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Idamycin (Idarubicin Hydrochloride) - Summary

 
 



WARNINGS

  1. IDAMYCIN (idarubicin hydrochloride for injection, USP) should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
  2. As is the case with other anthracyclines the use of IDAMYCIN can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease.
  3. As is usual with antileukemic agents, severe myelosuppression occurs when IDAMYCIN is used at effective therapeutic doses.
  4. It is recommended that IDAMYCIN be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
  5. Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.)
 

IDAMYCIN SUMMARY

Idamycin®
idarubicin hydrochloride for injection, USP

IDAMYCIN® (idarubicin hydrochloride for injection, USP) is a sterile, semi-synthetic antineoplastic anthracycline for intravenous use.

IDAMYCIN (idarubicin hydrochloride for injection, USP) in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American- British (FAB) classifications M1 through M7.


See all Idamycin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Idamycin (Idarubicin)

Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study. [2011.02.24]
We conducted a multi-institutional randomized study to determine whether high-dose daunorubicin would be as effective as standard-dose idarubicin in remission-induction therapy for newly diagnosed adult patients younger than 65 years of age with acute myeloid leukemia... Thus, high-dose daunorubicin and standard-dose idarubicin were equally effective for the treatment of adult acute myeloid leukemia, achieving a high rate of complete remission and good long-term efficacy.

A phase I study of vorinostat in combination with idarubicin in relapsed or refractory leukaemia. [2010.07]
Histone deacetylase inhibitors (HDACi) affect chromatin remodelling and modulate the expression of aberrantly silenced genes. HDACi have single-agent clinical activity in haematological malignancies and have synergistic anti-leukaemia activity when combined with anthracyclines in vitro... The combination of vorinostat and idarubicin is generally tolerable and active in patients with advanced leukaemia and should be studied in the front-line setting.

Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. [2010.03]
A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML)...

Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. [2009.11.10]
PURPOSE: To compare the antitumor efficacy of three different anthracyclines in combination with cytarabine and etoposide in adult patients with newly diagnosed acute myeloid leukemia (AML)... CONCLUSION: In adult patients with AML who do not receive an allogeneic SCT, the use of mitoxantrone or idarubicin instead of daunorubicin enhances the long-term efficacy of chemotherapy.

Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. [2007.10]
BACKGROUND AND OBJECTIVES: Treatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation... CONCLUSIONS: Adding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.

more studies >>

Clinical Trials Related to Idamycin (Idarubicin)

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes [Recruiting]
The goals of this study are to learn about the effectiveness, the side-effects, if waiting to give the idarubicin and cytarabine may change the side effects or effectiveness, and to identify factors to predict for responses to this therapy. The trial will examine combination of three chemotherapy drugs. These drugs are decitabine, idarubicin, and cytarabine

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes [Recruiting]
The goal of this clinical research study is to learn if E7070 given alone or in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the study drug/study drug combination will also be studied.

Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas [Recruiting]

Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML) [Recruiting]
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.

A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia [Recruiting]
The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

more trials >>


Page last updated: 2011-12-09

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