英文药名: Epzicom (Abacavir/Lamivudine Tablets) 中文参考药名: Epzicom（阿巴卡韦拉米夫定片） 这个药在加拿大通常也叫: Kivexa 药品介绍 艾滋病是由人免疫缺陷病毒(Human Immunodeficiency Virus,HIV)引起的全身免疫缺陷性疾病，患者免疫功能低下，故该疾病被称为获得性免疫缺陷综合征。 由Glaxo Smith Kline (GSK)公司研制，商品名：Epzicom，2004年8月2日批准上市。本品为复方片剂，剂量1天1次，由阿巴卡韦（商品名：Ziagen）600mg和拉米夫定（商品名：Epivir）300mg组成。 临床研究发现：两者联合用药与各自使用药效相似，复方片剂使患者用药方便。 8月2日，美国FDA批准了葛兰素史克（GlaxoSmithKline）制药公司生产的由核苷类逆转录酶抑制剂（NRTIs）拉米夫定（lamivudine，3TC，Epivir）和硫酸阿巴卡韦（abacavir sulfate ，ABC，Ziagen）组合而成的复方片剂Epzicom作为处方药用于治疗HIV-1感染。 Epzicom作为一种新型复方药物，只需一日用药1次（1片），且不受水和食物的影响。患者接受本品治疗时需要同时接受其它类型的抗逆转录病毒药物的治疗并且不要和其它核苷类/核苷酸类抗逆转录酶抑制剂一起使用。据目前所知，拉米夫定和硫酸阿巴卡韦与蛋白酶抑制剂（PI）及非核苷类逆转录酶抑制剂（NNRTI）均没有药动学相互作用，因此Epzicom可以和PI类或NNRTI类药物联合使用。 Epzicom的制造商葛兰素史克公司同时于8月2日宣布启动一项优惠计划（voucher program），根据该计划，公司将向患者免费提供为期60天的Epzicom治疗。参与此项计划的患者可以是初次接受抗病毒治疗者，也可以是接受过治疗但想改换疗法者。患者可以通过医疗卫生提供者在一定时间内获得一定量的Epzicom治疗。 葛兰素史克开发的前2个用于治疗HIV感染的复方制剂拉米夫定+齐多夫定（lamivudine+zidovudine，Combivir）已经于1997年获准在美国上市，硫酸阿巴卡韦+拉米夫定+齐多夫定（abacavir sulfate+lamivudine+zidovudine，Trizivir）已经于2000年获准在美国上市。 此次公司向FDA提交Epzicom新药申请前经过了多项临床研究、研究纳入的患者数超过了5800例。其中重要的研究包括： 1、CAL10001研究，其目的在于确定Epzicom和拉米夫定、硫酸阿巴卡韦分开使用的生物等效性。 2、比较300mg、每日2次（BID）硫酸阿巴卡韦与600mg、每日1次（QD）硫酸阿巴卡韦的疗效，两者均与300mg 、QD拉米夫定和600mg、QD依发韦仑（efavirenz）联合用药。 生产厂家: Glaxo Smith Kline 英文药名: Epzicom (Abacavir/Lamivudine Tablets) 中文药名: 阿巴卡韦拉米夫定片 【原产地英文商品名】EPZICOM (600/300)mg/tab 30tabs/box 【原产地英文药品名】ABACAVIR SULFATE/LAMIVUDINE 【中文参考商品译名】EPZICOM (600/300)毫克/片 30片/盒 【中文参考药品译名】硫酸阿巴卡韦/拉米夫定 【生产厂家中文参考译名】VIIV HLTHCARE 【生产厂家英文名】VIIV HLTHCARE Epzicom Generic Name: abacavir and lamivudine (a BAK a veer and la MIV yoo deen) Brand Names: Epzicom ------------------------------------------------------------ What is Epzicom? Epzicom (abacavir and lamivudine) is an antiviral medication. It is in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. Epzicom helps keep the HIV virus from reproducing in the body. Epzicom is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS. Epzicom may also be used for purposes not listed in this medication guide. ------------------------------------------------------------ Important information about Epzicom Stop using Epzicom and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat. Once you have had an allergic reaction to Epzicom, you must never use it again. Before taking Epzicom, tell your doctor if you have kidney disease, heart disease, high blood pressure, or a risk factor for heart disease such as smoking, diabetes, or high cholesterol. You may need a blood test before you start taking Epzicom for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction. Read the Warning Card that comes with Epzicom, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for. Some people develop lactic acidosis while taking Epzicom. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses, you could have a dangerous or even fatal allergic reaction when you start taking the medicine again. If you stop taking Epzicom for any reason, talk to your doctor before you start taking the medication again. ------------------------------------------------------------ Before taking Epzicom You should not take Epzicom if you have liver disease. Do not take this medicine if you have ever had an allergic reaction to abacavir or lamivudine. Tell your doctor if you have had an allergic reaction to any medicine that contains abacavir, such as Trizivir or Ziagen. Once you have had an allergic reaction to abacavir, you must never use it again. You may need a blood test before you start taking Epzicom for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction. Some people develop a life-threatening condition called lactic acidosis while taking Epzicom. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. To make sure you can safely take Epzicom, tell your doctor if you have any of these other conditions: kidney disease; heart disease or high blood pressure; or a risk factor for heart disease such as smoking, diabetes, or high cholesterol. FDA pregnancy category C. It is not known whether Epzicom will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Epzicom. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Epzicom should not be given to children under 18 years old. ------------------------------------------------------------ How should I take Epzicom? Take Epzicom exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. You may take Epzicom with or without food. This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for. HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor. If you have hepatitis B you may develop liver symptoms after you stop taking Epzicom, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Epzicom. Visit your doctor regularly. Store Epzicom at room temperature away from moisture and heat. ------------------------------------------------------------ What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Do not allow Epzicom to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking it again. If you stop taking Epzicom for any reason, talk to your doctor before you start taking the medication again. ------------------------------------------------------------ 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 taking Epzicom? Avoid taking other medications that contain abacavir or lamivudine, such as Combivir, Epivir, Trizivir, or Ziagen. Taking Epzicom will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. ------------------------------------------------------------ Epzicom side effects Stop using Epzicom and call your doctor at once if you have any of these signs of an allergic reaction: Group 1 - fever; Group 2 - rash; Group 3 - nausea, vomiting, diarrhea, stomach pain; Group 4 - general tiredness, body aches; Group 5 - shortness of breath, cough, sore throat. Once you have had an allergic reaction to Epzicom, you must never use it again. If you stop taking Epzicom for any reason, talk to your doctor before you start taking the medication again. Other serious side effects that may not be signs of an allergic reaction include: stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired; fever, chills, body aches, flu symptoms; or white patches or sores inside your mouth or on your lips. Less serious Epzicom side effects include: changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk); sleep problems or strange dreams; headache, depression, anxiety; or mild diarrhea. 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. ------------------------------------------------------------ What other drugs will affect Epzicom? Tell your doctor about all other medicines you use, especially: methadone (Methadose, Dolophine); ribavirin (Copegus, Rebetron, Virazole); interferon (Rebetron, Roferon, Intron, Alferon, Infergen, Avonex, Rebif, Betaseron, Actimune); or other medications that contain abacavir or lamivudine (Combivir, Epivir, Trizivir, Ziagen). This list is not complete and other drugs may interact with Epzicom. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.