近日，美国食品药品监督管理局（FDA）批准了Palforzia[Peanut (Arachis hypogaea) Allergen Powder-dnfp]。Palforzia是第一种批准用于花生过敏患者的治疗方法。也是一种口服免疫疗法，可缓解因意外接触花生而发生的过敏反应，包括过敏反应。Palforzia被批准用于确诊为花生过敏的患者。初始剂量递增可能适用于4至17岁的患者。4岁及以上的患者可以继续增加剂量和维持剂量。Palforzia与避免花生的饮食搭配使用。 Palforzia不适用于过敏反应的紧急治疗，包括过敏反应。
批准日期：2020年3月31日 公司：Aimmune Therapeutics, Inc
PALFORZIA（花生过敏原[Peanut(Arachis hypogaea)Allergen Powder-dnfp]）粉剂，口服使用
美国初次批准：2020年
警告：厌气菌有关完整的框内警告，请参阅“完整处方信息”。
•PALFORZIA可能引起过敏反应，可能危及生命，并可能在PALFORZIA治疗期间的任何时间发生。
•开出可注射的肾上腺素处方，指导和培训患者适当的使用方法，并指导患者在使用时立即寻求医疗护理。
•请勿对哮喘未控制的患者服用PALFORZIA。
•过敏反应后可能需要调整剂量。
•在初始剂量递增和每个递增剂量水平的第一剂给药期间和之后，至少要观察患者60分钟。
•PALFORZIA仅可通过称为PALFORZIA REMS的受限制程序使用。
作用机理
Palforzia作用机制尚未建立。
适应症和用途
PALFORZIA是一种口服免疫疗法，可缓解可能发生的过敏反应，包括过敏反应意外接触花生。PALFORZIA已获准用于确诊为花生过敏的患者。初始剂量升级可能适用于4至17岁的患者。
4年后的患者可以继续增加剂量和维持年龄及以上。
PALFORZIA与避免花生的饮食搭配使用。
使用限制：不适用于过敏性疾病的紧急治疗反应，包括过敏反应。
剂量和给药
仅用于口服
•请勿吞服胶囊。
•请勿吸入粉末。
•打开胶囊或小袋，将全部剂量的PALFORZIA粉倒入冷藏或室温下的半固态食品中。
•混合均匀。
•消耗整个体积。初始剂量递增
总剂量          剂量配置
0.5毫克        0.5毫克胶囊/粒
1毫克          1毫克胶囊/粒
1.5毫克        0.5毫克的胶囊/粒；1毫克胶囊/粒
3毫克           3个1毫克胶囊
6毫克          6个1毫克胶囊
加药
每日总剂量     每日剂量配置
3毫克          3个1毫克胶囊
6毫克          6个1毫克胶囊
12毫克       2毫克1毫克胶囊： 10毫克胶囊/粒
20毫克       20毫克胶囊
40毫克       2个20毫克胶囊
80毫克       4个20毫克胶囊
120毫克      1个20毫克胶囊； 1个100毫克胶囊
160毫克      3个20毫克胶囊； 1个100毫克胶囊
200毫克     2个100毫克胶囊
240毫克     2个20毫克胶囊； 2个100毫克胶囊
300毫克     1个300毫克香包
每日总剂量   每日剂量配置
300毫克     300毫克的香囊/盒
剂量形式和强度
口服粉剂有0.5mg 1 mg，10 mg，20 mg和100 mg胶囊或300 mg香囊提供。
禁忌症
•哮喘不受控制。
•嗜酸性粒细胞性食管炎或其他嗜酸性粒细胞性胃肠病的病史。
警告和注意事项
•过敏反应：PALFORZIA可能引起过敏反应。教育患者认识过敏反应的体征和症状。
处方可注射的肾上腺素，指导和培训患者正确使用它的方法，并指导患者在其使用后立即就医。
•哮喘：在开始PALFORZIA之前，请确保哮喘患者的哮喘得到控制。如果患者正在经历急性哮喘发作，则应暂时停用PALFORZIA。尚未对患有严重哮喘的患者进行PALFORZIA研究。
•嗜酸性食管炎：PALFORZIA与嗜酸性食管炎有关。监测患者的体征和症状，如果怀疑是嗜酸性食管炎，应停止PALFORZIA。
•胃肠道反应：如果患者出现慢性或复发性局部胃肠道过敏症状，请考虑调整剂量或中止治疗。
不良反应
在PALFORZIA治疗的受试者中报告的最常见不良反应（发生率≥5％，比安慰剂治疗的受试者高至少5个百分点）是腹痛，呕吐，恶心，口腔瘙痒，口腔感觉异常，咽喉刺激，咳嗽，鼻漏，打喷嚏，喉咙紧绷，喘息，呼吸困难，瘙痒，荨麻疹，过敏反应和耳朵瘙痒。

包装供应/存储和处理方式
PALFORZIA商业包装介绍
购买者见原包装
在2°C至8°C（36°F至46°F）的温度下冷藏。 不要冻结。 存放在原始包装中，直到用于防潮
完整说明资料附件：
https://www.palforzia.com/static/pi_palforzia.pdf
PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp]
Powder for oral administration
Initial U.S. Approval: 2020
IMPORTANT SAFETY INFORMATION
PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.
You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.
You will receive the first dose of all dose increases in a healthcare setting.
In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.
If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.
You will return to the healthcare setting for any trouble tolerating your home doses.
Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:
Trouble breathing or wheezing
Chest discomfort or tightness
Throat tightness
Trouble swallowing or speaking
Swelling of your face, lips, eyes, or tongue
Dizziness or fainting
Severe stomach cramps or pain, vomiting, or diarrhea
Hives (itchy, raised bumps on skin)
Severe flushing of the skin
WHAT IS PALFORZIA?
PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4through 17years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.
PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.
You must maintain a strict peanut-free diet while taking PALFORZIA.
Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk eva luation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.
You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.
Your doctor may decide that PALFORZIA is not the best treatment if:
You are unwilling or unable to receive (or self-administer) injectable epinephrine.
You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.
What are the possible side effects of PALFORZIA?
The most commonly reported side effects of PALFORZIA were: stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.