TEBENTAFUSP-TEBN INJ
Clinical Criteria Summary
Document 595: Bispecific Antibody CRS and ICANS Neurotoxicity Supportive Care Guidance Jan 2026
Criteria for Blinatumomab
- Indication: Relapsed or Refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
- Pre-medication: Dexamethasone 16 mg IV
Criteria for Elranatamab
- Indication: Relapsed or Refractory Multiple Myeloma (BCMA target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 20mg PO/IV, Diphenhydramine 25mg PO, Acetaminophen 650mg PO
- Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis
Criteria for Epcoritamab
- Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
- Pre-medication: Dexamethasone 15mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: PJP prophylaxis, Antiviral prophylaxis
Criteria for Glofitamab
- Indication: Relapsed or Refractory large B-cell lymphoma (CD20 target)
- Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50mg PO/IV, Acetaminophen 500-1000 mg PO
- Additional Supportive Meds: Obinutuzumab day 1, Tumor lysis prophylaxis if at risk, Antiviral prophylaxis, PJP prophylaxis
Criteria for Mosunetuzumab
- Indication: Relapsed or Refractory follicular lymphoma (CD20 target)
- Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50-100 mg PO/IV, Acetaminophen 500-1000 mg
Criteria for Talquetamab
- Indication: Relapsed or Refractory multiple myeloma (GPRC5D target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: Antiviral prophylaxis
- Keratotoxicity Management Criteria: Topical emollients for erythema/rash; saliva replacement therapy (VA National Formulary products include Artificial Saliva Oral Spray, Lozenge, Liquid and Gel) for oral toxicities
Criteria for Tebentafusp
- Indication: HLA-A*02:01 unresectable or metastatic uveal melanoma
- Pre-medication: None specified
Criteria for Teclistamab
- Indication: Relapsed or Refractory multiple myeloma (BCMA target)
- REMS Requirement: Required
- Pre-medication: Dexamethasone 16mg PO/IV, Diphenhydramine 50mg PO/IV, Acetaminophen 650-1000mg PO
- Additional Supportive Meds: Antiviral prophylaxis
Document 669: MON Tebentafusp KIMMTRAK Monograph Nov 2024 2
Indication & Patient Population
- Metastatic or recurrent uveal melanoma that is HLA-A*02:01 positive
- Unresectable or metastatic disease
- Not a candidate for resection or radiation
- Liver-only metastases following progression on liver-directed therapy
- Metastases not limited to liver-only
Dosing & Administration
- Initial 3 step-up doses in Cycle 1: 20mcg IV D1, 30mcg IV D8, 68mcg IV D15
- Subsequent dosing: 68mcg IV weekly
- Dosage form: Injection (100mcg/0.5mL single-dose vial)
Monitoring & Safety Requirements
- Monitor for Cytokine Release Syndrome (CRS) at least 16 hours after the first 3 infusions
- If no Grade 2 or worse hypotension occurs during or after the third infusion, subsequent infusions require monitoring for at least 30 minutes
- Monitor for skin reactions
- Measure baseline AST/ALT/TBili and monitor for elevated LFTs
- Monitor for EF toxicity
Facility & Infrastructure Requirements
- Facility must be equipped to monitor and manage Cytokine Release Syndrome (CRS) if needed