Ellence: profile and news






Addition of Ellence® to Standard Chemotherapy Does Not Improve ...  Mar 2, 2006
According to an article recently published in the Journal of Clinical Oncology, the addition of the chemotherapy agent Ellence® (epirubicin) to the standard ... - Cancer Consultants (press release),

Genta Appoints Seasoned Pharma Executive, Lloyd Sanders, as Vice ...  Jan 17, 2006
2000, led a 90-member sales force, and shared responsibility for the sales success of products that included Camptosar(R) (irinotecan), Ellence(R) (epirubicin ... - PR Newswire (press release),

Pfizer Fourth-Quarter and Full-Year 2005 Financial Results Reflect ...  Jan 19, 2006
221 (1) DETROL/ DETROL LA 283 285 (1) 193 207 (7) 90 78 15 - ONCOLOGY 497 453 10 167 182 (8) 330 271 22 CAMPTOSAR 237 189 25 124 123 1 113 66 69 ELLENCE 94 90 ... - PR Newswire (press release),

Taxol®, Ifex® and Platinol® Effective Second-Line Therapy for ...  Sep 22, 2005
Doxil® (doxorubicin), Ellence®, Navelbine® (vinorelbine), Hycamtin® (topotecan), or biologic agents such as a suramin and retinoic acid have not ... - Cancer Consultants (press release),

Many meds don't mix with the sun  Sep 21, 2005
Anti-cancer agents: Bexaro-tene (Targretin), capecitabine (Xeloda), dacarbazine (DTIC), epirubicin (Ellence), fluorou-racil (5-FU), interferon alfa (Intron A ... - Pioneer Press,

The search is on for New Zealand’s first Pet Idol  Sep 1, 2005
...to take home the ultimate pet prize of $1,000 cash, one year’s supply of pet food from Chef or Champ (to the value of $1,000), a one year Ellence Ultra Plan ... - Scoop.co.nz (press release),

Pfizer seeks approval for cancer drug  Aug 10, 2005
Its few cancer treatments include three also acquired from the Pharmacia merger -- Aromasin and Ellence for breast cancer and Camptosar for colorectal cancer. ... - Reuters

Xeloda® and Radiation Therapy Effective for Elderly and ...  Aug 3, 2005
The combinations of methotrexate, Velban® (vinblastine), doxorubicin and Platinol (MVAC) or MVEC (methotrexate, Velban, Ellence® (epirubicin) and Platinol ... - Cancer Consultants (press release)

DePalma leads Georgeotwn to its highest seeding in Big East ...  Aug 4, 2005
But as Georgetown's all-time leading assister, she must be doing something right. ellence for the Hoyas during her collegiate career. ... - CollegeSports.com

Less Toxic Adjuvant Chemotherapy Regimen for Patients with Locally ...  Jul 29, 2005
...rates of progression-free survival and may be better tolerated than the “gold standard� regimen of MTX, Velbe® (vinblastine), Ellence® (epirubicin) and ... - Cancer Consultants (press release)

Pfizer Inc Second-Quarter 2005 Performance Report  Jul 20, 2005
188 16 DETROL/ DETROL LA 222 182 22 142 115 23 80 67 20 - ONCOLOGY 513 369 39 178 164 8 335 205 64 CAMPTOSAR 233 147 58 123 133 (8) 110 14 696 ELLENCE 96 88 10 ... - Yahoo News (press release)

Less Toxic Adjuvant Chemotherapy Regimen for Patients with Locally ...  Jul 25, 2005
...progression-free survival and may be better tolerated than the “gold standard� regimen of MTX, vinblastine (Velbe®), epirubicin (Ellence®) and Platinol (M ... - Cancer Consultants (press release) <**results**>

Higher Cumulative Doses of Epirubicin and Cyclophosphamide for ...  Jun 27, 2005
...a recent article published in the Journal of Clinical Oncology, higher cumulative doses of the chemotherapy agents epirubicin (Ellence®) and cyclophosphamide ... - Cancer Consultants (press release),

Higher Cumulative Doses of Epirubicin and Cyclophosphamide for ...  13 Sep 2002
...a recent article published in the Journal of Clinical Oncology, higher cumulative doses of the chemotherapy agents epirubicin (Ellence®) and cyclophosphamide ... - Cancer Consultants (press release),

FDA Safety Labeling Changes: Ellence, Abilify, Kaletra  Jun 1, 2005
On March 2, the FDA approved revisions to the safety labeling for epirubicin HCl injection (Ellence, made by Pfizer, Inc.) to warn of the cumulative dose ... - Medscape (subscription)

25 jobs to go at Cork pharmaceutical plants  Jun 7, 2005
...company employs 2,100 people across its seven facilities in Ireland, where pharmaceutical products such as Lipitor, Neurontin, Nicorette, Ellence and Estracyt ... - RTE Interactive,

