Fresenius Kabi announced today the U.S. launch of Epinephrine Injection, USP, in 30 mg per 30 mL multi-dose vials, expanding the company's emergency medicine portfolio with a critical life-saving medication. The product is indicated for emergency treatment of Type 1 allergic reactions, including anaphylaxis, in both adult and pediatric patients, as well as for increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock.
This new formulation adds to Fresenius Kabi's growing line of epinephrine products. In December 2024, the company introduced the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers, establishing its presence in this essential medication category.
"We are pleased to offer our customers a cost-effective solution that supports quality patient care," said Arun Verma, president of Fresenius Kabi Region U.S. and Member of the Executive Leadership Team, Fresenius Kabi AG. "At Fresenius Kabi, we are continually striving for new solutions as a trusted partner with the healthcare community."
Domestic Manufacturing Commitment
The newly launched Epinephrine Injection is manufactured in the United States, highlighting Fresenius Kabi's commitment to domestic pharmaceutical production. Since 2017, the company has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities.
This investment aligns with national efforts to strengthen the domestic supply chain for critical medications. More than 70% of the units shipped by Fresenius Kabi in the U.S. are drugs listed on the FDA's Essential Medicines List, underscoring the company's role in ensuring access to vital treatments.
Clinical Applications and Safety Considerations
Epinephrine, a non-selective alpha- and beta-adrenergic agonist, plays a crucial role in emergency medicine. The medication's dual indications make it valuable across multiple clinical scenarios, from severe allergic reactions to managing critically ill patients with septic shock.
Healthcare providers should be aware of important safety considerations when administering epinephrine. The medication should not be injected into buttocks, digits, hands, or feet, and extravasation into tissues should be avoided as it can cause local necrosis. Patients should be monitored for acute severe hypertension, and there is potential for pulmonary edema, which may be fatal.
Additional warnings include possible constriction of renal blood vessels, decreased urine formation, and the potential to induce serious cardiac arrhythmias or aggravate angina pectoris, particularly in patients with underlying heart disease.
Common adverse reactions to systemically administered epinephrine include headache, anxiety, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, peripheral coldness, nausea/vomiting, and respiratory difficulties. More serious complications such as arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have been reported.
Drug Interactions and Special Populations
Clinicians should be aware of numerous drug interactions with epinephrine. Medications that counter its pressor effects include alpha blockers, vasodilators, diuretics, antihypertensives, ergot alkaloids, and phenothiazine antipsychotics.
Drugs that potentiate epinephrine's effects include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, and oxytocin. Several medications can increase the arrhythmogenic potential of epinephrine, including beta blockers, certain anesthetics, quinidine, antihistamines, thyroid hormones, diuretics, and cardiac glycosides.
Special caution is advised when administering epinephrine to pregnant women, as it may cause fetal harm. Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company with more than 41,000 employees operating in over 100 countries. The company's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies for patients with critical and chronic conditions.
The company offers a diverse range of healthcare solutions, including biosimilars for autoimmune diseases and oncology, clinical nutrition products, MedTech devices such as infusion pumps and cell and gene therapy equipment, and blood collection supplies. Fresenius Kabi's I.V. Generics and Fluids for infusion therapy help save millions of lives annually in emergency medicine, surgery, oncology, and intensive care settings.
As part of the Fresenius Group, founded in 1912, Fresenius Kabi operates alongside Helios and Quirónsalud with a shared commitment to providing lifesaving and life-changing healthcare solutions globally. The company reports making a difference in the lives of 450 million patients annually through its comprehensive approach to healthcare.
