Paricalcitol
Generic Name: paricalcitol
Brand Names:
Paricalcitol
11 DESCRIPTION Paricalcitol USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula: Molecular formula is C 27 H 44 O 3 . Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use.
Overview
11 DESCRIPTION Paricalcitol USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula: Molecular formula is C 27 H 44 O 3 . Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use.
Uses
1 INDICATIONS AND USAGE Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. Paricalcitol injection is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Ensure serum calcium is not above the upper limit of normal before initiating ( 2.1 ) Administer paricalcitol injection intravenously through a hemodialysis vascular access at any time during dialysis ( 2.1 ). Adult Dose : Initiate at 0.04 mcg/kg to 0.1 mcg/kg (2.8 mcg to 7 mcg) no more frequently than every other day ( 2.2 ). Target maintenance dose to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits ( 2.2 ). Monitor serum calcium frequently (e.g., twice weekly) and intact PTH levels every 2 to 4 weeks after dose initiation or adjustment ( 2.2 ). See Table 1 in the full prescribing information for titration recommendations based upon intact PTH levels ( 2.2 ).
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Hypercalcemia [see Warnings and Precautions (5.1) ] Adynamic Bone Disease [see Warnings and Precautions (5.3) ] The most common adverse reactions (> 5% and more frequent than placebo) are nausea, vomiting and edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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.
Interactions
7 DRUG INTERACTIONS Table 4 includes clinically significant drug interactions with paricalcitol. Table 4. Clinically Significant Drug Interactions with Paricalcitol 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 paricalcitol dose as needed [see Warnings and Precautions (5.1) ] .
Warnings
5 WARNINGS AND PRECAUTIONS Hypercalcemia : Can occur during treatment with paricalcitol and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. The risk may be increased when paricalcitol is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Inform patients about symptoms of hypercalcemia and monitor serum calcium prior to initiation and during treatment and adjust dose accordingly ( 2 , 5.1 ). Digitalis toxicity : Risk increases with hypercalcemia. In patients using digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity. Monitor more frequently when initiating or adjusting the dose of paricalcitol ( 5.2 ). 4 CONTRAINDICATIONS Paricalcitol is contraindicated in patients with: Hypercalcemia [see Warnings and Precautions (5.1) ] Vitamin D toxicity [see Warnings and Precautions (5.1) ] Known hypersensitivity to paricalcitol or any of the inactive ingredients in paricalcitol.
Pregnancy
8.1 Pregnancy Risk Summary Limited data with paricalcitol in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution free from visible particles and is supplied as follows: 2 mcg per mL 1 mL Single-Dose Vials in a Carton of 25 NDC 55150-212-01 5 mcg per mL 1 mL Single-Dose Vials in a Carton of 25 NDC 55150-213-01 10 mcg per 2 mL (5 mcg/mL) 2 mL Single-Dose Vials in a Carton of 25 NDC 55150-214-02 10...
Frequently Asked Questions
What is Paricalcitol used for?▼
1 INDICATIONS AND USAGE Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. Paricalcitol injection is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis ( 1 ).
What are the side effects of Paricalcitol?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Hypercalcemia [see Warnings and Precautions (5.1) ] Adynamic Bone Disease [see Warnings and Precautions (5.3) ] The most common adverse reactions (> 5% and more frequent than placebo) are nausea, vomiting and edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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.
Can I take Paricalcitol during pregnancy?▼
8.1 Pregnancy Risk Summary Limited data with paricalcitol in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see Clinical Considerations) .
What are the important warnings for Paricalcitol?▼
5 WARNINGS AND PRECAUTIONS Hypercalcemia : Can occur during treatment with paricalcitol and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. The risk may be increased when paricalcitol is used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Inform patients about symptoms of hypercalcemia and monitor serum calcium prior to initiation and during treatment and adjust dose accordingly ( 2 , 5.1 ). Digitalis toxicity : Risk increases with hypercalcemia. In patients using digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity. Monitor more frequently when initiating or adjusting the dose of paricalcitol ( 5.2 ). 4 CONTRAINDICATIONS Paricalcitol is contraindicated in patients with: Hypercalcemia [see Warnings and Precautions (5.1) ] Vitamin D toxicity [see Warnings and Precautions (5.1) ] Known hypersensitivity to paricalcitol or any of the inactive ingredients in paricalcitol.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.