricalcitol capsules has been evaluated in three 24-week, double-blind, placebo- controlled, multi-centre clinical trials involving 220 CKD Stage 3 and 4 adult patients and in one 12-week, double-blind, placebo-controlled, multi-centre clinical trial involving 88 CKD Stage 5 adult patients. In addition, there is post-marketing experience with paricalcitol capsules from three additional studies, and paediatric experience from two studies. The most commonly reported adverse reactions for paricalcitol treated patients were hypercalcaemia and calcium phosphate product increased.

In the Stage 3/4 and Stage 5 clinical trials, the incidence of hypercalcaemia was Zemplar (3/167, 2%) vs placebo (0/137, 0%) and elevated calcium phosphate product was Zemplar (19/167, 11%) vs placebo (8/137, 6%).

Tabulated list of adverse reactions

All adverse reactions associated with Zemplar capsules are displayed in Table 3 by MedDRA System Organ Class, Preferred Term and frequency. The following frequency groupings are used: 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 the available data).

Table 3: Adverse Reactions Reported With Zemplar Capsules in Clinical Trials and From Post Marketing Experience


System Organ Class                 Frequency*                  Adverse Reaction 
Infections and infestations        Uncommon                    Pneumonia 
Immune system disorders            Uncommon                    Hypersensitivity 
Not known*                  Angioedema, laryngeal oedema
Endocrine Disorders                Uncommon                    Hypoparathyroidism 
Metabolism and nutrition           Common                      Hypercalcaemia, disorders                                                      hyperphosphataemia Uncommon                    Decreased appetite, hypocalcaemia

Nervous system disorders           Uncommon                    Dizziness, dysgeusia, headache 
Cardiac disorders                  Uncommon                    Palpitations 
Gastrointestinal disorders         Uncommon                    Abdominal discomfort, abdominal pain upper, constipation, diarrhoea,
dry mouth, gastroesophageal reflux disease, nausea, vomiting
Skin and subcutaneous tissue       Uncommon                    Acne, pruritus, rash, urticaria disorders
Musculoskeletal and connective     Uncommon                    Muscle spasms, myalgia tissue disorders
Reproductive system and breast     Uncommon                    Breast tenderness disorders
General disorders and              Uncommon                    Asthenia, malaise, oedema administration site conditions                                  peripheral, pain Investigations                     Common                       Calcium phosphate product increased
Uncommon                     Blood creatinine increased†, hepatic enzyme abnormal
*Frequencies for adverse reactions from post marketing experience cannot be estimated and have been reported as “Not Known.”
†
This adverse reaction has been observed in studies in predialysis patients (see also section 4.4).

Reporting of suspected adverse reactions
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