藥物警訊

Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

AUDIENCE: Psychiatry, Pharmacy, Patient

ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.

BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA's most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.

RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.

Health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy (REMS) requirements and current label recommendations. Notable requirements of the REMS include:

‧ For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program.

‧ Zyprexa Relprevv injections must be administered at a REMS-certified health care facility with ready access to emergency response services.

‧ Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours following an intramuscular injection.

‧ Patients receiving Zyprexa Relprevv must be accompanied to their destination from the health care facility.

Read the MedWatch safety alert, including links to the Drug Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA再更新有關注射抗精神病注射藥物Zyprexa Relprevv (olanzapine pamoate)後導致血中濃度升高之後續評估報告，FDA認為濃度升高不能排除因快速肌肉注射但延遲進入血流中等原因，導致死後才造成濃度過高。依據現有的資訊，FDA目前不修改有關使用Zyprexa Relprevv注射劑之建議，在未與醫療人員諮詢前，病人不應自行停藥。

Zyprexa Relprevv可幫助改善精神分裂症症狀，如幻聽，幻覺，變得多疑或退縮。Zypreza Relprevv仿單已註記注射後可能產生譫妄/鎮靜症候群（post-injection delirium sedation symptom, PDSS）之加框警語。

病人在每次給藥前應確實閱讀藥品說明，若出現疑似PDSS症狀，應立即通知醫療人員。而醫療人員應繼續依循Zyprexa Relprevv之藥品風險評估暨管控計畫(REMS)及最新的仿單建議，如下：

‧ 接受治療之病人、開方者、醫療機構及藥師皆應納入Zyprexa Relprevv之病人照護計畫。

‧ Zyprexa Relprevv注射劑應於有參與REMS且備有急救設施之醫療機構施打。

‧ 病人在接受肌肉注射後，應在醫院持續監測至少3小時。

‧ 接受Zyprexa Relprevv治療之病人離院時，應有人陪同離開。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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