Arsenic trioxide 10 mg/10 mL (1 mg/mL) for injection is formulated for the treatment of individuals with Acute Promyelocytic Leukemia who are refractory to or have relapsed from retinoid and anthracycline chemotherapy. Acute promyelocytic leukemia (APL) is a unique type of Myeloid Leukemia, a disease in which abnormal WBCs and abnormal bleeding and bruising occur.
The active pharmaceutical ingredient in Arsenic trioxide for injection, arsenic trioxide, is a chemical that has been used in medicines for years, including for the treatment of leukemia. This medicine is thought to prevent the creation of deoxyribonucleic acid (DNA), which is vital for leukemia cells in order to grow. Arsenic trioxide injection may induce the death of the unhealthy cells by degrading a fusion protein that lies in the unhealthy cells.
Serious Warnings & Precautions:
- Treatment with arsenic trioxide 10 mg/10 mL (1 mg/mL) injection may lead to a condition known as APL Differentiation Syndrome, which includes difficulty in breathing, coughing, weight gain, fever, and chest pain and may cause death.
- The medicine arsenic trioxide 1 mg/mL has an impact on the heart's electrical activity named prolongation of the QT interval. The prolongation of the QT interval can cause arrhythmias such as torsade pointes, which may be experienced as palpitations dizziness, and fainting and can be responsible for death.
- Prior to the first dose of arsenic trioxide Injection, a health specialist will perform a 12-lead ECG (electrocardiogram) and will perform tests in order to assess the existence/level of potassium, calcium, magnesium, and creatinine in the blood.
- While on treatment with this medicinal product, avoid taking drugs that can be responsible for causing a change in the rhythm of the heartbeat or drugs that can be responsible for causing a change in electrolyte levels (calcium, potassium, and magnesium).
- Injection arsenic trioxide should be administered under the appropriate supervision of a health specialist who is experienced in managing patients with acute leukemia.
- Treatment with Arsenic 10 mg/10mL for Injection may cause a condition named Encephalopathy (brain disease) which sometimes can be responsible for the death.
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Reference:
https://www.fresenius-kabi.com/us/news/fresenius-kabi-introduces-leukemia-drug-arsenic-trioxide
