Arsenic Trioxide (ARSENIC TRIOXIDE)

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Trade Name: ARSENIC TRIOXIDE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amring Pharmaceuticals Inc.

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/mL

Storage and handling

ARSENIC TRIOXIDE

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with arsenic trioxide have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hepatopathy, and multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold arsenic trioxide n
Cardiac Conduction Abnormalities: Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering arsenic trioxide, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer arsenic trioxide to patients with a ventricular arrhythmia or prolonged QTc interval. Withhold arsenic trioxide until resolution and resume at reduced dose for QTc prolongation n
Encephalopathy: Serious encephalopathy, including Wernickeu2019s, has occurred with arsenic trioxide. Wernickeu2019s is a neurologic emergency. Consider testing thiamine levels in patients at risk for thiamine deficiency. Administer parenteral thiamine in patients with or at risk for thiamine deficiency. Monitor patients for neurological symptoms and nutritional status while receiving arsenic trioxide. If Wernickeu2019s encephalopathy is suspected, immediately interrupt arsenic trioxide and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize n
WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES, AND ENCEPHALOPATHY INCLUDING WERNICKEu2019S
See full prescribing information for complete boxed warning.

Patients with acute promyelocytic leukemia (APL) treated with arsenic trioxide have experienced symptoms of differentiation syndrome, which may be life-threatening or fatal. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold arsenic trioxide. (, )
Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering arsenic trioxide, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer arsenic trioxide to patients with ventricular arrhythmia or prolonged QTc interval. Withhold arsenic trioxide until resolution and resume at reduced dose for QTc prolongation. (, )
Serious encephalopathy, including Wernickeu2019s, has occurred with arsenic trioxide. If Wernickeu2019s encephalopathy is suspected, immediately interrupt arsenic trioxide and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. ()

Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Arsenic trioxide is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. ()n

Relapsed or refractory APL:

Induction:
Consolidation:

Injection: 10 mg/10 mL (1 mg/mL) arsenic trioxide clear solution in a single-dose vial
Injection: 10 mg/10 mL (1 mg/mL) arsenic trioxide in single-dose vial. ()

Arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic.
Hypersensitivity to arsenic. ()

No data

Hepatotoxicity
Carcinogenesis
Embryo-Fetal Toxicity

The following clinically significant adverse reactions are described elsewhere in the labeling:
The most common adverse reactions (> 30%) are nausea, cough, fatigue, pyrexia, headache, abdominal pain, vomiting, tachycardia, diarrhea, dyspnea, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QTc prolongation, rigors, sore throat, arthralgia, paresthesia, and pruritus ).n n
To report SUSPECTED ADVERSE REACTIONS, contact Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641) or FDA at 1-800-FDA-1088 or n

Drugs That Can Prolong the QT/QTc Interval
Concomitant use of these drugs and arsenic trioxide may increase the risk of serious QT/QTc interval prolongation . Discontinue or replace with an alternative drug that does not prolong the QT/QTc interval while the patient is using arsenic trioxide. Monitor ECGs more frequently in patients when it is not feasible to avoid concomitant use.
Drugs That Can Lead to Electrolyte Abnormalities
Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation . Avoid concomitant use of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and arsenic trioxide.
Drugs That Can Lead to Hepatotoxicity
Concomitant use of these drugs and arsenic trioxide injection may increase the risk of serious hepatotoxicity . Discontinue or replace with an alternative drug that does not cause hepatotoxicity while the patient is using arsenic trioxide injection. Monitor liver function tests more frequently in patients when it is not feasible to avoid concomitant use.

No data

Lactation
Renal Impairment
Hepatic Impairment

Manifestations
Manifestations of arsenic trioxide overdosage include convulsions, muscle weakness, and confusion.
Management
For symptoms of arsenic trioxide overdosage, immediately discontinue arsenic trioxide and consider chelation therapy.
A conventional protocol for acute arsenic intoxication includes dimercaprol administered at a dose of 3 mg/kg intramuscularly every 4 hours until immediate life-threatening toxicity has subsided. Thereafter, penicillamine at a dose of 250 mg orally, up to a maximum frequency of four times per day (u2264 1 g per day), may be given.

Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is AsO, with a molecular weight of 197.8 and the following structural formula:
Arsenic trioxide injection is available in 10 mL, single-dose glass vials containing 10 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8.

No data

Carcinogenicity studies have not been conducted with arsenic trioxide n
Arsenic trioxide and trivalent arsenite salts have not been demonstrated to be mutagenic to bacteria, yeast, or mammalian cells. Arsenite salts are clastogenic (human fibroblast, human lymphocytes, Chinese hamster ovary cells, Chinese hamster V79 lung cells). Trivalent arsenic was genotoxic in the chromosome aberrations assay and micronucleus bone marrow assay in mice.
The effect of arsenic on fertility has not been adequately studied in humans. Decreased testicular weight and impaired spermatogenesis have been reported in animal studies. Male Wistar rat pups were administered 1.5 mg/kg sodium arsenite solution via the intraperitoneal route from postnatal days 1 to 14 and testes were collected for evaluation on postnatal days 15, 21, and 50. Results of this study revealed an altered morphology of the seminiferous tubules along with degeneration of spermatogenic cells, increased number of sperm with abnormal morphology, and decreased sperm counts. In beagle dogs administered intravenous arsenic trioxide for 90 days, reduced inner cell layers within seminiferous tubules and significantly decreased numbers of spermatocytes, spermatozoa, and sperm cells were observed at doses of 1 mg/kg/day and higher. The 1 mg/kg/day dose is approximately 3 times the recommended human daily dose on a mg/m basis.

