部分中文盐酸阿霉素脂质体处方资料（仅供参考）

美国FDA批准盐酸阿霉素脂质体注射剂 (doxorubicin HCl liposome injection，DOXIL)治疗进展期及铂类化疗药化疗后复发的卵巢癌患者。
DOXIL由Ortho Biotech Products公司的分公司Tibotec治疗公司在美国经销，最初是在1999年6月接到用于难治性卵巢癌的加速批准。此次批准后，DOXIL说明书中的有关数据将更新，包括来自随机III期临床试验的生存率、疾病进展时间及肿瘤应答率的相关数据。
通过加速批准，DOXIL获准治疗经紫杉醇及铂类化疗药为基础的治疗方案均难以治愈转移性卵巢癌患者，该次批准是以来自3个II期临床试验的肿瘤应答率为基础的。根据加速批准的规定，强生制药研发部(J&JPRD)完成了一个随机的III期临床试验，以证明该药用于复发的卵巢癌患者的临床益处。
2004年3月，J&JPRD提交了以III期临床试验数据为基础的补充新药申请(sNDA)。
在随机、多中心、非盲III期临床试验中，474位复发上皮卵巢癌患者被随机的给予每28天DOXIL50mg/m2或是每21天连续5天给药topotecan HCl 1.5 mg/m2/天。其中接受DOXIL治疗的有239位患者，接受topotecan HCl治疗的有235位患者。试验的首要终点，即开始治疗后的疾病进展时间，在两个治疗组中相当。DOXIL治疗组疾病进展时间的中位值是4.1月，topotecanHCl治疗组是4.2月，P值为0.617。
DOXIL治疗组患者生存率的中位值是14.4月，topotecan
HCl治疗组是13.7月，P值为0.05。DOXIL治疗组的全部肿瘤应答率是19.7%，topotecanHCl治疗组是17%。
在临床试验中，Doxil主要的、常见的副作用有：导致白细胞数减少，红细胞数下降，恶心，四肢综合症，口腔溃疡，呕吐，腹泻，便秘，食欲减退，疲倦，虚弱，急躁，轻度落发。有的还会出现输液反应，皮肤反应。四肢综合症，即为手掌、脚底红皮炎，特征为：肿胀、疼痛、发红，有的病人还会出现手足脱皮。有17％患者症状逐渐加重。对心脏的副作用也有报道，有的还十分严重。由于潜在地持久的毒副作用，还可能会产生抑制骨髓的后遗症，这些都应该引起高度重视。
卵巢癌是妇科肿瘤中致命性最高的癌症。据美国癌症学会预测，2005年美国将有2.22万患者被诊断为卵巢癌，将有1.6万以上的患者死于此症。有关报告显示，近50%的卵巢癌患者在5年内死亡。而且，近75%的患者确诊时已处于更加难以治疗的晚期阶段，5年生存率仅仅为25%。
Doxil是一种复合阿霉素脂质剂，也是一种采用静脉注射的化疗剂。Doxil采用一种新颖的、靶向传递系统的STEATH技术，能够避开免疫系统的检测和被免疫系统消灭，所以它们能在体内长时间循环。而循环时间会增加脂质体和药物含量，使之有可能达到预定肿瘤所在靶细胞。
【药理作用】：盐酸阿霉素的活性成分通过插入DNA双链的碱基对与核酸结合干扰DNA和RNA的合成。在脂质体包裹的阿霉素核周围与聚乙烯甘醇衍生物结合，形成阿霉素的脂质体。这种技术称为“隐蔽技术”(stealth technology)。阿霉素隐蔽脂质体是在其表面与甲氧聚乙烯甘醇(MPEG)结合。这种聚合体包裹后保护了隐蔽脂质体免受单核巨噬系统的吞噬，导致在血循环时间明显增加，可能有降低阿霉素心脏毒性、增加肿瘤靶组织吸收的作用。
【药动学】：体内半衰期大约55小时，给药后可测到低水平的Doxorubicinol(阿霉素的一种代谢物)。吸收后，本品明显分布到皮肤组织。血浆清除缓慢，剂量为20mg/m2时，平均清除率0.04lL/(h·m2)。
【适应症】：以前用过综合治疗后发展或不能耐受这些治疗的艾滋病相关的卡波西氏肉瘤。
【用法用量】：静脉滴注。成人剂量20mg/m2，以5%葡萄糖液250ml稀释，静脉滴注30～60分钟。稀释液在2～8℃冷冻保存下可稳定24小时，但不能与其他药物、盐水、抗生素混合。
【不良反应】：与阿霉素的常见毒副反应相似。
1.严重的骨髓抑制为剂量限制性毒性。
2.恶心、呕吐、粘膜炎、脱发均较多见。
【注意事项】：
1.心脏毒性与总剂量有关，推荐阿霉素的最大累积剂量为(550mg/m2)。以往用过蒽环类药物者，应减少总累积剂量。
2.治疗前、治疗期间及治疗后需作心脏监护，可监测。EKG、RNCA、超声心动图等。
------------------------------------------------

