Medical Editor: John P. Cunha, DO, FACOEP
What Is Zemplar Injection?
What Are Side Effects of Zemplar Injection?
Common side effects of Zemplar Injection include:
- gastrointestinal bleeding
- severe infection (sepsis)
- joint pain
- dry mouth
- swelling, and
- feeling unwell
Dosage for Zemplar Injection
The recommended initial dose of Zemplar is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered as a bolus dose no more frequently than every other day at any time during dialysis.
What Drugs, Substances, or Supplements Interact with Zemplar Injection?
Zemplar Injection During Pregnancy or Breastfeeding
During pregnancy, Zemplar should be used only if prescribed. It is unknown if Zemplar passes into breast milk. Breastfeeding while taking Zemplar is not recommended.
Our Zemplar (paricalcitol) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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The following serious adverse reactions are described below and elsewhere in the labeling:
- Hypercalcemia [see WARNINGS AND PRECAUTIONS]
- Adynamic Bone Disease [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Four placebo-controlled, double-blind, multicenter studies were conducted in 113 patients (51% male, 10% Caucasian, 81% African-American and 9% Hispanic, ranging in age from 18 to 90 years). Sixty-two patients were exposed to ZEMPLAR and the average dose at the end of treatment was 0.12 mcg/kg/dose with a mean number of 55 days of dosing across the studies. Discontinuation of therapy due to any adverse reaction occurred in 6.5% of patients treated with ZEMPLAR and 2.0% of patients treated with placebo. Adverse reactions occurring with greater frequency in the ZEMPLAR group and at a frequency of 2% or greater are presented in Table 3.
Table 3: Adverse Reactions Occurring at a Rate of 2% or Greater in Patients with CKD on Dialysis in Four Placebo-Controlled Studies
(n = 51) %
(n = 62) %
Other Adverse Reactions
The following adverse reactions occurred in less than 2% of the ZEMPLAR treated patients in the above mentioned studies and in additional double-blind, active-controlled and open-label studies:
Blood and Lymphatic System Disorders: Anemia, lymphadenopathy
Cardiac Disorders: Arrhythmia, atrial flutter, irregular heart rate, cardiac arrest, chest discomfort, chest pain, edema peripheral
Ear and Labyrinth Disorders: Ear discomfort
Endocrine Disorders: Hypoparathyroidism
Eye Disorders: Conjunctivitis, glaucoma, ocular hyperemia
Gastrointestinal Disorders: Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage
General Disorders: Asthenia, condition aggravated, fatigue, feeling abnormal, pain, swelling Infections: Nasopharyngitis, upper respiratory tract infection, vaginal infection
Injection site reactions: Injection site extravasation, injection site pain
Laboratory abnormalities: Hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia, increased aspartate aminotransferase, prolonged bleeding time
Metabolism and Nutrition Disorders: Decreased appetite, thirst, decreased weight
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, gait disturbance
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
The following adverse reactions have been identified during post-approval use of ZEMPLAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Allergic reactions, such as rash, urticaria, and angioedema (including laryngeal edema) have been reported.
Table 4 includes clinically significant drug interactions with ZEMPLAR.
Table 4: Clinically Significant Drug Interactions with ZEMPLAR
|Drugs that May Increase the risk of Hypercalcemia|
|Clinical Impact||Concomitant administration of high doses of calcium-containing preparations or other vitamin D compounds may increase the risk of hypercalcemia. Thiazide diuretics are known to induce hypercalcemia by reducing excretion of calcium in the urine.|
|Examples||Calcium-containing products, other vitamin D compounds or thiazide diuretics|
|Intervention||Monitor calcium more frequently and adjust ZEMPLAR dose as needed [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact||ZEMPLAR can cause hypercalcemia which can potentiate the risk of digitalis toxicity.|
|Intervention||Monitor patients for signs and symptoms of digitalis toxicity and increase frequency of serum calcium monitoring when initiating or adjusting the dose of ZEMPLAR in patients receiving digitalis compounds [see WARNINGS AND PRECAUTIONS].|
|Strong CYP3A Inhibitors|
|Clinical Impact||ZEMPLAR is partially metabolized by CYP3A. Exposure of ZEMPLAR will increase upon coadministration with strong CYP3A inhibitors [see CLINICAL PHARMACOLOGY].|
|Examples||Boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, and voriconazole|
|Intervention||If a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor, dose adjustment of ZEMPLAR may be necessary. Monitor intact PTH and serum calcium concentrations closely.|
Read the entire FDA prescribing information for Zemplar (Paricalcitol Tablets)
© Zemplar Patient Information is supplied by Cerner Multum, Inc. and Zemplar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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