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Arsenic Trioxide (Arsenic Trioxide)

Trade Name : Arsenic Trioxide

Nexus Pharmaceuticals Inc

INJECTION

Strength 1 mg/mL

ARSENIC TRIOXIDE

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Arsenic Trioxide (Arsenic Trioxide) which is also known as Arsenic Trioxide and Manufactured by Nexus Pharmaceuticals Inc. It is available in strength of 1 mg/mL per ml. Read more

Arsenic Trioxide (Arsenic Trioxide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with Arsenic Trioxide Injection have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain or peripheral edema, hypotension, and renal, hepatic, or multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Temporary discontinuation of Arsenic Trioxide Injection may be requirednn- [see Warnings and Precautions () and Adverse Reactions ()].
  • Cardiac Conduction Abnormalities: Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block, and a torsade de pointes-type ventricular arrhythmia, which can be fatal. Before initiating therapy, assess the QTc interval, correct pre-existing electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer Arsenic Trioxide Injection to patients with ventricular arrhythmia or prolonged QTcFnn- [see Warnings and Precautions ()].
  • Encephalopathy: Serious encephalopathy, including Wernicke's, has occurred in patients treated with Arsenic Trioxide Injection. Wernicke's 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 Injection. If encephalopathy is suspected, immediately interrupt Arsenic Trioxide Injection and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalizenn- [see Warnings and Precautions ()].
  • WARNING: DIFFERENTIATION SYNDROME,
  • CARDIAC CONDUCTION ABNORMALITIES, AND ENCEPHALOPATHY INCLUDING WERNICKE'S
  • See full prescribing information for complete boxed warning.
  • Patients treated with Arsenic Trioxide Injection may develop differentiation syndrome, which can be fatal. If symptoms occur, initiate high-dose steroids immediately and monitor hemodynamics. () Arsenic Trioxide Injection can cause QT interval prolongation and ventricular arrhythmia, which can be fatal. Before administering Arsenic Trioxide Injection, assess the QT interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Do not administer Arsenic Trioxide Injection to patients with ventricular arrhythmia or prolonged QTc F. (, )
  • Encephalopathy including Wernicke's encephalopathy (WE) occurred in patients receiving Arsenic Trioxide Injection. If Wernicke's encephalopathy is suspected, immediately interrupt Arsenic Trioxide treatment and initiate parenteral thiamine. ()
  • Arsenic Trioxide Injection is an arsenical indicated:n
  • In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. ()n
  • 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
  • Newly-diagnosed low-risk APL:
  • Relapsed or refractory APL:
  • Arsenic Trioxide Injection is an injectable solution for intravenous administration supplied as 10 mg /10 mL of arsenic trioxide in single-use vials.n
  • Injectable solution for intravenous administration supplied as 10 mg/10 ml of arsenic trioxide in single-use ampules. ()n
  • Arsenic Trioxide Injection is contraindicated in patients who are hypersensitive to arsenic.n
  • Hypersensitivity to arsenic. ()n
  • No data
  • Hepatotoxicity: Grade u22653 elevations in hepatic transaminase elevation have occurred in patients with newly diagnosed low or intermediate risk APL treated with Arsenic Trioxide in combination with tretinoin. Monitor hepatic function tests at least twice weekly during Arsenic Trioxide Injection therapy. ()n
  • Carcinogenesis: Arsenic trioxide is a human carcinogen. Monitor patients for the development of second primary malignancies. ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (, , )n
  • The following clinically significant adverse reactions are described elsewhere in the labeling.n
  • The most common adverse reactions (greater than 30%) were leukocytosis, neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, abdominal pain, hepatic toxicity, fever, rigors, fatigue, insomnia, tachycardia, QTc prolongation, edema, hyperglycemia, hypokalemia, hypomagnesemia, dyspnea, cough, rash or itching, sore throat, arthralgia, headaches, paresthesia, and dizziness. ()n
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  • Lactation: Advise women not to breastfeed. ()n
  • Renal Impairment: Monitor patients with severe renal impairment (creatinine clearance less than 30 mL/min) for toxicity when treated with Arsenic Trioxide Injection; dose reduction may be warranted. ()n
  • Hepatic Impairment: Monitor patients with severe hepatic impairment (Child-Pugh Class C) for toxicity when treated with Arsenic Trioxide Injection. ()n
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  • Arsenic Trioxide Injection is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsO, with a molecular weight of 197.8 and has the following structural formula:n
  • Arsenic Trioxide is available in 10 mL, single-use vials containing 10 mg of arsenic trioxide. Arsenic Trioxide 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 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.n
  • No data
  • Carcinogenicity studies have not been conducted with Arsenic Trioxide Injection by intravenous administration n
  • Arsenic trioxide and trivalent arsenite salts have not been demonstrated to be mutagenic to bacteria, yeast, or mammalian cells. Arsenite salts are clastogenic in vitro (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.n
  • 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/mu00b2 basis.n
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  • Manufactured in Belgium forNexus Pharmaceuticals, Inc. Lincolnshire, Illinois 60069USAn
  • Carton NDCn- Vial NDC
  • Arsenic Trioxide Injection
  • 10 X 10 mL Vials
  • 10 mg/10 mL (1 mg/mL) For Intravenous Use Only
  • Rx onlyn
  • Revised by Nexus Pharmaceuticals, Inc. 02/2020PIARSR001n
  • Principal Display Panel - 10 mL Carton Label
  • NDCn- 600
  • Rx Onlyn
  • Arsenic Trioxiden
  • 10 mg/10 mL (1 mg/mL)
  • For Intravenous Infusion Only
  • 10 x Single Dose Vialn
  • NEXUSn
  • PHARMACEUTICALSn
  • Principal Display Panel - 10 mL Vial Label
  • NDCn- 600
  • Rx Onlyn
  • Arsenic Trioxiden
  • 10 mg/10 mL (1 mg/mL)
  • For IntravenousInfusion Only
  • 10 mL Single Dose Vial

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