STELARA (ustekinumab) 45mg/0.5mL, 90mg/mL injection from Centocor Ortho

Stelara 90 mg/mL   45mg/mLSub-Q Syringe
GMedication name
eneric name: Ustekinumab - Injection
Brand name(s): Stelara
Uses
This medication is used to treat moderate to severe cases of plaque psoriasis. It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that may lead to the overproduction of skin cells and inflammation seen in plaque psoriasis.Ustekinumab does not cure plaque psoriasis, but it can help lessen the symptoms, including decreasing the amount of painful, itchy, sore patches of thick, red or inflamed skin covered with silvery scales known as plaques. It is not known if using ustekinumab for more than 2 years is safe and effective.
How to use
Read the Medication Guide provided by your pharmacist before you start using ustekinumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab.This medication is given by injection under your skin either in the upper arms, buttock, thighs, or abdomen as directed by your doctor. You will receive one dose, followed by a second dose 4 weeks later. Then this medication is given every 3 months.Dosage is based on your weight, medical condition, and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. The solution is normally colorless to light yellow. It may contain a few small white particles of protein. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse syringes.It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Therefore, choose a different injection site with each dose. Do not inject into skin that is irritated, sore, or infected.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.
Precautions
Before using ustekinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/returning infection (including hepatitis and tuberculosis), cancer.Ustekinumab can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Avoid receiving BCG vaccines for one year after completing treatment with ustekinumab. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk. Consult your doctor before breast-feeding.
Drug interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some of the products that may interact with this drug include: live vaccines (such as polio vaccine taken by mouth, flu vaccine inhaled through the nose, BCG).
Side effects
Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor promptly if you develop any signs of an infection, such as worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, or cold/flu symptoms. (See also Precautions section.)Ustekinumab may cause a rare (sometimes fatal) condition called RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).There is a rare risk of developing cancer due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.
Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
Do not share this medication with others.
Storage
Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light until the time of use. Discard any unused portion of the vial or syringe.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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 。 Ustekinumab has been authorised by the European Medicines Evaluation Agency (EMEA) for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light). Ustekinumab已获准为中度至重度牛皮癣治疗的成年人谁没有回应，或有禁忌，或不容忍，包括环孢素，甲氨蝶呤和其他全身治疗的欧洲药品评价局（EMEA） PUVA疗法（补骨脂素加紫外线A光）。

Psoriasis is a chronic skin disease that can be itchy, painful and debilitating.牛皮癣是一种慢性皮肤疾病，可发痒，痛苦和破坏性。 Around 1.5 million people in the UK1, 2 have psoriasis and it is estimated that 20-30% of those have severe disease.3 Psoriasis is often associated with potentially serious co-morbidities and substantial physical and emotional burdens.4,5大约150万UK1，2牛皮癣患者和估计20-30％的人有严重的disease.3银屑病往往与合作有关的潜在的严重，人民的发病率和大量的身体和感情burdens.4，5 In Phase III clinical studies, treatment with ustekinumab demonstrated a significant, visible improvement in patients' psoriasis with convenient 12 weekly maintenance dosing, as well as demonstrating improvements in quality of life.6,7 This means that patients need just 5 doses a year versus up to 104 injections with currently available biologic therapies.在第三阶段的临床研究，治疗与ustekinumab表现出显着，在与维修方便给药12周患者的牛皮癣明显改善，以及展示的life.6质量的改善，7这意味着，病人只需要5年与剂量高达104利用现有生物药物注射。 Furthermore, ustekinumab has been shown, in a head-to-head Phase III clinical study, to be more effective at 12 weeks than etanercept, a widely-used biologic treatment for psoriasis.8此外，ustekinumab已经表明，在头对头第三阶段的临床研究，更在12比依那西普，被广泛用于psoriasis.8生物治疗后有效

"This is an important day for patients with psoriasis and for their doctors. Two-thirds of patients taking STELARA in placebo-controlled trials saw a significant, visible improvement in their psoriasis in just 12 weeks" said Chris Griffiths, Professor of Dermatology at the University of Manchester. “这是一个与银屑病患者重要的日子，和他们的医生。两服用安慰剂的患者STELARA三分之二的对照试验发现显着，有明显改善，仅12个星期，其牛皮癣”克里斯格里菲思说，皮肤科教授曼彻斯特大学。 "This improvement is sustained for up to a year-and-a-half with just 5 doses a year, allowing patients to get on with their lives." “这种改善持续长达一年的比赛，只有5剂量一年半，从而使患者得到与他们的生活。”

