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Nivolumab volume of distribution

The clinical pharmacology profile of nivolumab was analyzed by a population pharmacokinetics model that assessed covariate effects on nivolumab concentrations in 1,895 patients who received 0.3–10.0 mg/kg nivolumab in 11 clinical trials. Nivolumab pharmacokinetics is linear with a time‐varying clearance.

What is Nivolumab

Nivolumab is a fully human IgG4 monoclonal antibody that acts as an immunomodulator by blocking ligand activation of programmed cell death 1 (PD-1) receptor on T cells. It is indicated for use in patients with unresectable (cannot be surgically removed) or metastatic melanoma who no longer respond to other drugs. Nivolumab is administered as an intravenous infusion over 60 minutes every 2 weeks.

Nivolumab mechanism of action

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death 1 (PD-1) receptor and selectively blocks interaction with its programmed death ligands PD-L1 and PD-L2. Upregulation of PD-1 ligands occurs in some tumors and signalling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumour tissue. The inhibitory effect of PD-1 and its ligands occurs through the promotion of apoptosis in antigen specific T cells while simultaneously blocking apoptosis in suppressor T cells. Blocking PD-1 activity has been shown to lead to decreased tumour growth in mouse tumour models.

Dosage forms of Nivolumab

Indication of Nivolumab

Nivolumab is indicated for the treatment of unresectable or metastatic melanoma for patients who no longer respond to treatment with other drugs. It is intended for use in patients who have been previously treated with ipilimumab and is used for melanoma patients after treatment with ipilimumab and a BRAF inhibitor in patients whose tumors express BRAF V600 gene mutations. Historically there have been very few effective treatments for advanced melanoma, which is why this product was approved under an FDA accelerated program to allow earlier patient access.

Toxicity of Nivolumab

Based on data from animal studies, there is risk of fetal harm when administered to pregnant women. It is therefore advisable for pregnant women to use contraception during treatment and for 5 months afterwards. There have been reported cases of severe pneumonitis or interstitial lung disease, including fatal cases, with the use of nivolumab during clinical trials. Therefore, patients taking this drug should be monitored for signs and symptoms of pneumonitis. During clinical trials there have also been reports of the development of immune-mediated colitis, immune-mediated hepatitis with increased liver test abnormalities, immune-mediated nephritis and renal dysfunction, immune-mediated hypothyroidism and hyperthyroidism, and rare cases of other immune-mediated reactions such as pancreatitis, uveitis, demyelination, autoimmune neuropathy, adrenal insufficiency, and facial and abducens nerve paresis.