氟达拉滨FLUDARABINE(福达华仿制药)

产地国家:美国

处方药:是

所属类别: 50毫克/2毫升/瓶

包装规格: 50毫克/2毫升/瓶

计价单位:瓶

原产地英文商品名:FLUDARABINE(FLUDARA GENERIC) 50MG/2ML/VIAL

原产地英文药品名:FLUDARABINE PHOSPHATE

中文参考商品译名:氟达拉滨(福达华仿制药) 50毫克/2毫升/瓶

中文参考药品译名:磷酸氟达拉滨

简介:

磷酸氟达拉滨 [fludarabine phosphate]不同适应症和各年龄组别患者的用法用量药品英文名Fludarabine药品别名2-氟阿糖腺苷酸、磷酸氧阿糖腺苷药物剂型注射剂(冻干粉):50mg。药理作用其抗肿瘤的作用机制类似阿糖胞苷,所不同的是,本品不被腺苷脱氨酶脱氨而失活。药动学静脉给药后,本品的磷酸盐迅速被脱磷酸而成为氟达拉滨,此基质被淋巴细胞摄取后再磷酸化成为具有活性的三磷酸氟达拉滨。在一次给药后4h细胞内的三磷酸氟达拉滨可达峰值。本品从血象中清除呈三相,终末t1/2约为10~30h。大多数药物随尿排出,24h内约可排出60%的给药量。本品的药动学具有明显的个体差异。

适应症:主要用于治疗慢性淋巴细胞白血病。

禁忌症:对本品过敏者、哺乳者、骨髓抑制明显者禁用。

注意事项:肝肾功能不全、患有感染性疾病者慎用。

不良反应:1.主要不良反应是骨髓抑制,表现为白细胞减少、血小板减少和贫血,常因此而使剂量受限。白细胞最低值一般出现在2~3周后。2.骨髓抑制可能严重并逐渐加重,延长的淋巴细胞减少可能招致机会感染的出现。3.其他还有咳嗽、呼吸困难、肺炎、胃肠障碍、口炎、水肿、心绞痛、肿瘤崩解综合征、皮疹、溶血性贫血、出血性膀胱炎、周围神经病、激动、精神错乱、视力减退和昏迷。高剂量可引起进展性脑病和视觉缺失。

用法用量:本品可静脉注射或输注(30min输完),常用量为25mg/m2,连用5天。28天后可重复给药。

药物相应作用:1.合用喷司他丁可加重肺毒性。2.合用阿糖胞苷可降低本品的代谢活化,且使阿糖胞苷的细胞内浓度上升。3.合用双嘧达莫或其他腺苷摄取抑制剂可降低本品的疗效。专家点评临床试用于治疗难治性慢性淋巴细胞性白血病,有效率达57%。完全缓解率13%。

推荐用量:25mg/m2,在约30min内静脉注射,每天1次,连用5天为1个疗程,每28天重复1个疗程,至少用3个疗程。本品毒副作用多,大剂量时1/3发生延迟的进展性脑瘤,失明,甚至死亡,应慎用。

MIMS药物分类:化疗用药

英文版说明书:

