Alternate Name(s):
Yervoy
Classification:
Antineoplastic - recombinant, fully human monoclonal antibody that binds to and blocks human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)
Original Date:
October 2023
Indications:
- As a single agent, it is used in the treatment of unresectable or metastatic melanoma
- In combination with nivolumab, it is used in the treatment of unresectable or metastatic melanoma in previously untreated patients
- In combination with nivolumab for the treatment of unresectable malignant pleural mesothelioma
Reconstitution and Stability:
- Available as 5 mg/mL (10 mL and 40 mL) single use vial
- Pale yellow in appearance.
- Store vials refrigerated (2 – 8ᵒC). DO NOT FREEZE. Protect from light
- Allow vials to stand at room temperature for approximately 5 minutes prior to withdrawal of contents.
- Protect from light. DO NOT SHAKE. Mix by gently inverting.
- Undiluted and diluted solutions of ipilimumab may be stored for up to 24 hours either under refrigeration (2 to 8°C) or at room temperature (20 to 25°C).
- Do not use if solution is cloudy, has significant discolouration, particles or any foreign material observed. Final product should be clear, colourless to pale yellow.
Compatibility:
- Solutions compatible: 0.9% Sodium Chloride, 5% Dextrose
- Additives/Above Cassette Compatible: No information
- Y-Site compatibility: No information
- Incompatible: DO NOT infuse with any other medication or solution
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES – administer via large volume pump Infuse with a sterile 0.2 – 1.2 micron low-protein-binding in-line filter Usual dilution: 1 - 4 mg/mL Infusion time: 30 minutes When administered in combination with nivolumab, infuse nivolumab first followed by ipilimumab. Infusion of ipilimumab should be initiated 30 minutes after the completion of nivolumab. |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- 1 - 3 mg/kg administered every 3 weeks for 4 doses. May be given in combination with nivolumab
Potential hazards of parenteral administration:
- Infusion related reactions are possible and could include, but are not limited to: anaphylaxis, hypersensitivity reactions (rash, urticaria, flushing, bronchospasm)
- Common adverse effects include: diarrhea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite and abdominal pain.
- Ipilimumab can cause severe and fatal immune-mediated adverse reactions, including enterocolitis, intestinal perforation, hepatitis, dermatitis (including toxic epidermal necrosis), neuropathy, and endocrinopathy
- The safety and efficacy has not been established in patients with ocular melanoma or active central nervous metastases
*For any infusion toxicities, refer to protocol for detailed information on management*
Notes:
- Anaphylactic precautions at bedside
- Monitor vital signs (temperature, pulse, blood pressure, and respirations) pre-infusion, every 15 minutes x 2, every 30 minutes during the infusion, and for 6 hours post-infusion for cycle 1 (may be reduced to 90 minutes post infusion for subsequent cycles)
- Infusion must be administered through a non-pyrogenic, low protein-binding 0.2 – 1.2 micron in-line filter