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Caelyx Delays Time to Disease Progression as Maintenance Therapy in,Patients with Metastatic Breast Cancer

arcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.

Schering-Plough Corp. has exclusive ex-U.S. marketing rights to CAELYX,
except in Japan and Israel, through a distribution agreement with ALZA, a wholly owned subsidiary of Johnson & Johnson of New Brunswick, N.J., USA. The product is marketed in the United States under the trade name DOXIL® by Ortho Biotech Products, L.P.
Important Safety Information from the U.S. label for DOXIL
Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. The use of DOXIL may lead to cardiac toxicity. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy. DOXIL should be administered to patients with a history of cardiovascular disease only when the potential benefit outweighs the risk. Cardiac function should be carefully monitored in patients treated with DOXIL. Acute infusion-related reactions have occurred in up to 10% of patients treated with DOXIL. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported.

Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Severe myelosuppression may occur. Dosage should be reduced in patients with impaired hepatic function. Accidental substitution of DOXIL for doxorubicin HCl has
resulted in severe side effects. DO NOT SUBSTITUTE. Use of DOXIL should be limited to physicians experienced in the use of cancer chemotherapeutic agents. The most common side effects reported with DOXIL therapy included asthenia (weakness), abdominal pain, fever, pain, mucou
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