Standardized Protocols Support Safe Outpatient Bispecific Step-Up Dosing

In an interview with Pharmacy Times, Manale Maksour, PharmD, BCOP, BCPS, associate director of Pharmacy Services at American Oncology Network, discussed the infrastructure and coordination required to safely administer bispecific step-up dosing in the outpatient setting, as well as strategies for monitoring and managing cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS).

Maksour emphasized that outpatient bispecific therapy requires a multidisciplinary approach with clearly defined responsibilities across the care team. Pharmacists, nurses, physicians, clinic staff, emergency departments, and affiliated hospitals must all understand their roles before a program begins treating patients. Responsibilities may include identifying appropriate candidates, obtaining and preparing treatment, monitoring patients during and after administration, conducting follow-up calls, and coordinating escalation of care when complications occur.

At American Oncology Network, standardized guidelines have been developed to outline each team member’s responsibilities and create a consistent approach across participating practices. Maksour explained that this level of preparation is essential because outpatient step-up dosing is complex and cannot be implemented safely without established workflows and communication pathways.

CRS and ICANS remain central concerns during the step-up dosing period. Even carefully selected patients may experience these toxicities, although many cases of CRS are low grade. To reduce risk, some patients may receive prophylactic tocilizumab, intravenous fluids, and other premedications. Patients may also return to the clinic on subsequent days for additional fluids and dexamethasone.

Home monitoring is another important part of the process. Patients and caregivers are instructed to check temperature and vital signs and to contact the care team immediately if fever or other concerning symptoms develop. Depending on the severity of the reaction, patients may return to the clinic for treatment or be transferred to the hospital for more intensive management.

Maksour stressed that standardized protocols, careful patient selection, proactive supportive care, and rapid access to hospital-based treatment are critical to making outpatient bispecific step-up dosing safe and sustainable.