Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
Approximately 600 patients were treated with paricalcitol in Phase II/III/IV clinical trials.
Overall, 6% of the paricalcitol treated patients reported adverse reactions.
The most common adverse reaction associated with paricalcitol therapy was hypercalcaemia, occurring in 4.7% of patients. Hypercalcaemia is dependent on the level of PTH oversuppression and can be minimised by proper dose titration.
Tabulated list of adverse reactions
Adverse events at least possibly related to paricalcitol, both clinical and laboratory are displayed by MedDRA System Organ Class, Adverse reaction and frequency. The following frequency groupings are used: Very common ( ≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10,000, <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data).

System Organ Class                                   Preferred Term                            Frequency Infections and infestations          Sepsis, pneumonia, infection , pharyngitis, vaginal        Uncommon infection, influenza
Neoplasms benign, malignant          Breast cancer                                              Uncommon and unspecified (including cysts and polyps)
Blood and lymphatic system           Anaemia, leukopenia, lymphadenopathy                       Uncommon disorders
Immune system disorders              Hypersensitivity                                           Uncommon Laryngeal oedema, angioedema, urticaria                    Not Known* Endocrine Disorders                  Hypoparathyrodism                                          Common Hyperparathyrodism                                         Uncommon
Metabolism and nutrition             Hypercalcaemia, Hyperphosphataemia                         Common disorders
Hyperkalaemia, hypocalcemia, anorexia,                     Uncommon

Psychiatric disorders                Confusional state, delirium, depersonalization, agitation, Uncommon insomnia, nervousness
Nervous system disorders             Headache, dysgeusia                                        Common Coma, cerebrovascular accident, transient ischemic         Uncommon attack, syncope, myoclonus, hypoaesthesia,
paraesthesia, dizziness
Eye disorders                        Glaucoma, conjunctivitis                                   Uncommon Ear and labyrinth disorders          Ear disorder                                               Uncommon Cardiac disorders                    Cardiac arrest, arrhythmia, atrial flutter                 Uncommon Vascular disorders                  Hypertension, hypotension                                   Uncommon Respiratory, thoracic and           Pulmonary oedema, asthma, dyspnoea, epistaxis, cough Uncommon mediastinal disorders
Gastrointestinal disorders          Rectal haemhorrhage, colitis, diarrhoea, gastritis,         Uncommon dyspepsia, dysphagia, abdominal pain, constipation,
nausea, vomiting, dry mouth, gastrointestinal disorder gastrointestinal haemorrhage                                Not known Skin and subcutaneous tissue        Pruritus                                                    Common disorders
Bullous dermatitis, alopecia, hirsutism, rash,              Uncommon hyperhidrosis
Musculoskeletal and connective      Arthralgia, joint stiffness, back pain, muscle twitching,   Uncommon tissue disorders                    myalgia
Reproductive system and breast      Breast pain, erectile dysfunction                           Uncommon disorders
General disorders and               Gait disturbance, oedema, peripheral oedema, pain,          Uncommon administration site conditions      injection site pain, pyrexia, chest pain, condition aggravated, asthenia, malaise, thirst
Investigations                    Bleeding time prolonged, aspartate aminotransferase     Uncommon increased, laboratory test abnormal, weight decreased
*Frequencies for adverse reactions from postmarketing experience cannot be estimated and have been reported as “Not known.”


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 events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il