Navigation Links
Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer
Date:9/10/2009

se of doxorubicin HCl approaches 550 mg/m2
  • Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose
  • Cardiac toxicity may also occur at lower cumulative doses (400 mg/m2) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy
  • Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate
    • Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
    • The initial rate of infusion should be 1 mg/min to minimize the risk of infusion reactions
  • Severe myelosuppression may occur
  • DOXIL dosage should be reduced in patients with impaired hepatic function
  • Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis
  • Contraindications

    • Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL
    • Nursing mothers

    Additional Safety Information

    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/16/2014)... , Sept. 16, 2014  The Council ... entrepreneurial support organization in the country, today released ... Report . It showed that ... North Carolina startups in the technology, ... more global investment from a variety of sources. Significant ...
    (Date:9/16/2014)... Sept. 16, 2014 /PRNewswire-iReach/ -- Researchers found that ... identifies patients with bone fragility fracture when today,s ... people worldwide are at risk of fracture for ... bone strength test, the DEXA bone density scan. ... for Bone and Mineral Research Annual Conference (ASBMR) ...
    (Date:9/16/2014)... RENU 28, the world's first and only skin gel ... in Australia and New Zealand in mid-August . , The ... tour will make stops in Brisbane on September 16, the ... on the 20th, and Melbourne on the 22nd. , Helping ... to educate people about the new product and business opportunity ...
    (Date:9/15/2014)... JOSE, Calif. , Sept. 15, 2014 /PRNewswire/ ... Proposals (RFP) for flexible, printed product demonstrators (demos) ... a two-stage RFP process with pre-proposals due on ... January 2015.  Funds for proposals ultimately selected are ... and have a significant cost share by the ...
    Breaking Biology Technology:CED's Mid-Year Update to its Innovators Report Shows NC Startups Attracting Investment From Across the Globe with Several High-Profile Investment Deals, IPOs and Acquisitions Signaling Strength of Entrepreneurial Sector 2CED's Mid-Year Update to its Innovators Report Shows NC Startups Attracting Investment From Across the Globe with Several High-Profile Investment Deals, IPOs and Acquisitions Signaling Strength of Entrepreneurial Sector 3CED's Mid-Year Update to its Innovators Report Shows NC Startups Attracting Investment From Across the Globe with Several High-Profile Investment Deals, IPOs and Acquisitions Signaling Strength of Entrepreneurial Sector 4ActiveLife's BMSi Test Provides Hope for 160 Million with Undetectable Risk of Bone Fracture 2ActiveLife's BMSi Test Provides Hope for 160 Million with Undetectable Risk of Bone Fracture 3Global Wellness Company Hosts ASEA Australia Tour September 16-22 2FlexTech Alliance Issues 2015 Request for Proposals in Flexible, Printed Electronics 2
    ... SAN FRANCISCO, Calif., April 8, 2008 Raven,biotechnologies, ... discovery,and development of monoclonal antibody therapeutics (MAbs) for ... agreement with Monogram,Biosciences, Inc., under which Monogram will ... VeraTag(TM) technology for diagnosis,of cancer., "Raven,s extensive ...
    ... Flexibility, Expanding Physicians ... the Treatment of Prostate Cancer, SUNNYVALE, Calif., April ... global leader in the field of radiosurgery,announced today that ... the,International Journal of Radiation Oncology*Biology*Physics -- also known,as the ...
    ... The Board of Molecular Vision today,announces that discussions ... have now ceased. Acrongenomics has been unable to,complete ... the Board of,Molecular Vision believes that the best ... discussions to a conclusion. Acrongenomics remains a,significant shareholder ...
    Cached Biology Technology:Raven biotechnologies Announces Collaboration With Monogram Biosciences to Advance Diagnostic Cancer Technologies 2CyberKnife Prostate Cancer Planning Study Published in Leading Radiation Oncology Journal 2CyberKnife Prostate Cancer Planning Study Published in Leading Radiation Oncology Journal 3CyberKnife Prostate Cancer Planning Study Published in Leading Radiation Oncology Journal 4
    (Date:9/16/2014)... YORK (17 September, 2014)More than $100 trillion in ... of annual carbon dioxide (CO2)a 40 percent reduction ... 2050 if the world expands public transportation, walking ... report released by the University of California, Davis, ... (ITDP). , Further, an estimated 1.4 million ...
    (Date:9/16/2014)... its own bacterial identity. That,s the conclusion of University ... studied the genetic fingerprints of bacteria on 57 species ... study demonstrates for the first time that host plants ... possess very different microbial communities on their leaves," said ... in the UO,s Institute of Ecology and Evolution who ...
    (Date:9/16/2014)... the Keystone XL pipeline (KXL) would likely increase oil ... researchers surveyed by the non-profit organization Near Zero. The ... Climate Impact," and includes both supporters and opponents of ... oil sands could lead to significantly higher greenhouse gas ... markets respond. , "This report examines three main ...
    Breaking Biology News(10 mins):Global shift away from cars saves US$100 trillion, eliminates 1,700 MT of CO2 pollution 2Global shift away from cars saves US$100 trillion, eliminates 1,700 MT of CO2 pollution 3Global shift away from cars saves US$100 trillion, eliminates 1,700 MT of CO2 pollution 4Global shift away from cars saves US$100 trillion, eliminates 1,700 MT of CO2 pollution 5Microbiome research shows each tree species has a unique bacterial identity 2Keystone XL would likely raise oil sands production and greenhouse gas emissions 2
    ... CITY People at risk for a certain form of ... better chance at surviving or even avoiding the diseases, thanks ... Institute at LDS Hospital. The Intermountain Heathcare group of ... cost-effective way to identify patients who may have Lynch syndrome, ...
    ... of researchers at the Department of Energy,s BioEnergy Science ... controls ethanol production capacity in a microorganism. This discovery ... that produce higher concentrations of ethanol at lower costs. ... the scientific discoveries of its labs and research centers ...
    ... study by an international team including professor John Graves of ... species of tunas and billfishes are threatened and in need ... issue of Science magazine,s Policy Forumis the first ... of the International Union for Conservation of Nature (IUCN). ,The ...
    Cached Biology News:Study: New process that can save at-risk cancer patients is effective and significantly less costly 2Study: New process that can save at-risk cancer patients is effective and significantly less costly 3Single, key gene discovery could streamline production of biofuels 2Study helps assess global status of tuna and billfish stocks 2Study helps assess global status of tuna and billfish stocks 3