TECLISTAMAB-CQYV INJ,SOLN
Clinical Criteria Summary
Document 442: Teclistamab TECVAYLI Criteria May 2023
Exclusion Criteria
- Known hypersensitivity to teclistamab or its excipients
- Known active central nervous system involvement or signs of meningeal involvement
- Active viral, bacterial, or uncontrolled systemic fungal infection
- Pregnancy
- Breastfeeding
Inclusion Criteria
- 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 for the oncologic condition provided by VA or VA Community Care oncology provider certified with the Tecvayli REMS program
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- All step-up doses and first treatment dose must be administered in a hospital setting with observation for 48 hours following each dose due to the risk of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS)
- Tocilizumab may be useful in patients not responding to dexamethasone for the management of CRS
Additional Inclusion Criteria
- 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 five months after stopping treatment
- For patients who are breastfeeding: Counseling provided on avoiding breastfeeding while on treatment and for five months after stopping treatment
Document 448: MON Teclistamab TECVAYLI Monograph May 2023
Indication & Patient Population
- Relapsed or refractory multiple myeloma in patients who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Dosing & Administration
- Subcutaneous administration only.
- Step-up dosing schedule: Day 1 (0.06 mg/kg), Day 4 (0.3 mg/kg), Day 7 (1.5 mg/kg). Doses may be administered 2 to 4 days after the prior dose, up to 7 days to allow for resolution of adverse reactions.
- Weekly dosing schedule: 1.5 mg/kg once weekly starting one week after the first treatment dose and doses thereafter.
- Pre-treatment medications required 1 to 3 hours prior to each step-up dose and the first treatment dose: corticosteroid (oral or IV dexamethasone 16 mg), H1 receptor antagonist (oral or IV diphenhydramine 50 mg or equivalent), and antipyretic (oral or IV acetaminophen 650-1000 mg or equivalent). Pre-treatment may also be required for subsequent doses in patients who repeat the step-up schedule due to delay or experience CRS.
Hospitalization & Monitoring Requirements
- Patients must be hospitalized for 48 hours following administration of each step-up dose due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
- Monitor liver enzymes and bilirubin at baseline and during treatment due to hepatotoxicity risk.
- Monitor for signs and symptoms of infection; withhold treatment in patients with an active infection during the step-up dosing period.
- Monitor blood cell counts at baseline and during treatment; consider granulocyte colony stimulating factors (GCSF) for grade 4 neutropenia or grade 3 neutropenia accompanied by an infection.
Toxicity Management Criteria
- CRS: Withhold teclistamab until CRS resolves. Administer pretreatment medications prior to next dose. Hospitalize patient for 48 hours following the next dose for Grade 2+ CRS. Permanently discontinue for Grade 3-4 CRS.
- ICANS: Withhold teclistamab until ICANS resolves. Administer dexamethasone 10 mg IV every 6 hours until resolution to grade 1 or less, then taper. Monitor neurologic symptoms and consider neurologist consultation. Hospitalize patient for 48 hours following the next dose for Grade 2+ ICANS. Permanently discontinue for Grade 3-4 ICANS.
REMS & Facility Requirements
- Available only through the TECVAYLI REMS program.
- Prescribers must be certified and complete training; patients must be counseled on risks and provided a patient wallet card.
- Healthcare settings that dispense teclistamab must be certified with the program and verify ordering providers are certified.
- Treatment restricted to facilities capable of admitting patients for 48 hours to receive all step-up doses and first treatment dose, with staff trained in managing CRS and ICANS.
Special Populations & Contraindications
- Contraindications: None explicitly stated.
- Embryo-fetal toxicity: Advise females of reproductive potential to use effective contraception during treatment and for five months after the last dose. Advise parents not to breastfeed during and for five months after the last dose.
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