Zemplar Injection (Paricalcitol Injection Fliptop Vial)

Zemplar has been evaluated for safety in clinical studies in 609 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 in the Zemplar group at a frequency of 2% or greater and with an incidence greater than that in the placebo group, regardless of causality, are presented in the following table:

Adverse Event Incidence Rates for All Treated Patients In All Placebo-Controlled Studies

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 (see Clinical Studies).

Other Adverse Reactions Observed During Clinical Evaluation of Zemplar Injection (paricalcitol injection fliptop vial)

The following adverse reactions, with a causal relationship to Zemplar, occurred in < 2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set. In addition, the following also includes adverse reactions reported in Zemplar-treated patients who participated in other studies (non placebo-controlled), including double-blind, active-controlled and open-label studies:

Blood and Lymphatic System Disorders

Anemia, lymphadenopathy

Cardiac Disorders

Arrhythmia, atrial flutter, cardiac arrest

Ear and Labyrinth Disorders

Ear discomfort

Endocrine Disorders

Hyperparathyroidism, hypoparathyroidism

Eye Disorders

Conjunctivitis, glaucoma, ocular hyperemia

Gastrointestinal Disorders

Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage

General Disorders and Administration Site Conditions

Asthenia, chest discomfort, chest pain, condition aggravated, edema peripheral, fatigue, feeling abnormal, gait disturbance, injection site extravasation, injection site pain, pain, swelling, thirst

Infections and Infestations

Nasopharyngitis, upper respiratory tract infection, vaginal infection

Investigations

Aspartate aminotransferase increased, bleeding time prolonged, heart rate irregular, laboratory test abnormal, weight decreased

Metabolism and Nutrition Disorders

Decreased appetite, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia

Musculoskeletal and Connective Tissue Disorders

Joint stiffness, muscle twitching, myalgia Neoplasms Benign,

Malignant and Unspecified

Breast cancer

Nervous System Disorders

Cerebrovascular accident, dizziness, dysgeusia, headache, hypoesthesia, myoclonus, paresthesia, syncope, unresponsive to stimuli

Psychiatric Disorders

Agitation, confusional state, delirium, insomnia, nervousness, restlessness

Reproductive System and Breast Disorders

Breast pain, erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders

Cough, dyspnea, orthopnea, pulmonary edema, wheezing

Skin and Subcutaneous Tissue Disorders

Alopecia, blister, hirsutism, night sweats, rash pruritic, pruritus, skin burning sensation

Vascular Disorders

Hypertension, hypotension

Additional Adverse Events Reported During Post-marketing Experience

Allergic reactions, such as rash, urticaria, and angioedema (including laryngeal edema) have been reported.