近日，抗肿瘤化疗副作用新药Neulasta(pegfilgrastim)获美国FDA批准上市。Neulasta在每个化疗疗程中只需要使用一次，主要适应征是用于减低化疗过程中感染的发生率,这种感染常常表现为中性粒细胞减少症相关的发热(即发热与抗感染的白细胞数量的严重下降有关)。中性粒细胞是白细胞的一种，在人体抵抗病原微生物感染中发挥着重要的作用。在非骨髓来源的恶心肿瘤肿瘤患者的化疗过程中，化疗药物也会引起髓系粒细胞的抑制作用，因而会出现中性粒细胞减少症，常常会增加临床中性粒细胞减少症相关的发热的发病率。
中性粒细胞减少症是大多数肿瘤化疗中最常见也是最严重的一种并发症。有超过一半的肿瘤患者会在化疗中出现严重的中性粒细胞减少症，这使得他们极易发生严重的危及生命的感染。平均只有不到10%的患者在化疗前接受过预防中性粒细胞减少症的治疗，研究表明30%-40%未接受此方面预防治疗的化疗患者将会出现带有发热症状的中性粒细胞减少症。每年都有数千患者因为中性粒细胞减少症及其并发症而就医,并且会因此而需要重新住院治疗。
批准日期：2016年8月17日 公司：安进公司
NEULASTA（非格司亭[pegfilgrastim]）注射液，用于皮下注射
美国最初批准：2002年
最近的重大变化
警告和注意事项，主动脉炎：06/2018
警告和注意事项，核成像：06/2018
作用机制
Pegfilgrastim是一种集落刺激因子，通过与特定细胞表面受体结合而作用于造血细胞，从而刺激增殖，分化，定型和终止细胞功能活化。
适应症和用法
Neulasta是一种白细胞生长因子
在患有非骨髓性恶性肿瘤的患者中，接受与临床上显着的发热性中性粒细胞减少症发生率相关的骨髓抑制性抗癌药物，降低感染的发生率，如发热性胃减少所表现的。
增加急性接受骨髓抑制剂量辐射（急性放射综合征造血亚综合征）的患者的存活率。
使用限制
Neulasta不适用于动员外周血祖细胞用于造血干细胞移植。
剂量和给药
癌症患者接受髓鞘
o抑制性化疗6 mg每个化疗周期皮下注射一次。
o在细胞毒性化学疗法给药前14天和24小时之间不要给药。
o对体重小于45 kg的儿科患者使用基于体重的剂量;参见表1。
患者急性接受骨髓抑制剂量的放射治疗
o两次剂量，每次6毫克，皮下注射一周。在怀疑或确认暴露于放射性抑制剂量的辐射后，尽快给予第一剂，并在一周后给予第二剂。
o对体重小于45 kg的儿科患者使用基于体重的剂量;参见表1。
剂量形式和强度
注射：单剂量预充式注射器中的6mg/0.6mL溶液仅供手动使用。
注射：在单剂量预充式注射器中加入6mg/0.6mL溶液
与Neulasta的体内注射器共同包装。
禁忌症
对人粒细胞集落刺激因子如pegfilgrastim或非格司亭有严重过敏反应史的患者。
警告和注意事项
致命性脾破裂：评估报告左上腹部肩部疼痛，脾脏肿大或脾破裂的患者。
急性呼吸窘迫综合征（ARDS）：评估患有发热，肺部浸润或呼吸窘迫的患者。停止ARDS患者的Neulasta。
严重的过敏反应，包括过敏反应：在患有严重过敏反应的患者中永久性地停用Neulasta。
Neulasta的体上注射器使用丙烯酸粘合剂。对于对丙烯酸粘合剂有反应的患者，使用本产品可能会产生明显的反应。
致命的镰状细胞危象：已经发生过。
肾小球肾炎：如果可能存在因果关系，评估并考虑Neulasta的剂量减少或中断。
潜在的设备故障：指示患者如果怀疑体上注射器可能没有按预期进行，则通知他们的医疗保健提供者。
不良反应
最常见的不良反应（与安慰剂相比，发病率差异≥5％）是骨痛和四肢疼痛。
包装提供/存储和处理
Neulasta单剂量预充式注射器，用于手动使用
Neulasta注射液是一种透明，无色的溶液，由预装的单剂量注射器提供，供手动使用，含有6 mg pegfilgrastim，配有27号，1/2英寸针头和UltraSafe®针头护罩。
预装注射器的针帽含有干燥的天然橡胶（乳胶的衍生物）。
Neulasta以包含一个无菌6mg/0.6mL预装注射器的分配包装提供
（NDC 55513-190-01）。
Neulasta预充式注射器不带刻度标记，仅用于输送注射器的全部内容物（6 mg/0.6mL），以便直接给药。对于体重小于45 kg且需要小于注射器全部剂量的儿科患者，建议不要使用预充式注射器直接给药。
将冷藏温度保存在纸箱中36°F至46°F（2°C至8°C）之间，以避免光照。别摇了。 Discardsyringes在室温下储存超过48小时。避免冻结;如果冷冻，在给药前在冰箱中解冻。如果冷冻不止一次，请丢弃注射器。
完整说明资料附件：
https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/neulasta/neulasta_pi_hcp_english.ashx
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包装规格[以下美国上市包装产品，不同规格和不同价格，采购者以咨询为准]
NEULASTA 6MG/0.6ML PFS 1/PAC  PEGFILGRASTIM  "AMGEN USA, INC."  55513-0190-01      
NEULASTA PFS 6MG SINGLE 0.6ML PEGFILGRASTIM  AMGEN USA INC  55513-0190-01          
NEULASTA 6MG/0.6ML DELIVERY KIT 1/EA PEGFILGRASTIM  "AMGEN USA, INC."  55513-0192-01
NEULASTA ONPRO KIT  PEGFILGRASTIM  AMGEN USA INC  55513-0192-01  
Neulasta®
Class: Supportive care
Generic Name: Pegfilgrastim (peg-fill-GRASS-tem)
Trade Name: Neulasta®
For which conditions is this drug approved? Neulasta® has been FDA approved to decrease the risk of infection associated with treatment for cancer. Specifically, Neulasta® is approved for patients being treated for non-hematologic cancers with agents that are associated with causing low white blood cell levels, a condition that leaves patients susceptible to potential life-threatening infections. