Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest

Introduction

Bebtelovimab has not been fully approved by the FDA. The FDA (Food and Drug Administration) has granted it an emergency use permission (EUA). This EUA authorizes Bebtelovimab to be used in specific populations to treat mild-to-moderate COVID-19. Adults and children are among those at high risk of developing severe COVID-19, which could result in hospitalization or death. When other FDA-approved or permitted COVID-19 therapies are unavailable, Bebtelovimab is used. Bebtelovimab-induced bradycardia leading to cardiac arrest is a rare complication seen in patients after using Bebtelovimab.

What Is Bebtelovimab?

Monoclonal antibodies (MABs) have been used to prevent the worsening of symptoms and severe sickness associated with COVID-19 syndrome, a serious consequence of infection with the SARS-CoV-2 virus. Bebtelovimab is a brand-new monoclonal antibody (MAB) that is only used for SARS-CoV-2 Omicron variants and has been approved for use in emergencies. Bebtelovimab works by neutralizing the SARS-CoV-2 variants of the Omicron variant. Bebtelovimab functions by attaching to the highly effective spike of the SARS-CoV-2 glycoprotein receptor-binding domain known as LY-CoV1404. In patients with SARS-CoV-2 infection, MABs have been successful in lowering hospitalization rates and stopping the course of symptoms.

What Is the Dosage of Bebtelovimab?

• Bebtelovimab is given as a single intravenous injection containing 175 mg over a minimum of 30 seconds to adults (18 years of age and older) and children (12 years of age and older and weighing at least 88.18 pounds). Within seven days following the onset of symptoms and as soon as direct SARS-CoV-2 virus testing results are positive, Bebtelovimab should be given.

• Pediatric patients under the age of 12 or those weighing under 88.18 pounds are not allowed to use Bebtelovimab. Bebtelovimab's efficacy and safety have not been examined in pediatric patients. Bebtelovimab serum exposures in patients aged 12 to less than 18 and weighing at least 88.18 pounds are anticipated to be comparable to those seen in adults when using the recommended dose regimen.

What Is Bradycardia?

Bradycardia is defined by a heart rate that is typically below 60 beats per minute, which is lower than what is considered normal. A heart rate ranging from 40 to 60 beats per minute is generally considered typical when a person is at rest, particularly in cases involving young, healthy adults or individuals who are highly physically fit. Bradycardia can manifest as symptoms such as weakness, drowsiness, shortness of breath, fatigue, or chest discomfort. Various factors can trigger bradycardia, including underlying heart conditions, medications, or electrolyte imbalance.

The treatment of bradycardia varies depending on the severity and origin of the patient's disease. When an irregular cardiac rhythm is caused by an underlying illness, such as thyroid disorders, treatment may focus on treating that condition. Treatment options may include modifying existing medications and, in some cases, surgery. If existing treatment options do not properly address the issue, surgery to implant a pacemaker may be required in some circumstances.

What Is Bebtelovimab-Induced Bradycardia?

• Multiple organ systems are affected by SARS-CoV-2 infection, including the heart. It may cause myocarditis, arrhythmias, cardiomyopathies, and acute coronary syndromes. According to reports, sinus bradycardia affected 7.2 to 33 % of patients with COVID-19 syndrome, although it goes away after the infection is treated.

• The method by which SARS-CoV-2 affects the cardiac system may involve multiple factors and is frequently influenced by the severity of the illness. According to a theory put forth, the angiotensin-converting enzyme 2 receptors allow for myocardial infection that results in bradycardia.

• Researchers attribute the bradycardia to the Bebtelovimab infusion based on the timing of its onset. Bebtelovimab has an estimated half-life of 11.5 days, which could explain the persistent bradycardia and hypotension after cardiac arrest, as well as the necessity for pressors. Bebtelovimab has been linked to anaphylactic reactions and vasovagal syncope.

• There have been reported instances of COVID-19 patients experiencing a deterioration in their clinical condition after receiving treatment with SARS-CoV-2 monoclonal antibodies (Bebelovimab).

• This deterioration may manifest as various symptoms, including fever, decreased oxygen levels, heightened breathing difficulties, irregular heart rhythms such as atrial fibrillation, sinus tachycardia or bradycardia, fatigue, and changes in mental alertness. Some of these cases have necessitated hospitalization.

• It remains uncertain whether these events were directly linked to the use of SARS-CoV-2 monoclonal antibodies or if they were primarily a result of the natural progression of COVID-19.

What Are the Adverse Effects Associated With Bebtelovimab?

• At the injection site, discomfort, pain, edema, or bruising could appear.

• Bebtelovimab may cause an injection reaction that might manifest as low or high blood pressure, drowsiness, a fast or irregular heartbeat, pain in the chest, difficulty breathing, chills, fever, headache, vomiting, confusion, sweating, or muscle soreness up to 24 hours after the injection.

• Bebtelovimab has been associated with serious hypersensitivity reactions, including anaphylaxis, which have also been seen with other COVID-19 mAbs.

• When Bebtelovimab was given in combination with other monoclonal antibodies, hypersensitivity responses lasting longer than 24 hours were reported, and reactions to infusions might be severe or even fatal.

• If signs and symptoms appear, stop the IV infusion right away and start the necessary drugs and or supportive care.

• After injection, there have been reports of clinical exacerbation of COVID-19 signs and symptoms. It may include a high temperature, hypoxia or increased breathing difficulty, arrhythmia (such as atrial fibrillation, sinus rhythm disorders, or bradycardia), exhaustion, and altered mental status. Some of these incidents necessitated hospitalization.

• When given to hospitalized COVID-19 patients needing mechanical ventilation or high-flow oxygen, monoclonal antibodies may be linked to worse clinical outcomes.

Other side effects of Bebtelovimab include:

• Infusion-related reactions.

• Itching.

• Rashes.

• Nausea.

• Vomiting.

• Trouble breathing.

• Fever.

• Chills.

• Hives.

• Problems breathing.

• Facial, lip, tongue, or throat swelling.

• Dizziness.

• Low or high blood pressure.

• Disorientation.

• Sweating.

• Aches and pains in the muscles.

Conclusion

Bradycardia and bradycardia-mediated cardiac arrest brought on by Bebtelovimab infusion are usually rare. The cause is currently unknown, but it could be a vasovagal episode or an unidentified cardiovascular mechanism. Future studies are required to examine the cardiac effects of Bebtelovimab and to better understand the causes of bradycardia brought on by SARS-CoV-. Healthcare professionals must be extremely careful while choosing Bebtelovimab and must keep close observation and cardiac monitoring throughout the infusion.