克拉屈滨（Mavenclad）：用途、作用机制和副作用

Cladribine (brand name: Mavenclad) is an oral prescription medication used to treat adults with relapsing forms of multiple sclerosis (MS). Unlike many MS medications that require continuous treatment, Mavenclad is taken in two yearly treatment courses designed to provide long-lasting disease control. Because of its potential risks, Mavenclad is generally prescribed when another MS treatment has not worked well or cannot be tolerated. Read on to learn how Mavenclad works, its uses, recommended dosage, possible side effects, and cost. 

Note: This article is about cladribine tablets, sold under the brand name Mavenclad. Cladribine injection, sold under the brand name Leustatin, is used to treat cancer of the blood and bone marrow. 

克拉屈滨（Mavenclad）简介及用途

Mavenclad是一种处方药品牌名称。其活性成分是克拉屈滨，一种嘌呤类抗生素。 抗代谢物 其作用机制是通过减少参与多发性硬化症的某些免疫细胞。. 

美国食品药品监督管理局 (FDA) 于 2019 年批准克拉屈滨片用于治疗复发型多发性硬化症成人患者。由于 Mavenclad 存在严重风险，包括增加患癌风险和胎儿损伤风险，因此通常仅用于对其他多发性硬化症治疗反应不佳或无法耐受的患者。. 

Mavenclad 为 10 毫克口服片剂。片剂为圆形，颜色为白色至类白色。. 

Mavenclad 不建议用于症状类似多发性硬化症但未达到多发性硬化症诊断标准的人。. 

克拉屈滨（Mavenclad）作用机制

克拉屈滨治疗多发性硬化症的确切作用机制尚未完全阐明。据生产商称，其作用机制是通过减少免疫细胞的数量，特别是巨噬细胞。 B细胞和T细胞, 这些免疫细胞会导致炎症，并损伤神经的保护层（髓鞘）。Mavenclad 通过减少这些免疫细胞的数量，帮助降低疾病活动度和复发率。治疗后，免疫系统会随着时间推移逐渐重建。. 

克拉屈滨（Mavenclad）的疗效如何？

临床研究表明，Mavenclad 可显著降低复发型多发性硬化症患者的疾病活动度。在 III 期 CLARITY 临床试验中，接受 Mavenclad 治疗的患者与接受安慰剂的患者相比，复发次数更少，新出现的脑部 MRI 病灶更少，残疾进展也更慢。由于该疗法采用两年疗程而非持续用药，许多患者无需每日服药即可获得持久疗效。您对治疗的反应取决于多种因素，例如疾病严重程度、既往治疗史和整体健康状况。.

Important Cladribine (Mavenclad) Warnings

This medication may increase the risk of cancer and harm an unborn baby (fetus). 

Risk of cancer

Taking cladribine tablets may make you more likely to develop cancer. Discuss the risk with your healthcare provider. Ask your healthcare provider if you need cancer screening. 

Risk of harm to the fetus

If you are a female who is able to get pregnant, your healthcare provider will order a pregnancy test before each treatment course. 

Taking cladribine tablets during pregnancy may cause birth defects or the loss of pregnancy. Don’t take this medication if you are pregnant or plan to get pregnant. If you become pregnant during treatment with cladribine, stop the treatment and call your healthcare provider right away. 

Hormonal contraceptives, including birth control pills, may not completely prevent pregnancy when used with cladribine tablets. Thus, use another birth control method along with the hormonal contraceptives during treatment and for at least 6 months after the final dose of each treatment course. 

If you are a male with a female partner who can get pregnant, use an effective method of birth control during treatment and for at least 14 weeks after the final dose of each treatment course. 

Before Taking Cladribine (Mavenclad) Tablets

Don’t take this medication if you:

• Have cancer 
• Have HIV, 结核 (TB), hepatitis, or any other active infection
• Are allergic to cladribine or any other product component
• Are breastfeeding or pregnant

Before you receive your first dose of cladribine, inform your provider if you:

• Suspect you have an infection
• Have heart, liver, or kidney problems
• Have cancer or had it in the past
• Have used, currently use, or plan to use medications that affect the immune system or blood cells
• Have used, currently use, or plan to use other medications for multiple sclerosis
• Have recently been vaccinated or are scheduled to get vaccinated (vaccination with live or live-attenuated vaccines within 4 to 6 weeks before, during, or after treatment with cladribine is not usually recommended)
• 已怀孕或计划怀孕
• Are breastfeeding or plan to breastfeed (Avoid breastfeeding during and for 10 days after the final dose of the treatment cycle)

克拉屈滨（Mavenclad）剂量 

您的医疗保健提供者将根据您的体重确定剂量。Mavenclad 的治疗疗程为两个年度疗程。每个疗程的推荐总剂量为 1.75 mg/kg。每个疗程分为两个治疗周期。. 

