Coronavirus disease 2019 (COVID-19), mild to moderate: Reserve for patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization
藥理
Antiviral Agent; Monoclonal Antibody Bamlanivimab and etesevimab are both recombinant neutralizing human IgG1k monoclonal antibodies to the spike protein of SARS-CoV-2. They bind to different, but overlapping receptors, thus blocking the spike protein attachment to the human ACE2 receptor. Use of the combination is expected to reduce the risk of viral resistance.
藥動學
Absorption: Cmax: Bamlanivimab (700 mg): 196 mg/L Etesevimab (1.4 g): 504 mg/L Distribution: Vd: Bamlanivimab: 2.87 L (central); 2.71 L (peripheral) Etesevimab: 2.38 L (central); 1.98 L (peripheral) Metabolism: Bamlanivimab and etesevimab are expected to be degraded into small peptides and component amino acids via catabolic pathways in the same manner as endogenous IgG antibodies. Half-life elimination: Bamlanivimab: 17.6 days Etesevimab: 25.1 days
禁忌症
There are no contraindications listed in the FDA emergency use authorization (EUA) fact sheet for health care providers.
懷孕分類
The potential benefits or risks of in utero exposure to bamlanivimab and etesevimab to the fetus are not known Use may be considered in pregnant patients, particularly those with over 1 additional risk factor. According to the EUA (emergency use authorization), dose adjustments are not recommended for patients who are pregnant.
哺乳分類
It is not known if bamlanivimab or etesevimab are present in breast milk; however, bamlanivimab and etesevimab are humanized monoclonal antibodies (IgG1); maternal IgG is present in breast milk
副作用
>10%: Pruritus, hypersensitivity reaction (including type 1 hypersensitivity reaction, flushing, facial swelling, rash at injection site, skin rash), fever Frequency not defined: Anaphylaxis, infusion related reaction
劑量和給藥方法
COVID-19, weight over 40kg: (IV) administer Bamlanivimab 700 mg and etesevimab 1.4 g together as a single IV infusion; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset
小兒調整劑量
Emergency use authorization from the FDA is based on likelihood of similar exposures in patients >12 years of age weighing >40 kg
腎功能調整劑量
No dosage adjustment recommended
肝功能調整劑量
Mild impairment: No dosage adjustment recommended Moderate or severe impairment: There are no dosage adjustments provided (has not been studied)