New product offers additional option for treating Paget’s disease, hypercalcemia, and postmenopausal osteoporosis
LAKE ZURICH, Ill.--(BUSINESS WIRE)--#FreseniusKabi--Fresenius Kabi, an operating company of Fresenius, announced today it has introduced Calcitonin Salmon Injection, USP Synthetic, a calcium regulator, for the treatment of symptomatic Paget’s disease of the bone and hypercalcemia. The drug is also used to treat postmenopausal osteoporosis when alternative treatments are not suitable. Fresenius Kabi Calcitonin Salmon Injection is formulated, filled and packaged in the United States.
Available in 400 I.U./2 mL (200 I.U./mL) vials, the new product adds to the company’s generic injectables portfolio that delivers affordable treatments and a reliable supply for patient care.
“We continue to broaden our portfolio of essential medicines in the U.S. with the launch of Calcitonin Salmon. At Fresenius Kabi, every product addition further underscores our commitment to the ‘supply chain of care’ for patients,” said Arunesh Verma, president of Fresenius Kabi Region U.S. and member of the executive leadership team at Fresenius Kabi AG.
Since 2017, Fresenius Kabi has invested nearly $1 billion to modernize and expand its advanced U.S. pharmaceutical production and distribution facilities to strengthen supply chains of care in and for the U.S.
INDICATION AND USAGE
Calcitonin Salmon synthetic injection is a calcitonin, indicated for the following conditions:
- Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable
- Treatment of hypercalcemia
- Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated
Limitations of Use:
- Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis
IMPORTANT SAFETY INFORMATION
Calcitonin Salmon Injection, USP Synthetic is contraindicated in patients with a hypersensitivity to calcitonin-salmon or any of the excipients.
Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin-salmon.
Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D.
Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon treated patients.
Circulating antibodies to calcitonin-salmon may develop and may cause loss of response to treatment.
The most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%).
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.
There are no data to support use in children.
This Important Safety Information does not include all the information needed to use Calcitonin Salmon Injection, USP Synthetic safely and effectively. Please see accompanying full prescribing information for Calcitonin Salmon Injection, USP Synthetic. Full prescribing information is also available at www.fresenius-kabi.com/us.
About Fresenius Kabi
As a global health care company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 43,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide.
The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually. With Vision 2026, as part of the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of health care.
Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing health care solutions on a global scale.
For more information, please visit www.fresenius-kabi.com. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.
Contacts
Matt Kuhn
(847) 220-3033
matt.kuhn@fresenius-kabi.com
