Nivolumab

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Nivolumab is a monoclonal antibody that belongs to the class of immune checkpoint inhibitors. It works by blocking the programmed death receptor-1 (PD-1) on T cells, thereby enhancing the body's immune response against cancer cells.

Indications

Patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent. -Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent. -Patients with unresectable or metastatic melanoma, in combination with ipilimumab. -Patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. -Patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. -Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving NIVOLUMAB. -Patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. -Patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab. adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT. -Patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. -Patients with locally advanced or metastatic urothelial carcinoma who -Have disease progression during or following platinum-containing chemotherapy -Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. -Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. -Patients with hepatocellular carcinoma who have been previously treated with sorafenib.

Dosage

Administer NIVOLUMAB as an intravenous infusion over 30 minutes. Unresectable or metastatic melanoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. -NIVOLUMAB with ipilimumab: NIVOLUMAB 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Adjuvant treatment of melanoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Metastatic non-small cell lung cancer -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Advanced renal cell carcinoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. NIVOLUMAB with ipilimumab: NIVOLUMAB 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Classical Hodgkin lymphoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Recurrent or metastatic squamous cell carcinoma of the head and neck - NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Locally advanced or metastatic urothelial carcinoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer -NIVOLUMAB 240 mg every 2 weeks. Hepatocellular carcinoma -NIVOLUMAB 240 mg every 2 weeks or 480 mg every 4 weeks.

Contra-Indications

-Nivolumab is contraindicated in individuals with known hypersensitivity to the drug. Caution is advised in patients with autoimmune disorders, as immune checkpoint inhibitors can exacerbate these conditions. -Hypersensitivity.

Special Precautions

Paediatric: Safety and efficacy in pediatric patients of less than 12 year of age have not been established. Pregnancy: It can cause fetal harm Lactation: Data not sufficient Elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Side Effects

NIVOLUMAB as a single agent: fatigue, rash, musculoskeletal pain, diarrhoea, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, and abdominal pain. -NIVOLUMAB with ipilimumab for melanoma: fatigue, rash, diarrhoea, nausea, pyrexia, vomiting, and dyspnea. -NIVOLUMAB with ipilimumab for renal cell carcinoma: fatigue, rash, diarrhoea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite

Drug Interactions

Nivolumab may interact with other immunosuppressive drugs or vaccines. Patients should inform their healthcare provider about all medications, including over-the-counter drugs and supplements.