|Manufacturer:||Bristol-Myers Squibb Company|
|Other Info:||Manufactured by:Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in GermanyDistributed by:Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USA51-029991-005643-8000Revised March 2005|
ETOPOPHOS for Injection is indicated in the management of the following neoplasms:Refractory Testicular Tumors-ETOPOPHOS for Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.Small Cell Lung Cancer-ETOPOPHOS for Injection in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.
-- Tumors or cancer of the TESTIS. Germ cell tumors (GERMINOMA) of the testis constitute 95% of all testicular neoplasms.
Small cell carcinoma of lung
-- radiosensitive tumor composed of small, oval, undifferentiated cells that are intensely hematoxyphilic and typically bronchogenic.
ETOPOPHOS for Injection is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide, etoposide phosphate, or any other component of the formulations.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
Patients being treated with ETOPOPHOS must be frequently observed for myelosuppression both during and after therapy.
Myelosuppression resulting in death has been reported following etoposide administration.
Dose-limiting bone marrow suppression is the most significant toxicity associated with ETOPOPHOS therapy.
Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of ETOPOPHOS: platelet count, hemoglobin, white blood cell count, and differential.
The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.
The toxicity of rapidly infused ETOPOPHOS in patients with impaired renal or hepatic function has not been adequately evaluated.
The toxicity profile of ETOPOPHOS when infused at doses >175 mg/m2 has not been delineated.
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