From the Guidelines
Nivolumab (Opdivo) 240mg is typically administered as an intravenous infusion every 2 weeks. This fixed dose of 240mg has replaced the previous weight-based dosing in many treatment protocols for various cancers including melanoma, non-small cell lung cancer, renal cell carcinoma, and others, as supported by recent guidelines such as those published in the Journal of Clinical Oncology 1. The two-week interval allows the drug to maintain therapeutic levels in the bloodstream while balancing efficacy and tolerability. Nivolumab works as an immune checkpoint inhibitor by blocking PD-1 receptors, which enhances T-cell activity against cancer cells.
Key Considerations
- The dosing schedule may vary based on specific cancer types, combination therapies, or individual patient factors.
- For example, in some cases, an alternative dosing of 480mg every 4 weeks may be used, as indicated by the US FDA prescribing information and discussed in various studies including those referenced in the NCCN guidelines 1.
- Treatment typically continues until disease progression or unacceptable toxicity occurs.
- Infusions generally take about 30 minutes to complete, and patients should be monitored for infusion-related reactions during and after administration.
Evidence Base
The recommendation for the dosing frequency of Nivolumab 240mg is based on the most recent and highest quality evidence available, including guidelines and studies published in prestigious journals such as the Journal of Clinical Oncology 1 and the Journal of the National Comprehensive Cancer Network 1. These sources provide the foundation for current clinical practice in the administration of Nivolumab for the treatment of various cancers.
From the FDA Drug Label
The recommended dosages of OPDIVO as a single agent are presented in Table 1. Table 1: Recommended Dosages for OPDIVO as a Single Agent
- 30-minute intravenous infusion (UC) or 480 mg every 4 weeks* Until disease recurrence or unacceptable toxicity for up to 1 year Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer Adult patients and pediatric patients age 12 years and older and weighing 40 kg or more: 240 mg every 2 weeks* or 480 mg every 4 weeks* Until disease progression or unacceptable toxicity Adjuvant treatment of resected esophageal or gastroesophageal junction cancer 240 mg every 2 weeks* or 480 mg every 4 weeks* Until disease progression or unacceptable toxicity for a total treatment duration of 1 year
The dosing frequency of Nivolumab (Opdivo) 240mg is every 2 weeks 2.
From the Research
Dosing Frequency of Nivolumab 240mg
- The dosing frequency of Nivolumab (Opdivo) 240mg is every 2 weeks 3, 4, 5.
- This dosing regimen has been approved in several countries, including Japan and China, as an alternative to the previously approved 3 mg/kg every 2 weeks dosing regimen 4, 5.
- Studies have shown that the exposure of nivolumab 240mg every 2 weeks is comparable to or slightly higher than that of the 3 mg/kg every 2 weeks regimen 4, 5.
- The safety and efficacy profiles of the 240mg every 2 weeks regimen have been demonstrated to be similar to those of the 3 mg/kg every 2 weeks regimen in various tumor types, including non-small cell lung cancer, melanoma, and renal cell carcinoma 4, 5.
- Model-based simulations have also explored the possibility of extending the dosing intervals of nivolumab, with results suggesting that regimens such as 240mg every 6 weeks or 480mg every 8 weeks could maintain minimal effective plasma concentrations in a significant proportion of patients 6.