PARICALCITOL- paricalcitol injection
West-Ward Pharmaceutical Corp
Paricalcitol Injection is an active vitamin D2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.
For intravenous use through hemodialysis vascular access port only.
The recommended starting dose of Paricalcitol Injection is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered through a hemodialysis vascular access port as a bolus dose at any time during dialysis. Dosing should not occur more frequently than every other day. The drug product should not be injected directly into a vein. Dosage should be individualized. If a satisfactory parathyroid hormone (PTH) lowering response is not observed using the recommended starting dose, the dose may be increased by 2 to 4 mcg every 2 to 4 weeks based on PTH levels (refer to Table 1).
|PTH Level at Follow-up Visit||Dosage Adjustment|
|Above target and PTH increased||Increase|
|Above target and PTH decreased by less than 30%||Increase|
|Above target and PTH decreased by 30 to 60%||No Change|
|Above target and PTH decreased by more than 60%||Decrease|
|At target and PTH stable||No Change|
When initiating Paricalcitol Injection or adjusting Paricalcitol Injection dose, measure serum calcium and phosphorus frequently (e.g., twice weekly) and PTH every 2 to 4 weeks. Once a maintenance dose has been established, serum calcium and phosphorus should be measured at least monthly and plasma PTH every 3 months.
Paricalcitol Injection is available in the following presentations:
- 2 mcg per mL single dose vial
- 5 mcg per mL single dose vial
- 10 mcg per 2 mL (5 mcg per mL) multiple dose vial
Paricalcitol Injection is contraindicated in patients with evidence of:
- Hypercalcemia [see Warnings and Precautions (5.1) ]
- Vitamin D toxicity [see Warnings and Precautions (5.1) ] or
- Hypersensitivity to paricalcitol or any inactive ingredient in this product [see Adverse Reactions (6.2) ]
Hypercalcemia may occur during Paricalcitol Injection treatment and may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or vitamin D (i.e., all forms). Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Hypercalcemia may be so severe as to require emergency attention.
High intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia. Prevention of such adverse reactions requires frequent serum calcium monitoring and careful Paricalcitol Injection dose adjustments.
Concomitant use with other active vitamin D analogues should be avoided during Paricalcitol Injection treatment to prevent hypercalcemia.
Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss.
Hypercalcemia of any cause increases the risk of digitalis toxicity. In patients using Paricalcitol Injection concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity and increase frequency of monitoring when initiating or adjusting the dose of Paricalcitol Injection [see Dosage and Administration (2) ].
Concomitant use of Paricalcitol Injection with strong CYP3A inhibitors will increase the levels of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing therapy with drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required [see Drug Interactions (7.1), Clinical Pharmacology (12.3) ].
Adynamic bone disease with subsequent increased risk of fractures may develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection dose [see Dosage and Administration (2) ].
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.
Safety has been evaluated in clinical studies conducted with another paricalcitol injection product in 609 patients with CKD Stage 5. 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 paricalcitol injection (dosage titrated as tolerated, [see Clinical Studies (14) ]) and 2% of 51 patients treated with placebo for 1 to 3 months. Adverse reactions occurring with greater frequency in the paricalcitol group and at a frequency of 2% or greater are presented in the following table:
|Adverse Reaction|| |
Placebo (n=51) %
|Paricalcitol Injection(n=62) %|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Musculoskeletal and Connective Tissue Disorders|
Specific laboratory parameters [i.e., changes in mean Calcium (Ca), Phosphorus (P), and Calcium Phosphorus product (Ca × P)] were followed in an open-label safety study conducted with another paricalcitol injection product for up to 13 months in duration in this patient population and results are shown below [see Clinical Studies (14) ].
Other Adverse Reactions Associated with Paricalcitol Injection Use
The following adverse reactions occurred in less than 2% of the paricalcitol-treated patients in the above mentioned double-blind, placebo-controlled clinical trials and in additional 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: 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
Laboratory Investigations and Vital Signs: Increased aspartate aminotransferase, prolonged bleeding time, irregular heart rate, decreased weight
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
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