VUMON is generally contraindicated in patients who have demonstrateda previous hypersensitivity to teniposide and/or Cremophor EL(polyoxyethylated castor oil).

VUMON is a potent drug and should be used only by physicians experiencedin the administration of cancer chemotherapeutic drugs. Blood counts, as wellas renal and hepatic function tests, should be carefully monitored prior toand during therapy.

Patients being treated with VUMON (teniposide injection) shouldbe observed frequently for myelosuppression both during and after therapy.Dose-limiting bone marrow suppression is the most significant toxicity associatedwith VUMON therapy. Therefore, the following studies should be obtained atthe start of therapy and prior to each subsequent dose of VUMON: hemoglobin,white blood cell count and differential, and platelet count. If necessary,repeat bone marrow examination should be performed prior to the decision tocontinue therapy in the setting of severe myelosuppression.

Physicians should be aware of the possible occurrence ofa hypersensitivity reaction variably manifested by chills, fever, urticaria,tachycardia, bronchospasm, dyspnea, hypertension or hypotension, and facialflushing. This reaction may occur with the first dose of VUMON and may belife threatening if not treated promptly with antihistamines, corticosteroids,epinephrine, intravenous fluids, and other supportive measures as clinicallyindicated. The exact cause of these reactions is unknown. They may be dueto the Cremophor EL (polyoxyethylated castoroil) component of the vehicle or to teniposide itself. Patients who have experiencedprior hypersensitivity reactions to VUMON are at risk for recurrence of symptomsand should only be re-treated with VUMON if the antileukemic benefit alreadydemonstrated clearly outweighs the risk of a probable hypersensitivity reactionfor that patient. When a decision is made to re-treat a patient with VUMONin spite of an earlier hypersensitivity reaction, the patient should be pretreatedwith corticosteroids and antihistamines and receive careful clinical observationduring and after VUMON infusion. In the clinical experience with VUMON atSJCRH and the National Cancer Institute (NCI), re-treatment of patients withprior hypersensitivity reactions has been accomplished using measures describedabove. To date, there is no evidence to suggest cross-sensitization betweenVUMON and VePesid.

One episode of sudden death, attributed to probable arrhythmiaand intractable hypotension, has been reported in an elderly patient receivingVUMON combination therapy for a non-leukemic malignancy. (See ADVERSEREACTIONS.) Patients receiving VUMON treatment should be under continuousobservation for at least the first 60 minutes following the start of the infusionand at frequent intervals thereafter. If symptoms or signs of anaphylaxisoccur, the infusion should be stopped immediately, followed by the administrationof epinephrine, corticosteroids, antihistamines, pressor agents, or volumeexpanders at the discretion of the physician. An aqueous solution of epinephrine1:1000 and a source of oxygen should be available at the bedside.

For parenteral administration, VUMON should be given only by slowintravenous infusion (lasting at least 30 to 60 minutes) since hypotensionhas been reported as a possible side effect of rapid intr