抗器官排斥新药Envarsus获欧盟批准上市
近日，欧盟委员会（EC）已批准抗器官排斥药物Envarsus（原名LCP-Tacro），用于成人肾脏和肝脏移植者，预防器官排斥反应。
Envarsus的获批，是基于在稳定的肾脏移植者中开展的III期3001研究、在新生肾移植受者中开展的3002研究、以及在肾脏移植和肝脏移植患者中开展的一项广泛的I期和II期临床项目的有利数据。
研究3001和3002表明，envarsus每天给药一次并不逊色于每日两次剂量目前领先的器官移植，普乐可复（他克莫司）。第一阶段和第二阶段的疗效的药代动力学数据，在MAA提交启用外推到肾和肝移植受者更广泛的人群。
目前，在欧盟每年约有20000例肾移植和7000例肝脏移植手术。
XR的器官排斥反应的肾移植患者的预防是通过美国FDA的监管审查，并有一个活动在2014年10月30日行动日期。veloxis并不期望在美国接受额外的肝指示veloxis并不期望在美国接受额外的肝指示envarsusXR获得孤儿药指定由美国FDA接受同种异体肾移植患者的器官排斥反应的预防。
此外，Veloxis已向FDA提交了Envarsus XR的新药申请（NDA），寻求批准用于肾脏移植者预防器官排斥，目前正在接受FDA的审查，同时FDA已指定该药的处方药用户收费法（PDUFA）目标日期为2014年10月30日。此前，FDA已授予Envarsus XR孤儿药地位，用于同种一体肾移植患者，预防器官排斥。
Envarsus 0.75mg, 1mg & 4mg Prolonged-release tablets
ENVARSUS XR,
 a once a day anti-rejection medicine for kidney transplant patients
Just once a day ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Doctors have depended on tacrolimus to help prevent rejection for about 20 years; it is the most commonly used anti-rejection medicine (also called an immunosuppressant) in the US.
Designed to deliver tacrolimus more smoothly over the whole day
honeycombsHome.pngIf your doctor prescribed ENVARSUS XR, you will be switching from another form of tacrolimus. ENVARSUS XR is an extended-release tablet that is taken just once a day in the morning.
Important Safety Information
What is the most important information I should know about ENVARSUS XR?
ENVARSUS XR can cause serious side effects, including:
Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR that can cause death.
Call your doctor right away if you have symptoms of an infection such as:
•fever
•cough or flu-like symptoms
•warm, red, or painful areas on your skin
•sweats or chills
•muscle aches
What is ENVARSUS XR?
ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.
ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules or tacrolimus immediate-release capsules. Your doctor should decide what medicine is right for you.
Who should not take ENVARSUS XR?
Do not take ENVARSUS XR if you are allergic to tacrolimus or any of the ingredients in ENVARSUS XR. See the end of this leaflet for a complete list of ingredients in ENVARSUS XR.
What should I tell my doctor before taking ENVARSUS XR?
Before you take ENVARSUS XR, tell your doctor if you:
•plan to receive any live vaccines. Ask your doctor if you are not sure if your vaccine is a live vaccine.
•have or have had liver, kidney or heart problems.
•have any other medical conditions.
•are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
•are breastfeeding or plan to breastfeed. ENVARSUS XR can pass into your breast milk. You and your doctor should decide if you will take ENVARSUS XR or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.
How should I take ENVARSUS XR?
Take ENVARSUS XR exactly as your doctor tells you to take it.
Your doctor may change your dose of ENVARSUS XR if needed. Do not stop taking or change your dose of ENVARSUS XR without talking to your doctor.
Take ENVARSUS XR once daily with fluid (preferably water) on an empty stomach at the same time each day (preferably in the morning).
Take ENVARSUS XR tablets whole. Do not chew, divide or crush ENVARSUS XR tablets before swallowing. If you cannot swallow ENVARSUS XR tablets whole, tell your doctor.
If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after missing your dose. If the time after you miss your dose is more than 15 hours, the missed dose should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take 2 doses at the same time.
If you take too much ENVARSUS XR, call your doctor or go to the nearest hospital emergency room right away.
What should I avoid while taking ENVARSUS XR?
Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, BCG (TB vaccine), yellow fever, chicken pox (varicella), or typhoid.
Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.
You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.
You should not drink alcohol while taking ENVARSUS XR.
What are the possible side effects of ENVARSUS XR?
ENVARSUS XR may cause serious side effects, including:
See “What is the most important information I should know about ENVARSUS XR?”
Graft rejection and other serious reactions. People who take ENVARSUS XR have sometimes been given the wrong medicine because some medicines have the same ingredient (tacrolimus) as ENVARSUS XR. Check your ENVARSUS XR when you get a new prescription to make sure you have received the right medicine.
•Call your doctor right away if you think you were given the wrong medicine.
•Ask your doctor or pharmacist if you are not sure what ENVARSUS XR should look like.
High blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take ENVARSUS XR. Call your doctor right away if you have:
•frequent urination
•confusion
•fruity smell on your breath
•increased thirst or hunger
•drowsiness
•nausea, vomiting, or stomach pain
•blurred vision
•loss of appetite
Kidney problems. Your doctor may do certain tests to check for kidney function while you take ENVARSUS XR.
Nervous system problems. Call your doctor right away if you get any of these symptoms while taking ENVARSUS XR. These could be signs of a serious nervous system problem:
•confusion
•numbness and tingling
•vision changes
•coma
•headache
•muscle tremors
•seizures             
High levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take ENVARSUS XR.
High blood pressure. Your doctor will monitor your blood pressure while you take ENVARSUS XR.
Changes in the electrical activity of your heart (QT prolongation).
The most common side effects of ENVARSUS XR include, diarrhea, urinary tract infection, low red blood cell count (anemia), high blood pressure, and constipation.
These are not all the possible side effects of ENVARSUS XR. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ENVARSUS XR?
Store ENVARSUS XR at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
Safely throw away medicine that is out of date or no longer needed.
Keep ENVARSUS XR and all medicines out of reach of children.
General information about the safe and effective use of ENVARSUS XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ENVARSUS XR for a condition for which it was not prescribed. Do not give ENVARSUS XR to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ENVARSUS XR. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ENVARSUS XR that is written for health professionals. For more information, go to www.ENVARSUSXR.com or call 1-844-Veloxis (1-844-835-6947).
What are the ingredients in ENVARSUS XR?
Active ingredient: tacrolimus USP
Inactive ingredients: hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF
Manufactured by: Rottendorf Pharma GmbH, 59320 Ennigerloh, North Rhine-Westphalia, Germany
Marketed by: Veloxis Pharmaceuticals Inc. 499 Thornall Street, 3rd floor Edison, New Jersey 08837, United States