Fresenius Kabi Launches Synthetic Calcitonin Salmon Injection, USP
Fresenius Kabi, a subsidiary of Fresenius, announced the launch of Calcitonin Salmon Injection, USP Synthetic, a calcium-regulating medication designed to treat symptomatic Paget’s disease of the bone and hypercalcemia. This injection is also indicated for the treatment of postmenopausal osteoporosis when other treatment options are not appropriate. The drug is formulated, filled, and packaged in the United States, ensuring high-quality production standards.
Fresenius Kabi, a global healthcare company, has announced the launch of Calcitonin Salmon Injection, USP Synthetic, which is now available in 400 I.U./2 mL (200 I.U./mL) vials. This new product enhances the company’s extensive generic injectables portfolio, offering affordable treatments while ensuring a reliable supply to support patient care. With this launch, Fresenius Kabi continues its commitment to providing high-quality medicines that meet the diverse needs of patients and healthcare providers across the U.S.
Arunesh Verma, president of Fresenius Kabi Region U.S. and a member of the executive leadership team at Fresenius Kabi AG, shared the company’s vision behind the product addition, stating, “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.”
The company’s continued investment in the U.S. market is reflected in its efforts to modernize and expand pharmaceutical production and distribution facilities. Since 2017, Fresenius Kabi has invested nearly $1 billion to enhance the U.S. supply chain, reinforcing the company’s ability to meet the growing healthcare needs of patients nationwide.
Indication and Usage
Calcitonin Salmon Synthetic Injection is a calcitonin product indicated for the following conditions:
- Symptomatic Paget’s disease of bone: It is used when alternative treatments are not suitable.
- Hypercalcemia: For managing elevated calcium levels in the blood.
- Postmenopausal osteoporosis: When alternative treatments are not suitable. However, fracture reduction efficacy has not been demonstrated.
Limitations of Use
It is important to note that, due to a possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated periodically.
Important Safety Information
As with any medication, it is essential to understand the potential risks associated with Calcitonin Salmon Injection, USP Synthetic. The product is contraindicated in patients who have hypersensitivity to calcitonin-salmon or any of its excipients.
Serious allergic reactions, including fatal anaphylaxis, have been reported. Physicians are advised to consider skin testing in patients who may have a suspected hypersensitivity to calcitonin-salmon prior to initiating treatment.
The use of this product may lead to hypocalcemia (low calcium levels in the blood). Therefore, it is crucial to ensure adequate intake of calcium and vitamin D during treatment.
A meta-analysis of 21 clinical trials indicates that calcitonin-salmon treatment may increase the risk of malignancies. Healthcare providers should closely monitor patients for any signs of malignancy.
In some cases, patients may develop circulating antibodies to calcitonin-salmon, which could reduce the efficacy of the treatment.
The most commonly reported adverse reactions include nausea (with or without vomiting) in about 10% of patients, injection site inflammation in 10% of patients, and flushing of the face or hands in 2% to 5% of patients.
Drug Interactions
There is a known interaction between calcitonin-salmon and lithium. The concomitant use of these two drugs may lower plasma lithium concentrations due to increased urinary clearance of lithium. As a result, healthcare providers may need to adjust the lithium dose during treatment.
Use in Children
Currently, there is no data to support the use of calcitonin-salmon in pediatric populations.
How to Report Suspected Adverse Reactions
Fresenius Kabi encourages healthcare professionals to report suspected adverse reactions. They can contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company committed to improving patient outcomes and advancing medical treatments. With a workforce of more than 43,000 employees and operations in over 100 countries, the company focuses on providing essential products and technologies for the care of patients with critical and chronic conditions.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. Their extensive portfolio in Clinical Nutrition includes both enteral and parenteral products, helping to improve patients’ nutritional status. In MedTech, the company supplies vital infusion pumps, cell and gene therapy devices, and blood collection products.
The company’s I.V. Generics and Fluids for infusion therapy are vital in emergency medicine, surgery, oncology, and intensive care, saving millions of lives annually.
Fresenius Kabi operates as part of the Fresenius Group, which also includes Helios and Quirónsalud, combining their expertise to provide life-saving healthcare solutions worldwide. As part of their Vision 2026 and #FutureFresenius strategy, the company is committed to developing and delivering new products and technologies, expanding its position as a global leader in therapies, and shaping the future of healthcare.
