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Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies
AUDIENCE: Infectious Disease
FDA notified healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems. Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning.
BACKGROUND: Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults.
RECOMMENDATION: The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫護人員，早產兒使用Kaletra (lopinavir/ritonavir)口服液劑已經被報導會有嚴重的健康安全問題。Kaletra口服液劑內含乙醇(alcohol)和丙烯乙二醇(propylene glycol)，且因為早產兒代謝propylene glycol的能力較低，所以對於早產兒的健康安全會有較高的風險，可能會導致一些不良事件如嚴重的心、腎或呼吸問題。因為剛出生的新生兒立即使用Kaletra口服液劑，可能會有嚴重或致死的後果，所以產品標示將加上新的警示。Kaletra口服液劑是一種抗病毒藥品，與其它抗反轉錄病毒藥品併用來治療出生14天以上的嬰幼兒(早產或足月)或成人的HIV-1感染。
在早產兒滿預定出生日後14天內或足月兒14天大以前，都應避免使用Kaletra口服液劑，除非醫護人員認為新生兒出生後立即使用Kaletra口服液劑來治療HIV感染的利益大於風險。在這種案例下，FDA強烈建議要監測血清滲透壓、血清肌氨酸酐及其它毒性症狀。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm246167.htm
[Posted 03/08/2011]
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
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資料來源：藥師週刊（第1724期）
