Alternate Name(s):
Opdivo
Classification:
Anti-PD- 1 monoclonal antibody; immune checkpoint inhibitor
Original Date:
July 2019
Revised Date:
February 2024
Indications:
- Monotherapy or in conjunction with other immunotherapy or chemotherapy for multiple neoplasms, such as colorectal cancer, melanoma, Hodgkin lymphoma, primary mediastinal B-cell lymphoma, relapsed leukemia, renal cell carcinoma, etc
Reconstitution and Stability:
- Supplied as 10 mg/mL vials (100 mg & 40 mg). Vials must be refrigerated and protected from light. Do not freeze or shake vials.
- May be infused undiluted (10 mg/mL) or diluted with NS or D5W
- When dosed based on weight (ie mg/kg), nivolumab injection can be infused undiluted, or diluted to a concentration as low as 0.35 mg/mL.
- When dose is fixed (ie 240 mg or 360mg), nivolumab injection can be infused undiluted or diluted so as not to exceed a total infusion volume of 160 mL. For patients weighing < 40kg, the total volume of infusion must not exceed 4 mL/kg
- Avoid vigorous mixing or shaking during drug preparation and handling.
- Undiluted and diluted solutions of Nivolumab are stable 24 hrs refrigerated and protected from light or for 8 hours at room temperature and room light.
- Visually inspect drug solution for particulate matter and discoloration prior to administration. Discard if solution is cloudy, if there is pronounced discoloration (solution may have a pale-yellow colour), or if there is foreign particulate matter other than a few translucent to white, amorphous particles. Do not shake.
Compatibility:
- Solutions compatible: NS or D5W
- Incompatible: do not administer other medications through the same IV line
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM |
NO |
| IV Push | NO |
| IV Intermittent Infusion |
YES Usual dilution: may be undiluted, or diluted with NS or D5W to a concentration as low as 0.35 mg/mL. Do not exceed a total infusion volume of 160 mL. Infuse with a sterile 0.2 - 1.2 micron low-protein binding in-line filter. Infusion time: 30 minutes |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Dosing depends on indication and treatment protocol. Refer to specific protocol
- < 18 years old: 3 mg/kg/dose IV q2weeks (max 240 mg/dose)
- > 18 years old: 240 mg/dose IV q2weeks or 480mg/dose IV q4weeks
Potential hazards of parenteral administration:
- Common (> 20%): fatigue
- Occasional (< 20%): infusion reaction (may include fever, chills, shakes, itching, rash, hyper/hypotension, difficulty breathing during and immediately after Nivolumab administration), anemia, neutropenia, thrombocytopenia, adrenal insufficiency, hyper/hypothyroidism, uveitis, abdominal pain, colitis, diarrhea, dry mouth, nausea, pancreatitis, increased ALT/AST, increased bilirubin, increased creatinine, arthralgia, anorexia, pleural effusion
- Rare (< 3%): severe allergic reaction, cytokine release syndrome, blurred vision, colonic perforation, mucositis, myositis, rhabdomyolysis, encephalopathy, nervous system disorders, acute kidney injury, autoimmune disorders
For any infusion toxicities, refer to protocol for detailed information on management
Notes:
- Anaphylactic precautions at bedside.
- Vital signs,including BP: immediately prior to infusion, q15min during 1st hr, q30min during 2nd hr and hourly during 3rd hr and until completion of the infusion. Also monitor 30 and 60 min post infusion.
References:
- Children's Oncology Group protocol AREN1721, ANHL1931, AALL1821, AHOD2131; Opdivo product monograph accessed 7May2019, 1Dec2021, 1Feb2024