Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, today announced the launch of Paricalcitol Injection, a generic version of AbbVie's Zemplar®. Hospira obtained U.S. Food and Drug Administration (FDA) approval of paricalcitol on Oct. 21 and launched the product Nov. 1.
LAKE FOREST, Ill.
Nov. 5, 2014
(NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced the launch of Paricalcitol Injection, a generic version of
U.S. Food and Drug Administration
) approval of paricalcitol on
and launched the product
paricalcitol - available in three multi-dose vial configurations - is approved for the prevention and treatment of secondary hyperparathyroidism associated with Stage 5 chronic kidney disease (CKD). Hyperparathyroidism contributes to the development of metabolic bone disease.
Sterile use of multi-dose vials can reduce waste because the vial's entire contents can be utilized over time, as opposed to single-dose vials, which require clinicians to discard the unused volume of solution after drawing up the patient's specific dose. The current branded drug offers only one of three sizes as a multi-dose configuration.
Paricalcitol Injection will give U.S. hemodialysis patients access to a high-quality, lower-cost alternative to the branded product, and increased dosing efficiency and reduced waste to healthcare providers in the renal dialysis and hospital dialysis markets. Paricalcitol reinforces
commitment to meet patient and caregiver needs in the renal space," said
, president, U.S.,
will offer multi-dose configurations in 5 mcg and 10 mcg vials of paricalcitol in a 5 mcg/mL concentration, and then 2 mcg vials of paricalcitol in a 2 mcg/mL concentration. These are the concentrations that customers have used for many years.
specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as ADD-Vantage™ drug delivery system and iSecure™ prefilled syringes. Therapeutic segments include analgesia, anesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas.
also has robust pipelines of both generic and biosimilar drugs.
Indications and Usage
Paricalcitol Injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.
Important Safety Information
Paricalcitol Injection is contraindicated in patients with evidence of hypercalcemia, vitamin D toxicity or hypersensitivity.
Hypercalcemia: Hypercalcemia may occur during paricalcitol treatment and may be exacerbated by concomitant administration of high doses of calcium containing preparations, thiazide diuretics, or vitamin D compounds. Concomitant use with other active vitamin D analogues should be avoided during Paricalcitol Injection treatment to prevent hypercalcemia.
Digitalis Toxicity: Potentiated by hypercalcemia of any cause. Monitor serum calcium and patients more frequently with careful dose adjustments when Paricalcitol Injection is used concomitantly with digitalis compounds.
Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors: Concomitant use of paricalcitol with strong CYP3A inhibitors will increase the exposure of paricalcitol. If a patient initiates or discontinues therapy with a strong CYP3A inhibitor, dose adjustment of Paricalcitol Injection may be required, and PTH and serum calcium concentrations should be closely monitored.
Adynamic Bone Disease: This may develop if PTH levels are suppressed to abnormal levels. Monitor PTH levels and adjust Paricalcitol Injection doses.
The most common adverse reactions (greater than 5% and more frequent than placebo) include nausea, vomiting and edema.
For more information, including the full prescribing information, please visit www.hospira.com.
is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio,
is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in
Lake Forest, Ill.
, and has approximately 17,000 employees. Learn more at www.hospira.com.