About Psoriasis 关于银屑病

Psoriasis is a chronic, immune-mediated inflammatory disease resulting in the over-production of skin cells which accumulate on the surface of the skin, leading to raised, red, scaly plaques that may itch and bleed.牛皮癣是一种慢性，免疫介导的炎症性疾病导致的过度生产的皮肤细胞，这些细胞在皮肤表面的积累，导致提出的，红色，鳞片状斑块，可能痒和流血。 It is estimated that 1.5 million people in the UK have psoriasis.1,2 Twenty to thirty percent of those with psoriasis have severe disease.3 In addition to the significant impact that psoriasis can have on quality of life,5 many patients report feeling dissatisfied and frustrated with some existing treatment options which can be inconvenient and time consuming to use.5据估计，150万英国人民psoriasis.1，2 20至30人的百分之银屑病有严重disease.3除了重大影响，牛皮癣可能对生活质量，5很多病人的报告感到不满和沮丧与一些现有的治疗方案，可带来不便，耗费时间use.5

About Ustekinumab 关于Ustekinumab

Ustekinumab is a new, fully human monoclonal antibody with a novel mechanism of action that targets the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). Ustekinumab是一个新的，完全人源单克隆抗体的新的作用机制为目标的细胞因子白细胞介素p41消费者亚基- 12（IL - 12的）和IL - 23（白细胞介素- 23）。 IL-12 and IL-23 are naturally occurring proteins that are important in regulating immune responses and are thought to be associated with some immune-mediated inflammatory disorders, including plaque psoriasis.白细胞介素- 12和IL - 23是天然的蛋白质在调节免疫反应的重要和被认为是与某些免疫介导的炎症性疾病，包括牛皮癣。

Clinical trials 临床试验

The authorisation of ustekinumab is based on data from two large pivotal Phase III, multi-centre, randomised, double-blind, placebo controlled trials (PHOENIX 1 & 2).在ustekinumab授权是基于两个大的至关重要的第三阶段，多中心的随机，双盲，安慰剂对照试验数据（凤凰城1＆2）。 6,7 These trials involved nearly 2,000 adult patients in whom the efficacy and tolerability of ustekinumab in the treatment of moderate-to-severe plaque psoriasis was evaluated.6,7 The primary endpoint of both trials was a reduction in psoriasis severity (measured using the Psoriasis Area and Severity Index, PASI) of at least 75% (PASI 75) by week 12. 6,7这些试验涉及近2000名成年患者的疗效和治疗的耐受性的ustekinumab中度至重度牛皮癣是evaluated.6，7这两个试验的主要终点是在牛皮癣的严重程度减少（衡量使用银屑病面积和严重程度指数，PASI）为至少75％（PASI 75的）的第12周。 Just over two-thirds of patients achieved this outcome in both studies (after two doses at weeks 0 and 4).6,7 Improvement in skin quality was seen after just two weeks in PHOENIX 1.短短的两年，三分之二的患者达到这两项研究的结果（后两个星期，0和4）.6,7剂量改善皮肤质量仅仅两年后，在凤凰城一周看到。 6 Significant improvements in quality of life for patients suffering with psoriasis was seen as early as week 2 in PHOENIX 16, and was sustained with maintenance treatment in both studies.6,7 6重要的生活质量的改善与银屑病患者被视为第2周早在凤凰城16日，并与维修都studies.6，7治疗持续

Both PHOENIX 1 and PHOENIX 2 are currently ongoing and will last five years, with data up to 76 weeks published so far.双方凤凰1和菲尼克斯2是目前正在进行之中，将过去5年中，一个数据，迄今发表76个星期。 6 The benefits of maintenance therapy were generally shown to last for up to a year-and-a-half in patients receiving ustekinumab every 12 weeks.6第六维持治疗的好处，一般显示持续长达一年的比赛，在接受ustekinumab每12 weeks.6患者一半

