部分中文德泊噻处方资料（仅供参考）

FDA正式批准了阿糖胞苷注射剂(cytarabine liposome injection，DepoCyt)，用于治疗一种致命性的淋巴瘤综合征——肿瘤性脑膜炎。此前，DepoCyt获得了FDA的快速批准资格。

FDA批准本品基于2项随机临床研究的结果。在研究中，受试者为200例新生肿瘤性脑膜炎患者，肿瘤类型有实体瘤、淋巴瘤和血液瘤等。第1项研究表明，大多数接受本品治疗的患者无疾病的神经性恶化。第2项研究表明，通过测定脑脊液(CSF)中恶性细胞清除率，接受本品治疗的患者的全细胞响应有所增强。

阿糖胞苷可以控制肿瘤性脑膜炎，但该药半衰期短，需每周进行2次脊柱注射。DepoCyt为化疗试剂阿糖胞苷的持续释放剂型，每2周给药1次。本品可逐渐释放至脑脊液中，因此具有较长的半衰期、延长的治疗浓度及更均匀的药物分布。 

DepoCyt是一种缓释的化学治疗药物。阿糖胞苷可以控制淋巴瘤性脑膜炎，但是由于其半衰期较短，每周需要进行2次脊椎穿刺，而DepoCyt仅需2周使用1次。DepoCyt可以将阿糖胞苷缓慢的释放进入脑脊髓液，因此可以显著的增加其半衰期，延长作用时间，而且其分布也更加均匀。只有进行过膜内肿瘤化学治疗药物操作的有资格的医师才可以使用DepoCyt。在所有的临床试验中最常见的不良反应为化学性蛛网膜炎，该不良反应的最初症状为恶心、呕吐、头痛已经发烧。如果不采取治疗措施，化学性蛛网膜炎有致命的危险。同时服用地塞米松可以减少该不良反应的发生率和严重程度。因此使用DepoCyt治疗的患者应同时使用地塞米松，以缓和化学性蛛网膜炎的症状。

DEPOCYT is a sustained release formulation of cytarabine approved for the treatment of lymphomatous meningitis. The unique liposomal encapsulation of DEPOCYT is designed to release cytarabine into the cerebrospinal fluid over an extended period of time: DEPOCYT has a half-life of up to 82.4 hours, compared to 3.4 hours for unencapsulated cytarabine.As a result, treatment with DEPOCYT is well distributed throughout the CSF and offers prolonged exposure of the tumor cells to cytarabine.Because DEPOCYT is a sustained release formulation, it provides convenient dosing of every two weeks as compared to twice weekly with unencapsulated cytarabine.

Two randomized, multi-center clinical trials of DEPOCYT in patients with neoplastic meningitis (n=223) were conducted; 57 patients had lymphomatous meningitis.  Patients were treated intrathecally with either with 50mg of DEPOCYT every two weeks or unencapsulated cytarabine twice weekly.  In Study  DEPOCYT achieved a complete response rate of 41% compared with only 6% for unencapsulated cytarabine.  In Study 2 lymphomatous meningitis subset analysis, DEPOCYT achieved a complete response rate of 33% compared with 17% for unencapsulated cytarabine.  Complete response was prospectively defined as both (i) conversion of positive to negative CSF cytology and (ii) the absence of neurologic progression.
In the controlled clinical trials, the most common severe adverse event was chemical arachnoiditis. Other reported adverse events included headache, nausea, and vomiting; these adverse events are manageable and are consistent with those commonly seen with intrathecal chemotherapy. Dexamethasone should be concomitantly administered with DEPOCYT® (cytarabine liposome injection) to reduce the risk and severity of chemical arachnoiditis.
Cytarabine, the active component of DEPOCYT, can cause fetal harm if a pregnant woman is exposed to the drug systemically. However, the concern for fetal harm following intrathecal DEPOCYT administration is low because systemic exposure to cytarabine is negligible. Despite the low apparent risk for fetal harm, women of childbearing potential should be advised to avoid becoming pregnant.

