"By Megan Brooks
Medscape Medical News
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of tolvaptan (Jinarc, Otuska) to slow progression of cyst developmen"...
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
|Adverse Event||Zemplar (n = 62) %||Placebo (n = 51) %|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Musculoskeletal and Connective Tissue Disorders|
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
Ear and Labyrinth Disorders
General Disorders and Administration Site Conditions
Infections and Infestations
Nasopharyngitis, upper respiratory tract infection, vaginal infection
Aspartate aminotransferase increased, bleeding time prolonged, heart rate irregular, laboratory test abnormal, weight decreased
Metabolism and Nutrition Disorders
Musculoskeletal and Connective Tissue Disorders
Joint stiffness, muscle twitching, myalgia Neoplasms Benign,
Malignant and Unspecified
Nervous System Disorders
Reproductive System and Breast Disorders
Respiratory, Thoracic and Mediastinal Disorders
Skin and Subcutaneous Tissue Disorders
Additional Adverse Events Reported During Post-marketing Experience
Read the Zemplar Injection (paricalcitol injection fliptop vial) Side Effects Center for a complete guide to possible side effects
Specific interaction studies were not performed with Zemplar Injection. Paricalcitol is not expected to inhibit the clearance of drugs metabolized by cytochrome P450 enzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A nor induce the clearance of drug metabolized by CYP2B6, CYP2C9 or CYP3A.
A multiple dose drug-drug interaction study with ketoconazole and paricalcitol capsule demonstrated that ketoconazole approximately doubled paricalcitol AUC0-∞; (see CLINICAL PHARMACOLOGY). Since paricalcitol is partially metabolized by CYP3A and ketoconazole is known to be a strong inhibitor of cytochrome P450 3A enzyme, care should be taken while paricalcitol is co-administered with ketoconazole and other strong P450 3A inhibitors including the following drugs but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole.
Digitalis toxicity is potentiated by hypercalcemia of any cause, so caution should be applied when digitalis compounds are prescribed concomitantly with Zemplar.
Read the Zemplar Injection Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/20/2011
Additional Zemplar Injection Information
- Zemplar Injection Drug Interactions Center: paricalcitol iv
- Zemplar Injection Side Effects Center
- Zemplar Injection Overview including Precautions
- Zemplar Injection FDA Approved Prescribing Information including Dosage
Zemplar Injection - User Reviews
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