Combination Chemotherapy in Addition to Gemzar® Improves Survival ...  Jun 6, 2005
This trial included 52 patients with advanced pancreatic cancer who were treated with either PEFG (Platinol®, Ellence®, Gemzar, 5-fluoruracil), or Gemzar ... - Cancer Consultants (press release),

Pfizers invest €100m in plant  Jun 8, 2005
...said. Products currently manufactured at these two facilities include Lipitor, Neurontin, Nicorette, Ellence and Estracyt. Pfizer ... - Ireland Online,

DePalma leads Georgeotwn to its highest seeding in Big East ...  Jun 8, 2005
But as Georgetown's all-time leading assister, she must be doing something right. ellence for the Hoyas during her collegiate career. ... - CollegeSports.com,

Pfizer Inc First-Quarter 2005 Performance Report  Apr 19, 2005
208 196 6 DETROL/ DETROL LA 252 206 22 180 145 24 72 61 18 - ONCOLOGY 479 312 54 164 125 31 315 187 69 CAMPTOSAR 212 91 132 104 81 30 108 10 891 ELLENCE 90 80 ... - PR Newswire

/SECOND AND FINAL ADD -- NYTU041B -- Pfizer Inc Earnings/  Apr 19, 2005
FirstRESOURCE: Aromasin, Camptosar, Celebrex, Ellence, Emcyt, Idamycin, Trelstar, and Zinecard are made available to eligible low-income uninsured oncology ... - PR Newswire

Court rules against Mayne generic  Feb 18, 2005
...this week overturned a decision that had cleared the way for Mayne's pharmaceutical division to start selling Epirubicin - its version of Pfizer's Ellence. ... - Age (subscription),

Gleevec® Promising for AIDS-Related Kaposi’s Sarcoma  Feb 15, 2005
...of disease often include a type of chemotherapy regimen containing anthracycline-based chemotherapy (doxorubicin (Adriamycin®) and Ellence® (epirubicin)), or ... - Cancer Consultants (press release),


Other information


Indication
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Pharmacology
Epirubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Epirubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Epirubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific.

Mechanism Of Action
Epirubicin has antimitotic and cytotoxic activity. It inhibits nucleic acid (DNA and RNA) and protein synthesis through a number of proposed mechanisms of action: Epirubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. It also interferes with DNA replication and transcription by inhibiting DNA helicase activity.

Drug Category
Antineoplastic Agents; ATC:L01DB03

Brand Names/Synonyms
4'-Epiadriamycin; 4'-Epidoxorubicin; CCRIS 2261; Ellence; Epi-Dx; Epiadriamycin; Epidoxorubicin; Epirubicin; Epirubicina [Inn-Spanish]; Epirubicina [Spanish]; Epirubicine [French]; Epirubicine [Inn-French]; Epirubicinum [Inn-Latin]; Epirubicinum [Latin]; HSDB 6962; IMI 28; Pharmorubicin Pfs; Pidorubicina [Inn-Spanish]; Pidorubicine [Inn-French]; Pidorubicinum [Inn-Latin]; Ridorubicin; WP 697

Dosage Forms
POWDER FOR SOLUTION; SOLUTION

Absorption
100%

Interactions
-->Interactions for Epirubicin:

ELLENCE when used in combination with other cytotoxic drugs may show on-treatment additive toxicity, especially hematologic and gastrointestinal effects.

Concomitant use of ELLENCE with other cardioactive compounds that could cause heart failure (e.g., calcium channel blockers), requires close monitoring of cardiac function throughout treatment.

There are few data regarding the coadministration of radiation therapy and epirubicin. In adjuvant trials of epirubicin-containing CEF-120 or FEC-100 chemotherapies, breast irradiation was delayed until after chemotherapy was completed. This practice resulted in no apparent increase in local breast cancer recurrence relative to published accounts in the literature. A small number of patients received epirubicin-based chemotherapy concomitantly with radiation therapy but had chemotherapy interrupted in order to avoid potential overlapping toxicities. It is likely that use of epirubicin with radiotherapy may sensitize tissues to the cytotoxic actions of irradiation. Administration of ELLENCE after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.

Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity.

Cimetidine increased the AUC of epirubicin by 50%. Cimetidine treatment should be stopped during treatment with ELLENCE.

Drug-Laboratory Test Interactions

There are no known interactions between ELLENCE and laboratory tests.



Chemical IUPAC Name
10-(4-amino-5-hydroxy-6-methyl-oxan-2-yl)oxy-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-9,10-dihydro-7H-tetracene-5,12-dione

Chemical Formula
C27H29NO11

Half Life
half-lives for the alpha, beta, and gamma phases of about 3 minutes, 2.5 hours and 33 hours, respectively

Drug Type
Approved Drug

# Accession No
APRD00361

CAS Registry Number
56420-45-2

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