Fresenius Kabi Launches Icatibant Injection to Treat Acute Attacks of Hereditary Angioedema in Adults

LAKE ZURICH, Ill., December 1, 2020 - Fresenius Kabi announced today it has introduced icatibant injection in the United States with immediate availability. Icatibant injection is an FDA-approved and cost-effective alternative to treat acute attacks of hereditary angioedema (HAE) in adults.

Icatibant injection is therapeutically equivalent to Firazyr^®, and supplied as a 3 mL prefilled, single-use syringe that is self-administered subcutaneously into the abdominal area. Icatibant injection can be used both in and out of the home - after training with a health care professional. It treats acute attacks in adults over the age of 18 with HAE, a rare and potentially life-threatening genetic condition impacting roughly 6,000 Americans.

"For people with HAE, an acute attack can occur anywhere, at any time and can be life-threatening," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi wants to be a valuable resource for patients and their care teams, which is why we are offering a patient support program for the first time."

In conjunction with launching its first specialty drug, Fresenius Kabi is launching KabiCare (kabicare.us), a comprehensive patient support program. KabiCare can help eligible patients access icatibant injection and remain compliant with their therapy by providing access to live case managers, co-pay assistance, self-injection training and pharmaceutical samples to bridge a patient's therapy in the event there is a delay in a patient's coverage.

Fresenius Kabi expects that additional products may be supported by the KabiCare program to help eligible patients access important medications that Fresenius Kabi intends to launch in the future. To learn more about Fresenius Kabi's icatibant injection, please visit www.icatibantinjection.com and to learn more about KabiCare, please visit kabicare.us.

About Icatibant Injection

Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

Laryngeal attacks: Following treatment of laryngeal attacks with icatibant injection, advise patients to seek immediate medical attention.

The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increases, dizziness, and rash.

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.

Icatibant injection is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant injection may attenuate the antihypertensive effect of ACE inhibitors.

Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified.

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

This Important Safety Information does not include all the information needed to use icatibant injection safely and effectively. Please see the full prescribing information for icatibant injection, including Patient Information at www.fresenius-kabi.com/us.

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