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During the clinical trials, doses up to 7000 mg, 10 times the authorized bamlanivimab, were administered without any dose-limiting toxicity. In case of overdose, supportive treatment is recommended, along with monitoring of vitals and clinical status. In case of an overdose, there is no specific antidote. Specific Populations Pediatric use: Phase 2/3 of the BLAZE-1 Trial was completed in December 2021. No dosing adjustments were made to a population of 12-18 years and weighing at least 40 kg. Dosing adjustment recommendation besides this age/weight group is mentioned above. Geriatric use: BLAZE- 1 Trial included 30% of age 65 and 10% 75. No pharmacokinetic differences were noted compared to the younger population. Renally impairment: Renal impairment is not expected as the drug is not eliminated via urine. Hepatic impairment: The drug has not been evaluated in cases of moderate or severe hepatic impairment. With mild hepatic impairment, it has been shown to have no difference compared to normal hepatic function. Pregnancy: Human IgG1 antibodies can cross the placental barrier, so the drug has the potential to do the same. The FDA recommends using the drug in pregnant women if the potential benefit outweighs the risk to both the mother and the fetus. There is no sufficient data regarding birth defects secondary to drug use. Lactating mothers: Bamlanivimab has a molecular weight of 146,000 Da. Because it is a very large protein, the amount of the drug in the milk is expected to be low.[11] There is no data available regarding the effect of bamlanivimab on breast milk production and breastfed infants [2]. The use of the drug should be considered on an individual basis. Nonclinical Toxicology studies, including carcinogenesis, mutagenesis, and reproductive toxicology, have not yet been conducted.

Bamlanivimab has been associated with decreasing the viral load and further spreading the disease (even as monotherapy), as shown in phase 1 of the BLAZE-1 trial. The other study by Ganesh et al. at Mayo Clinic facilities from November 2020 and February 2021 revealed that bamlanivimab reduced hospitalization rate on days 14 and 21, along with lower intensive care admission and all-cause mortality.[12] However, with emerging new strains of the SARS-CoV-2 virus that are resistant to only bamlanivimab therapy, the FDA revoked the use of bamlanivimab monotherapy in April 2021.[9] Later, data from phase 2/3 (ambulatory setting) of BLAZE-1 therapy revealed that combination therapy with etesevimab has decreased the incidence of hospitalization and death in high-risk populations.[10][13] The data from phase 3 of the BLAZE-1 clinical trial revealed an accelerated decline in viral load in patients receiving the combination therapy and reduced hospitalization rate by 70%.[14] The Phase 2/3 BLAZE-1 Trial included the pediatric population; the youngest participant was 10 months old and weighed 8.6 kg. BLAZE-2 study involved a single infusion of bamlanivimab 4200 mg vs. placebo in residents and staff of a skilled nursing facility after a confirmed positive COVID-19 test. The data revealed a reduced risk of being infected by 57%, which supported post-exposure prophylaxis treatment.[15] Primary care, Urgent, and Immediate care physicians should triage patients meeting the criteria for receiving the monoclonal antibody therapy.[13][16] Patients should only receive the infusion at a well-equipped infusion center with access to advanced health facilities in case of an adverse event. Pharmacists help in dose preparation and storage of the drug, and nurses assist in administering and monitoring the patient during and 1-hour post-infusion. Physicians and Nurses should coordinate to educate the patient regarding possible adverse effects and provide the patient with the fact sheet about the drug provided by the FDA before the drug administration. The care team and the patient should follow the directions in the fact sheet to notify of any adverse event within 7 calendar days.