NIVOLUMAB/ HYALURONIDASE-NVHY INJ,SOLN
Clinical Criteria Summary
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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
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Indications
- Solid tumors including: Renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC), Squamous Cell Carcinoma (SCC) of the head & neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma (ESCC), gastroesophageal junction (GEJ) cancer, gastric cancer, and esophageal adenocarcinoma
Dosage & Administration
- Dosing varies by malignancy; may be given in combination with other agents except ipilimumab
- Every 2-week dosing: 600 mg/10,000 units
- Every 3-week dosing: 900 mg/15,000 units
- Every 4-week dosing: 1200 mg/20,000 units
- Administered via subcutaneous injection over 3-5 minutes in the abdomen or thigh by a healthcare professional
- Dose volume varies from 5-10 mL; dose to be drawn up into a syringe
Contraindications & Warnings
- None listed for contraindications or boxed warnings
- Severe and fatal immune-mediated adverse reactions
- Complications of allogeneic hematopoietic stem cell transplant
- Embryo-fetal toxicity
- Should not be administered intravenously
Combination Restrictions
- Not approved for use in combination with ipilimumab
- Should not be used in combination with a thalidomide analogue and dexamethasone for multiple myeloma outside of the clinical trial setting
VHA Formulary & Clinical Considerations
- Demonstrated noninferiority to intravenous nivolumab based on pharmacokinetic endpoints (time-averaged exposure over 28 days and minimum steady-state exposure) and overall response rate relative risk in advanced/metastatic clear cell RCC
- May replace intravenous nivolumab when given as monotherapy
- Not approved for use in Hodgkin Lymphoma; should not replace intravenous nivolumab in this setting