Alymsys 用于癌症治疗：用途、作用机制和副作用

Alymsys (bevacizumab-maly) is a cancer medicine that inhibits tumor growth by limiting the blood supply that cancer cells need to grow and spread. This cancer-targeted drug is typically prescribed to treat various types of cancer, including brain tumors, colorectal cancer, kidney cancer, and many other forms of cancer. 

In 2022, Alymsys was approved in the United States as a 生物仿制药 到 Avastin (a branded drug) because it works the same way as Avastin (bevacizumab) but is less expensive than the brand drug. 

Alymsys is given as an IV infusion. You may experience high blood pressure, headache, or nosebleed during treatment with Alymsys. Read on to learn its uses, how it works, recommended dosage, possible side effects, and precautionary measures.  

Alymsys: FDA-Approved Uses

Alymsys is approved to treat adult patients with any of the following types of cancers:

• Metastatic colorectal cancer 
• Persistent, recurrent, or metastatic cervical cancer
• Metastatic or advanced non-small cell lung cancer
• Metastatic renal cell carcinoma (kidney cancer)
• Recurrent glioblastoma (a type of brain tumor)
• Ovarian, fallopian tube, or primary peritoneal cancer

Alymsys can be given alone or together with other anticancer treatments like chemotherapy or immunotherapy.

Alymsys: Working Mechanism

Alymsys (bevacizumab-maly) is a monoclonal antibody and belongs to the vascular endothelial growth factor (VEGF) inhibitor drug class. This monoclonal antibody (bevacizumab-maly) is specifically designed to target and block the VEGF activity. 

VEGF is a protein that is released by cancer cells to create new blood vessels within the tumor. These blood vessels provide the tumor with nutrients and oxygen to grow and spread rapidly. 

When Alymsys is infused in the body, it blocks the VEGF activity. As a result, tumor growth slows down due to limited blood supply. 

Drug Forms

Alymsys comes in the form of an injection solution in single-dose vials: 

• 100mg /4 ml (25 mg/ml) 
• 400 mg/16 ml (25 mg/ml)

推荐剂量

Dosage varies depending on cancer type, treatment regimen, and individual patient factors. Refer to the prescribing information for complete dosing recommendations. 

1. 转移性结直肠癌（mCRC）

The recommended dosage when Alymsys is administered in combination with intravenous fluorouracil-based chemotherapy is:

• 5 mg/kg IV every 2 weeks with bolus-IFL chemotherapy 
• 10 mg/kg IV every 2 weeks with FOLFOX4 

After progression, patients may receive a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks. 

2. Non-Small Cell Lung Cancer (NSCLC)

For patients with NSCLC, a dose of 15 mg/kg is given intravenously every 3 weeks in combination with carboplatin and paclitaxel. 

3. 复发性胶质母细胞瘤

For patients with recurrent glioblastoma, a dosage of 10 mg/kg is administered intravenously every 2 weeks.

4. Metastatic Renal Cell Carcinoma

The recommended dosage for patients with kidney cancer is 10 mg/kg, given intravenously every 2 weeks in combination with interferon alfa.

5. Persistent, Recurrent, or Metastatic Cervical Cancer

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

6. Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan. 

Alymsys: Administration Process

Alymsys is administered by a healthcare professional via IV infusion (the drug is delivered directly into your vein). The Alymsys infusion process usually takes 1.5 hours to complete. 

The first infusion will be given to you over 90 minutes. If this is well-tolerated, the second infusion may be given over 60 minutes. Later, all subsequent infusions from that point until the end of your treatment may be administered over 30 minutes. 

笔记： Alymsys should be stopped at least 28 days before surgery or not restarted until at least 28 days after major surgery and adequate wound healing.

可能的副作用

Here is a list of common and potentially adverse effects you may experience with Alymsys treatment. 

常见副作用

The most common side effects of Alymsys include:

• 高血压
• 头痛
• Nose bleeds
• Tiredness or asthenia (weakness)
• Diarrhea and abdominal (belly) pain
• Cold symptoms (i.e., congestion or runny nose, or itching)
• High levels of protein in the urine (proteinuria) 
• 眼睛干涩或流泪
• Dry or flaky skin
• 口味变化
• Peeling or blistering skin

不良反应

Though it’s rare, Alymsys can also possibly cause serious side effects like:

• Gastrointestinal perforation (hole in the gut wall)
• Fistulas (abnormal openings between organs or tissues that may cause drainage, infection, or pain). 
• Hemorrhage (bleeding) 
• Arterial thromboembolism (blood clots in the arteries)
• 充血性心力衰竭
• Serious kidney problems
• 伤口愈合不良
• 卵巢衰竭
• Coughing or spitting blood
• Confusion, blindness, or any other changes in vision and brain functions
• High fevers or chills
• Hypertensive encephalopathy
• Renal injury
• 胚胎-胎儿毒性 
• 肾病综合征
• Serious infusion reactions (such as trouble breathing, itching or hives, flushing, swelling, chest pain, fast heartbeat, dizziness, fainting)

笔记： You might receive Alymsys along with other medications. If so, ask your provider what side effects you might expect from other anticancer medications you’re taking.

Alymsys: Precautionary Measures

Before receiving Alymsys infusion, tell your doctor if you:

• Have had major surgery within the last month, or problems with wound healing
• Plan to have surgery within the next 4 weeks (28 days)
• Have had any other health problems, such as diabetes, kidney disease, heart problems, high blood pressure, or bleeding problems, or a perforation (a hole or tear) in your esophagus, stomach, or intestines
• Are pregnant, plan to become pregnant, or plan to start a family in the future 
• Are breastfeeding or plan to breastfeed. Do not breastfeed while using this medicine and for at least 6 months after your last dose. 

成本

Since Alymsys is a biosimilar of Avastin, it is generally considered a more cost-effective option. But the pricing of this drug may also vary based on dosage, treatment schedule, healthcare facility, and insurance coverage. 

In the United States, the estimated cash price is approximately $700 for a 100 mg/4 ml vial and around $2,800 for a 400 mg/16 ml vial. Therefore, the overall treatment costs may increase due to repeated IV infusions over several months. 联系我们 如果您对经济援助感兴趣，或者 copay assistance for Alymsys.