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Rubex (Doxorubicin Hydrochloride) - Summary

 
 



WARNINGS

  1. Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the intramuscular or subcutaneous route.
  2. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2*. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. This toxicity may occur at lower cumulative doses in patients with prior mediastinal irradiation or on concurrent cyclophosphamide therapy or with pre-existing heart disease. Pediatric patients are at increased risk for developing delayed cardiotoxicity.
  3. Dosage should be reduced in patients with impaired hepatic function.
  4. Severe myelosuppression may occur.
  5. Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

* Data on file at Pharmacia & Upjohn.

 

RUBEX SUMMARY

RUBEX®
(doxorubicin hydrochloride for injection, USP)

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine.

RUBEX (doxorubicin) is indicated for the following:

RUBEX (doxorubicin hydrochloride for injection, USP) has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.


See all Rubex indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Rubex (Doxorubicin)

First-line treatment of metastatic or locally advanced unresectable soft tissue sarcomas with conatumumab in combination with doxorubicin or doxorubicin alone: a phase I/II open-label and double-blind study. [2012]
sarcoma... INTERPRETATION: Addition of conatumumab to doxorubicin appeared to be safe but

A randomized controlled study into the efficacy and toxicity of pegylated liposome encapsulated doxorubicin as an adjuvant therapy in dogs with splenic haemangiosarcoma. [2011.12]
Safety and efficacy of pegylated liposome encapsulated doxorubicin (PL-DOX) was compared with free doxorubicin as an adjuvant monotherapy in dogs with splenic haemangiosarcoma after splenectomy in a randomized prospective clinical trial. A total of 17 dogs in each group were treated... Cardiotoxicity was not seen in either treatment groups.

Hepatic arterial infusion of doxorubicin-loaded microsphere for treatment of hepatocellular cancer: a multi-institutional registry. [2011.10]
BACKGROUND: Hepatic intra-arterial therapy for unresectable hepatocellular cancer (HCC) has been shown to improve overall survival, but can have significant toxicity. A recent prospective randomized controlled trial demonstrated superior response rates and significantly less morbidity and doxorubicin-related adverse events with drug-eluting beads with doxorubicin (DEBDOX) compared with conventional chemoembolization. The aim of this study was to confirm the efficacy of DEBDOX for the treatment of unresectable HCC... CONCLUSIONS: Hepatic intra-arterial injection of DEBDOX is safe and effective in the treatment of HCC, as demonstrated by a minimal complication rate and robust and durable tumor response. Copyright (c) 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Rapid early monoclonal protein reduction after therapy with bortezomib or bortezomib and pegylated liposomal doxorubicin in relapsed/refractory myeloma is associated with a longer time to progression. [2011.08.15]
BACKGROUND: A rapid and early monoclonal (M) protein response during initial therapy in patients with multiple myeloma had been identified as a predictor of superior long-term outcome in some--but not all--studies... CONCLUSIONS: These analyses supported the possibility that a robust early M protein response is a good prognostic factor for long-term outcome of myeloma patients with relapsed and/or refractory disease receiving bortezomib or PLD + bortezomib. Copyright (c) 2011 American Cancer Society.

Lyso-thermosensitive liposomal doxorubicin: an adjuvant to increase the cure rate of radiofrequency ablation in liver cancer. [2011.08]
Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide...

more studies >>

Clinical Trials Related to Rubex (Doxorubicin)

Vincristine, DOXIL® (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Completed]
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).

A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma [Active, not recruiting]
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

A Study Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer [Active, not recruiting]
The purpose of this research study is to determine if the combination of Yondelis and Doxil is better at improving overall survival over Doxil alone in subjects with relapsed advanced ovarian cancer.

A Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel in Patients With Advanced Breast Cancer [Active, not recruiting]
This study will evaluate the safety and effectiveness of a combination of doxorubicin HCl liposome injection (DOXIL/CAELYX) and docetaxel in women with recurrent advanced breast cancer who received anthracycline in the adjuvant or neoadjuvant setting.

The safety and effectiveness of the combination will be compared to treatment with docetaxel alone (monotherapy). The purpose of this research study is to determine if overall survival for the docetaxel and DOXIL/CAELYX treated group is longer than that for the group treated with docetaxel alone. Additional comparisons between the two treatment groups include: response rate (how much your tumor shrinks in response to the drug), time to progression, safety, and quality of life.

Combination Study Of SB-485232 (Interleukin 18) And Doxil For Advanced Stage Epithelial Ovarian Cancer [Recruiting]
The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination.

more trials >>


Page last updated: 2013-02-10

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