The Medical Letter on Drugs and Therapeutics
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only)
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Med Lett Drugs Ther. 2023 Jan 9;65(1667):e9   doi:10.58347/tml.2023.1667d
 Select a term to see related articles  Actemra   baricitinib   COVID-19   dexamethasone   Olumiant   tocilizumab 

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

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