通用中文 | 苯达莫司汀注射剂 | 通用外文 | Bendamustine Hydrochloride |
品牌中文 | 品牌外文 | Levact | |
其他名称 | TreandaPZN: 09083140 | ||
公司 | Mundi(Mundi) | 产地 | 德国(Germany) |
含量 | 100mg/瓶 2.5mg/ml | 包装 | 5瓶/盒 |
剂型给药 | 粉针剂 | 储存 | 室温 |
适用范围 | 何杰金病;非何杰金淋巴瘤;浆细胞瘤(多发性骨髓瘤);慢性淋巴细胞白血病(CLL);乳腺癌。 |
通用中文 | 苯达莫司汀注射剂 |
通用外文 | Bendamustine Hydrochloride |
品牌中文 | |
品牌外文 | Levact |
其他名称 | TreandaPZN: 09083140 |
公司 | Mundi(Mundi) |
产地 | 德国(Germany) |
含量 | 100mg/瓶 2.5mg/ml |
包装 | 5瓶/盒 |
剂型给药 | 粉针剂 |
储存 | 室温 |
适用范围 | 何杰金病;非何杰金淋巴瘤;浆细胞瘤(多发性骨髓瘤);慢性淋巴细胞白血病(CLL);乳腺癌。 |
商品名称: Treanda
通用名称: 苯达莫司汀注射剂
英文名称: Bendamustine Hydrochloride
汉语拼音: Yansuanbendamositingzhusheji
【适 应 症】主要应用于单独或与其它抗肿瘤药物联合用药来治疗下列恶性肿瘤:何杰金病;非何杰金淋巴瘤;浆细胞瘤(多发性骨髓瘤);慢性淋巴细胞白血病(CLL);乳腺癌。
【药理特点】盐酸苯达莫司汀(Bendamustine Hydrochloride)是一种双功能基烷化剂,具有抗肿瘤和杀细胞作用。本品的抗肿瘤和杀细胞作用主要归功于DNA单链和双联通过烷化作用交联,这打乱了DNA的功能和DNA的合成,也会使DNA和蛋白之间,以及蛋白和蛋白之间产生交联,从而发挥抗肿瘤作用。本品作为单用或联合化疗,对何杰金氏淋巴瘤和非何杰金氏淋巴瘤的治疗反应率分别为61%~97%和41%~48%。
【用法用量】本品用于何杰金病、非何杰金淋巴瘤、多发性骨髓瘤、CLL和乳腺癌。其剂量血癌为50~60mg/m2/d,3~5天或每3~4周为100~120mg/m2;实体瘤每4周为120~150mg/m2,每日1次,30~60min静脉滴注。盐酸苯达莫司汀作为单用或联合化疗,对何杰金病和非何杰金淋巴瘤的治疗反应率分别为61%~97%和41%~48 %。对多发性骨髓瘤病人,苯达莫司汀/泼尼松治疗的完全反应率较高(32%),美法仑/泼尼松疗法反应更持久。在环磷酰胺、长春新碱、泼尼松治疗方案中,苯达莫司汀取代环磷酰胺,对发展中低度毒性非何杰金淋巴瘤有相似的反应率。在环磷酰胺、甲氨蝶呤、氟尿嘧啶治疗方案中,苯达莫司汀取代环磷酰胺,使转移性乳腺癌病人的缓解期从6.2个月延长至15.2个月。
苯达莫司汀治疗CLL时,以28天为一个治疗周期,一般需要6个治疗周期。在每个治疗周期的第一天和第二天给药,推荐剂量为100mg/m2。该药经静脉滴注给药,每次给药时间不应少于30分钟。
苯达莫司汀治疗NHL时,以21天为一个治疗周期,一般需要8个治疗周期。在每个治疗周期的第一天和第二天给药,推荐剂量为120mg/m2。每次给药时间不应少于60分钟。
【配制流程】该药每100mg须先溶于20ml无菌注射用水,充分振摇直到完全溶解成澄清、无色或淡黄色溶液,溶解时间一般不超过5分钟,溶解后浓度为5mg/ml。在溶解后30分钟之内,根据需要抽取适量苯达莫司汀水溶液,转移至500ml氯化钠注射液(0.9%)或葡萄糖氯化钠注射液(2.5%/0.45%)中,并确保苯达莫司汀在注射液中的最终浓度在0.2~0.6mg/ml之间。配制好的注射液可在2~8℃冷藏保存24小时,或在室温及自然光下保存3小时。
盐酸苯达莫司汀作为新一代抗癌药物,对多种癌症具有明显的治疗作用。临床应用表明,本品单独治疗或联合用药治疗非何杰金淋巴瘤、多发性骨髓瘤、CLL和乳腺癌等,疗效确切,明显降低复发率与死亡率,而且不良反应小,安全性好。
【规格】注射用:25mg/瓶;100mg/瓶
【贮藏】该药储存温度不应超过30℃,避光保存,使用前临时配制。
【生产企业】美国Cephalon公司
What is Treanda?
