Fresenius Kabi Launches First Room-Temperature Stable Rocuronium Bromide Injection
Fresenius Kabi, an operating company of Fresenius and a leading provider of essential medicines and medical technologies, has announced the launch of Rocuronium Bromide Injection Room Temperature Stable (RTS). This is the first-ever formulation of Rocuronium Bromide Injection that does not require refrigeration, marking a significant milestone in medication storage and logistics.
Rocuronium Bromide Injection RTS is designed for storage at room temperature, simplifying supply chain management and potentially reducing costs associated with cold storage. This innovation aims to improve operational efficiency in hospitals and healthcare facilities.
About Rocuronium Bromide Injection
Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent. It is commonly used as an adjunct to general anesthesia for tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Traditional formulations of rocuronium require refrigeration, which can complicate storage and transportation. The RTS formulation allows healthcare providers to store the medication at room temperature, eliminating the need for a cold supply chain and freeing refrigerated space for other critical medications.
Key Benefits of Rocuronium Bromide RTS
1. Simplified Storage and Logistics
Rocuronium Bromide Injection RTS can be safely stored at room temperature, removing the requirement for refrigeration. This reduces complexity in hospital pharmacies and during transportation, as cold-chain logistics are no longer necessary. The room-temperature formulation also reduces the risk of temperature-related drug spoilage, ensuring that the medication remains safe and effective.
2. Cost Efficiency
By eliminating refrigeration needs, hospitals and clinics can lower storage and transportation costs. Facilities no longer need to dedicate refrigerated space solely to rocuronium, allowing more efficient use of storage areas.
3. U.S.-Based Manufacturing
Rocuronium Bromide Injection RTS is formulated, filled, and packaged in the United States at Fresenius Kabi’s facility in Grand Island, New York. Since 2017, Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced pharmaceutical production and distribution capabilities across the U.S.
More than 70% of Fresenius Kabi’s U.S. shipments are drugs listed on the FDA’s Essential Medicines List, reflecting the company’s commitment to providing high-quality, essential medications to patients nationwide.
Statements from Leadership
Joel Rosenstack, President of U.S. Pharmaceuticals at Fresenius Kabi, emphasized the importance of this launch:
The introduction of Rocuronium Bromide Injection RTS highlights our leadership in providing innovative solutions that help customers improve efficiency and deliver quality care. Our strong commitment to U.S. manufacturing helps ensure a reliable supply for patients and clinicians.
The RTS formulation is currently available in two presentations:
Clinical Use and Indications
Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia for:
- Rapid sequence tracheal intubation
- Routine tracheal intubation
- Providing skeletal muscle relaxation during surgery or mechanical ventilation
It is essential that Rocuronium Bromide Injection is used in conjunction with adequate anesthesia or sedation, as improper administration can lead to serious complications.
Safety Information
Contraindications
Rocuronium Bromide Injection is contraindicated in patients with known hypersensitivity to rocuronium bromide or other neuromuscular blocking agents.
Warnings and Precautions
- Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and antagonist administration are immediately available.
- Anaphylaxis: Severe allergic reactions have been reported. Consider the risk of cross-reactivity with other neuromuscular blocking agents.
- Risk of Death from Medication Errors: Accidental administration can be fatal.
- Residual Paralysis: Use a reversal agent when residual paralysis is likely to occur.
Adverse Reactions
The most commonly reported adverse reactions (occurring in approximately 2% of patients) include:
- Transient hypotension
- Transient hypertension
Drug Interactions
- Succinylcholine: Rocuronium’s use before succinylcholine has not been studied.
- Nondepolarizing Muscle Relaxants: Interactions may occur.
- Enhanced Rocuronium Activity: Possible with inhalation anesthetics, certain antibiotics, quinidine, magnesium, lithium, local anesthetics, and procainamide.
- Reduced Rocuronium Activity: Possible with anticonvulsants.
Use in Specific Populations
- Pregnancy: Not recommended for rapid sequence induction in Cesarean sections.
- Pediatric Use: Onset time and duration may vary by dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients.
Impact on Healthcare Facilities
The RTS formulation offers several operational advantages:
- Streamlined logistics due to elimination of refrigeration requirements
- Cost savings from reduced need for cold-chain storage and transport
- Optimized pharmacy space by freeing refrigerated storage for other critical medications
- Enhanced supply reliability with U.S.-based production and distribution
Hospitals and clinics can now maintain adequate stocks of rocuronium without the complexity and cost of temperature-controlled storage, supporting more efficient patient care.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company dedicated to providing essential medicines and medical technologies. With extensive experience in pharmaceuticals and medical devices, the company focuses on high-quality, reliable, and innovative solutions that improve patient outcomes.
In the U.S., Fresenius Kabi has invested heavily in manufacturing infrastructure, ensuring a steady supply of essential medications, including those listed on the FDA’s Essential Medicines List. For more information about the company and its initiatives, visit moreinamerica.com.
Summary
Fresenius Kabi’s launch of Rocuronium Bromide Injection RTS represents a major advancement in anesthesia care and medication logistics. The room-temperature stable formulation offers:
- Easier storage and handling
- Reduced transportation costs
- Improved supply chain efficiency
- Continued high standards of safety and efficacy
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