MEDICAL GUIDANCE ONLY: This document provides general clinical guidance for emergency management of BiTE therapy complications. It does not replace clinical judgment, established protocols, or the medical decision-making of the treating healthcare provider. Treatment decisions should be tailored to individual patient needs and circumstances. Dear Provider, I am currently receiving treatment with a bispecific T-cell engager antibody, also known as BiTE therapy. BiTE therapy can cause potentially life-threatending adverse effects such as: • •
Cytokine release syndrome (CRS) Immune effector cell-associated neurotoxicity syndrome (ICANS)
IF I HAVE A FEVER, PLEASE INCLUDE STEROIDS (DEXAMETHASONE) AS PART OF MY CARE PLAN. While steroids (dexamethasone) are strongly recommended for fever in BiTE therapy patients as noted above, final treatment decisions should integrate the complete clinical assessment, patient history, and provider judgment.
POTENTIAL SIGNS AND SYMPTOMS
CRS
ICANS
Fever (100.4°F/38°C or higher) Hypotension Tachycardia Difficulty breathing Chills ± rigors Dizziness/lightheadedness Severe nausea, vomiting, and/or diarrhea Severe muscle or joint pain Headache
Confusion Altered consciousness Agitation Difficulty speaking Seizures Loss of balance Muscle weakness
Treatment of Grade 1 CRS
Treatment of Grade 1 ICANS • Start levetiracetam 500 mg by mouth twice daily • Add dexamethasone 10 mg IV x 1 if also exhibiting CRS
(fever without hypotension or hypoxia)
• Acetaminophen • Dexamethasone 4-12 mg PO or IV (optional) • IV fluids (optional) Treatment of Grade 2 CRS
(fever WITH hypotension ± hypoxia)
• • • •
All of the above PLUS: Admit to hospital Add low flow oxygen if hypoxic Tocilizumab 8 mg/kg (max 800 mg) IV x 1 over 1 hour
Treatment of Grade 3+ CRS
(fever WITH hypotension requiring vasopressor ± hypoxia requiring high flow oxygen or positive pressure)
• • • •
All of the above PLUS: Transfer to ICU Vasopressors as needed High flow oxygen or positive pressure ventilation as needed
Treatment of Grade 2 ICANS • All of the above • Repeat dexamethasone 10 mg IV after 6-12 hours if no improvement with first dose. Continue every 6-12 hours until grade 1 and then taper • Add tocilizumab 8 mg/kg (max 800 mg) IV over 1 hour if also exhibiting CRS Treatment of Grade 3+ ICANS • All of the above • Transfer to ICU • If no improvement from dexamethasone, switch to methylprednisolone 1000 mg IV 1-2 times/day x 3 days followed by rapid taper