Nivolumab

DEA Class; Rx

Common Brand Names; Opdivo

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

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

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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

Nivolumab

IV solution

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