Findings from an additional Phase III (head-to-head), randomised, multi-centre trial comparing ustekinumab and etanercept ( Enbrel ®) for the treatment of moderate-to-severe psoriasis showed ustekinumab was more effective than etanercept.8 The primary endpoint of the trial was a reduction in PASI of at least 75% by week 12.从调查结果增加第三阶段（头对头），随机，多中心的试验对比用于治疗ustekinumab和依那西普（Enbrel的 ®）中度至重度牛皮癣显示ustekinumab超过etanercept.8有效的主要终点试验是在PASI评分的至少75％削减12周。 At week 12, after two subcutaneous injections at weeks 0 and 4, 68% and 74% of patients receiving ustekinumab 45 mg or ustekinumab 90 mg, respectively, achieved a PASI 75 compared with 57% of patients receiving etanercept 50 mg subcutaneous injections twice weekly.8 12周时，两个星期后0和4，68％和74接受ustekinumab 45毫克或90毫克ustekinumab分别皮下注射治疗％，实现PASI 75比57接受依那西普50毫克每周两次皮下注射％的患者.8

Tolerability profile 耐受性

Ustekinumab therapy was generally well-tolerated during Phase III clinical trials.6,7 The most common side effects reported in Phase III clinical trials were arthralgia, cough, headache , injection site erythema, nasopharyngitis and upper respiratory tract infection. Ustekinumab治疗的普遍欢迎，在第三阶段的临床trials.6，7最常见的副作用耐受报告第三阶段临床试验，关节痛，咳嗽， 头痛 ，注射部位红斑，鼻咽炎，上呼吸道感染。 6,7 In general, adverse events were mild and did not require treatment adjustment. 6,7一般来说，不良反应轻微，不需要治疗调整。 No dose response was seen in the rates of adverse events, serious adverse events, or adverse events leading to study agent discontinuation.没有剂量反应视为对不良事件，严重不良事件，或导致中止学习剂的不良反应率。 6,7 6,7

Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Ustekinumab是一种选择性的免疫抑制剂，可能有可能增加感染的危险，并重新恢复潜伏感染。 Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with STELARA.应评估病人对结核病 （TB）的感染前主动与其STELARA治疗。

Ustekinumab is a selective immunosuppressant. Ustekinumab是一种选择性的免疫抑制剂。 Immunosuppressive agents have the potential to increase the risk of malignancy.免疫抑制剂有可能增加恶性肿瘤的危险。 Caution should be exercised when considering the use of STELARA in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.应谨慎行事时考虑STELARA患者使用一个恶性历史或在考虑继续在病人谁患上恶性肿瘤的治疗。

Centocor Ortho Biotech Inc. developed ustekinumab and has exclusive marketing rights to the product in the United States. Centocor公司奥托生物技术公司开发的ustekinumab，并享有独家销售权，以在美国的产品。 Janssen-Cilag has exclusive marketing rights in all countries outside of the United States.扬森齐拉格公司在境外的美国在所有国家享有独家销售权。

References 参考文献

1. 1。 National Statistics Online.国家统计局线上。 Population size.人口规模。 Available here. Accessed on November 27, 2008.可这里。于2008年11月27号访问。

2. 2。 The Psoriasis Association.银屑病协会。 What is psoriasis?什么是牛皮癣？ Available at: http://www.psoriasis-association.org.uk/what-is.html .可查阅：http://www.psoriasis-association.org.uk/what-is.html。 Accessed November 25, 2008.访问08年11月25日。

3. 3。 Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol. 2005;153(3):486-497.史密斯甲烷，安斯蒂影音，巴克金南， 等。英国皮肤科协会为在2005年银屑病的生物措施。 紫红ĵ皮肤科使用的准则。2005，153（3）:486 - 497。

4. 4。 Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol. 1995;32(6):982-986.亨泽勒吨，克里斯托弗斯大肠杆菌病的牛皮癣concomitance。ĵ皮肤科上午广东药学院。1995年，32（6）982 - 986。

5. 5。 Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey. Br J Dermatol. 2006;155(4):729-736.迪贝尔特雷升，Mrowietz ü，栏木甲， 等。对欧洲的影响银屑病患者的观点：病人的EUROPSO成员的调查。 紫红ĵ皮肤科。2006年，155（4）:729 - 736。

