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,                    Uncommon pharyngitis, vaginal 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,                    Not known* urticaria
Endocrine Disorders                     Hypoparathyroidism                               Common Hyperparathyroidism                              Uncommon
Metabolism and nutrition                Hypercalcaemia, Hyperphosphataemia               Common disorders
Hyperkalaemia, hypocalcemia, anorexia            Uncommon
Psychiatric disorders                   Confusional state, delirium,                     Uncommon depersonalization, agitation, insomnia,
nervousness
Nervous system disorders                Headache, dysgeusia                              Common 
Coma, cerebrovascular accident,                  Uncommon transient ischemic 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,            Uncommon mediastinal disorders                 epistaxis, cough
Gastrointestinal disorders            Rectal haemorrhage, colitis, diarrhoea,        Uncommon gastritis, 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,       Uncommon rash, hyperhidrosis
Musculoskeletal and                   Arthralgia, joint stiffness, back pain,        Uncommon connective tissue disorders           muscle twitching, myalgia
Reproductive system and               Breast pain, erectile dysfunction              Uncommon breast disorders
General disorders and                Gait disturbance, oedema, peripheral       Uncommon administration site conditions       oedema, pain, injection site pain, pyrexia, chest pain, condition aggravated, asthenia, malaise, thirst
Investigations                       Bleeding time prolonged, aspartate         Uncommon aminotransferase 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 Additionally, you can report to Unipharm Ltd. via the following address: https://unipharm.co.il/