Fresenius Kabi Launches Calcitonin Salmon Injection, USP Synthetic
Fresenius Kabi has made a significant stride by introducing Calcitonin Salmon Injection, USP Synthetic, a potent calcium regulator designed specifically for managing symptomatic Paget’s disease of the bone and addressing hypercalcemia. Additionally, this injection provides a treatment option for postmenopausal osteoporosis when other treatments may not suffice. Notably, Fresenius Kabi Calcitonin Salmon Injection is expertly formulated, filled, and packaged within the United States, ensuring a robust supply chain for delivering essential medications.
Expanding Access to Essential Medicines
Available in 400 I.U./2 mL vials, the introduction of this new product enhances the company's diverse portfolio of generic injectables, which is committed to providing affordable and available treatments for patient care. This effort is part of Fresenius Kabi's broader initiative to solidify its presence in the U.S. pharmaceutical market. Arunesh Verma, president of Fresenius Kabi Region U.S., mentioned, "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."
Investment in Pharmaceutical Capabilities
In a move to strengthen its healthcare contributions, Fresenius Kabi has devoted nearly $1 billion since 2017 to modernizing and expanding its advanced pharmaceutical production and distribution facilities in the U.S. This investment not only fortifies quality assurance but also enhances the overall supply chains of care in the region and beyond.
Indications and Usage of Calcitonin Salmon Injection
Calcitonin Salmon synthetic injection is primarily indicated for several conditions, including:
- Treating symptomatic Paget’s disease of the bone when alternative treatments are not suitable.
- Addressing hypercalcemia effectively.
- Managing postmenopausal osteoporosis in situations where alternative treatments are not appropriate. However, the drug is noted not to demonstrate fracture reduction efficacy.
Limitations of Use
It's important to highlight certain limitations associated with Calcitonin Salmon Injection. Due to potential links between calcitonin-salmon use and malignancies, healthcare professionals are encouraged to periodically re-evaluate the necessity for continued therapy.
Important Safety Information
Safety is paramount, and it is crucial to note that Calcitonin Salmon Injection, USP Synthetic is contraindicated for individuals with hypersensitivity to calcitonin-salmon or any of its components. Serious hypersensitivity reactions, even anaphylaxis, have been reported.
Moreover, patients must ensure an adequate intake of calcium and vitamin D as hypocalcemia can occur. A meta-analysis involving numerous clinical trials has suggested an increased risk of overall malignancies associated with calcitonin-salmon treatment.
It's also worth noting that circulating antibodies to calcitonin-salmon may develop, potentially leading to a diminished response to treatment. Common adverse reactions reported include nausea, injection site inflammation, and facial flushing.
Reporting Adverse Reactions
In case of any suspected adverse reactions, individuals can reach out to Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or contact the FDA at 1-800-FDA-1088.
Moreover, caution is advised when combining calcitonin-salmon with lithium, as it may reduce plasma lithium concentrations due to increased urinary clearance. The dosage of lithium might require adjustment under such circumstances.
About Fresenius Kabi
Fresenius Kabi stands as a testament to quality healthcare, operating globally as a dedicated health care company. Committed to life and innovation, the organization's products, technologies, and services cater to critical and chronic patient care needs. With a workforce exceeding 43,000 and operations across more than 100 countries, the company emphasizes the importance of high-quality, lifesaving medicines.
In the biopharma sector, Fresenius Kabi is leading the charge with state-of-the-art biosimilars developed for autoimmune diseases and oncology. The company holds a commendable market position in Clinical Nutrition, with a comprehensive portfolio of enteral and parenteral products that significantly boost patients’ nutrition. Additionally, in MedTech, Fresenius Kabi contributes essential devices, including infusion pumps and blood collection bags, which play a vital role in healthcare facilities worldwide.
Fresenius Kabi also prides itself on its I.V. Generics and infusion therapy solutions, which are critical in saving millions of lives across various medical domains, including emergency medicine and intensive care.
As part of its Vision 2026 initiative, Fresenius Kabi is committed to continuous improvement and innovation in healthcare, aspiring to enhance patient care and provide sustainable value to stakeholders while shaping the future of the healthcare landscape.
Frequently Asked Questions
What is Calcitonin Salmon Injection used for?
Calcitonin Salmon Injection is primarily used to treat Paget’s disease of the bone, hypercalcemia, and postmenopausal osteoporosis when alternative therapies may not be appropriate.
What are the key safety concerns with Calcitonin Salmon Injection?
This injection is contraindicated for those allergic to calcitonin-salmon and may cause serious allergic reactions. Hypocalcemia and potential malignancy risks must also be considered.
How has Fresenius Kabi invested in its healthcare capabilities?
Since 2017, Fresenius Kabi has invested nearly $1 billion to modernize and expand its U.S. pharmaceutical production and distribution facilities, ensuring robust supply chains for healthcare.
What are common side effects of Calcitonin Salmon Injection?
Common side effects include nausea, injection site inflammation, and flushing of the face or hands.
Where can I find more information about Fresenius Kabi?
More information can be found on Fresenius Kabi's website, which details their products, initiatives, and commitment to healthcare.
