NIVOLUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Autoimmune disease
- Immunosuppression requiring a corticosteroid equivalent to >10 mg per day of prednisone
- Primary immunodeficiency
- History of allogeneic hematopoietic stem cell or solid organ transplant
- Known pregnancy
- Breastfeeding
Inclusion Criteria (One must be fulfilled)
- Indication is FDA-approved
- Off-label use supported by high-level published data
Additional Inclusion Criteria (All must be fulfilled)
- Care is provided by a VA/VA Community Care oncology or hematology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
Additional Inclusion Criteria (If applicable)
- For females who can become pregnant: Pregnancy must be excluded prior to receiving either nivolumab product
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 5 months after stopping treatment
Product-Specific Administration Guidelines
- Nivolumab IV has approval in classical Hodgkin Lymphoma; nivolumab/hyaluronidase SUBQ does not replace nivolumab IV in this setting
- Nivolumab/hyaluronidase-nvhy should not replace nivolumab when given in combination with ipilimumab