Bamlanivimab (Investigational)

Bamlanivimab is a prescription medication used as a prophylaxis or in the treatment of COVID-19. 

• Bamlanivimab is available under the following different brand names:

Adult and pediatric dosage

IV solution

• Distributed as individual vials
• Bamlanivimab: 700mg/20mL (35mg/mL)
• Etesevimab: 700mg/20mL (35mg/mL)

COVID-19 (EUA)

Adult dosage

Treatment

• Bamlanivimab 700 mg plus Etesevimab 1400 mg as a single IV infusion
• Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in patients at high risk for progressing to severe COVID-19 and/or hospitalization.
• Post-exposure prophylaxis
• Bamlanivimab 700 mg plus Etesevimab 1400 mg as a single IV infusion together as soon as possible following exposure

Pediatric dosage

Treatment

• Children 1-12 kg: Bamlanivimab 12 mg/kg plus Etesevimab 24 mg/kg
• Children between 12-20 kg: Bamlanivimab 175 mg plus Etesevimab 350 mg
• Children between 20-40 kg: Bamlanivimab 350 mg plus Etesevimab 700 mg
• Children 40 kg or over: Bamlanivimab 700 mg plus Etesevimab 1400 mg

Post-exposure prophylaxis

• Children 1-12 kg: Bamlanivimab 12 mg/kg plus Etesevimab 24 mg/kg
• Children between 12-20 kg: Bamlanivimab 175 mg plus Etesevimab 350 mg
• Children more than 20 but less than 40 kg: Bamlanivimab 350 mg plus Etesevimab 700 mg
• Children 40 kg or over: Bamlanivimab 700 mg plus Etesevimab 1400 mg

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Bamlanivimab include:

• nausea, 
• dizziness, 
• itching, and
• pain, soreness, swelling, or bruising of the skin at the injection site

Serious side effects of Bamlanivimab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe dizziness, 
• rash, 
• low blood pressure, 
• fever, 
• chills, 
• nausea, 
• headache, and
• muscle pain 

Rare side effects of Bamlanivimab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result 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.

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, health care provider or pharmacist first.

• Bamlanivimab has no noted severe interactions with other drugs. 
• Bamlanivimab has no noted serious interactions with other drugs. 
• Bamlanivimab has no noted moderate interactions with other drugs. 
• Bamlanivimab has no noted minor interactions with 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 drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity
  • Potential for serious hypersensitivity reaction, including anaphylaxis
  • 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 (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, diaphoresis
• Clinical worsening after administration
  • Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status
  • Some of these events required hospitalization
  • Unknown if these events were related to monoclonal antibodies or were due to progression of COVID-19
• Severe COVID-19
  • Treatment benefit not observed in patients hospitalized due to 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
  • Not authorized for use in patients
• Who are hospitalized due to COVID-19, OR
  • Who require oxygen therapy due to COVID-19, OR
  • Who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to 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 prevalence of resistant variants in their area
  • Health care providers should review antiviral resistance information provided by state and local health departments
  • Variant proportions circulating in the US can be monitored at the CDC website
• Fold reduction in susceptibility
  • Pseudotyped virus-like particle neutralization data of etesevimab plus bamlanivimab together (September 2021) B.1.1.7 - Alpha (UK origin): No change
  • B.1.351 - Beta (South Africa origin): 431
  • P.1 - Gamma (Brazil origin): 252
  • B.1.617.2/AY.3 - Delta (India origin): No change
  • B.1.617.2 AY1/AY.2 – Delta sublineages (India origin): 1,235
  • B.1.427/B.1.429 - Epsilon (California origin): 9
  • B.1.526 - Iota (New York origin): 30
  • B.1.517.1 - Kappa (India origin): 6
  • C.37 - Lambda (Peru origin): No change
  • B.1.621 - Mu (Colombia origin): 116
• Authentica SARS-CoV-2 neutralization data of etesevimab plus bamlanivimab together (September 2021)
  • B.1.1.7 - Alpha (UK origin): No change
  • B.1.351 - Beta (South Africa origin): >325
  • B.1.617.2/AY.3 - Delta (India origin): No change
  • B.1.427/B.1.429 - Epsilon (California origin): 11
  • B.1.526 (New York origin): 11
• 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

• Insufficient data to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Use during pregnancy only if potential benefit outweighs the potential risk for the mother and fetus
• Pregnancy is a risk factor for severe COVID-19 disease
• No dosage adjustment recommended by the manufacturer
• Lactation
  • Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production
  • Maternal IgG is known to be present in human milk
  • Breastfeeding females with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19
  • No dosage adjustment recommended by the manufacturer