. Author manuscript; available in PMC: 2020 Sep 29.

Published in final edited form as: J Pediatr Oncol Nurs. 2017 Jan 6;34(3):160–172. doi: 10.1177/1043454216680595

Table 5.

Dose Modification Guidance for Management of Hypotension During Administration of Dinutuximab in Combination With GM-CSF, IL-2, and RA.^a,b

Symptomatic and/or systolic BP less than 70 mm Hg or a decrease >15% below baseline
Onset of symptoms	•Discontinue dinutuximab infusion and IL-2 or GM-CSF • Administer supportive measures^c
Symptoms resolve	•Resume dinutuximab infusion at 0.875 mg/m²/h • If BP remains stable for >2 hours, resume IL-2 or G-CSF • If BP remains stable for >2 hours after resuming IL-2 or GM-CSF, increase dinutuximab to 1.75 mg/m²/h
First recurrence	•Discontinue dinutuximab infusion and IL-2 or GM-CSF • Resume dinutuximab infusion at 0.875 mg/m²/h once BP is stable
Symptoms resolve	•Resume IL-2 or GM-CSF following day at 50% dose if BP remains stable • Start IL-2 or GM-CSF at 50% dose when given with dinutuximab. Increase to full dose if tolerated for remainder of cycle • If IL-2 or GM-CSF is not tolerated at 50% dose, give dinutuximab alone for remainder of cycle
Second recurrence	•Discontinue IL-2 or GM-CSF for remainder of cycle
Subsequent cycles	• Start IL-2 or GM-CSF at 50% dose, if tolerated increase to full dose next day • If IL-2 is not tolerated at 50% dose, substitute with GM-CSF for remainder of IL-2 cycle • If GM-CSF is not tolerated at 50% dose, administer chl4.l8 alone for remainder of GM-CSF cycles

Abbreviations: BP, blood pressure; GM-CSF, granulocyte-macrophage colony-stimulating factor; IL-2, interleukin 2; IV, intravenous; RA, 13-cis-retinoic acid.

Variation in these guidelines may be necessary according to institutional protocols and clinical judgment of individual patients.

Data from Unituxin (dinutuximab) injection, for intravenous use [prescribing information]. (United Therapeutics Corp., 2015).

Supportive measures for patients with symptomatic hypotension and/or systolic BP less than 70 mm Hg or a decrease >15% below baseline refers to sections of the prescribing instructions containing the warning regarding risk of hypotension with dinutuximab therapy. In this section, recommendations include administration of normal saline as clinically indicated. If hypotension persists, repeat normal saline infusion, or administer IV albumin or packed red cells as clinically indicated. Vasopressor therapy may be necessary to restore adequate perfusion pressure.