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Otsuka Pharmaceutical and PDL BioPharma Close Sale of IV Busulfex
Date:3/10/2008

dministered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs, and the management of patients with severe pancytopenia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. SEE "WARNINGS" SECTION OF FULL PRESCRIBING INFORMATION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS.

At the recommended dosage, IV Busulfex produced profound myelosuppression in all patients (i.e., severe granulocytopenia, thrombocytopenia, anemia, or a combination thereof). Frequent complete blood counts should be monitored during treatment and until recovery. Hepatic veno-occlusive disease was diagnosed in 5/61 patients and was fatal in 2/5 cases. Anticonvulsant prophylactic therapy should be administered prior to treatment. Caution should be exercised in patients with a history of seizure disorder or head trauma or who are receiving other potentially epileptogenic drugs. Bronchopulmonary dysplasia with pulmonary fibrosis is a rare but serious condition following chronic busulfan therapy. Women of childbearing potential should be advised to avoid becoming pregnant as busulfan may cause fetal harm.

The most common nonhematological adverse events were nausea (92% mild/moderate, 7% severe), stomatitis (71% grade 1-2, 26% grade 3-4), vomiting (95% mild/moderate), anorexia (64% mild/moderate, 21% severe), diarrhea (75% mild/moderate, 5% grade 3-4), insomnia (83% mild/moderate, 1% severe), and fever (78% mild/moderate, 3% life-threatening).(1)

Please see FULL PRESCRIBING INFORMATION, including Boxed WARNING for Busulfex (http://www.ivbusulfex.com/29932_PI.pdf).(1)

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the
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SOURCE Otsuka Pharmaceutical Co., Ltd., and PDL BioPharma, Inc.
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