Centocor Ortho Biotech Products, L.P.

http://www.DOXIL.com

Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer

Thursday 10th of September 2009 17:27

Contraindications

    --  Patients with a history of hypersensitivity reactions to a conventional
        doxorubicin formulation or the components of DOXIL

    --  Nursing mothers

Additional Safety Information

    --  Cardiac function should be carefully monitored
        --  Congestive heart failure or cardiomyopathy may occur after
            discontinuation of anthracycline therapy
        --  For patients with a history of cardiovascular disease, or if the
            results of cardiac monitoring indicate possible cardiac injury, the
            benefit of therapy must be weighed against the risk of myocardial
            injury
        --  In the randomized multiple myeloma study, 25 patients (8%) in the
            VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus
            DOXIL arm experienced left ventricular ejection fraction decrease
            (defined as absolute decrease greater than or equal to 15% over
            baseline or a greater than or equal to 5% decrease below
            institutional lower limit of normal)
    --  Myelosuppression may occur; frequently monitor complete blood count
        (including platelet count), at least prior to each dose of DOXIL
        --  In patients with recurrent ovarian cancer or AIDS-related
            Kaposi's sarcoma, hematologic toxicity (based on platelet count
            or absolute neutrophil count) may require dose reduction or delay in
            administration of DOXIL
        --  In patients with multiple myeloma, hematologic toxicity (based on
            platelet count, absolute neutrophil count, hemoglobin level, or
            neutropenia with fever) may require dose reduction, delay in
            administration, or suspension of DOXIL and/or VELCADE
        --  Persistent severe myelosuppression may result in superinfection,
            neutropenic fever, or hemorrhage
        --  Sepsis occurring during neutropenia has resulted in discontinuation
            of treatment and in rare cases of death
    --  DOXIL may potentiate the toxicity of other anticancer therapies,
        especially hematologic toxicities, when used in combination with other
        therapies that suppress bone marrow
    --  Hand-foot syndrome (HFS) may occur during therapy with DOXIL
        --  Based on HFS toxicity grade, dose reduction, or delay in
            administration, or discontinuation of DOXIL may be required
        --  HFS was generally observed after 2 to 3 cycles of treatment, but may
            occur earlier
        --  The reaction was mild in most patients, resolving in 1 to 2 weeks
        --  The reaction can be severe and debilitating in some patients,
            resulting in discontinuation of therapy
    --  DOXIL is an irritant, not a vesicant; use precautions to avoid
        extravasation
    --  DOXIL can cause fetal harm when used during pregnancy
    --  Recall reaction has occurred with DOXIL administration after
        radiotherapy
    --  DOXIL may interact with drugs known to interact with the conventional
        formulation of doxorubicin HCl
    --  In patients with recurrent ovarian cancer, the most common all-grade
        adverse reactions (ARs) >20% (DOXIL vs topotecan, respectively)
        included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs
        63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs
        35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and
        rash (29% vs 12%)
        --  In addition, 19% vs 52.3% reported alopecia (all grades)
        --  Grade 3/4 hematologic ARs reported in >5% (DOXIL vs topotecan,
            respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)
    --  In patients with multiple myeloma, the most common all-grade ARs >20%
        (VELCADE plus DOXIL vs VELCADE, respectively) included: neutropenia (36%
        vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue
        (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48%
        vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31%
        vs 31%), mucositis/stomatitis (20% vs 5%), peripheral neuropathy (42% vs
        45%), neuralgia (17% vs 20%), and rash (22% vs 18%)
        --  In addition, 19% vs <1% reported HFS

    --  In patients with AIDS-related Kaposi's sarcoma, ARs reported in
        greater than or equal to 5% of DOXIL-treated patients were: neutropenia
        (ANC <1000/mm3, 46%; <500/mm3, 11%), anemia (Hb <10 g/dL, 58%;
        <8 g/dL, 16%), thrombocytopenia (<150,000 platelets/mm3, 61%),
        nausea (18%), asthenia (7%), fever (8%), alopecia (9%), vomiting (8%),
        diarrhea (5%), and stomatitis (5%)

Please visit www.doxil.com for the full Prescribing Information, including Boxed WARNINGS.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech redefines the standard of care in immunology, nephrology, and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Products, L.P. were consolidated in late 2008, and was renamed Centocor Ortho Biotech. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care.

SOURCE Centocor Ortho Biotech Products, L.P.

Source PR Newswire


www.prnewswire.co.uk

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