Bebtelovimab (Investigational)

Bebtelovimab is a monoclonal antibody indicated for emergency use for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients aged 12 years and older who weigh 40 kg and more.

• Bebtelovimab is available under the following different brand names: Bebtelovimab

Common side effects of Bebtelovimab include:

• infusion-related reactions
• itching
• rash
• nausea
• vomiting

Serious side effects of Bebtelovimab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• low or high blood pressure
• slow, fast, or irregular heartbeat
• chest pain
• trouble breathing 
• fever
• chills 
• nausea 
• headache 
• confusion 
• sweating
• muscle pain

Rare side effects of Bebtelovimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 175 mg/2 mL single-dose vial

COVID-19 (EUA)

Adult dosage

• 175 mg as a single IV injection over at least 30 seconds
• Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset
• Additional indication criteria
• Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and
• High risk for progression to severe COVID-19, including hospitalization or death, and
• Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate

Pediatric dosage

Indication

• Children younger than 12 years: Not authorized
• Children aged 12 years and older (weighing 40 kg and more): 175 mg as a single IV injection over at least 30 seconds
• Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset
• Additional indication criteria
  • Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and
  • High risk for progression to severe COVID-19, including hospitalization or death, and
  • Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Bebtelovimab has no noted severe interactions with any other drugs
• Bebtelovimab has no noted serious interactions with any other drugs
• Bebtelovimab has no noted moderate interactions with any other drugs
• Bebtelovimab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bebtelovimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bebtelovimab?”

Cautions

• Hypersensitivity
  • Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 monoclonal antibodies (mAbs), and may occur with bebtelovimab
  • Hypersensitivity reactions occurring above 24 hours after infusion were observed with bebtelovimab when administered with other mAbs
  • Infusion-related reactions may be severe or life-threatening
  • If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care
  • Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions, dizziness, and diaphoresis
  • Administer appropriate medication/supportive care if infusion-related reactions occur
• Clinical worsening after administration
  • Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status
  • Some of these events required hospitalization
  • Unknown if these events were related to mAbs or were due to progression of COVID-19
• Severe COVID-19
  • Treatment benefits not observed in patients hospitalized with COVID-19
  • Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
  • Therefore, not authorized for use in patients
    • Who are hospitalized with COVID-19, or
    • Who requires oxygen therapy for COVID-19, or
    • Who requires an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19–related comorbidity)
• Viral variants
  • Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies
  • Prescribing clinicians should consider the prevalence of resistant variants in their area
  • Health care providers should review antiviral resistance information provided by state and local health departments
  • November 4, 2022: Expected reduced activity against Omicron subvariants BQ.1 and BQ.1.1 (fold reduction in susceptibility above 672); prescribers should monitor regional variant frequency data to determine if using Bebtelovimab remains effective
  • Variant proportions circulating in the US can be monitored at the CDC website
• Drug interaction overview
  • Not renally excreted or metabolized by CYP450 enzymes
  • Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely

Pregnancy and Lactation

• Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Use during pregnancy if the potential benefit outweighs the potential risk for mother and fetus
• Pregnant women are considered a high-risk population for severe COVID-19
• Clinical considerations
  • COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death
• Lactation
  • Data are unavailable on the presence of the drug in human or animal milk, its effects on breastfed infants or milk production
  • Maternal IgG is known to be present in human milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for bebtelovimab and any potential adverse effects on the breastfed child from bebtelovimab or the underlying maternal condition
  • Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19