Fludarabine Injection(floo dare’ a been)IMPORTANT WARNING:Fludarabine injection must be given under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.Fludarabine injection can cause a decrease in the number of blood cells made by your bone marrow. This decrease may cause you to develop dangerous symptoms and may increase your risk of having a serious or life-threatening infection. Your doctor may prescribe other medications to decrease the risk that you will develop a severe infection during your treatment.Tell your doctor if you have or have ever had a low number of any type of blood cells in your blood or any condition that affects your immune system and if you have ever developed an infection because your blood cell levels were too low.If you experience any of the following symptoms, call your doctor immediately: shortness of breath; fast heartbeat; headache; dizziness; pale skin; extreme tiredness; unusual bleeding or bruising; black, tarry, or bloody stool; vomit that is bloody or that looks like coffee grounds; and fever, chills, cough, sore throat, difficult, painful, or frequent urination, or other signs of infection.Fludarabine injection can also cause damage to the nervous system .If you experience any of the following symptoms, call your doctor immediately: seizures, agitation, confusion, and coma (loss of consciousness for a period of time).Fludarabine injection may cause serious or life-threatening conditions in which the body attacks and destroys its own blood cells.Tell your doctor if you have ever developed this type of condition after receiving fludarabine in the past.If you experience any of the following symptoms, call your doctor immediately: dark urine, yellow skin, tiny red or purple dots on the skin, nosebleeds, heavy menstrual bleeding, blood in the urine, coughing up blood, or difficulty breathing due to bleeding in the throat.In a clinical study, people with chronic lymphocytic leukemia who used fludarabine injection along with pentostatin (Nipent) were at high risk of developing serious lung damage.In some cases, this lung damage caused death. Therefore, your doctor will not prescribe fludarabine injection to be given along with pentostatin (Nipent).Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to fludarabine injection.Talk to your doctor about the risks of receiving fludarabine injection.Why is this medication prescribed?Fludarabine injection is used to treat chronic lymphocytic leukemia(CLL; a type of cancer of the white blood cells) in adults who have already been treated with at least one other medication and have not gotten better. Fludarabine injection is in a class of medications called purine analogs.It works by slowing or stopping the growth of cancer cells in your body.How should this medicine be used?Fludarabine injection comes as a powder to be added to fluid and injected over 30 minutes intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient clinic.It is usually injected once a day for 5 days in a row.This treatment period is called a cycle, and the cycle may be repeated every 28 days for several cycles.Your doctor may need to delay your treatment or adjust your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with fludarabine injection.Other uses for this medicineFludarabine injection is also sometimes used to treat non-Hodgkin’s lymphoma (NHL; cancer that begins in a type of white blood cell that normally fights infection) and mycosis fungoides (a type of lymphoma that affects the skin). Talk to your doctor about the risks of usingthis medication for your condition.This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.What special precautions should I follow?Before receiving fludarabine injection,tell your doctor and pharmacist if you are allergic to fludarabine, any other medications, or any of the ingredients in fludarabine injection. Ask your pharmacist for a list of the ingredients.tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medication listed in the IMPORTANT WARNING section or cytarabine(Cytosar-U, DepoCyt). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.tell your doctor if you have or have ever had kidney disease.Also tell your doctor about all the other chemotherapy medications you have received and if you have ever been treated with radiation therapy (cancer treatment that uses waves of high energy particles to kill cancer cells). Before you receive chemotherapy or radiation therapy in the future, tell your doctor that you have been treated with fludarabine.you should know that fludarabine injection may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men.However, you should not assume that you or your partner cannot become pregnant.If you are pregnant or breast-feeding, you should tell your doctor before you begin receiving this medication. You should not plan to have children while receiving fludarabine injection or for at least 6 months after treatments.Use a reliable method of birth control to prevent pregnancy during this time. Talk to your doctor for further details.Fludarabine injection may harm the fetus.if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving fludarabine injection.you should know that fludarabine injection may cause tiredness, weakness, confusion, agitation, seizures, and vision changes.Do not drive a car or operate machinery until you know how this medication affects you.talk to your doctor before you receive any vaccinations during your treatment with fludarabine injection.you should know that you may develop a serious or life-threatening reaction if you need to receive a blood transfusion during your treatment with fludarabine injection or at any time after your treatment. Be sure to tell your doctor that you are receiving or have received fludarabine injection before you receive a blood transfusion.What special dietary instructions should I follow?Unless your doctor tells you otherwise, continue your normal diet.What side effects can this medication cause?Fludarabine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:loss of appetitenauseavomitingconstipationdiarrheamouth soreshair lossnumbness, burning, pain, or tingling in the hands, arms, feet, or legsmuscle or joint painheadachedepressionsleep problemsSome side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call yourdoctor immediately:chest pain or discomfortfast or irregular heartbeathearing losspain along the side of the bodyswelling of the arms, hands, feet, ankles, or lower legsrashhivesdifficulty breathing or swallowingpeeling or blistering skinFludarabine injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone [1-800-332-1088].In case of emergency/overdoseIn case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.Symptoms of overdose may include:unusual bruising or bleedingfever, chills, cough, sore throat, or other signs of infectiondelayed blindnesscomaWhat other information should I know?Ask your doctor or pharmacist if you have any questions about fludarabine injection.It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital.It is also important information to carry with you in case of emergencies.Brand namesFludara®Other names2-Fluoro-ara-A Monophosphate, 2-Fluoro-ara AMP, FAMP.

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