Paxus PM Warnings

PAXUS PM should be administered under the supervision of a physician with experiences of the use of chemotherapeutic agents.
PAXUS PM must be administered as a diluted solution.
Severe hypersensitivity reactions characterized by anaphylaxis, dyspnea, hypotension requiring treatment, angioedema, and generalized urticaria were observed in 4.9% of patients in clinical study for breast cancer. If severe hypersensitivity reactions occur, the discontinuation of drug and the following treatment should be given; IV infusion of pheniramine maleate 45.5 mg (or its equivalent).
Administration of epinephrine or its equivalent until the resolution of hypersensitivity reactions or total 6 doses, IV administration at hypotension which does not respond to epinephrine or its equivalent.
Spray of albuterol or its equivalent at stridor which does not respond to adrenaline or its equivalent.
Infusion of methylprednisolone 125 mg or its equivalent to prevent recurrent or advanced allergy.
When premedication is determined to be necessary to minimize the risk of severe hypersensitivity reactions in breast cancer, premedication may be given approximately 30 minutes prior to therapy, including hydrocortisone 100 mg IV (or its equivalent), pheniramine maleate 45.5 mg IV (or its equivalent) and cimetidine 300 mg or ranitidine 50 mg IV (or its equivalent).
PAXUS PM should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm³. Bone marrow suppression (primarily neutropenia) is a dose-dependent and a dose-limiting toxicity. Frequent monitoring of blood counts should be instituted during PAXUS PM treatment. Patients should not be re-treated with subsequent cycles of PAXUS PM until neutrophil counts recover to a level > 1500 cells/mm³ and platelet counts recover to a level >100,000 cells/mm³.