DEPOCYT is contraindicated in patients who are hypersensitive to cytarabine or any component of the formulation, and in patients with active meningeal infection.
-----------------------------------------------
DepocytGeneric Name: cytarabine liposome (Intrathecal route)
sye-TARE-a-been LYE-poh-some
Intrathecal routeSuspension
Cytarabine liposome injection should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache, and fever was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone. Patients receiving cytarabine liposome should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis .

In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache, and fever was a common adverse event with cytarabine liposome. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone and patients receiving cytarabine liposome should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis .

Commonly used brand name(s):

In the U.S.

Depocyt
Available Dosage Forms:

Suspension
Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Depocyt
Liposomal cytarabine belongs to the group of medicines known as antineoplastics. It is used to treat cancer of the lymph system that has spread to the brain.

Liposomal cytarabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Some effects may occur after treatment with liposomal cytarabine has been stopped.

Before you begin treatment with liposomal cytarabine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Liposomal cytarabine is to be administered only by or under the immediate supervision of your doctor.

Before Using Depocyt
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of liposomal cytarabine in children with use in other age groups.

Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of liposomal cytarabine in the elderly with use in other age groups.

Pregnancy

Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Bacillus of Calmette and Guerin Vaccine, Live
Influenza Virus Vaccine, Live
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine
Varicella Virus Vaccine
Yellow Fever Vaccine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Active meningitis—Use is not recommended
Blockage to cerebrospinal fluid flow— Increased risk of neurotoxicity
Proper Use of Depocyt
This medicine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using Depocyt
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Depocyt Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
Back pain
fever
headache
nausea
neck pain or rigidity
sleepiness
vomiting
weakness
Less common
Black, tarry stools
blood in urine or stools
chills
cough or hoarseness
lower back or side pain
painful or difficult urination
pinpoint red spots on skin
sore throat
swelling of fingers, hands, arms, lower legs, or feet
unusual bleeding or bruising
Rare
Fast or irregular breathing
puffiness or swelling around the face
shortness of breath
sudden, severe decrease in blood pressure
unusual tiredness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Constipation
urinary incontinence
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

DepoCyt(控释注射用阿糖胞苷、cytarabine)

商品名为DepoCyt。本品系一阿糖胞苷注射用缓释制剂，用称之为贮库泡沫（DepoFoom）的脂质基质包周一次直接注入脑脊液中，而不是常规定蛛网膜下腔化疗1周二次用药。此次批准标志着美国有了贮库泡沫注射技术的首个产品。

DepoCyte™ (cytarabine脂肪微粒注射剂)已获欧盟核准上市，适应症为治疗淋巴瘤脑膜炎。这是第一个经由欧盟药品委员会审查核准的淋巴瘤脑膜炎治疗药。
淋巴瘤脑膜炎是一种严重的癌症并发症，当癌细胞扩散至脑膜、脊髓膜、脑脊髓液时，称为淋巴瘤脑膜炎。根据美国淋巴瘤研究基金会的统计，7~15%罹患淋巴瘤的病人会发生淋巴瘤脑膜炎。

应用SkyePharma的专利制剂技术DepoFoam™所研发的DepoCyte™是一种缓释型的cytarabine注射剂，药品注射入脊髓鞘后，cytarabine缓缓地释入脑脊髓液中，时间可长达二周以上；而传统的cytarabine注射剂则需每周投药二次，通常需要预先植入导管于脑中。此外，DepoCyte能够长时间维持较高的cytarabine浓度，因此治疗效果较佳。
DepoCyte™已于美国、加拿大核准上市，商品名为DepoCyt。

---------------------------------------------------------------
原产地英文商品名:
DEPOCYT 50mg/5mls/vial
原产地英文药品名:
CYTARABINE LIPOSOMAL
中文参考商品译名:
德泊噻 50毫克/5毫升/瓶
中文参考药品译名:
阿糖胞苷脂质体
生产厂家中文参考译名:
PACIRA PHARMS INC
生产厂家英文名:
PACIRA PHARMS INC