Intaxel Warnings

Paclitaxel (INTAXEL) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Patients should be pretreated with corticosteroids (such as dexamethasone), diphenhydramine or promethazine hydrochloride and H2 antagonists (such as cimetidine or ranitidine) before receiving Intaxel (see Dosage & Administration). Severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema and generalized urticaria have been reported in 2% of the patients receiving Paclitaxel. These reactions were probably histamine mediated. Patients who experience severe hypersensitivity reactions to Paclitaxel should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose limiting toxicity. Neutrophil nadirs have been reported at a median of 11 days. INTAXEL should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm³. Frequent monitoring of blood counts should be instituted during INTAXEL treatment. Patients should not be retreated with subsequent cycle of INTAXEL until neutrophils recover to a level of >1,500 cells/mm³ and platelets recover to a level of >100,000 cells/mm³.
Severe conduction abnormalities have been documented in less than 1% patients during Paclitaxel therapy. In one case insertion of a pacemaker was required due to the recurrence of atrioventricular block.
Use in Pregnancy: In rats and rabbits, Paclitaxel was shown to result in abortions, decreased corpora lutea, a decrease in implantation and live fetuses, increased reabsorptions and embryo-fetal deaths. No gross external, soft issue or skeletal alterations occurred. There are no studies in pregnant women. If INTAXEL is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with INTAXEL.