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Nivolumab

    Brands

    DEA Class; Rx

    Common Brand Names; Opdivo

    • Antineoplastics, Monoclonal Antibody; 
    • PD-1/PD-L1 Inhibitors

    Programmed death receptor-1 (PD-1) blocking monoclonal antibody
    Used for certain types of colorectal cancer, esophageal cancer, gastric cancer, gastroesophageal junction (GEJ) cancer, head and neck cancer, hepatocellular cancer, Hodgkin lymphoma, melanoma, mesothelioma, non-small cell lung cancer, renal cell cancer, and urothelial cancer
    Immune-mediated reactions have been reported; treatment may need to be withheld or permanently discontinued

    Indicated for melanoma in patients with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting

    Indicated as a single agent or in combination with ipilimumab

    Non-Small Cell Lung Cancer (NSCLC)

    Resectable NSCLC

    • Indicated as neoadjuvant treatment in combination with platinum-doublet chemotherapy for resectable (tumors ≥4 cm or node positive) NSCLC

    Metastatic NSCLC

    • Monotherapy
      • Indicated for metastatic NSCLC with progression in patients on or after platinum-based chemotherapy
    • Combination therapy with ipilimumab
      • Indicated in combination with ipilimumab for first-line treatment of metastatic NSCLC in adults whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations
    • Combination with ipilimumab and platinum chemotherapy
      • Indicated in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for first-line treatment of metastatic or recurrent NSCLC in adults with no EGFR or ALK genomic tumor aberrations

    Indicated as first-line treatment for unresectable malignant pleural mesothelioma in combination with ipilimumab

    Renal Cell Carcinoma

    First-line treatment

    • Combination with cabozantinib
      • Indicated in combination with cabozantinib for first-line treatment of advanced renal cell carcinoma (RCC)
    • Combination with ipilimumab
      • Indicated for patients with intermediate or poor risk, previously untreated advanced RCC

    Prior antiangiogenic therapy

    • Indicated as a single agent for advanced RCC in patients who have received prior antiangiogenic therapy

    Indicated for classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, or ≥3 lines of systemic therapy (eg, autologous HSCT)

    Indicated for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients with disease progression on or after a platinum-based therapy

    Urothelial Carcinoma

    Locally advanced or metastatic

    • Indicated for locally advanced or metastatic urothelial carcinoma (UC) in patients who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

    Adjuvant treatment

    • Indicated for adjuvant treatment of UC in patients at high risk of recurrence after undergoing radical resection

    —

    Melanoma

    • Increased AST (28%)

    • Hyponatremia (25%)

    • Increased alkaline phosphatase (22%)

    • Rash (21%)

    • Pruritus (19%)

    • Cough (17%)

    • Increased ALT (16%)

    • Hyperkalemia (15%)

    • URTI (11%)

    NSCLC

    • Fatigue (50%)

    • Lymphopenia (47%)

    • Dyspnea, hyponatremia (38%)

    • Musculoskeletal pain (36%)

    • Cough (32%)

    • Nausea (29%)

    • Increases creatinine (22%)

    • Hypercalcemia, hypokalemia, hypomagnesemia (20%)

    • Vomiting, asthenia (19%)

    • Hypocalcemia, hyperkalemia, diarrhea (18%)

    • Edema, pyrexia (17%)

    • Abdominal pain, rash, increased AST (16%)

    • Increased alkaline phosphatase, thrombocytopenia (14%)

    • Chest pain, arthralgia, decreased appetite and weight (13%)

    • Increased ALT (12%)

    Severe infusion-related reactions can occur; discontinue in patients with severe or life-threatening infusion reactions

    Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT); closely monitor for evidence of GVHD and intervene promptly; consider benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT

    May cause fetal harm when administered to pregnant females

    When used in combination with ipilimumab, refer to prescribing information for additional risk information that applies to the combination use treatment

    In clinical trials in multiple myeloma patients, the addition of a PD-1 blocking antibody to a thalidomide analog plus dexamethasone resulted in increased mortality

    Based on its mechanism of action and data from animal studies, fetal harm may occur when administered to a pregnant woman

    There are no available human data informing the drug-associated risk

    Unknown if distributed in human breast milk; advise women to discontinue breastfeeding during treatment

    Adults

    Monotherapy: 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.
    Combination therapy with ipilimumab: 3 mg/kg IV every 3 weeks.
    Combination therapy with ipilimumab and platinum-doublet chemotherapy: 360 mg IV every 3 weeks.
    Combination therapy with cabozantinib: 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.
    Combination therapy with mFOLFOX6 or XELOX/CapeOx: 360 mg IV every 3 weeks or 240 mg IV every 2 weeks.

    Geriatric

    Monotherapy: 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.
    Combination therapy with ipilimumab: 3 mg/kg IV every 3 weeks.
    Combination therapy with ipilimumab and platinum-doublet chemotherapy: 360 mg IV every 3 weeks.
    Combination therapy with cabozantinib: 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.
    Combination therapy with mFOLFOX6 or XELOX/CapeOx: 360 mg IV every 3 weeks or 240 mg IV every 2 weeks.

    Adolescents

    Single agent (colorectal cancer only): 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.

    Children

    12 years: Single agent (colorectal cancer only): 480 mg IV every 4 weeks or 240 mg IV every 2 weeks.1 to 11 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Nivolumab

    IV solution

    • 10mg/mL (4mL, 10mL)
    • Further dilution required before administration