STELARA（USTEKINUMAB）注射液

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近日，欧盟委员会批准治疗斑块型银屑病的新型生物制剂STELARA(TM) (ustekinumab)在欧洲27个国家上市销售。该药治疗成人中-重度斑块型银屑病，主要用于那些对其他全身性治疗药物（包括ciclosporin，methotrexate和PUVA等）应答不充分，有禁忌症候或耐受不好的患者。在欧洲国家，有2-3%的人深受银屑病困扰。
这次ustekinumab获准的依据是在两项大型关键III期临床实验中获取的数据，该实验属多中心随机双盲安慰剂对照实验，共招募了2000名受试患者，主要检测药物治疗中-重度斑块型银屑病的安全性和疗效。结果发现，2/3的受试者达到了主要临床终点，用药12周以后，在病变面积和病情严重指数的改善至少达到75%。
上述临床实验结果表明，患者使用ustekinumab治疗之后，能有效缓解病情，提高生活质量。而且该药每年只需注射4次，它为患者带来了全新的治疗选择。
在用药过程中，最常见的副作用为关节痛、咳嗽、头痛、注射部位出现红斑、鼻咽炎和上呼吸道感染，这些不良反应多数都比较轻微，未影响治疗。该药导致的严重副作用主要为重度感染、恶性肿瘤和心血管疾病等，但出现这些不良反应的几率极小，与预计的情况相符。
扬森齐拉格公司宣布与减缓STELARA发射（ustekinumab），用于治疗成年人的一类新生物制品第一，到重度斑块型银屑病 。

Stelara
Generic Name: ustekinumab
Date of Approval: September 25, 2009
Company: Centocor Ortho Biotech Inc.
Treatment for: Psoriasis
FDA Approves Stelara
The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.
Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body’s own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.
Stelara Medication Guide
Read this Medication Guide before you start taking Stelara and each time before you get an injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment with Stelara.
What is the most important information I should know about Stelara?
Stelara is a medicine that affects your immune system. Stelara can increase your chances of having serious side effects, including:
Serious Infections: Stelara may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking Stelara, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
Your doctor should check you for TB before starting Stelara.
If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Stelara and during treatment with Stelara.
Your doctor should watch you closely for signs and symptoms of TB during treatment with Stelara.
You should not start taking Stelara if you have any kind of infection unless your doctor says it is okay.
Before starting Stelara, tell your doctor if you think you have an infection or have symptoms of an infection such as:
fever, sweats, or chills
muscle aches
cough
shortness of breath
blood in your phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinate more often than normal
feel very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have TB, or have been in close contact with someone who has TB.
After starting Stelara, call your doctor right away if you have any symptoms of an infection (see above).
Stelara can make you more likely to get infections or make an infection that you have worse.
People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. It is not known if people who take Stelara will get any of these infections, because of the effects of Stelara on these proteins in your body.
Cancers: Stelara may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:
headache
seizures
confusion
vision problems
What is Stelara?
Stelara is a prescription medicine used to treat adults 18 years and older with moderate or severe psoriasis that involves large areas or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
Stelara may improve your psoriasis but may also lower the ability of your immune system to fight infections. This may also increase your risk for certain types of cancer.
It is not known if Stelara is safe and effective in children.
It is not known if taking Stelara for more than 2 years is safe and effective.
What should I tell my doctor before receiving Stelara?
Before receiving Stelara, tell your doctor if you:

have any of the conditions or symptoms listed in the section "What is the most important information I should know about Stelara?"
have recently received or are scheduled to receive an immunization (vaccine). People who take Stelara should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking Stelara or one year after you stop taking Stelara.
receive phototherapy for your psoriasis.
have any other medical conditions.
are pregnant or planning to become pregnant. It is not known if Stelara will harm your unborn baby. You and your doctor should decide if you will take Stelara.
are breast-feeding or plan to breast-feed. It is thought that Stelara passes into your breast milk. You should not breast-feed while taking Stelara without first talking with your doctor.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
other medicines that affect your immune system.
certain medicines that can affect how your liver breaks down other medicines.
Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How will I receive Stelara?
Stelara is given by injection under the skin (subcutaneous injection).
Stelara should only be given by a healthcare provider as directed by your doctor.
Your doctor will decide the right dose of Stelara for you and how often you should receive it.
Be sure to keep all of your scheduled follow-up appointments.
What should I avoid while receiving Stelara?
You should not receive a live vaccine while taking Stelara. See "What should I tell my doctor before taking Stelara?"
Stelara side effects
Stelara can increase your chances of having serious side effects. See "What is the most important information I should know about Stelara?"
Common side effects of Stelara include:
upper respiratory infections
headache
tiredness
These are not all of the possible side effects of Stelara. Tell your doctor about any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist.
What are the ingredients in Stelara?
Active ingredient: ustekinumab
Inactive ingredients: sucrose, L-histidine, and polysorbate 80

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