6. 6。 Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). The Lancet. 2008;371:1665-74莱奥纳尔迪氯，金博尔抗体，Papp介绍家， 等。ustekinumab的疗效和安全性，一人interleukin-12/23单克隆抗体，在牛皮癣患者：76从一项随机，双盲，安慰剂对照试验结果一周（凤凰1）。 柳叶刀。2008年; 371:1665-74

7. 7。 Papp K, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). The Lancet. 2008;371:1675-84.援巴亩，兰利的RG，Lebwohl M 等。ustekinumab的疗效和安全性，一人interleukin-12/23单克隆抗体，在牛皮癣患者：52从一项随机，双盲，安慰剂对照试验结果一周（凤凰2）。 柳叶刀。2008年; 371:1675-84。

8. 8。 Griffiths C, Strober B, van de Kerkhof PCM, et al. A Phase 3, Multicenter, Randomized Study Comparing Ustekinumab and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis.格里菲思荤，斯特罗贝尔乙，范德克尔克霍夫的PCM 等。甲3期多中心随机研究的比较适度和依那西普治疗Ustekinumab到中度牛皮癣。 Poster presented at: 17th Congress of European Academy of Dermatology and Venereology; 2008 September 17-21; Paris, France.海报提交：第17届党代会欧洲皮肤性病学学院; 2008年9月17号至二十一日，法国巴黎。 Poster FP1336.海报FP1336。

 
 
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.

STELARA

Manufacturer:
Centocor Ortho Biotech, Inc.

Pharmacological Class:
Interleukin-12 and interleukin-23 antagonist

Active Ingredient(s):
Ustekinumab 45mg/0.5mL; soln for SC inj; preservative-free.

Indication(s):
Moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.

Pharmacology:
Ustekinumab is a human IgG1k monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23. These cytokines are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. Ustekinumab was shown in vitro to disrupt interleukin-12 and interleukin-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor.

Clinical Trials:
Two double-blind, placebo-controlled studies were conducted in patients 18 years or older with plaque psoriasis who were candidates for phototherapy or systemic therapy. The patients had at least 10% body surface involvement and a Psoriasis Area and Severity Index (PASI) score of ≥12; baseline PASI scores ranged from about 17–18. Patients with guttate, erythrodermic, or pustular psoriasis were excluded.

For both studies, subjects were randomized to ustekinumab 45mg, 90mg, or placebo. Those randomized to ustekinumab received 45mg or 90mg, regardless of weight, at weeks 0, 4, and 16. Those randomized to placebo received placebo at weeks 0 and 4, and were crossed over to ustekinumab 45mg or 90mg at weeks 12 and 16. The endpoints were the proportion of subjects who achieved at least a 75% reduction in the PASI score from baseline to week 12 (PASI 75) and treatment success (cleared or minimal) on the Physician's Global Assessment, which indicates the physician's overall assessment of psoriasis, focusing on thickness, induration, erythema, and scaling. Baseline PGA score was marked or severe in 44% of the 766 subjects in Study 1 and in 40% of the 1230 subjects in Study 2.

In Study 1, 67% of patients achieved PASI 75 in the ustekinumab 45mg group, 66% in the 90mg, and 3% in the placebo group. In Study 2, 67% of patients given 45mg ustekinumab and 76% of patients given ustekinumab 90mg achieved PASI 75, compared to 4% for placebo.

Legal Classification:
Rx

Adults:
≥18yrs: ≤100kg: 45mg SC once then 4wks later, then once every 12wks. >100kg: 90mg once then 4wks later, then once every 12wks. Rotate inj site.

Children:
<18yrs: not recommended.

Precaution(s):
Active infections: not recommended. Increased risk of serious or fatal infections, esp. in IL-12/IL-23 genetically deficient patients (eg, mycobacteria, salmonella, BCG vaccines). Monitor for new infection; discontinue if serious infection develops. Conditions that predispose to infection. Test for and treat latent tuberculosis prior to initiating therapy. Avoid close contact with live vaccine recipients. History of malignancies. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs or is suspected. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interaction(s):
Concomitant live vaccines, other immunosuppressants, phototherapy: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. May affect CYP450 substrates.

Adverse Reaction(s):
Nasopharyngitis, upper respiratory tract infection, headache, fatigue; infections, malignancies, RPLS.

How Supplied:
Single use vial (0.5mL)—1

Last Updated:
11/5/2009