Arsenic Trioxide – Targeted Acute Promyelocytic Leukemia Therapy

Arsenic Trioxide is a highly effective antineoplastic medication that has revolutionized the treatment of specific forms of leukemia. Despite the historical reputation of arsenic as a potent toxin, in strict therapeutic doses, it acts as a powerful cytotoxic agent capable of inducing cancer cell death while sparing healthy tissues when administered correctly.

The mechanism of action of arsenic trioxide is unique and multifaceted. The primary target of the drug is the specific fusion protein PML-RARα, which is formed as a result of a genetic translocation in patients with acute promyelocytic leukemia (APL). Arsenic trioxide binds to this protein, triggering its degradation, which releases the block on blood cell differentiation. As a result, immature leukemic cells (promyelocytes) are allowed to mature into normal, functioning granulocytes. Additionally, the drug activates the caspase cascade, inducing programmed cell death (apoptosis), and inhibits angiogenesis, depriving the tumor of its nutrient support. Due to these mechanisms, the drug achieves long-term molecular remission even in patients with relapsed disease.

The drug is administered exclusively via intravenous infusion under the strict supervision of qualified medical personnel in a hospital setting.

Wikipedia page
Arsenic Trioxide

Indications

Arsenic Trioxide is indicated for the treatment of adults and children with the following hematological conditions:

  • Acute Promyelocytic Leukemia (APL): induction of remission and consolidation in patients with newly diagnosed low-to-intermediate risk APL (in combination with all-trans retinoic acid, ATRA).
  • Relapsed APL: therapy for patients who have experienced a relapse or lack of response to prior retinoid and anthracycline therapy.
  • Genetic Confirmation: use of the drug requires mandatory confirmation of the t(15;17) translocation or the expression of the PML/RAR-alpha gene.

Dosage and administration

The dosage of the drug is calculated individually and depends on the treatment phase and the patient's overall health status.

  • Induction Schedule: the drug is administered daily at a dose of 0.15 mg/kg of body weight until complete bone marrow remission is achieved (not exceeding 50–60 doses).
  • Consolidation Schedule: several weeks after induction, the consolidation cycle begins (usually 0.15 mg/kg daily in short courses of 5 days per week for 5 weeks).
  • Administration Method: intravenous infusion lasting from 1 to 2 hours. If acute reactions occur, the infusion time may be extended to 4 hours.
  • Monitoring: during treatment, daily ECG monitoring of the QT interval and regular analysis of blood electrolytes are essential.
  • Special Considerations: the dose does not require adjustment based on age but requires extreme caution in patients with renal impairment.

Given the high biological activity of the drug, the following strict contraindications apply:

  • Hypersensitivity: proven allergy to arsenic compounds or any excipients in the solution.
  • Cardiac Arrhythmias: presence of congenital long QT syndrome or serious, uncorrected cardiac conduction disorders.
  • Pregnancy and Lactation: the drug has a pronounced teratogenic effect; breastfeeding must be completely discontinued during therapy.
  • Renal Insufficiency: severe kidney impairment requires careful risk assessment because the drug is primarily excreted through the urinary system.

The use of arsenic trioxide may be accompanied by the development of specific adverse reactions:

  • APL Differentiation Syndrome: a life-threatening condition manifested by dyspnea, fever, and edema, requiring immediate administration of glucocorticosteroids.
  • Cardiotoxicity: prolongation of the QT interval on the ECG, which can lead to dangerous ventricular arrhythmias such as Torsades de Pointes.
  • Neurological Disorders: peripheral neuropathy (numbness, tingling sensations), headache, insomnia, and increased anxiety.
  • GI and Skin: nausea, vomiting, diarrhea, abdominal pain, as well as skin rashes and hyperpigmentation.
  • Hepatotoxicity: elevation of liver transaminases and bilirubin levels, usually reversible after temporary suspension of therapy.

Frequently Asked Questions

Arsenic trioxide is an inorganic compound that, in extremely small and strictly controlled doses, exerts a powerful antitumor effect. Its mechanism of action is unique: it induces the specific degradation of the PML-RARα fusion protein, which forces abnormal leukemia cells to "mature" into normal blood cells or triggers their programmed cell death (apoptosis).
Arsenic trioxide is a highly effective treatment for acute promyelocytic leukemia (APL). It is indicated for patients with newly diagnosed disease (often in combination with all-trans retinoic acid, ATRA), as well as for those who have relapsed or failed to respond to previous chemotherapy.
This is a serious complication that can occur at the beginning of treatment when a large number of leukemia cells begin to mature simultaneously. Symptoms include shortness of breath, fever, and pulmonary edema. At the first signs of this syndrome, physicians prescribe high-dose steroids to prevent life-threatening consequences, and arsenic trioxide treatment may be temporarily withheld.
Arsenic trioxide can cause QTc interval prolongation, which can lead to dangerous heart rhythm disturbances. Patients must undergo an ECG before starting treatment and regularly during the course (at least twice a week). It is also vital to maintain normal levels of electrolytes, specifically potassium and magnesium, in the blood.
Arsenic trioxide is administered only by intravenous infusion over 1–2 hours (the infusion may be extended to 4 hours if adverse reactions occur). Treatment typically consists of two phases: induction (until remission is achieved) and consolidation (to maintain the response). The complete course can last several months depending on the specific treatment protocol.

List of medicines by active substance

-15%
Arsenam 10 10 mg / 10 ml GLS
View
GLS

Arsenam 10

Arsenic Trioxide
10 mg / 10 ml 1 vial
1258₴ 1483₴
✅ All products loaded (1)

Contact us

Choose a convenient way to contact

We work daily from 9:00 to 20:00