Fulphila (Pegfilgrastim): Uses, Benefits, Side Effects, and Safety Information

什么是培非格司亭？

Pegfilgrastim (pronounced [peg fil GRA stim]), which is also known by the brand name Neulasta, is a hematopoietic agent that is used to treat neutropenia. Neulasta was the first medication produced based on the active element pegfilgrastim. Pegfilgrastim is not a hazardous drug, nor is it a form of chemotherapy.

基于 Neulasta，已经生产出几种不同的生物仿制药，其中一种称为 Fulphila。Fulphila 在作用机制、给药途径、强度和剂量方面与 Neulasta 相似。

什么是生物仿制药？

一个 生物类似药 是一种低成本的替代品 biologic medicine that is similar but not identical to the original medicine. There is no clinical difference. Biosimilars are similar to the FDA-approved medicines in their potency, purity, safety, and efficacy, and can be used interchangeably.

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

培非格司亭是一种血细胞集落刺激剂 (CSA)，已被癌症患者成功用于刺激白细胞（更具体地说是中性粒细胞）的生长。它通过直接刺激骨髓中性粒细胞的生成来实现这一目的。

Fulphila如何使用d？

Fulphila 已获得美国食品药品监督管理局 (FDA) 批准，用于治疗和预防化疗或放疗引起的（发热性）中性粒细胞减少症。

可用配方

Fulphila 仅提供皮下注射剂型。该注射剂为一次性预充式注射器，用于皮下注射，剂量为 6 毫克/0.6 毫升。 

注射部位包括臀部上部、大腿前侧、下腹部（距肚脐 2 英寸）或上臂外侧。请勿注射至皮肤敏感、淤青、发红、鳞状或坚硬的部位，并避开有疤痕或妊娠纹的部位。注射后，请勿揉搓注射部位。如果您对乳胶过敏，请勿触摸预充式注射器，也请勿将未使用的药物保留在预充式注射器中以备后用。在接受医疗保健提供者提供的适当培训之前，请勿尝试自行进行皮下注射。

漏服剂量

如果您错过剂量，请立即联系您的医生重新安排。

贮存

将 Fulphila 存放在冰箱中，避免冷冻。如果冷冻，请在使用前在冰箱中解冻。注射前，应将 Fulphila 在室温下解冻（从冰箱中取出）30 分钟。最多可在室温下保存 72 小时。请勿摇晃药瓶，并将其存放在原包装中避光保存。

处理

如果 Fulphila 在室温下放置超过 72 小时，请丢弃。如果 Fulphila 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 Fulphila。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

While on the pegfilgrastim therapy, you must follow some precautions. Always tell your physician about any medications you are already taking. Do not start any new prescription medications or over-the-counter products such as vitamins or herbal supplements without checking with your physician or pharmacist first, as they may interact with Fulphila or affect your blood counts.  Avoid taking Fulphila within 14 days before or 24 hours after having chemotherapy.

怀孕和 Fulphila

孕妇、计划怀孕的女性以及哺乳期女性在开始使用 Fulphila 前必须咨询医生。该药物对胎儿或婴儿的风险尚不清楚。

副作用

As with any other medication, you may encounter side effects while taking pegfilgrastim. Many people have mild or no side effects as the medication is used because its benefits in preventing serious infections are often greater than the risks. A few things to keep in mind are:

• 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。 

When to Call Your Doctor or Get Emergency Help

Some side effects are rare but serious. Call your doctor and get emergency help right away if you notice any of the following:

Injection-Site Pain

大多数针头都会疼痛，但 Fulphila 尤其容易引起注射部位疼痛，即使在注射完成后仍会持续一段时间。此外，注射部位还经常会出现轻微瘀伤、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Fulphila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Fulphila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。

骨骼或肌肉疼痛可以通过服用泰诺或美林等非处方止痛药来控制。在开始任何新的非处方疗法之前，请咨询您的医生或药剂师。

血小板减少症、白细胞增多症

It is essential to keep up with regular blood tests, especially the complete blood count test (CBC). This blood test can detect potential side effects of Fulphila, including:

• 白细胞增多 (a higher-than-normal white blood cell level)
• 血小板减少症 (a lower-than-normal platelet count, which can make you bleed or bruise more easily)

Contact your physician if you notice any unusual bleeding, tiny red or purple spots on the skin, or bruising that appears without a clear reason.

肺部问题，称为急性呼吸窘迫综合征（ARDS）

ARDS is a serious lung condition where your lungs cannot get enough oxygen into your blood. Contact a physician or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.

肾脏损伤

Pegfilgrastim can sometimes affect how your kidneys work. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine, brown-colored urine, or if you notice you urinate less than usual.

毛细血管渗漏综合征（CLS）

Fulphila can rarely cause a problem called capillary leak syndrome, where fluid leaks from your blood vessels into your body’s tissues. CLS can quickly become life-threatening if not treated. Get emergency medical help right away if you develop any of the following symptoms: swelling or puffiness (especially in the arms, legs, or face), urinating less often, trouble breathing, swelling or fullness in the abdominal area, dizziness, or faintness.

血管炎症

如果您的皮肤上出现紫斑或红斑，请联系您的医生。

脾脏破裂

A ruptured spleen is one of the most severe side effects of Fulphila. The spleen, an organ on the upper left side of your abdomen that helps filter your blood, may become enlarged and possibly rupture, which can be life-threatening. Call your doctor right away if you have pain in the upper left stomach (abdomen) area or in your left shoulder.

Common or Less Severe Side Effects:

These side effects are usually mild and go away as your body adjusts to the medication, but tell your doctor if they bother you or don’t improve:

• 出汗
• 深色尿液
  

Remember, most people tolerate Fulphila well, and many side effects are mild or temporary. The main goal of this medication is to help your white blood cell count recover and lower your risk of serious infection. Always contact your doctor, nurse, or pharmacist if you are unsure whether a symptom might be related to Fulphila or if you are worried about how you are feeling.

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。 预充式注射器的针帽含有天然橡胶（源自乳胶）。如果您对乳胶过敏，请勿操作预充式注射器。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 Fulphila，并立即致电医生或寻求紧急救助。
• 患有镰状细胞病的患者。 使用 Fulphila 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 Fulphila。
• 接受放射治疗的患者。 Fulphila may increase the risk of developing a precancerous condition called myelodysplastic syndrome (MDS), which affects how your bone marrow makes blood cells, or a type of blood cancer called acute myeloid leukemia (AML).

常见问题解答

Fulphila 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 Fulphila 则旨在对抗化疗的后遗症。

Fulphila 是如何服用的？

Fulphila 仅提供预充式注射剂。可皮下注射。未经医疗保健提供者的适当培训，请勿自行进行皮下注射。