Fresenius Kabi Introduces Adenosine Injection, USP Simplist® Prefilled Syringes in 6 mg per 2 mL and 12 mg per 4 mL Presentations

LAKE ZURICH, Ill., April 8, 2019 - Fresenius Kabi announced today the immediate availability in the United States of Adenosine Injection, USP in 6 mg per 2 mL and 12 mg per 4 mL single dose in Simplist^® ready-to-administer prefilled syringes.

Fresenius Kabi has sold 6 mg per 2 mL and 12 mg per 4 mL Adenosine Injection, USP vial presentations since 2013 and 60 mg per 20 mL and 90 mg per 30 mL vial presentations since 2018. With the addition of the two new Simplist prefilled syringe presentations, the company now offers the broadest portfolio of Adenosine Injection, USP.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.

“These new additions to our Adenosine product line provide clinicians in hospitals and cardiology centers with affordable generic alternatives to care for their patients and reflect Fresenius Kabi’s significant investment in the ongoing expansion of our Simplist prefilled syringe portfolio,” said John Ducker, president and CEO of Fresenius Kabi USA.

About Adenosine Injection, USP in 6 mg per 2 mL and 12 mg per 4 mL Simplist^® prefilled syringes

Indications and Usage

Adenosine Injection, USP is indicated intravenously for the conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). Adenosine Injection, USP does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm.

Important Safety Information

Intravenous Adenosine Injection, USP is contraindicated in:

• Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker).
• Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker).
• Known hypersensitivity to adenosine.

Heart Block: May produce a short lasting first-, second- or third-degree heart block. Appropriate resuscitative measures should be available.

Arrhythmias at time of conversion to normal sinus rhythm: A variety of new rhythms may appear on the electrocardiogram. May take the form of premature ventricular contractions, atrial premature contractions, atrial fibrillation, sinus bradycardia, sinus tachycardia, skipped beats, and varying degrees of A-V nodal block. Such findings were seen in 55% of patients.

Respiratory Alkalosis: Intravenous administration has been shown to increase minute ventilation (Ve) and reduce arterial PCO2.

Respiratory compromise: Has occurred during adenosine infusion in patients with obstructive pulmonary disease. Use with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis, etc.) and should be avoided in patients with bronchoconstriction or bronchospasm (e.g., asthma).

Digoxin or combination of digoxin and verapamil when combined with adenosine injection, USP may be rarely associated with ventricular fibrillation; use with caution in the presence of these agents.

The most common adverse reactions include facial flushing (18%), shortness of breath/dyspnea (12%), chest pressure (7%), Nausea (3%), headache (2%), lightheadedness (2%), dizziness, tingling in arms, and numbness (1%).

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.

This Important Safety Information does not include all the information needed to use Adenosine Injection, USP safely and effectively. Please click on this link (https://tinyurl.com/y6a2kuuf) for the full prescribing information for Adenosine Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.

For additional information about all Simplist ready-to-administer prefilled syringes please visit www.simplist-us.com.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.