Fresenius Kabi Introduces New Simplist® Fentanyl Citrate Injection, USP 50 mcg per 1 mL in Ready-to-Administer Prefilled Syringe

First-to-market exclusive presentation designed to enhance opioid medication safety

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today the U.S. introduction of Fentanyl Citrate Injection, USP 50 mcg per 1 mL in its proprietary Simplist^® ready-to-administer prefilled syringe, the only 1 mL presentation available in the U.S. today. The 50 mcg per 1 mL prefilled syringe is designed to support initiatives at hospitals nationwide to reduce waste and diversion and help ensure safe delivery of the medication by eliminating steps where errors can occur.

Simplist^® Fentanyl ready-to-administer prefilled syringes come in Fresenius Kabi’s proprietary MicroVault^® packaging system that also supports secure dispensing of narcotics and reduces the opportunity for diversion. Because the syringes require no assembly, they streamline point-of-care preparation. The presentation reduces the potential for product waste and makes it easier for health care professionals to dispense the prescribed dose.

Fresenius Kabi is a leader in injectable medicines with a growing U.S. portfolio of prefilled syringes.

“The introduction of an exclusive smaller-dose fentanyl injection is an important expansion of our Simplist^® ready-to-administer prefilled syringe portfolio in line with our commitment to the secure dispensing of controlled substances for the safe delivery of drugs to patients,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are proud to design, develop and introduce products and labeling that support the safe dispensing of controlled substances, and all products.”

About Simplist^® Fentanyl MicroVault^® Prefilled Syringe

Fresenius Kabi’s Simplist^® prefilled syringes were associated with an error rate that was four times lower when compared to traditional medication administration practice¹, according to a study published in the Journal of Patient Safety in 2018. The Simplist Fentanyl prefilled syringe is manufacturer prepared in the United States, with a 24-month shelf life, and is a single-unit dose, supporting best practices for medication administration. Learn more about the Simplist^® Ready-to-Administer Prefilled Syringe portfolio at www.simplist-us.com.

INDICATIONS AND USAGE

Fentanyl Citrate Injection, for intravenous or intramuscular use, is indicated for:

• Analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as the need arises.
• Use as an opioid analgesic supplement in general or regional anesthesia.
• Administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• Use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Fentanyl Citrate Injection should be administered only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids. Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning Fentanyl Citrate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Fentanyl Citrate Injection is contraindicated in patients with a hypersensitivity to fentanyl.

Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement: Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks.

Severe Cardiovascular Depression: Monitor during dosage initiation and titration.

Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, or Head Injury: Monitor for sedation and respiratory depression.

The most common serious adverse reactions were respiratory depression, apnea, rigidity, and bradycardia.

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.

Concomitant Use of CNS Depressants: May decrease pulmonary arterial pressure and may cause hypotension. See full prescribing information for management instructions. For post-operative pain, start with the lowest effective dosage and monitor for potentiation of CNS depressant effects.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Fentanyl Citrate Injection because they may reduce the analgesic effect of Fentanyl Citrate Injection or precipitate withdrawal symptoms.

Pregnancy: May cause fetal harm.

Lactation: Infants exposed to Fentanyl Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression.

Geriatric Patients: Titrate slowly and monitor for CNS and respiratory depression.

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

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. To learn about U.S. career opportunities at Fresenius Kabi, visit us at https://www.fresenius-kabi.com/us/join-us.

1. Hertig JB, Degnan DD, Scott CR, et al. A comparison of error rates between intravenous push methods: a prospective, multisite, observational study. J Patient Saf. 2018; 14 (1): 60 - 65.