第一疗程（第一年）

治疗周期 1：每天服用一次推荐剂量，连续服用 4 至 5 天。. 

治疗周期 223至27天后重复给药。. 

第二疗程（第二年）

治疗周期 1：在第一个疗程的第二个周期最后一次给药后至少 43 周内，每天服用一次推荐剂量，连续服用 4 至 5 天。. 

治疗周期 2： 23至27天后重复给药。. 

正确使用

• 严格按照医嘱服用Mavenclad。每日服用量不得超过两片。. 
• 打开包装后立即吞服整片药片。.
• 请勿压碎、咀嚼或掰开药片。.
• 您可以随餐或不随餐服用此药。. 
• 严格按照医嘱完成每个治疗周期，并在对治疗方案进行任何更改之前咨询您的医疗保健提供者。. 
• 处理药片时请保持双手干燥。服用药片后，请立即彻底洗手。. 

• 尽量减少药片与皮肤的直接接触。不要触摸鼻子、眼睛和其他身体部位。. 
• 如果药片接触到物体表面，请立即用水冲洗该表面。.
• 服用本剂量药物时，请与其他口服药物至少间隔 3 小时。.
• 如果漏服一次，请在当天想起后立即补服。如果已过一天，则在第二天补服。切勿同时服用两剂。. 

Monitoring During Treatment

Your healthcare provider will monitor you before and during treatment to help ensure Mavenclad is safe and effective. This may include blood tests to check your lymphocyte (white blood cell) count, liver function, and kidney function. You will also be screened for infections such as tuberculosis, hepatitis, and HIV before starting treatment. Women who can become pregnant will need a pregnancy test before each treatment course.

Cladribine (Mavenclad) Side Effects

常见副作用

• 上呼吸道感染
• 白细胞计数低
• 头痛

Talk to your healthcare provider or pharmacist if any side effects worsen or persist. 

严重的副作用

Call your healthcare provider immediately or seek emergency care if you have:

• 发烧、喉咙痛、发冷、肌肉疼痛、咳嗽或其他感染迹象
• 咳嗽、胸痛、咳血或咳痰、疲倦、体重减轻、食欲不振、畏寒、发烧、盗汗
• 伴有水疱的疼痛性皮疹
• 皮肤出现灼烧感、刺痛感、麻木感或瘙痒感
• 皮疹、呼吸或吞咽困难、面部、嘴唇、舌头或喉咙肿胀
• 发冷、发烧、恶心、呕吐、背部、侧腹或腹股沟疼痛、尿频尿痛
• 异常出血或瘀伤
• 身体一侧无力、手臂或腿部协调性丧失、力量下降、平衡障碍、意识混乱、视力、思维、记忆或性格改变
• 呼吸急促、心跳加快、头痛、头晕、皮肤苍白、意识混乱、疲倦
• Nausea, vomiting, extreme tiredness, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark urine
• 呼吸急促、心跳过快或不规则、身体某部位肿胀

Cladribine (Mavenclad) Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Ask your insurance provider whether your plan covers this medication or requires prior authorization. 

Many insurance plans, including Medicare Part D and commercial insurance plans, cover Mavenclad, although prior authorization is often required. Depending on your insurance coverage, you may still have copays or coinsurance. Your healthcare provider or specialty pharmacy can help verify your benefits and estimate your out-of-pocket costs before treatment begins. 

EMD Serono, Inc., a subsidiary of Merck, provides financial and treatment support to patients through its MS LifeLines support service. 

If you are eligible and have commercial insurance, you may qualify for the MS LifeLines Co-Pay Assistance Program. To learn more, 联系我们 如果您对经济援助感兴趣，或者 copay assistance for cladribine.

结论

Mavenclad is an effective oral treatment option for certain adults with relapsing forms of multiple sclerosis. Although it is taken for only two yearly treatment courses, careful monitoring is necessary because of its potential risks, including infections, cancer, and fetal harm. If you’re considering Mavenclad, talk with your healthcare provider about whether its benefits outweigh the risks for your specific situation.