Fresenius Kabi Introduces New Presentation for Fentanyl Citrate Injection, USP in Simplist® Ready-to-Administer Prefilled Syringes

LAKE ZURICH, Ill., July 11, 2023 – Fresenius Kabi announced today the launch and immediate availability in the U.S. of Fentanyl Citrate Injection, USP in 100 mcg per 2 mL Simplist® ready-to-administer prefilled syringes, the only 100 mcg per 2 mL presentation available on the market in a manufacturer-prepared prefilled syringe.

Fresenius Kabi Fentanyl Citrate Injection, USP is the most recent manufacturer-prepared product available in the company’s proprietary, ready-to-administer portfolio of Simplist prefilled syringes, designed for efficient medication delivery and ease of use, to help eliminate steps where errors can occur.¹ Fresenius Kabi currently has 14 products in 25 presentations in its Simplist portfolio.

Fentanyl citrate is currently listed as in shortage by the U.S. Food and Drug Administration.

"Fresenius Kabi is pleased to add this presentation of Fentanyl to our portfolio of Simplist prefilled syringes, further demonstrating our commitment to patient safety and combating drug diversion," said John Ducker, president and CEO of Fresenius Kabi USA. "By offering this critical care product in secure and convenient ready-to-administer packaging, we are helping frontline health care professionals administer this prescription safely and confidently by helping to minimize administration errors and reduce drug waste.”

Ready-to-administer (RTA) medication systems are recommended by the Joint Commission,² the Institute for Safe Medication Practices (ISMP),³ the American Society of Health-System Pharmacists (ASHP),⁴ and the Anesthesia Patient Safety Foundation (APSF).⁵ The use of RTA syringes have proven to provide efficiencies that allow medical staff to focus on their patients and in one case study, reduce fentanyl citrate waste events by 42 percent.⁶

Simplist Fentanyl Citrate Injection, USP is formulated, filled, and packaged in the U.S. using fully automated state-of-the-art technology. The company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals, clinics and health systems. To learn more about how Fresenius Kabi is strengthening America’s supply chain of care for essential medicines, please visit MoreInAmerica.com.

To learn more about the Simplist portfolio with pharmacy clinical education support, please visit 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

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.

References

1. Fanikos, J., Burger, M., & Canada, T. (2017). An assessment of currently available i.v. push medication delivery systems. American Journal of Health-System Pharmacy, 74(9), e230-e235.
2. Joint Commission Resources. (2022). 2022 Comprehensive Accreditation Manual (CAMH) for Hospitals. Standard MM 03.01.03. Oakbrook Terrace, IL.
3. Institute for Safe Medicine Practices. (2022). Safe Practice Guidelines for Adult IV Push Medications. Accessed June 23, 2022.
4. American Journal of Health-System Pharmacy. (2013). ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, 70(18), 1619-1630. doi:10.2146/sp130001
5. Anesthesia Patient Safety Foundation. (2019). Recommendations of the Four Work Groups at the 2018 APSF Stoelting Conference on Medication Safety - Anesthesia Patient Safety Foundation. Accessed Jan. 2022.
6. Data provided by Baptist Health Floyd and analyzed by Fresenius Kabi’s Simplist Support Team. https://simplist-us.com/resources/case-study/baptist-health/.