Thrombocytopenia
GAZYVA in combination with chlorambucil caused Grade 3 or 4 thrombocytopenia in 11% of
patients in the trial. In 5% of patients, GAZYVA caused acute thrombocytopenia occurring
within 24 hours after the GAZYVA infusion. Fatal hemorrhagic events during Cycle 1 have also
been reported in patients treated with GAZYVA.
Monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially during
the first cycle. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more
frequently until resolution and consider subsequent dose delays of Gazyva and chlorambucil or
dose reductions of chlorambucil. Transfusion of blood products (i.e., platelet transfusion) may
be necessary. Consider withholding concomitant medications which may increase bleeding risk
(platelet inhibitors, anticoagulants), especially during the first cycle.
ThrombocytopeniaGAZYVA in combination with chlorambucil caused Grade 3 or 4 thrombocytopenia in 11% ofpatients in the trial. In 5% of patients, GAZYVA caused acute thrombocytopenia occurringwithin 24 hours after the GAZYVA infusion. Fatal hemorrhagic events during Cycle 1 have alsobeen reported in patients treated with GAZYVA.Monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially duringthe first cycle. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts morefrequently until resolution and consider subsequent dose delays of Gazyva and chlorambucil ordose reductions of chlorambucil. Transfusion of blood products (i.e., platelet transfusion) maybe necessary. Consider withholding concomitant medications which may increase bleeding risk(platelet inhibitors, anticoagulants), especially during the first cycle.
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