Fresenius Kabi Introduces Epinephrine Injection, USP, in 30 mg per 30 mL Multi-Dose Vials

New product expands company’s line of Epinephrine injectables

Fresenius Kabi, an operating company of Fresenius, announced today that Epinephrine Injection, USP, is now available in the United States in 30 mg per 30 mL multi-dose vials.

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Epinephrine Injection in a 30 mg per 30 mL Multi-Dose Vial is now available from Fresenius Kabi, expanding the company’s offerings of Epinephrine Injection. In December 2024, Fresenius Kabi introduced the first generic version of Epinephrine, USP, in a 1 mg per mL vial.

Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The product launch adds to the company’s offerings of Epinephrine Injection. In December 2024, Fresenius Kabi introduced the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers.

“We are pleased to offer our customers a cost-effective solution that supports quality patient care,” said Arun Verma, president, 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.”

Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. Since 2017, Fresenius Kabi has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. More than 70% of the units shipped by Fresenius Kabi in the U.S. are drugs listed on the FDA’s Essential Medicines List. To learn more, visit our More in America page.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

• Do not inject into buttocks, digits, hands, or feet.
• Avoid extravasation into tissues, which can cause local necrosis.
• Monitor patient for acute severe hypertension.
• Potential for pulmonary edema, which may be fatal.
• May constrict renal blood vessels and decrease urine formation.
• May induce potentially serious cardiac arrhythmias or aggravate angina pectoris, particularly in patients with underlying heart disease.
• Presence of sulfite in this product should not deter use.

ADVERSE REACTIONS

Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.

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.

DRUG INTERACTIONS

• Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, ergot alkaloids, and phenothiazine antipsychotics.
• Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin.
• Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias.
• Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm.

Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.

INDICATIONS AND USAGE

Epinephrine is a non-selective alpha- and beta-adrenergic agonist indicated:

• For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
• To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

This Important Safety Information does not include all the information needed to use Epinephrine Injection, USP safely and effectively. Please see full prescribing information for Epinephrine Injection, USP.

About Fresenius Kabi

As a global healthcare 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 41,000 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 biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad global 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 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 healthcare 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 healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line with 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 healthcare.

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 healthcare 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250520245987/en/

"Fresenius Kabi, an operating company of Fresenius, announced today that Epinephrine Injection, USP, is now available in the United States in 30 mg per 30 mL multi-dose vials...the product launch adds to the company’s offerings of Epinephrine Injection."