美国食品药品管理局批准Provenge (sipuleucel-T)，一种新治疗为某些有晚期前列腺癌人用他们自身免疫系统与疾病斗争。FDA的生物制品评价和研究中心执行主任Karen Midthun医学博士说“Provenge为当前可得到有限治疗晚期前列腺癌提供一种新治疗选择”。遗传工程和生物技术新闻称：这标志进入新癌症治疗：自身细胞免疫治疗。
Generic Name and Formulations:
Sipuleucel-T (autologous CD54+ cells activated with PAP-GM-CSF); minimum 50 million cells/dose; suspension for IV infusion.
Company:
Dendreon
Indications for PROVENGE:
Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Adult Dose for PROVENGE:
Autologous use only. Obtain product release from manufacturer, match patient identity on product and Cell Product Disposition form, check expiration date and time on product before infusing. Premedicate 30 minutes before infusion with acetaminophen and antihistamine. Give three doses at 2-week intervals. For each dose: give entire contents of bag by IV infusion over 60 minutes; do not use filter; do not use if clumps do not disperse with gentle mixing. Observe patient for at least 30 minutes after infusion. May interrupt or slow infusion if acute transfusion reaction occurs; do not restart if product at room temp for >3 hours.
Children's Dose for PROVENGE:
Not applicable.
Pharmacological Class:
Autologous cellular immunotherapy.
Warnings/Precautions:
Cardiac or pulmonary conditions. Each dose requires a standard leukapheresis procedure about 3 days before infusion. If scheduled infusion is missed, do an additional leukapheresis procedure if treatment course is to be continued. Risk of disease transmission. Pregnancy, lactation: not applicable.
Interactions:
May be antagonized by concomitant chemotherapy or immunosuppressive therapy.
Adverse Reactions:
Infusion reactions (eg, chills, fever, respiratory events, GI upset, hypertension, tachycardia), fatigue, back pain, joint ache, headache.
Note:
If product sterility tests indicate microbial contamination, manufacturer will contact physician (tests are incomplete at time of infusion).
How Supplied:
Patient-specific bag (250mL)—1
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