TALQUETAMAB-TGVS INJ,SOLN
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 621: Talquetamab TALVEY Criteria June 2024
Exclusion Criteria
- Known hypersensitivity to talquetamab or its excipients (e.g. polysorbate 20)
- Active viral, bacterial, or uncontrolled systemic fungal infection
- Known active central nervous system disease or signs of meningeal involvement
- Pregnancy
- Lactating
Indication & Treatment History
- Relapsed or refractory multiple myeloma in a patient who has received at least four prior lines of therapy including a proteasome inhibitor, and immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Care Setting & Provider Requirements
- Care for the oncologic condition provided by VA or VA Community Care oncology provider certified with the TALVEY REMS Program.
Performance Status & Supportive Care
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Goals of care and role of Palliative Care consult have been discussed and documented
Safety Monitoring & Hospitalization
- Due to risk of Cytokine Release Syndrome, patients should be hospitalized for 48 hours after all step-up doses in either the weekly or biweekly dosing schedules.
Reproductive Health & Counseling
- 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 three months after stopping treatment.
Nutritional Management
- For patients with poor nutritional intake or body mass index (BMI) < 18 (underweight): consult nutritionist/dietician.
Document 622: MON Talquetamab TALVEY Monograph June 2024
Indication & Population
- Adults with relapsed or refractory multiple myeloma
- ECOG PS 0-2
- Exclusions: CVA or seizure in prior 6 months, CNS or meningeal involvement, active or history of autoimmune disease (except vitiligo, resolved childhood atopic dermatitis, resolved Graves Disease)
Prior Therapy Requirements
- Received at least four prior lines of therapy (LOT)
- Prior therapies must include a proteasome inhibitor, an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody
- Continued approval contingent upon clinical benefit verified in a confirmatory trial
Dosage & Administration
- Injectable for subcutaneous administration
- Step-up dosing: D1: 0.01mg/kg SQ, D4: 0.06mg/kg SQ, D7: 0.4mg/kg (first full dose, then weekly)
- Alternate step-up schedule: D1: 0.01mg/kg SQ, D4: 0.06mg/kg SQ, D7: 0.4mg/kg SQ, D10: 0.8mg/kg SQ (first full dose, every 2 wks)
- SubQ dosing; hospitalization recommended x2
Monitoring & Safety Management
- REMS program required
- Monitor for cytokine release syndrome (CRS) and neurotoxicity including ICANS
- Monitor for oral toxicity, weight loss, infection, cytopenia, skin toxicity, and hepatotoxicity
- Advise effective contraception during and 3 months post-dose due to embryo-fetal toxicity
VHA-Specific Considerations
- First-in-class, off-the-shelf bispecific antibody directed against GPRC5D
- Provides an option for patients with limited access to CAR T-cell therapy due to specialized centers and/or manufacturing issues
- May be used as bridging therapy to CAR T-cell therapy due to quick time to response
- Caution use in patients with poor nutritional intake and/or BMI < 18; consult with nutrition services
Drug Interactions
- May increase exposure of CYP substrates (Risk C: monitor)
- Avoid denosumab as immunosuppressive effect may be enhanced (Risk D: modify therapy)