Asadin Injection (Arsenic Trioxide)

Adult administration

As arsenic trioxide, administer 0.15 mg/kg mixed in 5% dextrose or saline to make up to 100–250 mL, infused over 1–2 hours. 1. Induction therapy: Administer intravenously once daily until bone marrow remission, with a total administration count not to exceed 60. 2. Consolidation therapy: If remission is achieved, start 3–6 weeks after the end of induction, once daily for 5 weeks, totaling 25 administrations.

This drug must be used under strict supervision in a hospital during the treatment period. It should particularly be administered in a hospital where medical staff experienced in treating acute promyelocytic leukemia are present. This drug can cause cardiac rhythm disturbances; therefore, an electrocardiogram and tests for electrolytes and renal function must be performed prior to administration. During treatment, periodic electrocardiograms and monitoring of electrolyte levels to maintain them within the normal range are necessary. If symptoms of cardiac arrhythmia occur, immediately discontinue or adjust the drug administration. This drug can cause a serious side effect known as APL differentiation syndrome, so the patient’s condition must be observed closely, and if abnormal symptoms arise, treatment must be discontinued immediately, and appropriate care should be sought. It must not be administered to individuals with an allergy to arsenic, pregnant women, or women who may become pregnant. Patients with heart disease, impaired liver or kidney function, elderly individuals, and children should exercise extra caution when using this drug. This drug may cause various side effects such as liver dysfunction, decreased blood cells, gastrointestinal symptoms, and neurological abnormalities, hence regular testing is required. Pregnant women or those who may become pregnant should verify their pregnancy status before taking this drug, and effective contraception is required during treatment. Male patients must also use effective contraception during and at least 3 months following treatment. This drug may interact with other medications; therefore, any concurrent medications should be disclosed to healthcare providers and used cautiously. This drug can be harmful to the body; hence, rubber gloves and protective eyewear should be worn during handling, and if it comes into contact with skin or eyes, they should be washed immediately, and medical attention should be sought. In case of overdose, administration should be stopped immediately and professional treatment should be obtained. This drug can have serious effects on the fetus during pregnancy, thus it should not be used by pregnant women, and breastfeeding women should discontinue breastfeeding.

Serious side effects

Prolongation of QT interval on ECG, complete heart block, torsades de pointes (TdP) ventricular arrhythmia, APL differentiation syndrome, leukocytosis, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia, dyspnea, pulmonary infiltrates, pleural effusion, pericardial effusion, high fever, liver dysfunction, increased ALT, increased AST, jaundice, renal failure, oliguria, elevated blood pressure, severe edema, acute arsenic poisoning (seizures, muscle weakness, confusion), severe allergic reactions

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 prevent air and moisture from entering. It is best to maintain a storage temperature between 1 degree and 25 degrees Celsius at room temperature. This storage method helps maintain the drug's effectiveness for a longer period.

Appearance

A colorless transparent solution in a colorless transparent glass vial injection

Package unit

1 vial/box [10 mL/vial]