Medication info

Trisenox Injection 2mg/mL (Arsenic Trioxide) (Vial)

Prescription medicationInjections경구 · 정맥
Ingredient · strength
Arsenic Trioxide›1mg / 1mL
Manufacturer / importer
클리니젠코리아(유)
Appearance
A colorless and transparent liquid without particles contained in a colorless and transparent glass vial.
Packaging
5 vials/box [6mL/vial]
Approval status
Active

MFDS item code 202302004 · Approved 2023.06.29 · Insurance code 076100091

Summary

Main use
Induction and consolidation therapy effect for acute promyelocytic leukemia
Who uses it
Adults
Adult dosage
As arsenic trioxide, it is mixed with 0.15mg/kg in 5% dextrose solution or normal saline, and administered as an intravenous drip over 2 hours, within a volume of 100-250mL. 1. Newly diagnosed low-risk acute promyelocytic leukemia - Induction therapy: 0.15mg/kg, administered once daily via intravenous route until marrow remission is achieved, not to exceed 60 days. - Consolidation therapy: 0.15mg/kg, administered once daily.

Ingredients

Importer
클리니젠코리아(유)

Efficacy & effects

Induction and consolidation therapy effect for acute promyelocytic leukemia

  • Acute promyelocytic leukemia
  • acute myeloid leukemia
  • adult patients with acute promyelocytic leukemia
  • refractory acute promyelocytic leukemia
  • relapsed acute promyelocytic leukemia
View approved original text

This medication is used for patients diagnosed with acute promyelocytic leukemia through chromosome testing or genetic testing. In particular, it helps enhance therapeutic effects when used in combination with tretinoin in newly diagnosed low-risk adult patients with acute promyelocytic leukemia. It is also used for inducing remission and consolidation therapy in refractory or relapsed patients who have previously received tretinoin and chemotherapy. However, the effectiveness for other subtypes of acute myeloid leukemia has not yet been confirmed, and the efficacy and safety have not been established in cases of relapse after complete remission.

Dosage and Administration

Adult dosage

As arsenic trioxide, it is mixed with 0.15mg/kg in 5% dextrose solution or normal saline, and administered as an intravenous drip over 2 hours, within a volume of 100-250mL. 1. Newly diagnosed low-risk acute promyelocytic leukemia - Induction therapy: 0.15mg/kg, administered once daily via intravenous route until marrow remission is achieved, not to exceed 60 days. - Consolidation therapy: 0.15mg/kg, administered once daily.

Precautions

This medication must be administered in a hospital under thorough medical supervision during the duration of treatment. It should only be used in hospitals equipped with emergency medical systems staffed by experienced personnel in the treatment of leukemia, especially acute promyelocytic leukemia. Life-threatening differentiation syndrome may occur during the use of this medication, so if symptoms such as fever, difficulty breathing, hypoxia, weight gain, or edema appear, administration should be immediately stopped, and appropriate measures such as steroid treatment should be taken. It may affect the heart, so frequent monitoring of electrocardiograms and blood electrolyte levels should be conducted before and during administration; dose adjustments or discontinuation should be considered if abnormalities are detected. Neurological emergencies like encephalopathy, particularly Wernicke's syndrome, may occur, so neurological symptoms and nutritional status should be regularly monitored, and non-oral thiamine administration may be necessary as needed. This medication should not be used in individuals with allergic reactions to it or in pregnant or nursing women. Women of childbearing age must implement effective contraception during and for a certain period after treatment. Patients with a history of heart disease, electrolyte imbalances, or impaired liver or kidney function require special caution when using this medication. Regular blood tests, liver function tests, and neurological examinations should be conducted to detect adverse reactions early during treatment. This medication may interact with other drugs, exacerbating cardiac arrhythmias or hepatotoxicity, so consultation with a physician or pharmacist regarding concomitant medications is essential. In the event of overdose, symptoms such as seizures, weakness, and confusion may occur, so immediate cessation of administration and professional detoxification treatment should be pursued. During administration, it is mandatory to check for discoloration or foreign substances in the solution, and intravenous infusion should be performed slowly over more than 2 hours. If acute vascular reactions occur, the administration time may be extended. This medication is for single use only, and any leftover solution should not be reused or mixed with other drugs or infusions. When handling, wear rubber gloves and protective eyewear, and immediately wash with plenty of water if it contacts the eyes or skin, seeking medical attention afterward. Leftover medication and related equipment should be disposed of safely.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Nausea
  • discomfort in the stomach
  • vomiting
  • abdominal distension
  • abdominal pain
  • upper abdominal pain
  • diarrhea
  • constipation
  • loss of appetite
  • indigestion
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  • hypermotility
  • dry lips
  • toothache
  • gastric discomfort
  • reduced appetite
  • dry mouth
  • gum bleeding
  • lip ulcers
  • bloating
  • fecal incontinence
  • increased frequency of bowel movements
  • loose stools
  • bloody diarrhea
  • vasculitis
  • pallor
  • rash
  • erythema
  • erythematous rash
  • facial swelling
  • dry skin
  • dermatitis
  • pruritus
  • neurodermatitis
  • exfoliative dermatitis
  • localized

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 15 degrees and 30 degrees Celsius.

Appearance and packaging

Appearance

A colorless and transparent liquid without particles contained in a colorless and transparent glass vial.

Package unit

5 vials/box [6mL/vial]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.