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Neulasta® belongs to a group of drugs called colony stimulating factors. Neulasta® stimulates the growth of neutrophils, a type of white blood cell, which are important immune cells that fight infection caused by bacteria, viruses or fungus. Neutrophils can be damaged by chemotherapy and leave patients susceptible to severe infection. Neulasta® works by binding to areas on immature blood cells, which stimulates the blood cells to grow, reproduce and mature into neutrophils. Neulasta® is a long-acting form of another commonly used colony stimulating factor, Neupogen® (filgrastim), meaning it stays active in the body for a longer time than Neupogen®.
How is Neulasta® typically given (administered)? Neulasta® is given as a subcutaneous (under the skin) injection and comes in prefilled syringes. The recommended dose of Neulasta® is a prefilled syringe (6 mg) once per chemotherapy cycle. Neulasta® should not be given to infants, children, or adolescents weighing less than 45 kilograms.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Neulasta®.  Typically, blood will be drawn to check levels of white blood cells.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with Neulasta®?
There are no known common side effects attributable to Neulasta®.
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Neulasta®?
• Bone pain
• Changes in some laboratory tests, which tend to normalize following treatment
• Soreness or tenderness at the injection site
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Since Neulasta® is typically given with chemotherapy agents that are associated with causing low neutrophil levels, much of the following pertains to precautions that should be taken to minimize the risk of infection. However, all chemotherapy agents are associated with individual risks.
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as chemotherapy drugs may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• If Neulasta® is being administered at home, patients should make sure that they know how to safely store the drug and dispose of needles.
• Patients should not skip getting their blood drawn – important information, including responses to Neulasta® as well as to therapy, is obtained from these blood tests.
Are there special precautions patients should be aware of before treatment with Neulasta®?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should tell their physician if they had any reactions to prior therapy with Neupogen®.
When should patients notify their physician?
• Pain in the left side of the abdomen
• Pain in the left shoulder tip
• Fever
• Difficulty breathing
• Signs of allergic reaction (hives, skin rash, difficulty breathing, wheezing, facial swelling, fast pulse, sweating, low blood pressure)
• Signs of infection (fever, chills, cough, sore throat, redness, swelling)
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Copyright © 2010 CancerConnect Last updated 07/10.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
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