Table 3 Summary of recommendations for managing other serious AEs with GO

Thrombocytopenia

Monitor complete blood counts prior to each dose and perform routine clinical and laboratory surveillance testing during and after treatment

Monitor for signs and symptoms of infection or bleeding/hemorrhage, or other effects of myelosuppression during treatment

Manage severe bleeding, hemorrhage, or persistent thrombocytopenia using dose delay or permanent discontinuation of GO and provide supportive care per standard practice

If platelet count recovers to ≥ 100,000/mm³ ≤ 14 days following the planned start date of the consolidation course, initiate treatment with GO

If platelet count takes longer than 14 days to recover to ≥ 50,000/mm³, or if platelet count does not recover to ≥ 50,000/mm³, consolidation therapy should be re-evaluated, and a bone marrow aspirate should be performed to re-assess the patient’s status

Neutropenia

Monitor complete blood counts prior to each dose and perform routine clinical and laboratory surveillance testing during and after treatment

Monitor for signs and symptoms of infection or other effects of myelosuppression during treatment

Management of persistent neutropenia may require dose adjustment or treatment discontinuation

Infusion-related reactions

GO should not be administered in patients with hypersensitivity to the active substance or any excipients

Pre-medication with a corticosteroid, antihistamine, and acetaminophen is recommended 1 h prior to GO dosing

Infusion of GO should be performed under close clinical monitoring, including monitoring of pulse, blood pressure, and temperature

Closely monitor signs and symptoms of infusion-related reactions (e.g., fever, chills, hypotension, tachycardia, respiratory symptoms) that may occur during the first 24 h after administration, until signs and symptoms completely resolve

If infusion-related reactions occur, interrupt the infusion and institute appropriate medical management

• For mild, moderate, or severe infusion-related reactions, consider resuming the infusion at no more than half the rate at which the reaction occurred when symptoms resolve

• GO should be permanently discontinued upon occurrence of a severe infusion-related reaction or any life-threatening infusion-related reaction

Tumor lysis syndrome

In patients with hyperleukocytic AML, cytoreduction with leukapheresis, oral hydroxyurea, or cytarabine with/without hydroxyurea should be achieved prior to administration of GO

When patients receive cytarabine for leukoreduction, the treating physician should consider modifying the induction dosing schedule

• Monitor for signs and symptoms of TLS and treat according to standard medical practice

• Appropriate measures should be taken to prevent the development of TLS-related hyperuricemia, such as hydration and administration of antihyperuricemics (e.g., allopurinol) or other agents for the treatment of hyperuricemia (e.g., rasburicase)