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Basic Drug Info
Drug Name:ONXOL
Manufacturer:IVAX Research, Inc.
Other Info:



Clinical Trials:


Indications and Usage

ONXOL is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.ONXOL is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Prior therapy should have included an anthracycline unless clinically contraindicated.
Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Contraindications
ONXOL is contraindicated in patients who have a history of hypersensitivity reactions to ONXOL or other drugs formulated in polyoxyl 35 castor oil.ONXOL should not be used in patients with solid tumors who have baseline neutrophil counts of <1,500 cells/mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1,000 cells/mm3.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

solid tumor -- Cancer of body tissues other than blood, bone marrow, or the lymphatic system.

AIDS with Kaposi's sarcoma -- The most aggressive form of Kaposi sarcoma. It presents in patients who are infected with the human immunodeficiency virus. It can affect the skin and internal organs.

Warnings

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2-4% of patients receiving paclitaxel in clinical trials.

Fatal reactions have occurred in patients despite premedication.

All patients should be pretreated with corticosteroids, diphenhydramine and H2 antagonists.

(See “DOSAGE AND ADMINISTRATION” section.) Patients who experience severe hypersensitivity reactions to ONXOL should not be rechallenged with the drug.Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity.

Neutrophil nadirs occurred at a median of 11 days.

ONXOL should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 (<1,000 cells/mm3 for patients with KS).

Frequent monitoring of blood counts should be instituted during ONXOL treatment.

Patients should not be re-treated with subsequent cycles of ONXOL until neutrophils recover to a level >1,500 cells/mm3 (>1,000 cells/mm3 for patients with KS) and platelets recover to a level >100,000 cells/mm3.Severe conduction abnormalities have been documented in <1% of patients during ONXOL therapy and in some cases requiring pacemaker placement.

If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with ONXOL.Pregnancy: ONXOL can cause fetal harm when administered to a pregnant woman.

Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m2 basis) caused embryo and fetotoxicity, as indicated by intrauterine mortality, increased resorptions and increased fetal deaths.

Maternal toxicity was also observed at this dose.

No teratogenic effects were observed at 1 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality.

There are no adequate and well controlled studies in pregnant women.

If ONXOL is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.

Women of childbearing potential should be advised to avoid becoming pregnant.

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