Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Arsenic Trioxide, Berberis Aquifolium Root Bark, Oyster Shell Calcium Carbonate, Crude, Graphite, Centella Asiatica, And Sodium Chloride
Brand Name
D-65
Generic Name
Arsenic Trioxide, Berberis Aquifolium Root Bark, Oyster Shell Calcium Carbonate, Crude, Graphite, Centella Asiatica, And Sodium Chloride
Active Ingredient
Arsenic TrioxideCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 12 [hp_X]/mL | SOLUTION | SUBLINGUAL | 58264-0065 |
Detailed information about D-65
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for D-65, you must consult a qualified healthcare professional.
Arsenic Trioxide is a potent antineoplastic (cancer-fighting) agent primarily used to treat acute promyelocytic leukemia (APL). It belongs to the retinoid-like class of differentiating agents that induce cancer cell maturation and programmed cell death.
Dosage for Arsenic Trioxide is highly individualized based on the patient's body weight and the phase of treatment.
Arsenic Trioxide is approved for use in children with APL (typically ages 4 and older). The pediatric dose is generally the same as the adult dose (0.15 mg/kg/day), though pediatric patients must be monitored more closely for growth-related side effects and cardiac toxicity.
Patients with severe renal impairment (Creatinine Clearance < 30 mL/min) may require dose reductions, as arsenic is primarily cleared by the kidneys. Close monitoring for toxicity is mandatory.
While arsenic is methylated in the liver, clinical data on specific dose adjustments for hepatic impairment are limited. Healthcare providers will monitor liver function tests (LFTs) closely and may pause treatment if bilirubin or transaminases rise significantly.
Elderly patients (over 65) are at a higher risk for cardiac complications and electrolyte imbalances. Dosing remains the same, but monitoring frequency is typically increased.
Arsenic Trioxide is administered as an intravenous infusion over 1 to 2 hours. If a patient experiences acute vasomotor reactions (flushing, lightheadedness), the infusion time may be extended to 4 hours. It is usually administered daily in a clinical setting or infusion center. Patients should stay well-hydrated during the course of treatment to support renal clearance.
Because this medication is administered by healthcare professionals in a hospital or clinic, a missed dose is unlikely. However, if an appointment is missed, contact your oncology team immediately to reschedule. Consistency is critical for achieving remission in leukemia.
Signs of acute arsenic toxicity include severe nausea, vomiting, diarrhea, abdominal pain, and muscle twitching. In the event of a suspected overdose, the infusion must be stopped immediately. Treatment may involve chelation therapy with agents like dimercaprol (BAL).
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most patients receiving Arsenic Trioxide will experience some side effects, which may include:
> Warning: Stop taking Arsenic Trioxide and call your doctor immediately if you experience any of these.
Prolonged use of arsenic can lead to hyperpigmentation (darkening of the skin), hyperkeratosis (thickening of the skin on palms/soles), and a potential increased risk of secondary malignancies, though this risk is carefully weighed against the severity of the leukemia.
Arsenic Trioxide carries two significant FDA Black Box Warnings:
Report any unusual symptoms to your healthcare provider.
Arsenic Trioxide is a high-risk medication that requires intensive monitoring. Patients must be aware that while it is an effective treatment for APL, it requires frequent blood tests and heart monitoring to ensure safety.
According to the FDA (2024), Arsenic Trioxide is associated with Differentiation Syndrome, which can be fatal if not treated early with steroids. It is also associated with QT Interval Prolongation, which can lead to a dangerous ventricular arrhythmia known as Torsade de Pointes. Monitoring of electrolytes and EKG is mandatory.
Patients will undergo frequent testing, including:
Some patients experience dizziness or fatigue. If you feel lightheaded or excessively tired, avoid driving or operating heavy machinery until you know how the medication affects you.
Alcohol should be avoided or strictly limited, as it can increase the risk of liver toxicity and may worsen gastrointestinal side effects.
Do not stop treatment unless directed by your oncologist. Sudden discontinuation during the induction phase can lead to a rapid relapse of leukemia.
> Important: Discuss all your medical conditions with your healthcare provider before starting Arsenic Trioxide.
There are no known direct food-drug interactions with IV Arsenic Trioxide. However, maintaining a consistent diet to support stable electrolyte levels is recommended. Avoid excessive caffeine if you experience heart palpitations.
Arsenic Trioxide can cause false elevations in certain metabolic tests or interfere with specialized urine arsenic screenings used for environmental exposure testing.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
There is no known cross-sensitivity between Arsenic Trioxide and other common chemotherapy agents, but patients with sensitivities to other heavy-metal-based compounds should be monitored closely.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Arsenic Trioxide.
Arsenic Trioxide is classified as FDA Pregnancy Category D. Data from animal studies and the drug's mechanism of action indicate that it can cause fetal harm, including malformations and fetal death. Women of childbearing age must use highly effective contraception during treatment and for 6 months after the final dose. Men should use contraception for 3 months after the final dose.
Arsenic is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment with Arsenic Trioxide.
Arsenic Trioxide is approved for use in pediatric patients with APL. While effective, children may be more susceptible to side effects. Long-term studies on the impact of arsenic on growth and development are ongoing.
Clinical studies have included patients aged 65 and older. While no overall differences in efficacy were observed, elderly patients often have a higher incidence of cardiac and renal comorbidities, necessitating more frequent monitoring of EKGs and renal function.
Exposure to arsenic is increased in patients with severe renal impairment. A dose reduction may be considered for patients with a GFR < 30 mL/min. Dialysis does not significantly remove arsenic.
Patients with mild to moderate hepatic impairment should be monitored closely. If severe hepatotoxicity occurs (bilirubin > 3x upper limit of normal), treatment should be held until levels improve.