Treanda (bendamustine) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Treanda is used to treat chronic lymphocytic leukemia.
Treanda is also used to treat indolent B-cell non-Hodgkin lymphoma after other medicines have been tried without successful treatment of this condition.
Important information
Before you receive Treanda, tell your doctor if you have a weak immune system, fever or other signs of infection, a metabolic disorder or electrolyte imbalance, liver or kidney disease, or if you smoke.
Tell your caregiver right away if you have a fever, chills, itching, or a skin rash during or shortly after the injection.
Treanda can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).
Before taking this medicine
You should not be treated with Treanda if you are allergic to bendamustine or mannitol (Osmitrol).
To make sure Treanda is safe for you, tell your doctor if you have:
a weak immune system;fever or other signs of infection;a metabolic disorder or electrolyte imbalance;liver disease;kidney disease; orif you smoke.
Some people receiving Treanda have developed certain types of cancers. It is not known whether this medication causes cancer. Talk with your doctor about the risks and benefits of using Treanda.
Do not receive Treanda if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends.
It is not known whether bendamustine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How is Treanda given?
Treanda is injected into a vein through an IV. A healthcare provider will give you this injection.
Treanda is usually given for 2 days in a row every 21 to 28 days. You may receive up to 8 treatments total, depending on the condition being treated. Follow your doctor's instructions.
You may be given other medications to help prevent certain side effects of Treanda.
Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.
Treanda can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
If you have ever had hepatitis B, Treanda can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
Treanda dosing information
Usual Adult Dose for Chronic Lymphocytic Leukemia:
Recommended dose: 100 mg/m2 administered intravenously on days 1 and 2 of a 28 day cycle, up to 6 cycles. Treanda is intended for administration as an intravenous infusion over 30 minutes.
Consider using allopurinol as prevention for patients at high risk of tumor lysis syndrome for the first few weeks of treatment.
Treanda administration should be delayed in the event of grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], Treanda can be reinitiated at the discretion of the treating physician. Dose delays may be warranted.
Dose modifications for hematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on days 1 and 2 of each cycle.
Dose modifications for nonhematologic toxicity: for clinically significant grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on days 1 and 2 of each cycle.
Dose reescalation in subsequent cycles may be considered at the discretion of the treating physician.
Usual Adult Dose for non-Hodgkin's Lymphoma:
Recommended dose: 120 mg/m2 intravenously on days 1 and 2 of a 21 day cycle for up to 8 cycles. Treanda is intended for administration as an intravenous infusion over 60 minutes.
Treanda administration should be delayed in the event of a grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], Treanda can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.
Dose modifications for hematologic toxicity: for grade 4 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 4 or greater toxicity recurs, reduce the dose to 60 mg/m2 on days 1 and 2 of each cycle.
Dose modifications for nonhematologic toxicity: for grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Treanda injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Treanda?
Treanda may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Bendamustine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Treanda side effects
Get emergency medical help if you have any signs of an allergic reaction to Treanda: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body.Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Treanda.
Tell your caregivers at once if you have:
fever, chills, or itching during or shortly after the injection;pain, swelling, redness, skin changes, or signs of infection where the medicine was injected;severe ongoing nausea, vomiting, or diarrhea;pain or burning when you urinate;cough, chest pain, trouble breathing;liver problems - upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);low blood cell counts - fever, flu symptoms, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding;low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or;signs of tumor cell breakdown - confusion, fast or slow heart rate, fluttering in your chest, vomiting, diarrhea, tingling in your hands or feet, tingling around your mouth.
Common Treanda side effects may include:
fever, cough, mouth sores, trouble breathing;nausea, vomiting, diarrhea, constipation;headache, tiredness, dizziness;swelling in your hands or feet;loss of appetite, weight loss; ormild skin rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Treanda?
Tell your doctor about all your current medicines and any you start or stop using, especially:
allopurinol;ciprofloxacin;fluvoxamine;lansoprazole; oromeprazole.
This list is not complete. Other drugs may interact with bendamustine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.