Tocilizumab (Actemra®) was approved in August 2017 for the treatment of chimeric antigen receptor (CAR) T cell–induced cytokine release syndrome. In March 2020, the U.S. Food and Drug Administration approved a randomized, double-blind, placebo-controlled, phase III clinical trial to assess the safety and efficacy of tocilizumab plus standard of care in patients hospitalized with severe COVID-19 pneumonia.
Humanized interleukin-6 receptor-inhibiting monoclonal antibody.
- Treatment of CAR T-cell–induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients aged two years or older
- Treatment of active systemic juvenile idiopathic arthritis in patients aged two years or older
- Treatment of active polyarticular juvenile idiopathic arthritis in patients aged two years or older
- Treatment of giant cell arteritis in adult patients
- Treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs
Dosing for CRS
Administering more than 800 mg per infusion is not recommended for CRS.
- Weight less than 30 kg: 12 mg/kg
- Weight 30 kg or higher: 8 mg/kg
Give via IV infusion over 60 minutes. If symptoms show no clinical improvement after the first dose, repeat for up to three doses. Allow for at least an eight-hour interval between infusions. Tocilizumab may be administered alone or in combination with corticosteroids.
The most common reactions (≥ 5%) are upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions. Serious reactions are hypersensitivity reactions, serious infections, and gastrointestinal perforation.
Warnings and Precautions
Serious, sometimes fatal, infections because of bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving tocilizumab.
Tocilizumab should not be administered to patients with an active infection, including localized infections. Laboratory values, including liver enzymes, absolute neutrophil count, and platelet count, should be monitored for the need for dose adjustments; see the package insert for full dose modifications. Avoid use of live vaccines while on tocilizumab. Patients should be evaluated for risk and tested for latent tuberculosis (TB) prior to starting and monitored for TB symptoms throughout tocilizumab therapy. Assess patients for a history of diverticulitis or gastrointestinal ulcers.
Drug-Drug and Drug-Food Interactions
Tocilizumab interacts with CYP450; coadministering tocilizumab with CYP3A4 substrate drugs may decrease the substrate drugs' effectiveness. The effect may persist for several weeks after stopping tocilizumab therapy.
- Educate patients about signs and symptoms of infection.
- Communicate the reason for laboratory monitoring while on tocilizumab.
- Instruct patients to inform their provider immediately if they develop a fever, persistent stomach pain, or a change in bowel habits.
- Educate patients on signs of hypersensitivity reaction and to report symptoms to the nurse immediately.
In clinical trials, patients aged 65 or older had a higher incidence of infections.
Based on animal data, tocilizumab may cause fetal harm.