Note: This document contains side effect information about remimazolam. Some dosage forms listed on this page may not apply to the brand name Byfavo.
Applies to remimazolam: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Warning: Personnel and Equipment for Monitoring and Resuscitation, and Risks from Concomitant Use with Opioid Analgesics and Other Sedative-HypnoticsOnly personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer remimazolam.Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.Remimazolam has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and through the recovery period.Resuscitative drugs, and age-and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of remimazolam.Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous remimazolam can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.
Serious side effects of Byfavo
Along with its needed effects, remimazolam (the active ingredient contained in Byfavo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking remimazolam:
More common
- Blurred vision
- chest pain or discomfort
- confusion
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- fast, slow, pounding, or irregular heartbeat or pulse
- headache
- nausea
- nervousness
- pounding in the ears
- sweating
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- loss of voice
- runny or stuffy nose
- sneezing
- sore throat
Get emergency help immediately if any of the following symptoms of overdose occur while taking remimazolam:
Symptoms of overdose
- Agitation
- changes in patterns and rhythms of speech
- confusion
- difficulty sleeping
- disorientation
- drowsiness to profound loss of consciousness
- irregular, fast or slow, or shallow breathing
- loss of strength or energy
- mood or other mental changes
- nightmares
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- slurred speech
- talkativeness
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, or feeling of sluggishness
- unusual weak feeling
For Healthcare Professionals
Applies to remimazolam: intravenous powder for injection.
General
The most commonly reported side effects included hypotension, hypertension, respiratory depression, diastolic hypertension, systolic hypertension, hypoxia, diastolic hypotension, and bradycardia.[Ref]
Cardiovascular
In clinical studies, hypotension was defined as a decrease in systolic blood pressure (BP) to 80 mmHg or lower or in diastolic BP of 40 mmHg or lower, or a decrease in systolic or diastolic BP of at least 20% below baseline or requiring medical intervention; hypertension was defined as an increase in systolic BP to at least 180 mmHg or in diastolic BP to at least 100 mmHg, or an increase of systolic or diastolic BP of at least 20% over baseline or requiring medical intervention.
In a colonoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:
-Hypotension was reported in 33%, 44%, and 100% of patients, respectively.
-Hypertension was reported in 16%, 24%, and 0% of patients, respectively.
-Bradycardia was reported in 8%, 14%, and 50% of patients, respectively.
-Diastolic hypertension was reported in 6%, 14%, and 0% of patients, respectively.
-Tachycardia was reported in 7%, 8%, and 50% of patients, respectively.
-Diastolic hypotension was reported in 7%, 9%, and 0% of patients, respectively.
-Systolic hypertension was reported in 3%, 8%, and 0% of patients, respectively.
In a bronchoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:
-Hypotension was reported in 24%, 51%, and 64% of patients, respectively.
-Hypertension was reported in 20%, 40%, and 72% of patients, respectively.
-Diastolic hypertension was reported in 30%, 19%, and 0% of patients, respectively.
-Systolic hypertension was reported in 26%, 17%, and 4% of patients, respectively.
-Diastolic hypotension was reported in 13%, 21%, and 0% of patients, respectively.
-Bradycardia was reported in 1%, 6%, and 16% of patients, respectively.
Hypotension was reported as mild, moderate, and severe in 30.1%, 1.1%, and 0.1% of patients, respectively; diastolic hypotension was reported as mild in 8.7% of patients. Bradycardia was reported as mild, moderate, and severe in 6%, 0.1%, and 0.4% of patients, respectively.
In controlled trials in procedural sedation, patients 65 years and older had a higher frequency of events grouped under the term hypotension (47% vs 33.3%) than patients younger than 65 years; patients with American Society of Anesthesiologists Physical Status (ASA-PS) III to IV also showed a higher frequency for hypotension (43.6% vs 35.6%) than patients with ASA-PS I to II. Older age and higher ASA-PS were not associated with a higher frequency of bradycardia.
In a colonoscopy study, hypotension (58%), hypertension (42%), diastolic hypertension (10%), systolic hypertension (6%), bradycardia (3%), diastolic hypotension (3%), diastolic BP increased 3(%), BP increased (3%), and systolic BP increased (3%) were reported in patients with ASA-PS III and IV.[Ref]
Very common (10% or more): Hypotension (included hypotension, diastolic hypotension, blood pressure decreased, systolic blood pressure decreased, diastolic blood pressure decreased; up to 100%), hypertension (up to 72%), bradycardia (included bradycardia, sinus bradycardia, heart rate decreased; up to 50%), tachycardia (up to 50%), diastolic hypertension (up to 30%), systolic hypertension (up to 26%), diastolic hypotension (up to 21%)
Common (1% to 10%): Blood pressure increased, diastolic blood pressure increased, systolic blood pressure increased[Ref]
Respiratory
In a bronchoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:
-Hypoxia was reported in 16%, 35%, and 36% of patients, respectively.
-Respiratory rate increased was reported in 10%, 19%, and 36% of patients, respectively.
Hypoxia was reported as mild, moderate, and severe in 8%, 0.9%, and 0.3% of patients, respectively. Respiratory rate decreased was reported as mild and moderate in 1.5% and 0.4% of patients, respectively.
In controlled trials in procedural sedation, patients 65 years and older had a higher frequency of events grouped under the term respiratory depression (22.8% vs 9%) than patients younger than 65 years; patients with ASA-PS III to IV also showed a higher frequency for respiratory depression (17.6% vs 11.8%) than patients with ASA-PS I to II.
In a colonoscopy study, respiratory acidosis, respiratory rate decreased, and upper respiratory tract infection were reported in 19%, 3%, and 3% of patients with ASA-PS III and IV, respectively.
Respiratory depression (hypoxia/oxygen saturation decreased) was reported in 2 of 8 subjects with moderate liver dysfunction, and 1 of 3 with severe liver dysfunction enrolled in a dedicated trial assessing this drug in liver dysfunction.[Ref]
Very common (10% or more): Hypoxia (up to 36%), respiratory rate increased (up to 36%), respiratory acidosis (up to 19%), respiratory depression (included hypoxia, respiratory rate decreased, respiratory acidosis, bradypnea, dyspnea, oxygen saturation decreased, breath sounds abnormal, hypopnea, respiratory depression, respiratory distress; up to 13.1%)
Common (1% to 10%): Respiratory rate decreased, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting[Ref]
Other
Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Chills, feeling cold[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Somnolence[Ref]
