Paxoll Warnings

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea, hypotension requiring treatment, angioedema, and generalized urticaria have been observed in 2% of patients receiving PAXOLL. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H₂ antagonists. Patients who experience severe hypersensitivity reactions to PAXOLL should not be rechallenged with the drug.
Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose­ limiting toxicity. PAXOLL should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm³ (<1000 cells/mm³ for patients with KS). Frequent monitoring of blood counts should be instituted during Paxoll treatment. Patients should not be re-treated with subsequent cycles of PAXOLL until neutrophils recover to a level >1500 cells/mm³ (>1000 cells/mm³ for patients with KS) and platelets recover to a level >100,000 cells/mm³. If patients develop significant conduction abnormalities during Paxoll infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with PAXOLL.