Trisenox
Generic Name
Arsenic Trioxide
Manufacturer
Teva Pharmaceutical Industries Ltd.
Country
USA, Ireland
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Description
Overview of the medicine
Arsenic Trioxide is an inorganic arsenic compound used to treat acute promyelocytic leukemia (APL) that is refractory to retinoid and anthracycline chemotherapy.
Uses & Indications
Dosage
Adults
0.15 mg/kg body weight daily via intravenous infusion over 1-2 hours until bone marrow remission or for a maximum of 60 doses. Followed by consolidation therapy.
Elderly
No specific dose adjustment required based on age alone, but monitor renal and cardiac function.
Renal_impairment
Use with caution. Reduce dose to 50% for severe renal impairment (CrCl < 30 mL/min). Monitor carefully.
How to Take
Administer intravenously over 1-2 hours. Do not administer as a bolus injection. Dilute in 100-250 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
Mechanism of Action
Arsenic Trioxide induces apoptosis (programmed cell death) in APL cells and also causes differentiation of APL cells into mature granulocytes. It specifically targets the PML-RARα fusion protein, which is characteristic of APL.
Pharmacokinetics
Onset
Immediate onset with IV administration.
Excretion
Excreted renally, primarily as methylated metabolites.
Half life
Initial phase: ~1-2 hours; Terminal phase: ~10-15 hours (for total arsenic in plasma).
Absorption
Administered intravenously, so 100% bioavailability.
Metabolism
Mainly metabolized to mono- and dimethylated metabolites via enzymatic methylation in the liver.
Side Effects
Contraindications
- Hypersensitivity to arsenic or any component of the formulation.
- Patients with severe cardiac arrhythmias.
Drug Interactions
Hepatotoxic drugs
Increased risk of liver toxicity. Monitor liver function closely.
Drugs that prolong QT interval
Increased risk of QT prolongation and torsade de pointes (e.g., antiarrhythmics, antipsychotics, macrolides).
Storage
Store at 20°C to 25°C (68°F to 77°F). Do not freeze. Protect from light. Diluted solutions are stable for up to 24 hours at room temperature or 48 hours refrigerated.
Overdose
Symptoms include convulsions, muscle weakness, confusion, severe diarrhea, cardiotoxicity. Treatment is symptomatic and supportive; consider chelation therapy (e.g., dimercaprol) in severe cases.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Avoid during lactation. Advise women of reproductive potential to use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months when stored unopened according to instructions. Check specific product label.
Availability
Hospital pharmacies, specialized cancer centers
Approval Status
FDA approved
Patent Status
Patent expired for generic versions
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., APL0406, APL2000) have demonstrated high efficacy and safety in APL, particularly in combination with ATRA, leading to improved remission rates and overall survival.
Lab Monitoring
- ECG (before treatment and twice weekly during induction), Serum electrolytes (potassium, magnesium, calcium - correct abnormalities), Liver function tests (LFTs), Renal function tests, Complete blood count (CBC) with differential.
Doctor Notes
- Monitor ECG and electrolytes frequently, especially during induction. Correct hypokalemia and hypomagnesemia prior to initiation and throughout treatment. Differentiation Syndrome can be life-threatening and requires prompt treatment with corticosteroids. Ensure appropriate hydration.
- Patient education on signs of Differentiation Syndrome and peripheral neuropathy is crucial for early detection and management.
Patient Guidelines
- Report any signs of fever, shortness of breath, rapid weight gain, or swelling immediately.
- Avoid driving or operating heavy machinery if experiencing dizziness or fatigue.
- Maintain good hydration and follow your doctor's dietary advice.
Missed Dose Advice
Contact your doctor immediately for advice on missed doses.
Driving Precautions
May cause dizziness, fatigue, or visual disturbances. Advise patients to exercise caution when driving or operating machinery and to avoid these activities if affected.
Lifestyle Advice
- Avoid alcohol during treatment.
- Follow a balanced diet as advised by your healthcare provider.
- Avoid crowded places to minimize infection risk, as your immune system may be compromised.
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