- Surprising Reasons You're in Pain Slideshow
- Take the Pain Quiz
- Joint-Friendly Exercises to Reduce RA Pain Slideshow
What is Byfavo (remimazolam), and how is it used?
Byfavo (remimazolam) is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
What are the side effects of Byfavo?
Because clinical trials are conducted under widely varying conditions, adverse reaction 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.
The safety of Byfavo was evaluated in three prospective, randomized, double-blind, multicenter, parallel group clinical studies in 630 patients undergoing colonoscopy (two studies) or bronchoscopy (one study). Colonoscopy Study 1 and the bronchoscopy study evaluated American Society of Anesthesiologists (ASA) physical status I to III patients, and Colonoscopy Study 2 evaluated ASA III and IV patients.
All three studies evaluated the safety of Byfavo compared to placebo with midazolam rescue and an open-label midazolam treatment arm. Patients were administered a total dose ranging from 5 to 30 mg of Byfavo. In these studies, the most common adverse reactions (incidence greater than 10%) following Byfavo administration were
- diastolic hypertension,
- systolic hypertension,
- hypoxia, and
- diastolic hypotension.
There were two patients who experienced an adverse reaction that led to discontinuation of study drug. One patient in the Byfavo arm in the bronchoscopy study discontinued treatment due to bradycardia, hypertension, hypotension, hypoxia, and respiratory rate increase. One patient in the open-label midazolam arm in Colonoscopy Study 2 discontinued due to respiratory acidosis. No deaths were reported during the studies.
Adverse reaction data from Colonoscopy Study 1 and the bronchoscopy study analyzed according to the cumulative dose of concomitant fentanyl (<100 mcg, 100-150 mcg and >150 mcg) suggest an increase in some adverse reactions with increasing fentanyl dose, such as hypotension, hypertension, bradycardia, hypoxia, and increased respiratory rate (see Table 4 and Table 5).
Can you get addicted to Byfavo?
Byfavo contains remimazolam, a Schedule IV controlled substance (CIV).
Byfavo contains the benzodiazepine, remimazolam. Benzodiazepines are a class of sedative drugs with a known potential for abuse. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study conducted in recreational sedative abusers (n = 39), remimazolam (5 and 10 mg, IV) produced responses on positive subjective measures such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” that were statistically similar to those produced by the sedative midazolam (2.5 and 5 mg), and statistically greater than the responses on these measures that were produced by placebo.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. In a monkey physical dependence study, chronic administration of remimazolam produced withdrawal signs such as tremors, muscle rigidity, restlessness, impaired motor activity, and a reduction in food consumption upon drug discontinuation. One monkey of six in this study exhibited systemic convulsions and dissociation from the environment. These behaviors are consistent with benzodiazepine withdrawal, which suggests that remimazolam produces physical dependence.
What is the dosage for Byfavo?
- Individualize Byfavo dosing and titrate to desired clinical response.
- In clinical studies, fentanyl 25 to 75 mcg was administered for analgesia prior to the first dose of Byfavo. Supplemental doses of fentanyl were administered as needed for analgesia [see Clinical Studies].
- Recommended dosing guidelines:
|Induction of Procedural Sedation||For adult patients: Administer 5 mg intravenously over a 1-minute time period.|
|For ASA* III and IV patients: Administer 2.5 mg to 5 mg intravenously over 1 minute based on the general condition of the patient.|
|Maintenance of Procedural Sedation (as needed)||For adult patients: Administer 2.5 mg intravenously over 15 seconds.|
|At least 2 minutes must elapse prior to administration of any supplemental dose.|
|For ASA III and IV patients: Administer 1.25 mg to 2.5 mg intravenously over 15 seconds.|
|At least 2 minutes must elapse prior to administration of any supplemental dose.|
|*ASA = American Society of Anesthesiologists Physical Status Classification System|
What drugs interact with Byfavo?
Alcohol And Current Medications
Advise patients to notify their healthcare provider about alcohol or medication use. Alcohol and other CNS depressants, such as opioid analgesics and benzodiazepines, can have an additive effect when administered with Byfavo.
Opioid Analgesics And Other Sedative-Hypnotics
The sedative effect of intravenous Byfavo can be accentuated by concomitantly administered CNS depressant medications, including opioid analgesics, other benzodiazepines, and propofol.
Continuously monitor vital signs during sedation and through the recovery period. Titrate the dose of Byfavo when administered with opioid analgesics and sedative-hypnotics to the desired clinical response.
Is Byfavo safe to used while pregnant or breastfeeding?
