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Centocor Ortho Biotech is evaluating the FDA's letter and will respond to the agency as quickly as possible.
The sNDA for DOXIL was submitted to the FDA in September 2008. DOXIL currently is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. DOXIL in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. DOXIL is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
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DOXIL is marketed in the United States by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as CAELYX throughout the rest of the world, excluding Japan and Israel. For more information about DOXIL, please visit www.DOXIL.com.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS:
Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution
Contraindications
Additional Safety Information
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.
-- The use of DOXIL may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose 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
SOURCE Centocor Ortho Biotech Products, L.P.
