What is the maximum dose of Tocilizumab (Interleukin-6 receptor antagonist)?

From the Guidelines

The maximum dose of tocilizumab is 800 mg per dose, given as 8 mg/kg IV over 1 hour, not to exceed 800 mg/dose. This dose is recommended for patients with cytokine release syndrome, regardless of the grade of the syndrome 1. The dose may be repeated every 8 hours as needed, with a maximum of three doses in a 24-hour period and a total of four doses 1. It is essential to note that tocilizumab works by blocking interleukin-6 receptors, thereby reducing inflammation, and patients should be screened for latent tuberculosis and other infections before initiating therapy, as tocilizumab can increase infection risk by suppressing immune function.

Some key points to consider when administering tocilizumab include:

• The dose should not exceed 800 mg per infusion, regardless of the patient's weight 1
• The medication should be administered intravenously over 1 hour 1
• The dose may be repeated every 8 hours as needed, with a maximum of three doses in a 24-hour period and a total of four doses 1
• Patients should be closely monitored for signs of infection and other adverse events, and dose adjustments may be necessary for patients with hepatic impairment, neutropenia, thrombocytopenia, or elevated liver enzymes.

It is crucial to follow the recommended dosing guidelines and to carefully monitor patients receiving tocilizumab to minimize the risk of adverse events and ensure optimal treatment outcomes.

From the FDA Drug Label

Based on pharmacokinetic exposure and extrapolation between RA and GCA patients, when given IV on a mg/kg basis, tocilizumab doses exceeding 600 mg per infusion are not recommended in patients with GCA [see Dosage and Administration (2. 3)]. The maximum dose of Tocilizumab is 600 mg per infusion when given intravenously, as stated in the drug label 2.

From the Research

Tocilizumab Max Dose

• The maximum dose of tocilizumab is not explicitly stated in the provided studies, but the approved dose in the EU for the treatment of moderate to severe active rheumatoid arthritis is intravenous tocilizumab 8 mg/kg (and no less than 4.8 mg) 3.
• In the study "Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice", tocilizumab was administered at a dose of 8 mg/kg intravenously every 4 weeks 4.
• In the study "Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial", tocilizumab was administered subcutaneously at a dose of 162 mg once every 2 weeks 5.
• There is no mention of a maximum dose of tocilizumab in the other studies, but the dose used in the study "Tocilizumab treatment in COVID-19: A single center experience" is not specified 6.
• It is worth noting that the dose of tocilizumab may vary depending on the specific condition being treated and the patient's response to the medication, and should be determined by a healthcare professional 3, 4, 5.