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers exposed to Byfavo during pregnancy to monitor neonates for signs of sedation, respiratory depression, and feeding problems.
Instruct patients to inform their healthcare provider if they are pregnant during treatment with remimazolam. Advise women to consider reducing infant exposure by pumping and discarding breast milk for 5 hours after receiving Byfavo during procedural sedation.
There are no data on the effects of remimazolam in human milk, the effects on the breastfed infant or the effects on milk production. There are reports of sedation in infants exposed to benzodiazepines through breast milk. Monitor infants exposed to Byfavo through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours (approximately 5 elimination half-lives) after Byfavo administration in order to minimize drug exposure to a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Byfavo and any potential adverse effects on the breastfed child from Byfavo or from the underlying maternal condition.
Byfavo (remimazolam) is a benzodiazepine administered by injection to sedate adults who have to undergo minor surgical procedures lasting 30 minutes or less.
Multimedia: Slideshows, Images & Quizzes
Colorectal (Colon) Cancer Quiz: Test Your Medical IQ
What is colorectal (colon) cancer and who gets it? Take this quiz to find out how this disease may be prevented.
Picture of Colon
The long, coiled, tubelike organ that removes water from digested food. See a picture of the Colon and learn more about the...
Picture of Colon
The part of the large intestine that serves to remove water from digested food and let the remaining material, solid waste called...
Picture of Colon Cancer
Most, if not all, of these cancers develop from colonic polyps. Removal of these precancerous polyps can prevent colon cancer....
Colon Cancer: Symptoms, Signs, Screening, Stages
Colorectal cancer (colon cancer) is the cause of many cancer deaths. Learn about the warning signs, symptoms, screening process,...
Colon Cancer: How Your Diet Can Affect Colorectal Cancer
Diet, including nutrient, antioxidant, and vitamin intake, affects colon cancer risk. Certain dietary factors either decrease or...
Related Disease Conditions
Rigid and Flexible Sigmoidoscopy
Apart from the length, the flexible sigmoidoscope is more flexible to maneuver. Thus, it produces less discomfort. The rigid sigmoidoscopy has a lesser diagnostic yield than the flexible sigmoidoscopy.
Is Colonoscopy Painful? What to Expect?
Colonoscopy is a medical procedure to examine the inside of the large bowel (colon). It is done with the help of a long, thin, and flexible tube-like instrument that carries a camera and a light source at one end (colonoscope).
What Does a Colposcopy Test For?
Colposcopy is usually done at a doctor's office or clinic, and it typically takes 10 to 20 minutes. Usually, the procedure is not very painful, so it may not need any pain medication or anesthesia. Comfort-wise, it is usually similar to a Pap test.
What Is Laparoscopy Used For?
Laparoscopy is a minimally invasive surgery or keyhole surgery that helps diagnose and treat many health conditions. A laparoscope is a thin, flexible tube with a light and small video camera on the end. The tube is put into a small surgical cut made through the abdominal wall near the belly button.
What Is Laparoscopy in Gynecology?
Laparoscopy in gynecology (gynecological laparoscopy) is a less invasive alternative to open surgery. The procedure involves using a laparoscope (a long, thin tube with a light connected to a camera) to look inside the pelvic area to diagnose gynecological disorders or to perform surgery to treat gynecological conditions.
Treatment & Diagnosis
- Colonoscopy Procedure
- Flexible Sigmoidoscopy
- Cystoscopy and Ureteroscopy
- Virtual Colonoscopy
- Capsule Endoscopy
- Push Endoscopy
- Endoscopy vs. Colonoscopy
- Sigmoidoscopy vs. Colonoscopy
- How Painful Is a Colonoscopy?
- Is an Anoscopy Painful?
- Is A Flexible Sigmoidoscopy Painful?
- What Is Esophagoscopy Used For?
- What Is a Chromoendoscopy?
- How Long Does an Exploratory Laparoscopy Take?
- What Are Video Laryngoscopy and Fiberoptic-Assisted Tracheal Intubation?
- Colorectal (Colon) Cancer FAQs
- Colonoscopy With No Sedation
- The Death of Joan Rivers: Endoscopy and Anesthesia Risks
- Can virtual colonoscopy replace actual colonoscopy
- Can Laparoscopy Treat Ectopic Pregnancy?
- Avoid Red Jell-O Before a Colonoscopy
- How Often Should I Have a Colonoscopy with Celiac?
- How Soon Should I Have a Followup Colonoscopy?
Medications & Supplements
Latest Chronic Pain News
Daily Health News
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.