GENIXUS Announces Launch of KinetiXTM Rocuronium Bromide Injection 5mL & 10mL Ready-to-Administer Syringes

- Launch accelerated in response to market impacts anticipated from the natural disaster at Pfizer's Rocky Mount, NC drug manufacturing facility

- KinetiX Rocuronium Bromide Injection will be offered in both 5mL & 10mL ready-to-administer (RTA) syringe sizes

KANNAPOLIS, N.C.--(BUSINESS WIRE)--GENIXUS, a pharmaceutical company focused on transforming acute and critical care medicines, today announced the accelerated development and launch* of the latest product within their KinetiX syringe platform: Rocuronium Bromide Injection. The decision comes in response to the recent natural disaster impacting Pfizer's manufacturing site in Rocky Mount, NC, and the expected impact on the sterile injectables market as a result of this event.

"Our thoughts are with the individuals impacted by the natural disaster at Rocky Mount,” CEO of GENIXUS, Kendall Foster, stated. “We understand the gravity of the situation and the critical need for medications in the market. GENIXUS is committed to taking swift action to address these challenges and ensure patients have access to the medications they require."

KinetiX Rocuronium Bromide Injection possesses several key attributes inherent in the KinetiX platform:

• Intuitive labeling and color-coded plunger rod to support rapid identification
• Auto-dispensing cabinet (ADC) ready to keep product proximal to delivery site
• RFID-enabled with KitCheck^®, the latest technology in kit and tray management
• 5mL and 10mL RTA syringes offer flexibility to minimize waste
• Durable polymer syringe is clear and eliminates risks of glass
• 3-month beyond use date (BUD) at launch
  • Stability enhancements will be shared as program data become available

GENIXUS' Chief Commercial Officer (CCO), Seth Coombs, emphasized the company's determination to accelerate the launch of Rocuronium Bromide Injection to address the ongoing, and expected worsening, of shortages in the US market. "GENIXUS is fully dedicated to doing our part to support patient care during this critical time. Our decision to fast-track the development and market entry of Rocuronium Bromide Injection reflects our commitment to supporting the availability of essential medications for patients across the country."

KinetiX Rocuronium Bromide Injection is the 2^nd product in the syringe platform following GENIXUS’ launch of repackaged Propofol 10mL & 20mL RTA syringes earlier this year.**

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.

*Product will be compounded under the outsourcing provisions of Section 503B of the Federal Food, Drug, and Cosmetic Act 20 (FD&C Act).

** Please click here for Propofol complete prescribing information.

Rocuronium Bromide Injection
Compounded by Genixus, Corp.

Indications and Usage

Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Important Safety Information

Rocuronium bromide injection is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of rocuronium bromide injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

Rocuronium bromide, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. If rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide injection and drugs for which incompatibility with rocuronium bromide injection has been demonstrated or for which compatibility with rocuronium bromide injection has not been established.

Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.

Rocuronium bromide has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.

To prevent complications resulting from residual paralysis, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.

The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval.

Rocuronium bromide may be associated with increased pulmonary vascular resistance, so caution is appropriate in patients with pulmonary hypertension or valvular heart disease.

This Important Safety Information does not include all the information needed to use Rocuronium Bromide Injection safely and effectively. Please see full prescribing information for Rocuronium Bromide Injection.

To report SUSPECTED ADVERSE REACTIONS, contact Genixus at 1-833-436-4987, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contactus@genixus.com