The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).1 Tocilizumab was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for treatment of children 2-17 years old who are hospitalized with COVID-19 and require oxygen support.2
CLINICAL STUDIES – Issuance of the EUA for tocilizumab was based on the results of four randomized trials (three published; one summarized in the package insert) in a total of 5606 patients who were hospitalized with COVID-19 pneumonia.3-6 Patients received either tocilizumab or placebo in addition to usual care. In a meta-analysis of these trials examining the subgroup of patients who were receiving corticosteroids at baseline (n=4295), the mortality rate at day 28 was significantly lower with tocilizumab than with placebo (absolute risk reduction 4.6% [95% CI 1.9%-7.3%]); NNT 21.7).6
DOSAGE AND ADMINISTRATION – Actemra is available in single-dose vials containing 80, 200, or 400 mg of tocilizumab. The recommended dose of tocilizumab for treatment of COVID-19 is 12 mg/kg in patients weighing <30 kg and 8 mg/kg in those weighing ≥30 kg (max dose 800 mg). Tocilizumab should be administered as a single IV infusion over 60 minutes. If clinical status does not improve, a second dose can be administered ≥8 hours after the first.6 The wholesale acquisition cost of one dose of Actemra for a 70-kg patient is $3683.50.7
NIH GUIDELINES – The NIH recommends use of either tocilizumab or the oral Janus kinase inhibitor baricitinib (Olumiant) in adults hospitalized with COVID-19 who are receiving dexamethasone and have rapidly increasing conventional oxygen needs and systemic inflammation. Dexamethasone plus either tocilizumab or baricitinib is also recommended for those who require high-flow nasal cannula oxygen, ventilation, or ECMO.8
- FDA News Release. FDA roundup: December 23, 2022. Available at: https://bit.ly/3CAn6X1. Accessed January 9, 2023.
- An EUA for tocilizumab (Actemra) for COVID-19. Med Lett Drugs Ther 2021; 63:113.
- RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet 2021; 397:1637. doi:10.1016/s0140-6736(21)00676-0
- C Salama et al. Tocilizumab in patients hospitalized with Covid-19 pneumonia. N Engl J Med 2021; 384:20. doi:10.1056/ nejmoa2030340
- IO Rosas et al. Tocilizumab in hospitalized patients with severe Covid-19 pneumonia. N Engl J Med 2021; 384:1503. doi:10.1056/nejmoa2028700
- FDA. Fact sheet for health care providers: Emergency Use Authorization for Actemra (tocilizumab). December 21, 2022. Available at: https://bit.ly/360BR4Q. Accessed January 9, 2023.
- Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. January 5, 2023. Reprinted with permission by First Databank, Inc. All rights reserved. ©2023. www.fdbhealth.com/drug-pricing-policy.
- NIH. COVID-19 treatment guidelines. Therapeutic management of hospitalized adults with COVID-19. August 8, 2022. Available at: https://bit.ly/3DfsFsJ. Accessed January 9, 2023.