Arsenic trioxide was investigated in Study PLRXAS01, an open-label, single-arm trial in 40 patients with relapsed or refractory APL who were previously treated with an anthracycline and a retinoid regimen. Patients received arsenic trioxide 0.15 mg/kg/day intravenously over 1 to 2 hours until the bone marrow was cleared of leukemic cells or for a maximum of 60 days. The CR (absence of visible leukemic cells in bone marrow and peripheral recovery of platelets and white blood cells with a confirmatory bone marrow u2265 30 days later) rate in this population of previously treated patients was 28 of 40 (70%). Among the 22 patients who had relapsed less than one year after treatment with tretinoin, there were 18 complete responders (82%). Of the 18 patients receiving arsenic trioxide u2265 one year from tretinoin treatment, there were 10 complete responders (55%). The median time to bone marrow remission was 44 days and to onset of CR was 53 days. Three of 5 children, 5 years or older, achieved CR. No children less than 5 years old were treated.
Three to six weeks following bone marrow remission, 31 patients received consolidation therapy with arsenic trioxide, at the same dose, for 25 additional days over a period up to 5 weeks. In follow-up treatment, 18 patients received further arsenic trioxide as a maintenance course. Fifteen patients had bone marrow transplants. At last follow-up, 27 of 40 patients were alive with a median follow-up time of 484 days (range 280 to 755) and 23 of 40 patients remained in complete response with a median follow-up time of 483 days (range 280 to 755).
Cytogenetic conversion to no detection of the APL chromosome rearrangement was observed in 24 of 28 (86%) patients who met the response criteria defined above, in 5 of 5 (100%) patients who met some, but not all, of the response criteria, and 3 of 7 (43%) of patients who did not respond. RT-PCR conversions to no detection of the APL gene rearrangement were demonstrated in 22 of 28 (79%) of patients who met the response criteria, in 3 of 5 (60%) of patients who met some, but not all, of the response criteria, and in 2 of 7 (29%) of patients who did not respond.
Responses were seen across all age groups tested, ranging from 6 to 72 years. The ability to achieve a CR was similar for both sexes. There were insufficient patients of Black, Hispanic, or Asian ancestry to estimate relative response rates in these groups, but responses were seen in each group.

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How Supplied
Arsenic trioxide injection is supplied as a sterile, clear, colorless solution in 10 mL glass single-dose vials.
NDC 69918-720-02
NDC 69918-720-10
Storage and Handling
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [See USP Controlled Room Temperature]. Do not freeze.
Arsenic trioxide injection is a hazardous drug. Follow applicable special handling and disposal procedures.n

Differentiation Syndromen n- [see ].n- Cardiac Conduction Abnormalitiesn n n- [see and ].n- Encephalopathy and Wernickeu2019s Encephalopathy (WE)n n n- [see ].n- [see ].n- Embryo-Fetal Toxicity
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy n
Advise females of reproductive potential to use effective contraception during treatment with arsenic trioxide injection and for 6 months after the last dose n
Advise males with female partners of reproductive potential to use effective contraception during treatment with arsenic trioxide for 3 months after the last dose n
Lactationn n- [see )]n- Infertilityn n- [see ].n- Other Adverse Reactionsn n n- [see ].
n Manufactured for:n nAmring Pharmaceuticals Inc.nBerwyn, PA 19312 nwww.amringusa.comn
The Amring Logo and the u201cAu201d Logo are trademarks of Amring Pharmaceuticals Inc.
n Manufactured by:n Chemi Pharma LtdnHalfar, Birzebbugia BBG 3000, Maltann Origin Maltan Revised 11/2020

NDC 69918-720-01
Arsenic TrioxideInjection
10 mg/10 mL (1 mg/mL)
For Intravenous Use OnlyCaution: Cytotoxic Agent 10 mL Single-Dose VialRx only
AMRING PHARMACEUTICALS, INC.
NDC 69918-720-02u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0tRx Only
Arsenic Trioxide Injection
10 mg/10 mL (1 mg/mL)
For Intravenous Use Onlyn
2 x 10 mL Single-Dose Vialsn
AMRING PHARMACEUTICALS, INC.
NDC 69918-720-10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0tRx Only
Arsenic Trioxide Injection
10 mg/10 mL (1 mg/mL)
For Intravenous Use Onlyn
Caution: Cytotoxic Agentn
10 x 10 mL Single-Dose Vialsn
AMRING PHARMACEUTICALS, INC.

Select Strength and Packaging*

Ask for Quote

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Arsenic Trioxide (ARSENIC TRIOXIDE) which is also known as ARSENIC TRIOXIDE and Manufactured by Amring Pharmaceuticals Inc.. It is available in strength of 1 mg/mL.

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