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Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Oncology

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Trisenox (arsenic trioxide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Cell Therapeutics
Approval Status: Approved September 2000
Treatment Area: Acute Promyelocytic Leukemia

General Information

Trisenox (arsenic trioxide), injectable formulation, is indicated for the treatment of induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

Clinical Results

A multi-center pivotal trial was held, led by Memorial Sloan-Kettering Cancer Center, consisting of 40 patients ranging in age from 5 to 72. The drug was shown to be effective with 70% of the patients achieving complete remission. 86% showed clearing of the chromosomal abnormality that causes APL. Total remission was reached, on average, within two months after treatment with Trisenox began. At a median follow-up time of 16 months, 68% of patients who had achieved complete remission were still alive and 58% were disease free. (Company Web Site)

Side Effects

Common side effects include, but are not limited to:

  • leukocytosis
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • fatigue
  • edema
  • hyperglycemia
  • dyspnea
  • cough
  • rash or itching
  • headaches
  • dizziness

In clinical trials these side effects usually did not require interruption of therapy, nor have they been observed to be permanent or irreversible.

Approx. 23% of patients showed symptoms of APL-differentiation syndrome during or after their treatment with Trisenox. These symptoms include fever, weight gain, shortness of breath, and musculoskeletal pain. High-dose steroids and diuretics were used to manage these symptoms and the majority of patients were able to continue their treatment with Trisenox. Hyperleukocytosis occurred in aprox. 50% of patients undergoing Trisenox therapy. It did not require them to stop treatment.

Mechanism of Action

The mechanism of action of Trisenox is not completely understood. Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein PML-RAR alpha. (From FDA Label)

Additional Information

For more information about TRISENOX, please contact: • Professional Services: (800) 715-0944 Health care professionals can click on "Professional Services" above to request medical or drug information for TRISENOX. Normal business hours are 9:00 a.m. to 7:00 p.m., ET, Monday through Friday. After hours emergency coverage is also provided.

• Customer Service: (888) 305-2289 The Cell Therapeutics Customer Service team is the point of contact for all TRISENOX product orders, returns and credit inquiries. Business hours are 8:30 a.m. to 8:00 p.m., ET, Monday through Friday. (From Company Web Site)