Doxil
Pronunciation: DOX-oh-ROO-bi-sin
Generic Name: Doxorubicin Liposomal
Brand Name: Doxil
Doxil is used for:
Treating advanced ovarian cancer and AIDS-related Kaposi
sarcoma in certain patients. It is also used with another
medicine to treat a type of bone marrow cancer (multiple
myeloma) in certain patients.
Doxil is an antineoplastic antibiotic. It works by killing
cancer cells.
Do NOT use Doxil if:
you are allergic to any ingredient inDoxilortoconventional
doxorubicin
you have bone marrow depression
you are breast-feeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Doxil:
Some medical conditions may interact with Doxil. Tell your
doctor or pharmacist if you have any medical conditions,
especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are
breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have heart disease or liver problems
if you have had radiation therapy
if you have previously received treatment with other anticancer medicines (eg, daunorubicin, idarubicin, another anthracycline or anthracene) Some MEDICINES MAY INTERACT with Doxil.
Tell your health care provider if you are taking any other medicines, especially any of the following:
Barbiturates (eg, phenobarbital) or streptozocin because they may decrease Doxil's effectiveness Calcium channel blockers (eg, verapamil), cyclophosphamide, cyclosporine, or paclitaxel because the risk of side effects, such as heart problems, may be increased Anticoagulants (eg, warfarin) or trastuzumab because their actions and the risk of their side effects may be increased by Doxil Carbamazepine, digoxin, hydantoins (eg, phenytoin), live
vaccines, or valproic acid because their effectiveness may be decreased by Doxil
This may not be a complete list of all interactions that may occur. Ask your health care provider if Doxil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Doxil:
Use Doxil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Doxil is usually given as an injection at your doctor's
office, hospital, or clinic. If you will be using Doxil at
home, a health care provider will teach you how to use it. Be sure you understand how to use Doxil.
Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Doxil if it contains particles, is cloudy or
discolored, or if the vial is cracked or damaged.
Drinking extra fluids while you are taking Doxil is recommended. Check with your doctor for instructions.
If Doxil accidentally spills on your skin, wash it off
immediately with soap and water.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials.
Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Doxil, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Doxil.
Important safety information:
Doxil may reduce the number of clot-forming cells (platelets) in your blood.
To prevent bleeding, avoid situations in which
bruising or injury may occur.
Report any unusual bleeding,
bruising, blood in stools, or dark, tarry stools to your
doctor.
Doxil may lower the ability of your body to fight infection.
Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Doxil.
Talk with your doctor before you receive any vaccine.
Doxil may cause the urine to turn red. This is harmless and usually goes away 1 to 2 days after receiving a dose of Doxil.
Lab tests, including liver function, complete blood cell
counts, and heart function, may be performed while you use
Doxil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Doxil should not be used inCHILDREN;safetyandeffectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Doxil has been shown to cause harm to the fetus.
If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Doxil while you are pregnant. Doxil is found in breast milk. Do not breast-feed while taking Doxil.
Possible side effects of Doxil:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Diarrhea; hair loss; loss of appetite; nausea; pain, redness, or swelling at the injection site; red-colored urine 1 to 2 days after receiving Doxil; tiredness; vomiting; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bleeding or bruising; chest pain; cough; dizziness; fainting; flushing; hand-foot syndrome (tingling, burning, redness, swelling, flaking, small blisters or small sores on the palms of hands or sores of feet); headache; irregular or fast heartbeat; loose or bloody stools; rectal bleeding or irritation; serious infection (fever, chills, persistent sore throat); shortness of breath; sores in the mouth or on the lips; sudden weight gain; swelling of the face or ankles; tightness in the chest andthroat;unusualtiredness.
This is not a complete list of all side effects that may
occur.
If you have questions about side effects, contact your
health care provider. Call your doctor for medical advice
about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison
Control Centers), your local poison control center, or
emergency room immediately. Symptoms may include inflammation of the mouth.
Proper storage of Doxil:
Doxil is usually handled and stored by a health care provider.
If you are using Doxil at home, store Doxil as directed by
your pharmacist or health care provider. Keep Doxil out of the reach of children and away from pets.
General information:
If you have any questions about Doxil, please talk with your doctor, pharmacist, or other health care provider.
Doxil is to be used only by the patient for whom it is
prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
Check with your pharmacist about how to dispose of unused
medicine.
This information is a summary only.
It does not contain all information about Doxil. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
---------------------------------------------------------------
原产地英文商品名:
DOXIL 2mg/ml 10mls/vial
原产地英文药品名:
DOXORUBICIN HCL LIPOSOMAL
中文参考商品译名:
DOXIL 2毫克/毫升 10毫升/瓶
中文参考药品译名:
盐酸阿霉素脂质体
生产厂家中文参考译名:
奥多生物制药
生产厂家英文名:
ORTHO BIOTECH

