培非格司亭（Neulasta）

什么是 Pegfilgratism (Neulasta)？

Pegfilgrastim (pronounced [peg fil GRA stim]), which is also known by the brand name, Neulasta, is a medication that helps your body make more white blood cells. It’s used to raise the white blood cell count in people who receive certain chemotherapy or are exposed to high doses of radiation, which can both lower the white blood cell count. Neulasta was the first medication produced based on the active element pegfilgrastim. Pegfilgrastim is not chemotherapy. Clinics may still have special safety rules for handling any medication—follow your clinic’s rules. Several different biosimilars based on Neulasta have been produced to date. Common U.S. biosimilars include Fulphila, Udenyca, Ziextenzo, Nyvepria, Stimufend, and Fylnetra.

什么是中性粒细胞减少症？

中性粒细胞减少症发生在 中性粒细胞中性粒细胞减少症是一种白细胞，它帮助我们的身体抵抗感染。中性粒细胞减少症表明罹患严重细菌和真菌感染的风险更高。中性粒细胞减少症是接受化疗的癌症患者非常常见的副作用。

发热性中性粒细胞减少症是一种更为严重的疾病，中性粒细胞计数会降至危险的低水平，导致白细胞数量不足以抵抗感染。这可能会导致危及生命的感染。

作用机制

Pegfilgrastim binds (attaches) to the granulocyte colony-stimulating factor (G-CSF) receptor to stimulate the bone marrow to make and release more infection-fighting neutrophils.

Neulasta 如何使用？

可用配方

Neulasta is given as an injection under the skin. It is available as a prefilled syringe and as the Onpro on-body injector (OBI) that gives the dose later. Neulasta injection is available as a single-use prefilled syringe for subcutaneous injection at a dose of 6 mg/0.6 ml. (Children and adults with very low body weight may get different doses—your care team will guide this.)

皮下注射

You can inject into the stomach (at least 2 inches from the belly button), front of the thighs, upper outer arms, or upper outer buttocks. Don’t use spots that are sore, red, bruised, scarred, or hard. Don’t rub the injection site after the dose is given. The needle cap has dry natural rubber (a kind of latex). If you’re allergic to latex, don’t handle the capped syringe. You should not attempt to give yourself a subcutaneous injection until you have received the appropriate training from your healthcare provider.

专用皮肤贴片（体内注射器，OBI）

The Onpro device is set to give your dose about 27 hours after it’s put on, which is at least 24 hours after chemo. This is convenient for many patients because it saves them a trip to the doctor’s office the day after receiving chemotherapy.

If the device beeps, flashes, or you think it didn’t give the full dose, call your clinic right away. They may give you a replacement shot.

漏服剂量

如果您漏服一剂，请立即联系您的医生重新安排。如果OBI发生故障，无法按时送药，请立即咨询您的医生，并尽快安排手动注射。

贮存

Store Neulasta in the refrigerator and avoid freezing. If frozen, thaw in the refrigerator before use. For the prefilled syringe, take it out of the fridge for about 30 minutes before the shot. Throw it away if it has stayed at room temperature for more than 48 hours. Do not shake the vials, and keep them protected from light by storing them in their original containers. The OBI kit should be kept refrigerated until 30 minutes prior to use and should not be left at room temperature for more than 12 hours.

处理

如果 Neulasta 注射器在室温下放置超过 48 小时，或 OBI 试剂盒在室温下放置超过 12 小时，请丢弃。如果 Neulasta 冷冻超过一次，也请丢弃。注射后，请丢弃预充式注射器中剩余的 Neulasta。务必将预充式注射器丢弃至 FDA 批准的锐器处理容器中（请勿丢弃至生活垃圾）。

服用培非格司亭期间应避免什么

在接受培非格司亭治疗期间，您必须遵循一些预防措施。请务必告知您的医生您正在服用的任何药物。 未经医生或药剂师事先同意，请勿服用任何药物（即使是草药或非处方药）, 因为它们可能与 Neulasta 有相互作用。 避免在化疗前 14 天或化疗后 24 小时内服用 Neulasta。

怀孕和 Neulasta

Pregnant women, women who are planning to become pregnant, and breastfeeding women must consult a physician prior to initiating Neulasta. There isn’t much information on pregnancy or breastfeeding. Talk with your provider to discuss the medication’s risks and benefits for you and your baby.

