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当前位置:药品说明书与价格首页 >> 综合药讯 >> Valcyte可长期用于肾移植术后治疗

Valcyte可长期用于肾移植术后治疗

2011-01-02 22:07:53  作者:新特药房  来源:中国新特药网天津分站  浏览次数:102  文字大小:【】【】【
简介: 8月10日美国食品药品管理局(FDA)批准其生产的Valcyte(盐酸缬更昔洛韦)用于有巨细胞病毒(CMV)疾病风险的肾脏移植患者的长期治疗。 临床试验结果显示,Valcyte能够将肾移植后一年内CMV感染率从36.8%(接受 ...

8月10日美国食品药品管理局(FDA)批准其生产的Valcyte(盐酸缬更昔洛韦)用于有巨细胞病毒(CMV)疾病风险的肾脏移植患者的长期治疗。

临床试验结果显示,Valcyte能够将肾移植后一年内CMV感染率从36.8%(接受治疗100天)降低到16.8%(接受治疗200天)。因此,FDA批准该药物可较长时间使用。

巨细胞病毒是在器官移植手术6个月内引发疾病的首要原因,约有50%到80%的成人会感染该病毒,甚至可能潜伏终身。当自身免疫系统虚弱时,该病毒会相对活跃并引起疾病,CMV感染会引起肺部、肾脏、神经系统、肝脏以及胃肠道等并发症。

尽管对CMV感染进行控制,但在预防治疗100天之后仍有约1/3的患者发生CMV感染,所以该药物的批准为肾移植后关键期的防御感染治疗提供了新的重要信息.

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Valcyte
This page contains drug information on Valcyte.
The information provided includes the following:
what is Valcyte
the possible side effects of Valcyte
what happens if you miss a dose of Valcyte
what happens if you overdose with Valcyte
the most important information about Valcyte
how to use Valcyte
other Drugs that may affect Valcyte
what to avoid while using Valcyte
 
Generic Name: valganciclovir ( val gan SYE kloe veer)
Brand Names: Valcyte

What is the most important information I should know about valganciclovir?
 •  Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together. If your doctor switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte), the number of pills you use each day may change. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed.
 •  Using valganciclovir while you are pregnant may cause harm to the unborn baby. If a man fathers a child while using this medication, the baby may have birth defects. Use an effective form of birth control while you are using valganciclovir. If you are a man, use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir. 
 •  Do not use a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If you must handle a broken tablet, ask your doctor or pharmacist how to handle and dispose of the tablet safely.
 •  Valganciclovir can lower the blood cells in your body that control bleeding and help you fight infection. Your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. Contact your doctor right away if you have any bleeding or signs of infection (fever, chills, body aches, or flu symptoms).


What is valganciclovir?
 •  Valganciclovir is an antiviral drug. It works by preventing viral cells from multiplying in your body. Valganciclovir will not cure CMV but it can help control the infection.
 •  Valganciclovir treats cytomegalovirus (CMV) infection of the eye in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir also prevents CMV infection in patients who have received an organ transplant (kidney, heart, or kidney-pancreas).
 •  Valganciclovir may also be used for purposes other than those listed in this medication guide.
 •  Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). Be aware that the strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed. An overdose of this medication can cause serious illness.


What should I discuss with my healthcare provider before taking valganciclovir?
 •  Before taking this medication, tell your doctor if you have:
      · kidney disease, 
      · liver disease, or
      · a blood cell disorder (such as anemia).
 •  Tell your doctor if you are on hemodialysis or if you have recently had a radiation treatment.
 •  Valganciclovir is in the FDA pregnancy category C. This means that it is not known if it will be harmful to an unborn baby. A similar drug called ganciclovir (Cytovene) did cause birth defects in animal studies. Using valganciclovir while you are pregnant could also cause harm to the unborn baby. Do not use this medication without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment.
 •  If a man fathers a child while using valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir.
 •  This medication can affect fertility (your ability to have children), whether you are a man or a woman. 
 •  You should not breast-feed while you are using valganciclovir. It is not known if this medication passes into breast milk. If you have HIV or AIDS, you should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. 
 •  Valganciclovir may cause cancer. Talk to your doctor about your individual risk.


