EPCORITAMAB-BYSP INJ,SOLN

Clinical Criteria Summary

⇄ This criteria document covers 9 drugs .

See all drugs in this document

Indication: Relapsed or Refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Pre-medication: Dexamethasone 16 mg IV

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

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

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

Indication: Relapsed or Refractory follicular lymphoma (CD20 target)
Pre-medication: Dexamethasone 20mg IV, Diphenhydramine 50-100 mg PO/IV, Acetaminophen 500-1000 mg

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

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

Facility is not equipped to monitor and manage Cytokine Release Syndrome (CRS), if necessary
Absolute Neutrophil Count < 1000/µL
Platelet count < 75,000/µL (if no bone marrow involvement)
Total bilirubin > 1.5 times the upper limit of normal (unless Gilbert’s syndrome or liver involvement)
Alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase > 3 times the upper limit of normal (unless liver involvement)
Creatinine clearance < 45 ml/min
Active or uncontrolled infection
Unmanageable drug-drug interaction
Pregnancy
Lactating

Relapsed or refractory, diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma
Relapsed or refractory, follicular lymphoma (FL)

Previously treated with > 2 prior lines of therapy (including 1 line with anti-CD20 monoclonal antibody)
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

For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 4 months after stopping treatment

Patients with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma should be hospitalized for step-up dose on Cycle 1, Day 15 (first 48 mg dose) followed by 24 hours of monitoring

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma (HGBCL)
Relapsed or refractory follicular lymphoma (FL) grade 1-3A

> 2 prior lines of therapy (LOT) for both DLBCL and FL indications
For FL: must have received prior anti-CD20 monoclonal antibody, alkylator, or lenalidomide

CNS lymphoma
Allogeneic hematopoietic stem cell transplant (allo HSCT) or solid organ transplant (SOT) [DLBCL cohort]
Active infection
Impaired T-cell immunity [DLBCL cohort]
HIV infection, cardiovascular disease (CV disease), autoimmune disease [FL cohort]

Requires step-up dosing regimen for both DLBCL and FL: Day 1 (0.16 mg SQ), Day 8 (0.8 mg SQ), Day 15 first full dose (48 mg SQ)
Subsequent cycles follow a 28-day schedule with fixed 48 mg SQ dosing on specified days
Therapy continues until progressive disease or toxicity

Boxed warnings for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Additional warnings include infections, cytopenias, and embryo-fetal toxicity
First full dose must be administered in a hospital setting with monitoring for CRS/ICANS