Nivolumab


Other name

-

International/Other brands

Opdivo

Groups

Approved

Structure

Prescription products

NameDosageStrengthRouteLabeller
OpdivoSolution10 mgIntravenousBristol Myers Squibb
OpdivoInjection10 mg/mLIntravenousE.R. Squibb & Sons, L.L.C.

Target

PDCD1

Description

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.

Indications

Metastatic Melanoma; Refractory Hodgkin Lymphoma; Unresectable Melanoma ;Refractory, advanced Renal cell carcinoma; Refractory, metastatic Non-small cell lung cancer Refractory, metastatic Renal cell carcinoma

Other indications

-

Mechaism of action

-

Absorption

The intended route of administration is intravenous, therefore bioavailability is expected to be 100%.

Metabolism

As nivolumab is an antibody, the expected consequence of metabolism is proteolytic degradation to small peptides and individual amino acids, and receptor-mediated clearance.

Toxicity

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.