藥物警訊（藥師週刊 第1667期）

Velcade (bortezomib) : Starting Dose Adjustments for Patients with Hepatic Impairment
Audience: Hematology, Oncology healthcare professionals
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy. The changes also include new safety information on dose adjustment for patients with moderate to severe hepatic impairment in label Section 5.11, stating: "Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities."
Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Read the complete MedWatch 2010 Safety Summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
武田腫瘤研究中心和FDA發佈藥物安全警訊，通知醫護人員關於Velcade仿單中，肝損傷病人使用Velcade治療的起始劑量之修訂(section 2.5)。此外，也新增中度至重度肝損傷病人使用Velcade治療需調整劑量的安全性資訊(section 5.11)。其內容指出：「Bortezomib是經由肝臟酵素代謝，而對於中度至重度肝損傷病人，bortezomib的血中濃度會增加。因此，當這些病人使用Velcade時，必須降低起始劑量並且嚴密監測相關的毒性。」
Velcade的適應症為治療多發性骨髓瘤(multiple myeloma, MM)的病人，也可治療曾接受過至少一種治療方式的被套細胞淋巴瘤(mantle cell lymphoma, MCL)的病人。
相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198424.htm　　　　　　 [Posted 01/26/2010]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部

Zyprexa (olanzapine): Use in Adolescents
Audience: Neuropsychiatric healthcare professionals
Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that:
Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.
Section 17.14, Need for comprehensive Treatment Program in Pediatric Patients: Zyprexa is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age.
Read the complete MedWatch 2010 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
Lilly與FDA發佈藥物安全警訊，通知醫療人員關於治療精神分裂症與雙極性第一型燥症之藥物Zyprexa仿單的變更，其修正青少年（13~17歲）使用之適應症，更新內容如下：
第1部分：適應症與用法：最新的臨床試驗結果顯示，Zyprexa可用於治療患有精神分裂症與雙極性第一型燥症之青少年(13~17歲)病人。但需注意，當醫師為青少年病人選擇可行的治療方式時，需考慮此藥可能發生體重增加與血脂上升的副作用（增加的幅度較成人高）。當醫生為青少年開立處方時，也需考慮到可能發生的長期風險。此些考量會使得醫生在許多案例中優先考慮其他的治療藥物。（更新前的仿單內容：因為缺乏安全性與療效性的資料，不建議孩童和十八歲以下的青少年服用Zyprexa(olanzapine)）
第17.14部分：小兒病人綜合性治療計畫的需求：Zyprexa是治療罹患精神分裂症與雙極性第一型燥症的小兒病人完整療程的一部份，此療程可能也包含心理、教育與社交層面的評估考量。然而，13歲以下的病人使用Zyprexa的有效性與安全性還是尚未確定的。
相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm
[Posted 01/29/2010]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部