---------------------------------------------------------------
原产地英文商品名:
DOXIL 2mg/ml 25mls/vial
原产地英文药品名:
DOXORUBICIN HCL LIPOSOMAL
中文参考商品译名:
DOXIL 2毫克/毫升 25毫升/瓶
中文参考药品译名:
盐酸阿霉素脂质体
生产厂家中文参考译名:
奥多生物制药
生产厂家英文名:
ORTHO BIOTECH

---------------------------------------------------------------

リポソーマルドキソルビシン（抗がん性抗生物質）

商品名（製造・販売会社）

ドキシル（ヤンセンファーマ）
再発した卵巣がんに対して

「エイズ関連カポジ肉腫」を適応として承認された抗がん剤ですが、2009年4月には「再発した卵巣がん」が追加適応として承認されました。卵巣がんは他のがんと比較して患者さんの年齢が低いため、再発の可能性が比較的高くなっています。しかし、再発した際に使用できる薬剤も少ないことから、海外における再発卵巣がんの標準治療薬である本剤の承認が待ち望まれていました。
リポソームと呼ばれる超微小カプセルの中にドキソルビシンを閉じ込めた作りになっており、細菌などの外敵侵入に備える白血球であるマクロファージに捕まることなく、がん組織の血管に浸入します。がん組織内でドキソルビシンが徐々に放出されるため作用時間が長く、また骨髄抑制や脱毛、心毒性等の主要な副作用も軽減されました。

適応となるがん
がん化学療法後に増悪した卵巣がん、エイズ関連カポジ肉腫

主な副作用
心筋障害、骨髄抑制、手足症候群、口内炎、肝機能障害、間質性肺疾患、肺塞栓症

使用上の注意点
従来のドキソルビシンとは成分が同じでも、本剤はリポソームに封入した製剤ですので、有効性、安全性は異なります。したがって、本剤を従来のドキソルビシンの代替として使用することはできません。

その他
国内での治験データが極めて少ないため、製造販売後は一定数の症例に関するデータが集積されるまでの間は、投与患者すべての追跡調査が義務づけられています。

完整处方附件：http://www.info.pmda.go.jp/go/pack/4235402A1025_1_03/