AsiTri Injection (Arsenic Trioxide)

Adult administration

As arsenic trioxide, administer 0.15 mg/kg mixed with 5% dextrose solution or normal saline up to 100-250 mL over a period of 1-2 hours. 1. Induction therapy: Administer intravenously once daily until bone marrow remission is achieved. The total number of administrations should not exceed 60. 2. Consolidation therapy: If remission is achieved, start 3-6 weeks after completion of induction therapy. Administer once daily for 5 weeks, totaling 25 doses.

This drug may cause cardiac issues such as cardiac arrhythmias during treatment, hence it should be used under thorough medical supervision in a hospital. Particularly, QT prolongation, which is an abnormality of the heart's electrical signals, may occur and could lead to serious heart rhythm disorders, so regular ECG monitoring and checking of electrolyte levels in blood are necessary. Moreover, this drug is utilized for treating acute promyelocytic leukemia, and serious side effects similar to retinoic acid syndrome may occur during treatment, necessitating close monitoring of the patient's condition. This drug should not be used in individuals with hypersensitivity to arsenic or in pregnant women; women of childbearing age should confirm pregnancy status before administration, and strict contraception is required during treatment. Patients with cardiac disease, impaired liver or kidney function, elderly patients, and children should use this drug cautiously, and their condition should be frequently assessed during administration. This drug can cause various side effects, including abrupt increases or decreases in white blood cell counts, liver function abnormalities, elevated blood sugar, and neuropathy, therefore regular blood tests and clinical monitoring are required. Additionally, when used with other medications that may affect the heart, the risk of side effects may increase, hence consulting a physician is essential. In case of overdose, symptoms of toxicity may appear, and treatment should be stopped immediately with appropriate medical assistance. Caution should be exercised to avoid contact with skin or eyes during use, do not reuse any remaining solution after administration, and if extravasation occurs during infusion, treatment should be stopped immediately. Lastly, this drug can be harmful to the fetus, so pregnant women or nursing mothers should avoid its use, and nursing must be stopped if breastfeeding.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty in breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision changes, paralysis, urination changes.

Mild side effects

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

This drug should be stored in a sealed container to protect it from exposure to air and light. It is recommended to keep it in a cool place at a temperature below 25 degrees Celsius.

Appearance

A colorless and transparent aqueous solution in a colorless and transparent vial as an injection.

Package unit

10 milliliters/vial [(1 vial/box)]