Nivolumab and Relatlimab Can Be Combined in a Single Infusion Bag
Yes, nivolumab 480 mg and relatlimab 160 mg are administered together as a fixed-dose combination (FDC) intravenously every 4 weeks, infused over 30 minutes. This is the FDA-approved formulation and dosing regimen for unresectable or metastatic melanoma 1, 2.
Preparation and Administration
The combination is delivered as a fixed-dose combination product where both agents are combined in the same infusion bag:
- Dose: Relatlimab 160 mg + Nivolumab 480 mg
- Frequency: Every 4 weeks (Q4W)
- Infusion time: 30 minutes 2
- Route: Intravenous infusion
Key Pharmacokinetic Considerations
The FDC formulation has been specifically studied and validated:
- No drug-drug interaction exists between nivolumab and relatlimab when combined 3
- Geometric mean exposures are similar between single-agent vials (SAV) administered separately versus the FDC formulation 3
- Both drugs have similar volumes of distribution (6.6 L for relatlimab, 6.8 L for nivolumab) and half-lives (27 days for relatlimab, 26 days for nivolumab) 2
- Clearance at steady state: 7.6 mL/h for nivolumab and 5.5 mL/h for relatlimab 2
Clinical Evidence Supporting Combined Administration
The RELATIVITY-047 trial, which led to FDA approval, administered both agents together as a fixed-dose combination 1. This regimen demonstrated:
- Progression-free survival: 10.1 months (95% CI, 6.4-15.7) versus 4.6 months with nivolumab alone
- Hazard ratio: 0.75 (95% CI, 0.62-0.92); P = 0.006 2
- Manageable safety profile: Treatment-related adverse events in 18.9% versus 9.7% with nivolumab monotherapy 2
Important Caveats
- This combination is distinct from nivolumab plus ipilimumab, which uses different dosing (nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for 4 doses) 1
- The 30-minute infusion time for the nivolumab/relatlimab FDC is shorter than the traditional 60-minute infusion used for nivolumab monotherapy 4, 2
- No dose adjustments are required based on sex, age, race, or mild hepatic/renal impairment 2