Trisenox Injection (Arsenic Trioxide)

Adult administration

As Arsenic Trioxide, mix 0.15mg/kg with 5% dextrose solution or normal saline to a total volume of 100–250mL, to be administered over 1–2 hours. 1. Induction Therapy: Administer intravenously once daily until bone marrow remission is achieved. The total number of doses should not exceed 60 times. 2. Consolidation Therapy: If remission is achieved, begin 3–6 weeks after the end of induction. Administer once daily for 5 weeks, totaling 25 intravenous doses.

This drug must be used in a hospital under strict supervision of a physician for the entire duration of treatment. It should especially be administered at a medical institution where a physician experienced in treating acute promyelocytic leukemia is available. The drug may affect heart rhythm, requiring frequent ECG tests, and electrolyte levels must be checked regularly; if abnormalities are detected, immediate treatment is necessary. If arrhythmias occur, the use of the drug should be discontinued, or adjustments made in consultation with a doctor. This drug may cause a specific symptom known as APL differentiation syndrome; if symptoms appear, use should be immediately ceased, and appropriate treatment should be administered. Women with hypersensitivity to this drug or those who are pregnant or may become pregnant should not take this medication. Patients with heart disease, electrolyte imbalances, liver or kidney dysfunction, the elderly, and children should use this drug with caution. Various side effects may occur, including changes in white blood cell counts, liver function abnormalities, gastrointestinal symptoms, and skin rashes, so regular check-ups are necessary. Pregnant women or those who may become pregnant should avoid this medication as it can have serious effects on the fetus; effective contraception must be used, and if pregnancy is confirmed during treatment, the drug should be discontinued immediately. Male patients should also use contraception during and for at least 3 months after treatment. During treatment, changes in condition should be regularly monitored, and any abnormal symptoms must be reported to the doctor immediately. This drug interacts with other medications and can increase the risk of arrhythmias, so be sure to inform your physician about all medications being taken. The elderly are at an increased risk of side effects, thus require more careful observation. Lactating women should discontinue breastfeeding while on this medication as it can be transmitted through breast milk and cause serious side effects in infants. Safety in pediatric patients has not been established, so use in children should be approached with caution. In cases of overdose, symptoms of toxicity may appear, requiring immediate cessation of the medication and professional medical treatment. When administering the drug, do not leave any solution behind; if the drug leaks outside of the vessel, discontinue use immediately and discard remaining medication. When handling this drug, always wear protective equipment, and if it comes into contact with skin or eyes, rinse immediately with clean water and seek medical attention. This drug is genotoxic and may be carcinogenic, potentially impacting reproductive function; thus, caution is required when using it.

Serious side effects

QT prolongation on ECG, complete heart block, torsades de pointes ventricular arrhythmias, APL differentiation syndrome, leukocytosis (peripheral white blood cell count exceeding 30,000/mm³), pancytopenia, agranulocytosis, leukopenia, thrombocytopenia, liver function abnormalities, elevated ALT, elevated AST, elevated ALP, elevated LDH, increased serum bilirubin (jaundice), renal impairment, renal failure, oliguria, hypokalemia, hypomagnesemia, severe

Mild side effects

• Nausea
• abdominal discomfort
• vomiting
• abdominal bloating
• abdominal pain
• epigastric pain
• diarrhea
• constipation
• loss of appetite
• dyspepsia

This drug should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 15 degrees and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and ensures safe usage.

Appearance

A colorless, transparent aqueous solution contained in a colorless glass ampoule injection.

Package unit

10mL/ampoule, 10mL x 5 ampoules