- IDAMYCIN PFS Injection 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.
- As is the case with other anthracyclines the use of IDAMYCIN PFS 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.
- As is usual with antileukemic agents, severe myelosuppression occurs when IDAMYCIN PFS is used at effective therapeutic doses.
- It is recommended that IDAMYCIN PFS 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.
- Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.)
IDAMYCIN PFS SUMMARY
idarubicin hydrochloride injection
IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use.
IDAMYCIN PFS Injection 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.
Published Studies Related to Idamycin PFS (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.
Clinical Trials Related to Idamycin PFS (Idarubicin)
Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome [Recruiting]
The goal of this clinical research study is to learn if the combination of clofarabine,
idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine
can help control AML and MDS. The safety of these study drug combinations will also be
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
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]
Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia [Recruiting]
The purpose of this study is to determine whether idarubicin dose intensification is safe
and effective as a remission induction therapy for acute myeloid leukemia.
Page last updated: 2011-12-09