Paricalcitol

Paricalcitol Injection is an active vitamin D 2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5. Paricalcitol Injection is an active vitamin D 2 analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5. ( 1 )

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 ) ] Evidence of hypercalcemia, vitamin D toxicity or hypersensitivity. ( 4 )

Hypercalcemia : The risk may be increased when Paricalcitol Injection is used concomitantly with high dose calcium preparations, thiazide diuretics, or metabolically inactive or active forms of vitamin D. Monitor serum calcium when using Paricalcitol Injection and adjust dose accordingly. ( 5.1 ) Digitalis Toxicity : Hypercalcemia 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.

( 5.2 ) Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors : Use of Paricalcitol Injection with strong CYP3A inhibitors increases the concentration of paricalcitol in the blood. In patients on Paricalcitol Injection who are initiating or discontinuing drugs known to be strong CYP3A inhibitors, monitor serum calcium and PTH more frequently and adjust Paricalcitol Injection dose as required.

( 5.3 ) Adynamic Bone Disease : May develop if PTH levels are suppressed to abnormally low levels. Monitor PTH levels and adjust Paricalcitol Injection accordingly. ( 5.4 )

5.1Hypercalcemia

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.