Cuvitru：您需要了解的内容

Cuvitru (generic name: immune globulin) is derived from 人体血浆 and given to patients with antibody deficiencies to protect against infections. Plasma is an important component of the blood as it serves as its liquid base. 

Plasma is comprised of water, blood clotting factors (mainly fibrinogen), plasma proteins (such as albumin and globulin, which is essential in maintaining the volume pressure in the body), electrolytes (sodium, potassium, chloride, and calcium, all of which are necessary for maintaining blood pH), and immunoglobulins (these help fight infection and contain other enzymes, hormones, and vitamins). [13]   

此药属于 免疫球蛋白 drug class. It is FDA批准 [1] for use as a monotherapy or adjunct therapy with 其他药物.

Cuvitru Therapy

这 免疫球蛋白 solution is administered via subcutaneous infusion only. Cuvitru infusion works by replacing antibodies that are not functioning correctly or not present in the human body to help fight off infections. FDA-approved doses are given to increase extremely low blood immunoglobulin levels to required levels [2].

Cuvitru 适用于：

• Primary Humoral Immunodeficiency (PI) in adults and pediatric patients two years and older (people with inborn lack of antibody generation).
• Blood cancer patients with little antibody production and recurring infections when preventative antibiotics cannot be used [3].
• 骨髓 癌症患者及缺乏抗体且反复感染的患者。
• 移植另一名患者的骨髓细胞后，抗体水平下降。

Cuvitru 副作用

Allergic Reaction Symptoms:

• 皮疹
• 发烧 
• 麻疹
• 瘙痒
• 哮鸣
• 胸闷
• 呼吸困难
• 气促 
• 皮肤红肿 
• 面部和嘴唇肿胀

Symptoms Requiring Urgent Medical Attention:

• 发烧
• 发冷
• 腹胀
• 瘀伤
• 肿胀
• 癫痫
• 腹痛
• 困惑
• 弱点
• 深色尿液
• 咽喉痛
• 情绪波动
• 皮肤或眼睛发黄
• 出汗增多
• 心率异常
• 视力异常
• 言语异常

Urination Abnormalities:

• 体重增加
• 尿液中有血
• 尿频
• 排尿困难

Elevated or Decreased Blood Pressure: 

• 头晕
• 头痛
• 视力模糊

Respiratory Infections and Inflammation Such As:

• 鼻炎
• 鼻窦炎
• 哮喘性支气管炎

无菌性脑膜炎 (May Require Immediate Medical Attention):

• 发烧
• 发冷
• 呕吐
• 落枕
• 头痛
• 胃部不适
• 光敏感度

Injection Site Reactions:

• 瘙痒 
• Mild discomfort [4]
• 皮肤发红

These injection site reactions of Cuvitru infusion usually don’t require medical attention and go away within a few hours.

Injection site reactions of Cuvitru are less likely to occur after repeated use as the body adjusts to the drug.

血栓风险因素

Cuvitru has a 黑匣子警告 由于可能 导致血栓.

如果患者具有以下一个或多个风险因素，则发生血栓的风险会增加：

• 雌激素的使用
• 高龄 
• 久坐的生活方式 
• 高凝状态 
• 既往有血栓病史

可能还有其他因素，鼓励患者与医生讨论。

为预防或降低血栓风险，制造商建议以最低剂量和尽可能低的输注速度进行输注。治疗期间和治疗后，请监测体征和症状。

Cuvitru 计量

Cuvitru is available as: 5 ml, 10 ml, 20 ml, 40 ml, and 50 ml single-dose, ready-to-use vials containing 0.2 grams/ml.

Cuvitru is administered only as a subcutaneous (under the skin) injection using an infusion pump. The sites of administration are the stomach, thigh, upper arm, or side of the hip. Use a different administration site with every dose. Additionally, up to 4 infusion sites can be used at the same time, but make sure each infusion site is at least 4 inches apart from each other.

