Why introduce a room temperature stable formulation of Rocuronium Bromide Injection?
Room temperature stability helps simplify storage and logistics by eliminating the need for cold chain shipping and refrigeration, while maintaining access to a critical medication.

How is supply reliability supported by Fresenius Kabi?
Rocuronium Bromide Injection RTS is supported by Fresenius Kabi’s robust U.S. production footprint, expanded capacity, geographically-dispersed safety stock, and automated production capabilities.

What has changed – and what hasn’t?
The formulation is room temperature stable. Fresenius Kabi’s focus on quality, reliability, production investment, and supply continuity has not changed.

How does More in America relate to this product?
More in America is Fresenius Kabi’s commitment to strengthening U.S. production and supply reliability, which supports products like Rocuronium Bromide Injection RTS.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Rocuronium Bromide Injection is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) 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 an antagonist are immediately available.

• Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents.

• Risk of Death due to Medication Errors: Accidental administration can cause death.

• Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation.

• Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur.

ADVERSE REACTIONS

• Most common adverse reactions (2%) are transient hypotension and hypertension.

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. 

DRUG INTERACTIONS

• Succinylcholine: Use before succinylcholine has not been studied.

• Nondepolarizing muscle relaxants: Interactions have been observed.

• Enhanced Rocuronium Bromide Injection activity possible: Inhalation anesthetics, certain antibiotics, quinidine, magnesium, lithium, local anesthetics, procainamide.

• Reduced Rocuronium Bromide Injection activity possible: Anticonvulsants.

 
USE IN SPECIFIC POPULATIONS

• Pregnancy: Not recommended for rapid sequence induction in patients undergoing Cesarean section.

• Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients.

INDICATIONS AND USAGE

Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated 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.

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 at www.fresenius-kabi.com/us.