ADVERSE REACTIONS
Zemplar has been evaluated for safety in clinical studies in 454 CKD Stage 5 patients. In four, placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 6.5% of 62 patients treated with Zemplar (dosage titrated as tolerated, see CLINICAL PHARMACOLOGY - Clinical Studies) and 2.0% of 51 patients treated with placebo for 1 to 3 months. Adverse events occurring with greater frequency in the Zemplar group at a frequency of 2% or greater, regardless of causality, are presented in the following table:
Adverse Event Incidence Rates for All Treated Patients In All Placebo-Controlled Studies | Adverse Event | Zemplar (n = 62)
% | Placebo (n = 51)
% |
| Overall | 71 | 78 |
| Body as a Whole | | |
| Chills | 5 | 0 |
| Feeling unwell | 3 | 0 |
| Fever | 5 | 2 |
| Flu | 5 | 4 |
| Sepsis | 5 | 2 |
| Cardiovascular System | | |
| Palpitation | 3 | 0 |
| Digestive System | | |
| Dry mouth | 3 | 2 |
| Gastrointestinal bleeding | 5 | 2 |
| Nausea | 13 | 8 |
| Vomiting | 8 | 4 |
| Metabolic and Nutritional Disorders | | |
| Edema | 7 | 0 |
| Nervous System | | |
| Light-headedness | 5 | 2 |
| Respiratory System | | |
| Pneumonia | 5 | 0 |
A patient who reported the same medical term more than once was counted only once for that medical term.
Safety parameters (changes in mean Ca, P, Ca × P) in an open-label safety study up to 13 months in duration support the long-term safety of Zemplar in this patient population.
Potential adverse events of Zemplar Injection are, in general, similar to those encountered with excessive vitamin D intake. Signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Early
Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, and metallic taste.
Late
Anorexia, weight loss, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, hypercholesterolemia, elevated AST and ALT, ectopic calcification, hypertension, cardiac arrhythmias, somnolence, death, and rarely, overt psychosis.
Adverse Events During Post-marketing Experience
Taste perversion, such as metallic taste, and allergic reactions, such as rash, urticaria, pruritus, facial and oral edema rarely have been reported.
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