INDICATION AND IMPORTANT SAFETY INFORMATION

Indication

ULTIVA is indicated for IV administration:

• As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
• For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
• As an analgesic component of monitored anesthesia care in adult patients.

Important Safety Information

ULTIVA is contraindicated for epidural or intrathecal administration due to the presence of glycine in the formulation and in patients with hypersensitivity to remifentanil (eg, anaphylaxis).

ULTIVA contains remifentanil, a Schedule II controlled substance. Because opioids are sought by drug abusers and people with addiction disorders, employ strategies to reduce the risks such as proper storage and control practices.

Serious, life-threatening, or fatal respiratory depression has been reported with opioids. ULTIVA should be administered only by persons specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids. Monitor patients closely, particularly during initiation and titration. Resuscitative and intubation equipment, oxygen, and opioid antagonists must be readily available. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA by 50% or by temporarily discontinuing the infusion.

Hypotension, profound sedation, respiratory depression, coma, and death may result from the concomitant use of ULTIVA with benzodiazepines or other CNS depressants. Patients should be advised to avoid alcohol for 24 hours after surgery.

A potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue ULTIVA if serotonin syndrome is suspected.

Continuous infusions of ULTIVA should be administered only by an infusion device. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Discontinuation of ULTIVA should be preceded by the establishment of adequate postoperative analgesia.

IV tubing must be cleared to remove residual ULTIVA, which has been associated with respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates
>0.1 mcg/kg/min.

ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products.

Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs. Monitor heart rate during dosage initiation and titration.

Hypotension has been reported with ULTIVA and is responsive to decreases in administration, or to IV fluid or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Monitor blood pressure during dosage initiation and titration.

Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤75 mcg/kg/min.

Monitor for sedation and respiratory depression in patients susceptible to the intracranial effects of carbon dioxide retention.

Standard monitoring of patients should be maintained in the postoperative period to ensure adequate recovery without stimulation.

Most common adverse reactions (incidence ≥1%) were respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity.

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*Remifentanil is commonly referred to as Remi by anesthesia providers.