Fresenius Kabi Introduces Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company is a leading developer, manufacturer and provider of injected and infused medicines in the United States with special expertise in producing high quality, affordable generic alternatives to more expensive brand-name drugs.

"Fresnius Kabi is pleased to again expand our anesthesia and analgesia portfolio with the addition of Dexmedetomidine in a convenient, ready-to-use formulation," said John Ducker, president and CEO of Fresenius Kabi USA. "Fresenius Kabi is committed to enabling broader access to affordable, critical medications for clinicians and their patients."

To learn more about Fresenius Kabi's expanding centers for pharmaceutical manufacturing and innovation in the United States, including career opportunities, please visit us at www.fresenius-kabi.com/us.

About Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Indications and Usage

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and is a relatively selective alpha2-adrenergic agonist indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Important Safety Information

Monitoring: Continuously monitor patients while receiving dexmedetomidine hydrochloride.

Bradycardia and Sinus Arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration.

Hypotension and Bradycardia: May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction.

Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects.

Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate.

Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy.

Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.

The most common adverse reactions (incidence greater than 2%) are hypotension, bradycardia, and dry mouth.

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.

Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride or the concomitant medication may be required.

Geriatric Patients: Dose reduction should be considered.

Hepatic Impairment: Dose reduction should be considered.

Pregnancy: Based on animal data, may cause fetal harm.

Nursing Mothers: Caution should be exercised when administered to a nursing woman.

This Important Safety Information does not include all the information needed to use Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection safely and effectively. Please click on this link (https://tinyurl.com/y48s4udz) for the full prescribing information for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection. Full prescribing information is also available at www.fresenius-kabi.com/us.

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