Trade Name: Decitabine

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

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 50 mg/20mL

Storage and handling

DECITABINE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of decitabine (Decitabine) which is also known as Decitabine and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 50 mg/20mL.

decitabine (Decitabine) 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.

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  • Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
  • Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. ()
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  • Three Day Regimen:
  • Five Day Regimen:
  • For Injection: 50 mg of decitabine as a sterile, white to almost white lyophilized powder, in a single-dose vial for reconstitution.
  • For Injection: 50 mg of decitabine as a lyophilized powder in a single-dose vial for reconstitution. ()
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  • Neutropenia and Thrombocytopenia:
  • Embryo-Fetal Toxicity:
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or .
  • Drug interaction studies with decitabine have not been conducted. studies in human liver microsomes suggest that decitabine is unlikely to inhibit or induce cytochrome P450 enzymes. metabolism studies have suggested that decitabine is not a substrate for human liver cytochrome P450 enzymes. As plasma protein binding of decitabine is negligible (<1%), interactions due to displacement of more highly protein bound drugs from plasma proteins are not expected.
  • Lactation:
  • 8.2
  • There is no known antidote for overdosage with Decitabine for Injection. Higher doses are associated with increased myelosuppression including prolonged neutropenia and thrombocytopenia. Standard supportive measures should be taken in the event of an overdose.
  • Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of CHNO and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-u03b2-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1)-one and it has the following structural formula: n
  • Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO).
  • Decitabine for Injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment.
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  • Carcinogenicity studies with decitabine have not been conducted.
  • The mutagenic potential of decitabine was tested in several and systems. Decitabine increased mutation frequency in L5178Y mouse lymphoma cells, and mutations were produced in an transgene in colonic DNA of decitabine-treated mice. Decitabine caused chromosomal rearrangements in larvae of fruit flies.
  • In male mice given IP injections of 0.15, 0.3 or 0.45 mg/m decitabine (approximately 0.3% to 1% the recommended clinical dose) 3 times a week for 7 weeks, decitabine did not affect survival, body weight gain or hematological measures (hemoglobin and white blood cell counts). Testes weights were reduced, abnormal histology was observed and significant decreases in sperm number were found at doses u2265 0.3 mg/m. In females mated to males dosed with u2265 0.3 mg/m decitabine, pregnancy rate was reduced and preimplantation loss was significantly increased.
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  • Decitabine for Injection is a sterile, white to almost white lyophilized powder for intravenous use supplied as:
  • NDC 70121-1644-1, 50 mg single-dose vial individually packaged in a carton.
  • Store vials at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • Myelosuppression
  • Advise patients of the risk of myelosuppression and to report any symptoms of infection, anemia, or bleeding to their healthcare provider as soon as possible. Advise patients for the need for laboratory monitoring .
  • 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 .
  • Advise females of reproductive potential to use effective contraception while receiving Decitabine for Injection and for 6 months after last dose .
  • Advise males with female partners of reproductive potential to use effective contraception while receiving treatment with Decitabine for Injection, and for 3 months after the last dose. and .
  • Lactation
  • Advise women to avoid breastfeeding while receiving Decitabine for Injection and for at least 2 weeks after the last dose .
  • Made in Malta
  • Distributed by:n n n Bridgewater, NJ 08807
  • Rev. 07-2020-04
  • No data
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