Dexmedetomidine B. Braun Concentrate for Solution for Infusion Adverse Reactions

The following clinically significant adverse reactions are described in Precautions: Hypotension, bradycardia and sinus arrest; Transient hypertension.
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in Intensive Care Unit studies include hypotension, bradycardia and dry mouth.
Intensive Care Unit Sedation: Adverse reaction information is derived from the continuous infusion trials of Dexmedetomidine for sedation in the Intensive Care Unit setting in which 1,007 adult patients received Dexmedetomidine. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 7. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Hypotension, Bradycardia, and Sinus Arrest under Precautions]. (See Table 7.)

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Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Dexmedetomidine for sedation in the surgical intensive care unit setting in which 387 adult patients received Dexmedetomidine for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 8).

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In a controlled clinical trial, Dexmedetomidine was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in Dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 9. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Dexmedetomidine group is provided in Table 10. (See Table 9.)

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The following adverse events occurred between 2 and 5% for Dexmedetomidine and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%). (See Table 10.)

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Postmarketing Experience: The following adverse reactions have been identified during post-approval use of Dexmedetomidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypotension and bradycardia were the most common adverse reactions associated with the use of Dexmedetomidine during post-approval use of the drug. (See Table 11.)

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