How should I take valganciclovir?
 •  Valganciclovir should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take the medication for longer than your doctor has prescribed. 
 •  Take each dose with a full glass of water.
 •  Take valganciclovir with food.
 •  Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.
 •  It is very important to take this medicine at the same time each day. To best treat your condition, you should not miss any doses.
 •  Do not crush or break a valganciclovir tablet. Do not use a tablet that has been accidentally broken. The medicine from a broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken tablet, ask your doctor or pharmacist how to dispose of the tablet safely. 
 •  You should have your eyes checked at least every 4 to 6 weeks while you are using valganciclovir. Your doctor may want you to have eye exams more often.
 •  Valganciclovir can lower the blood cells in your body that help you fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
 •  Store valganciclovir at room temperature away from moisture and heat.


What happens if I miss a dose?
 •  Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
 •  Seek emergency medical attention if you think you have used too much of this medicine.
 •  Symptoms of a valganciclovir overdose may include seizure (convulsions), kidney failure (urinating more or less than usual, blood in the urine, swelling or numbness in your hands or feet, pain in your lower back or sides), or signs of liver damage (yellowing of the skin or eyes, severe and sudden stomach pain, diarrhea, vomiting).


What should I avoid while taking valganciclovir?
 •  If you have AIDS, follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles.
 •  Use birth control to prevent pregnancy while you are using valganciclovir, whether you are a man or a woman. Valganciclovir use by either parent can cause birth defects. If you are a man, use a condom to keep from causing a pregnancy while you are taking valganciclovir. Continue using condoms for at least 90 days after you stop taking valganciclovir.
 •  Valganciclovir can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.


What are the possible side effects of valganciclovir?
 •  Stop taking valganciclovir and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
      · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
      · easy bruising, unusual bleeding;
      · numbness or tingling in a part of the body;
      · signs of infection (fever, chills, body aches, flu symptoms); or
      · seizure (convulsions).
 •  Other, less serious side effects may be more likely to occur. Continue to take valganciclovir and talk to your doctor if you experience:
      · mild nausea, vomiting, diarrhea, stomach pain;
      · headache;
      · sleepiness or dizziness;
      · weakness, lack of coordination;
      · confusion;
      · tremor (uncontrolled shaking); or
      · sleep problems (insomnia).
 •  Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other Drugs will affect valganciclovir?
 •  Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together.
 •  Before taking valganciclovir, talk to your doctor if you are using any of the following Drugs:
      · zidovudine (Retrovir, AZT);
      · didanosine (Videx, ddI);
      · mycophenolate (CellCept);
      · Drugs that weaken your immune system (such as cancer medicine or steroids); or
      · probenecid (Benemid, Probalan).
 •  If you are using any of these Drugs, you may not be able to take valganciclovir, or you may require a dosage adjustment or special monitoring.
 •  There may be other Drugs not listed that can affect valganciclovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and Drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


Where can I get more information?
 •  Your pharmacist has additional information about valganciclovir written for health professionals that you may read.
 •  Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
 •  Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse Drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/ or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the Drugs you are taking, check with your doctor, nurse or pharmacist. 

FDA发布有关儿童使用缬更昔洛韦的新剂量指南

9月15日,FDA提醒医护人员,用于接受肾脏或心脏移植的儿童和青少年的Valcyte (valganciclovir,缬更昔洛韦)口服片和口服溶液的剂量推荐已被更新。此次更新的目的是为了预防低体重、低体表面积和血肌酐值极低的儿童患者的药物过量。目前,修订后的剂量指导已列入该药的标签中。Valcyte是一种抗病毒药,可有效用于进行过肾脏或心脏移植以及易发生巨细胞病毒(CMV)疾病的4个月~16岁儿童的CMV疾病预防。CMV是一种可在伴有免疫系统缺陷的人群(包括器官移植患者)中引起诸如肺炎或结肠炎等严重疾病的病毒。该药已在我国上市

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