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, angioedema and laryngeal edema rarely have been reported.
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REPORTS OF SUSPECTED ZEMPLAR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Zemplar. The information is not vetted and should not be considered as verified clinical evidence.
Possible Zemplar side effects / adverse reactions in 71 year old male
Reported by a health professional (non-physician/pharmacist) from Sweden on 2011-10-03
Patient: 71 year old male
Reactions: Gastrointestinal Haemorrhage, Atrial Fibrillation
Adverse event resulted in: hospitalization
Suspect drug(s):
Warfarin Sodium
Indication: Atrial Fibrillation
Start date: 2011-08-01
End date: 2011-08-01
Zemplar
Indication: Hyperparathyroidism
Start date: 2011-06-15
End date: 2011-09-07
Other drugs received by patient: Metoprolol Tartrate; Venofer; Sodium Polystyrene Sulfonate; Innohep Solution FOR Injection 1000anti-XA Ie/ml; Furosemide; Pamol; Renvela; Fenuril; Allopurinol; Sinemet; Natriumbikarbonat; Neorecormon Solution FOR Injection, PRE-Filled Syringe 3000 IE; Felodipine; Acetaminophen W/ Codeine
Possible Zemplar side effects / adverse reactions in 77 year old female
Reported by a physician from Austria on 2011-10-06
Patient: 77 year old female weighing 64.0 kg (140.8 pounds)
Reactions: Tracheobronchitis, Dyspnoea
Adverse event resulted in: hospitalization
Suspect drug(s):
Zemplar
Other drugs received by patient: Etalpha; Iterium; Phosphatbinder; Vilan; Resonlum A Pulver; Calcium Acetate; Mexalen; Pretreatment OF Shpt; Phosphatbinder; Cymbalta; Berodual; Pantoprazole Sodium; Cinacalcet; Bisoprolol Fumarate; Renvela; Calcium Carbonate; Etalpha; Risperdal; Theophylline; Vitarenal; Emla CR; Voltaren Eemulgel-Gel; Norvasc; Cefuroxime; Lovenox; Aspirin; Aranesp; Mixtard Human 70/30; Novalgin; Metoclopramide Hydrochloride; Citalopram Hydrobromide; Ceftriaxon; Ferrlecit
Possible Zemplar side effects / adverse reactions in 67 year old female
Reported by a physician from Austria on 2011-10-07
Patient: 67 year old female weighing 56.0 kg (123.2 pounds)
Reactions: Pancreatic Abscess, Renal and Pancreas Transplant Rejection, Procalcitonin Increased, C-Reactive Protein Increased, White Blood Cell Count Increased, Infectious Peritonitis
Adverse event resulted in: hospitalization
Suspect drug(s):
Zemplar
Other drugs received by patient: Renvela; Renvela; Etalpha; Aspirin; Norvasc; Rapamune; Pantoprazole Sodium; Levothyroxine Sodium; Renvela; Lovenox; Neorecormon; Etalpha; Bisoprolol Fumarate; Prograf; Xyzal
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