> Important: Special populations require individualized medical assessment.
Arsenic Trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in APL cells. It specifically targets the PML-RARα fusion protein. By inducing the sumoylation and subsequent proteasomal degradation of this protein, it restores the normal function of nuclear bodies and allows the white blood cells to differentiate into mature granulocytes.
The pharmacodynamics of Arsenic Trioxide are characterized by a gradual onset of action. Differentiation of leukemic cells typically begins within the first two weeks of treatment, with full bone marrow clearance usually occurring between 30 and 60 days of daily induction therapy.
| Parameter | Value |
|---|---|
| Bioavailability | 100% (IV administration) |
| Protein Binding | < 10% |
| Half-life (Initial) | 10–14 hours |
| Tmax | End of infusion (1–2 hours) |
| Metabolism | Hepatic Methylation (MMA, DMA) |
| Excretion | Renal (70–80%) |
Arsenic Trioxide is classified as an Antineoplastic Agent and specifically a Differentiating Agent. It is unique in oncology as it is an inorganic compound used for targeted molecular therapy.
Common questions about D-65
Arsenic Trioxide is primarily used to treat a specific type of blood cancer called Acute Promyelocytic Leukemia (APL). It is used both for newly diagnosed patients (often in combination with another drug called ATRA) and for patients whose cancer has returned after previous treatments. The drug works by helping immature blood cells mature into normal, healthy cells and by killing cancer cells. Because APL is a very aggressive form of leukemia, Arsenic Trioxide is considered a life-saving treatment. It is not typically used for other types of cancer or non-cancerous conditions.
The most common side effects include nausea, vomiting, diarrhea, fatigue, and fever, which often occur during the first few weeks of treatment. Many patients also experience skin rashes, headaches, and swelling in the hands or feet. More importantly, doctors watch for 'Differentiation Syndrome,' which can cause breathing problems and weight gain. Electrolyte imbalances, such as low potassium or magnesium, are also very frequent. Most of these side effects are manageable with supportive medications provided by your oncology team.
It is generally advised to avoid alcohol while undergoing treatment with Arsenic Trioxide. Alcohol can put additional strain on the liver, which is already working to process the medication and its metabolites. Furthermore, alcohol can contribute to dehydration and electrolyte imbalances, which increases the risk of dangerous heart rhythm side effects associated with arsenic. Always consult your oncologist before consuming alcohol, as they can provide guidance based on your specific liver function and overall health status. Minimizing alcohol helps ensure your body is in the best condition to handle the chemotherapy.
No, Arsenic Trioxide is not considered safe during pregnancy and is classified as a Pregnancy Category D medication. Clinical data and animal studies show that arsenic can cross the placenta and cause significant harm to a developing fetus, including birth defects or miscarriage. Women of childbearing age must have a negative pregnancy test before starting treatment and use highly effective birth control throughout therapy. Men should also use contraception to prevent pregnancy in their partners during treatment. If you become pregnant while taking this drug, you must notify your doctor immediately.
Arsenic Trioxide does not work instantly; it is a gradual process that takes several weeks. During the 'induction' phase, the drug begins to change the cancer cells, but a complete remission in the bone marrow usually takes between 30 and 60 days. Most patients will stay in the hospital or visit a clinic daily during this initial period. After remission is achieved, a second 'consolidation' phase is required to ensure all remaining cancer cells are eliminated. Your doctor will use blood tests and bone marrow biopsies to track your progress.
You should never stop taking Arsenic Trioxide or skip doses without consulting your oncologist. This medication is part of a strictly timed regimen designed to kill leukemia cells during their most vulnerable stages. Stopping treatment early can allow the cancer cells to multiply again, potentially leading to a relapse that is harder to treat. If you are experiencing severe side effects that make you want to stop, tell your doctor immediately. They can often provide other medications to manage your symptoms or adjust the timing of your doses safely.
Since Arsenic Trioxide is administered by healthcare professionals in a medical setting, missing a dose usually only happens if an appointment is skipped. If you miss an appointment, call your oncology clinic right away to reschedule. Consistency is vital for the success of leukemia treatment, and your doctors will want to get you back on schedule as soon as possible. Do not try to 'double up' on doses or take any other arsenic-containing products. Your medical team will adjust your treatment calendar to account for the delay.
Weight gain can occur while taking Arsenic Trioxide, and it is sometimes a sign of a serious complication called Differentiation Syndrome. This syndrome causes the body to retain fluid, leading to sudden weight gain, swelling, and difficulty breathing. While some minor weight changes can happen due to inactivity or other medications like steroids, any rapid increase in weight should be reported to your doctor immediately. They will likely check your lungs and heart for fluid buildup. Early detection of fluid retention is key to preventing serious respiratory issues.
Arsenic Trioxide has many potential drug interactions, especially with medications that affect heart rhythm. It is critical to tell your doctor about every medicine you take, including over-the-counter drugs, vitamins, and herbal supplements. Drugs that lower potassium or magnesium levels, such as certain diuretics, can make arsenic more dangerous for your heart. Some antibiotics and antidepressants can also interfere with heart rhythm when combined with arsenic. Your pharmacist and oncologist will screen your medication list for these 'QT-prolonging' drugs to ensure your safety.
Yes, Arsenic Trioxide is available as a generic medication. The brand name version is Trisenox, but several manufacturers now produce generic versions that are FDA-approved and therapeutically equivalent. Generic versions are typically more cost-effective for patients and hospitals while providing the same clinical benefits. Regardless of whether you receive the brand or generic version, the medication is administered the same way and requires the same intensive monitoring. Your insurance provider or hospital pharmacy will determine which version is used for your treatment.
Other drugs with the same active ingredient (Arsenic Trioxide)