Unitaxel Special Precautions

Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Patients receiving the drug should be pretreated with corticosteroids, antihistamines, and H2 antagonists (such as dexamethasone, diphenhydramine and cimetidine or ranitidine) to minimize hypersensitivity reactions. Severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in patients receiving paclitaxel. These reactions are probably histamine mediated. One of these reactions was fatal in a patient treated without premedication in a Phase I study. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Hematology: Paclitaxel should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm³. In order to monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Paclitaxel. Patients should not be retreated with subsequent cycles of paclitaxel until neutrophils recover to a level >1,500 cells/mm³ and platelets recover to a level >100,000 cells/mm³. In the case of severe neutropenia (>500 cells/mm³) during a course of paclitaxel therapy, a 20% reduction in dose for subsequent courses of therapy is recommended.
Hypersensitivity Reactions: Patients with a history of severe hypersensitivity reaction to products containing Cremophor+ EL should not be treated with paclitaxel. Minor symptoms such as flushing, skin reactions, dyspnea, hypotension or tachycardia do not require interruption of therapy.
However, severe reaction, such as hypotension requiring treatment, dyspnea requiring bronchodilators, angioedema or generalized urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy. Patients who have developed severe hypersensitivity reactions should not be rechallenged with paclitaxel.
Cardiovascular: Hypotension and bradycardia have been observed during administration of paclitaxel, but generally do not require treatment. Frequent vital sign monitoring particularly during the first hour of paclitaxel infusion, is recommended. Continuous cardiac monitoring is not required except for patients who develop serious conduction abnormalities.
Nervous System: Although the occurrence of peripheral neuropathy is frequent, the development of severe symptomatology is unusual and requires a dose reduction of 20% for all subsequent courses of paclitaxel.
Hepatic: There is no evidence that the toxicity of paclitaxel is enhanced in patients with abnormal liver function, but no data are available for patients with severe baseline cholestasis.
Use in Pregnancy & Lactation: There are no studies in pregnant women. Paclitaxel has been shown to be embryo and feto-toxic in rabbits and to decrease fertility in rats. Paclitaxel should not be administered to nursing mothers.