Fosaprepitant and Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Children

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2018;24(6) 

In This Article

Adverse Reactions

In a controlled trial comparing triple-therapy with fosaprepitant, ondansetron, and dexamethasone versus ondansetron and dexamethasone alone conducted in 1,001 adults, there were no significant differences in any of the adverse reactions reported.[1] The most commonly reported reactions included fatigue (in 15% of patients), diarrhea (13%), neutropenia (8%), asthenia (4%), anemia or peripheral neuropathy (3%), and leukopenia, dyspepsia, urinary tract infection, and pain in an extremity (2%). Infusion site reactions were reported in 2.2% of the triple-therapy patients versus 0.6% in the control group. These reactions included pain at the infusion site (1.2% in the triple-therapy versus 0.4% in the controls), irritation (0.2% versus 0), initial vessel puncture pain (0.2% versus 0), and thrombophlebitis (0.6% versus 0).

In a safety analysis of 69 infants, children, and adolescents receiving a single dose of fosaprepitant in addition to ondansetron and dexamethasone for prevention of CINV with HEC or MEC, the results were similar to those reported in adults.[1] The most common adverse reactions (all occurring in > 15% of patients) were anemia, neutropenia, thrombocytopenia, and febrile neutropenia. The results were also similar in a study of 3-day administration (1 day of fosaprepitant followed by 2 days of oral aprepitant).

Additional safety data comes from a recent single center observational study of aprepitant use in children published in the Journal of Oncology Pharmacy Practice. The authors evaluated the cases of 85 children treated with a total of 192 chemotherapy cycles.[12] Twenty-two patients had osteosarcomas and seven had Ewing's sarcoma; the most common treatments were cisplatin-based regimens or high-dose methotrexate. Aprepitant was given in combination with palonosetron and dexamethasone in 95% of the cycles. Seventy-three cycles (38%) were without adverse events. Fifty percent of cycles had at least one adverse reaction, with the most common being anorexia, febrile neutropenia, cough, and headache, all occurring in approximately 50% of patients. The authors call attention to the higher rate of adverse effects in their study suggesting that these results may better reflect routine clinical practice, and that while many of these adverse effects could be attributed to the chemotherapy, they may also reflect the impact of adding an NK1 antagonist.