KANNAPOLIS, N.C.--(BUSINESS WIRE)--Genixus, a pharmaceutical company focused on transforming acute and critical care medicines, is pleased to announce the execution of a contract with the 340B Prime Vendor Program, managed by Apexus LLC., for KinetiX Propofol 1% ready-to-administer (RTA) syringes, designed to simplify workflow and support effective care delivery.
KinetiX Propofol features several key attributes:
- Long-term shelf stability to support a hospital’s supply chain
- Intuitive labeling and color-coded plunger rod support rapid identification
- Auto-dispensing cabinet (ADC) ready to keep product proximal to delivery site
- RFID-enabled with the latest technology in kit and tray management
- 10ml and 20ml RTA syringes offer flexibility to minimize waste
- Durable polymer syringe eliminates risks of glass breakage and delamination
"We are excited about our agreement with Apexus and the opportunity to provide KinetiX Propofol to more hospitals and patients," said Kendall Foster, CEO of Genixus. “Propofol is a critical medication used for procedural sedation, during monitored anesthesia care, or as an induction agent for general anesthesia. With the introduction of our KinetiX RTA syringe platform, we look to support improvements in safety, speed, and satisfaction for clinicians, so they can spend more time on what they do best: patient care."
The contract with Apexus is a significant milestone for Genixus, as it expands access and supports their mission of simplifying acute & critical care medicines through innovation. Ordering for KinetiX Propofol will be available to covered entities beginning June 1 at https://order.genixus.supply.
About Genixus:
Genixus, headquartered in Kannapolis, North Carolina, is a development stage pharmaceutical manufacturer and FDA-registered repackager and 503B outsourcing provider of high-quality easy-to-use ready-to-administer products for acute and critical care. Leveraging the highest-quality biopharmaceutical manufacturing standards and innovative point-of-care design, Genixus is changing care delivery and helping healthcare professionals to achieve better quality outcomes for patients. For more information, visit www.genixus.com and follow the company on LinkedIn.
About the 340B Prime Vendor Program:
The 340B Prime Vendor Program, managed by Apexus™, is a contract awarded by the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B Drug Pricing Program. As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications, provides 340B education to all stakeholders, and helps support program integrity through technical assistance.
Propofol 1% Injectable Emulsion, USP
Repackaged by Genixus, Corp.
Indications and Usage
Indication |
Approved Patient Population |
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation |
Adults only |
Combined sedation and regional anesthesia |
Adults only (see prescribing information PRECAUTIONS) |
|
|
Induction of General Anesthesia |
Patients greater than or equal to 3 years of age |
Maintenance of General Anesthesia |
Patients greater than or equal to 2 months of age |
|
|
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients |
Adults only |
Safety, effectiveness, and dosing guidelines for propofol injectable emulsion, USP have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use.
Propofol injectable emulsion, USP is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations.
Propofol injectable emulsion, USP is not recommended for obstetrics, including Cesarean section deliveries.
Propofol injectable emulsion, USP is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol, USP are not known.
Important Safety Information
PROPOFOL should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Use of PROPOFOL has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. PROPOFOL is contraindicated in patients with a known hypersensitivity to propofol or any of PROPOFOL components, and also in patients with allergies to eggs, egg products, soybeans or soy products.
Strict aseptic technique must always be maintained during handling. PROPOFOL is a single access parenteral product (single patient ready to use syringe), which contains benzyl alcohol (10mg per mL) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination.
PROPOFOL has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with PROPOFOL. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly.
PROPOFOL should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.
Administer PROPOFOL with caution in patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis.
Abrupt discontinuation of PROPOFOL prior to weaning or for daily evaluation of sedation levels should be avoided.
For both adult and pediatric ICU sedation, PROPOFOL infusion has been associated with Propofol Infusion Syndrome, that have resulted in death.
Neurosurgical Anesthesia: When PROPOFOL is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decrease in cerebral perfusion pressure.
Cardiac Anesthesia: Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable.
This Important Safety Information does not include all the information needed to use PROPOFOL, Injectable Emulsion, USP safely and effectively. Please see full prescribing information for PROPOFOL, Injectable Emulsion, USP.
To report SUSPECTED ADVERSE REACTIONS, contact Genixus at 1-833-436-4987, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
