Product Information
Registration Status: ActiveOPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10mg/ML is approved to be sold in Singapore with effective from 2016-04-04. It is marketed by BRISTOL-MYERS SQUIBB (SINGAPORE) PTE LTD, with the registration number of SIN14975P.
This product contains Nivolumab 10mg/mL in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS DRIP use.
This product is manufactured by Bristol-Myers Squibb Holdings Pharma in PUERTO RICO.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
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.
Indication
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.
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.
Pharmacokinetics
- Absorption
- The intended route of administration is intravenous, therefore bioavailability is expected to be 100%.
- Distribution
- 8.0 L
- 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.
- Elimination
Clearance
9.5 mL/hr
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.
Active Ingredient/Synonyms
Nivolumab | Nivolumab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.