影响剂量计算的因素：

• 体重
• 病史
• 血液 IgG 水平
• 当前状况
• 治疗的临床反应

Based on these factors, the patient (a child or adult) may be prescribed a loading dose of at least 1.0 – 2.5 ml/kg of body weight divided over a few consecutive days. 

Following this loading dose, patients will start to receive Cuvitru infusions at regular intervals, from daily to once every two weeks.  

The total monthly dose ranges between 1.5 – 5.0 ml/kg of body weight after the loading dose.  

医生可能会随着时间的推移调整剂量以达到所需的临床反应和血清 IgG 水平。 

For patients switching from another IVIG brand, the Cuvitru dose will be based on the previous IVIG dose and adjusted according to the number and frequency of infusions (more on this below). 

不建议在未咨询医生的情况下更改剂量或服药间隔。 

You must speak to the doctor as early as possible if you miss a dose and get a new dosing schedule. Avoid doubling the dosage to catch up.

原发性免疫缺陷（PI）

A patient must receive immunoglobulin (Ig) therapy before receiving Cuvitru for PI. Additionally, a serum immunoglobulin G (IgG) level should be drawn to help guide Cuvitru dosing.

剂量

The starting Cuvitru dose will depend on the previous Ig dose:

• Switching from intravenous Ig (IVIG) to Cuvitru: The weekly Cuvitru dose is calculated by dividing the previous IVIG dose in grams by the number of weeks between doses, then multiplying by 1.3. For example, if the IVIG dose was 30 grams every 4 weeks, the weekly Hizentra dose would be calculated as follows: 30 divided by 4, then multiplied by 1.3, which equals 9.75 g (round up to 10 g) of Cuvitru once per week. 
• Switching from subcutaneous Ig (SCIG) to Hizentra: The weekly Cuvitru dose should be the same as the previous weekly SCIG dose.

Cuvitru should be started 1 week after the previous IVIG or SCIG dose and be given from once daily to up to once every 14 days, as long as the same weekly dose is maintained.

The dose can be adjusted based on clinical response and serum IgG levels.

输注速率

For the first two infusions, don’t use more than a volume of 60 ml per infusion site. The recommended infusion rate is 10-20 ml/hr per infusion site. For subsequent infusions, the infusion rate can be increased to up to 60 ml/hr per infusion site as tolerated.

Cuvitru Uses 

Cuvitru is used to treat: 

• Primary immunodeficiency diseases (PI)
• Idiopathic thrombocytopenic purpura (ITP)
• Chronic immune thrombocytopenic purpura
• Secondary humoral immunodeficiency diseases
• 慢性炎症性脱髓鞘性多发性神经病（CIDP）

此外， Cuvitru infusion is used to boost muscle strength in patients with 多灶性运动神经病（MMN）.

Cuvitru Cost

The cost of Cuvitru 治疗 varies depending on various factors, such as:

• Dispensing pharmacy
• The prescribed dosage
• The insurance provider

This medication is supplied in single-dose glass vials that typically contain 5 ml, 10 ml, 20 ml, 40 ml, and 50 ml protein per vial.

The base cost displayed on different pharmacies’ websites is set by the manufacturer, Takeda Pharmaceutical, exclusive of shipping costs and local tax. 

Depending on the dispensing pharmacy, the price of Cuvitru is nearly $210 (almost $42 per unit) for a supply of 5ml. That makes the total price for 50ml about $2,100 [9].

共同支付援助

Pharmaceutical companies generally sponsor different patient assistance programs (PAPs) to offer free or discounted medications to people who otherwise cannot pay for their drugs.

Takeda’s OnePath 共同支付援助 Program is one such program. It supports patients with Cuvitru prescriptions [10] [11]. Patients must be commercially insured to enroll in this program. 

This program covers certain out-of-pocket treatment costs and assists with navigating the health insurance process. In-house training from trained staff and education and support services are also available.

此外， HelloCUVITRU is a free trial program that covers the entire cost of the first four Cuvitru infusions, together with supplies required for administration [12]. To be eligible for this program, a patient must be two years or older, who was not previously enrolled in this program, and is currently not using the medication.