副作用

与任何其他药物一样，服用培非格司亭可能会出现副作用。以下几点需要注意：

• 您可能不会出现以下列出的所有副作用。许多人可能几乎没有副作用。
• 副作用的严重程度可能因人而异，因此不要将您的副作用与其他人的经历进行比较。
• 停止治疗后，大多数副作用都会改善。
• 不要隐瞒任何症状；当您感到任何不适时，请毫不犹豫地告诉您的医生或药剂师。

笔记：以下列出的副作用并非所有副作用的完整列表。如有任何疑问，请咨询您的医生。 

Neulasta 的一些更严重的副作用包括：

Injection-Site Pain

大多数针头都会疼痛，但 Neulasta 尤其以注射部位疼痛而闻名，即使在注射完成后仍会持续一段时间。此外，注射部位还经常出现轻微瘀伤、肿胀或发红。

Injection site pain can be controlled using over-the-counter painkillers such as Tylenol or Motrin, but usually, it resolves on its own within a few days. Consult your doctor or pharmacist prior to starting any new over-the-counter therapies.

骨骼和肌肉疼痛

这是Neulasta最常见的副作用，因为它会刺激骨髓（骨骼内部的海绵状物质），导致骨髓肿胀并引发潜在的骨痛。这种副作用通常在服用Neulasta后约1至2天出现，并可能持续长达一周，具体取决于个人情况。

Bone or muscle pains can be controlled using over-the-counter painkillers such as Tylenol or Motrin. Consult your doctor or pharmacist before starting any new over-the-counter therapies. Some people try an antihistamine (like loratadine) for bone pain. Ask your provider first to see if this is right for you. Keep in mind that it doesn’t work well for everyone.

血小板减少症、白细胞增多症

Your provider may check your blood cell counts. Sometimes white blood cells get very high, or platelets get low.

肺部问题，称为急性呼吸窘迫综合征（ARDS）

如果您出现呼吸急促（无论是否发烧）、呼吸困难或呼吸频率过快，请立即联系医生或寻求紧急医疗救助。

肾脏损伤

Kidney swelling (glomerulonephritis) can happen. Call your provider if you have puffy face/ankles, blood in urine, or are urinating less.

毛细血管渗漏综合征（CLS）

Neulasta 会导致液体从血管泄漏到身体组织中。 CLS 可能迅速导致您出现危及生命的症状。如果您出现以下任何症状，请立即寻求紧急医疗救助：肿胀或浮肿、排尿减少、呼吸困难、腹部肿胀以及饱胀感、头晕或昏厥。

血管炎症

Aortitis (swelling of a big artery) can happen. Call your provider for fever, tiredness, or deep belly/back pain.

脾脏破裂

脾脏破裂是Neulasta最严重的副作用之一。脾脏可能会肿大，甚至破裂，这可能致命。如果您感到左上腹部或左肩疼痛，请立即就医。

笔记： Serious allergic reactions can happen—rash, wheeze, face swelling, or trouble breathing, call 911. People with sickle cell disease can have a severe crisis—get help right away if you have new pain or trouble breathing.

Less severe, milder side effects include bone pain, arm/leg pain, tiredness, headache, nausea, and redness at the injection site.

不太严重的副作用包括：

• 出汗
• 深色尿液

防范措施

除非得到医生的批准，否则通常不建议将培非格司亭用于以下情况：

• 对人类粒细胞集落刺激因子 (CFS) 过敏的患者，例如 非格司亭 或培非格司亭产品。 过敏反应可能导致全身皮疹、呼吸急促、喘息、头晕、口周或眼周肿胀、心率加快和出汗。如果您出现任何这些症状，请停止使用 Neulasta，并立即联系医生或寻求紧急救助。
• 患有镰状细胞病的患者。 使用 Neulasta 可能会导致一种称为镰状细胞危象的病症，这种病症可能危及生命并需要停止使用 Neulasta。
• 接受放射治疗的患者。 In some people with breast or lung cancer, using pegfilgrastim with chemo and/or radiation has been linked to a higher risk of certain blood cancers (MDS/AML). Your team will watch for signs.

常见问题解答

Neulasta 是化学药剂吗？

不，它不是化疗药物。相反，它有助于治疗化疗的主要副作用——中性粒细胞减少症（白细胞计数低）。 化疗药物 旨在对抗癌细胞，而 Neulasta 则旨在对抗化疗的后遗症。

Neulasta 是如何服用的？

Neulasta 仅提供注射剂。它可以皮下注射（皮下），也可以作为专用皮肤贴剂（也称为 体内注射器 [OBI] or Neulasta OnPro) programmed by a healthcare provider. You should not attempt to give yourself a subcutaneous injection until you have received the appropriate training from your healthcare provider. Make sure your dose is at least 24 hours after chemo and not within the 14 days before your next chemo.