Stelara before and after

THURSDAY, Nov. 17, 2016 (HealthDay News) — People with moderate to severe Crohn’s disease who haven’t responded to other treatments may benefit from the drug ustekinumab (Stelara), a new study suggests.

Stelara is a monoclonal antibody that blocks the action of the inflammatory agents interleukin-12 and interleukin-23. The drug had been approved for the treatment of psoriasis and is now approved for treating Crohn’s disease as well.

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract. Crohn’s usually affects the end of the small bowel and the beginning of the colon. But it may affect any part of the gastrointestinal tract, from the mouth to the anus, according to the Crohn’s and Colitis Foundation of America (CCFA).

Crohn’s can cause diarrhea, rectal bleeding, an urgent need to move the bowels, stomach cramps, pain and constipation, the CCFA says.

“Stelara is effective for treatment leading to a clinical remission in patients with moderate to severe Crohn’s disease,” said study co-author Dr. William Sandborn. He’s a professor of medicine at the University of California, San Diego.

Remission was defined as relief from abdominal pain and diarrhea, he said.

Stelara was well-tolerated and “we did not see increased rates of serious infection or cancer, compared with patients who received placebo,” Sandborn said.

The drug is effective in patients who found no relief with anti-tumor necrosis factor (TNF) drugs, such as Remicade, Humira or Cimzia, and those patients who did, Sandborn said.

“These patients had limited treatment options previously, so this is a big advance. It is also very convenient for patients — the maintenance dosing is only once every eight weeks and patients can inject themselves,” he said.

Stelara can be given as a first-line or second-line therapy for Crohn’s, Sandborn said.

For the new research, Sandborn and his colleagues recruited two groups of patients, one with more than 700 people, and the other with more than 600. These patients hadn’t responded to anti-TNF treatment or had unacceptable side effects from it. The study volunteers were randomly assigned to receive either a single intravenous dose of Stelara or a placebo.

Hello! I don’t want to give you all a woe-is-me tale because we’re all suffering here, but it turns out I was allergic to Humira — developed hives from neck to toe (thanks for staying clear, face!!) after my second week (third injection in two weeks) on Humira. I took Humira for a terrible guttate flare that started in July.
It is too bad I’m allergic to Humira because I had become almost 100% clear! It’s now been about 2.5 weeks since the crazy hive flareup. I haven’t been taking any medications (except Zyrtec and Benadryl for hives) and haven’t applied any steroid creams. I’ve been eating healthy, limiting my drinking, and going tanning every other day. The former P spots are white (with tanning, they will go back to blending in with the rest of my skin, right?), which I am hoping is just healed P. I was hoping I was in remission, but this morning, I checked some of the white spots, and I see some sneaky redness coming back in the middle of some of them. I am wondering if this is the Humira in my system running out. My skin looks pretty good right now, so I’d rather not have to try another biologic if I have gone into remission, or am on my way. Anybody have any luck after taking a biologic by going into remission – if so, how were you able to remain clear? If the P does come back, however, I am being approved for Stelara. Anybody have any luck with Stelara?
Thank you all very much and I hope the best for all of you!

Stelara

How does this medication work? What will it do for me?

Ustekinumab belongs to the class of medications called selective immunomodulating agents, also known as biologics. It is used to treat chronic, moderate-to-severe plaque psoriasis for adults who are candidates for phototherapy or systemic therapy. It is also used for adolescents 12 to 17 years of age who can’t tolerate other therapies, or whose symptoms aren’t controlled by other therapies. It may be used alone or with methotrexate to treat to treat psoriatic arthritis.

Ustekinumab is also used to treat adults with moderately to severely active Crohn’s disease who can’t tolerate other medications, or whose symptoms aren’t adequately controlled by other medications.

Ustekinumab works by blocking the action of 2 proteins in the body that are part of the immune system. This decreases the activity of parts of the immune system that are believed to be involved in psoriasis and Crohn’s disease.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Subcutaneous solution

Each mL of sterile solution contains 90 mg of ustekinumab. It is available as a pre-filled syringe containing 45 mg (0.5 mL) or 90 mg (1.0 mL) of ustekinumab. Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Intravenous infusion

Each mL of sterile solution contains 5 mg of ustekinumab. It is available as a solution for intravenous infusion containing 130 mg per 26 mL. Nonmedicinal ingredients: sucrose, L-histidine and L-histidine hydrochloride monohydrate, polysorbate 80, L-methionine, and EDTA disodium salt dihydrate.

How should I use this medication?

To treat adults with either plaque psoriasis or psoriatic arthritis, the usual dose is 45 mg injected under the skin. The dose is repeated in 4 weeks, and then every 12 weeks thereafter. For people who weigh more than 100 kg, a dose of 90 mg may be used. When treating plaque psoriasis, some people may need to receive this medication every 8 weeks. The dose may be injected on top of the thigh or around the abdomen (about 2 inches away from the belly button).

For treating adolescents 12 to 17 years of age with plaque psoriasis, the dose is based on body weight.

For the treatment of Crohn’s disease, the first dose is given as an intravenous (into a vein) infusion and the dose is based on body weight. The dose is repeated as an injection under the skin 8 weeks after the first dose. The usual maintenance dose is 90 mg every 8 weeks.

Most people using this medication can be trained by a health care professional to give themselves the injection. Ustekinumab is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose.

Follow the instructions from your doctor or pharmacist when administering the medication. The solution should be colourless or slightly yellow and may contain a few small clear or white particles of protein. Do not use the injection if it appears cloudy or discoloured, or if you see other particles floating in it. After taking the medication out of the refrigerator, preparing the syringe, and choosing the injection site, inject the dose under the skin as instructed by your health care provider.

Use a different site for each injection to decrease the risk of skin irritation. Dispose of your used needles in an appropriate sharps container.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that this medication be given exactly as recommended by your doctor. If you have psoriasis, and you miss a dose and your psoriasis has not come back, inject the dose as soon as you remember. If you miss a dose and your psoriasis returns, contact your doctor. If you have Crohn’s disease and you miss a dose, contact your doctor for advice. Do not inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator, protect it from light, and keep it out of the reach of children. Do not freeze or shake the medication.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use ustekinumab if you:

  • are allergic to ustekinumab or any ingredients of this medication, including latex
  • have severe infections such as sepsis (bacterial infections that have spread throughout the body), tuberculosis, and opportunistic infections (infections that occur in people with weakened immune systems)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back pain
  • diarrhea
  • headache
  • injection site reactions such as pain, redness, or swelling
  • itchiness
  • muscle or joint pain
  • symptoms of upper respiratory tract infections such as the common cold or sinus infections (e.g., face discomfort or pain, nasal congestion, runny nose, sore throat, tiredness)
  • tooth ache or infection
  • vaginal yeast infection

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • increased redness and shedding of skin
  • red, itchy, painful rash
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of skin cancer, such as unusual moles (moles with irregular borders, multicoloured moles, moles larger than the size of a pencil eraser, or asymmetrical moles); small pearl-coloured bumps on the skin that may bleed easily; or red, raised, scaly patches of skin
  • signs of skin infection, such as redness, swelling, pain, and warmth

Stop using the medication and seek immediate medical attention if any of the following occur:

  • signs of an allergic reaction such as difficulty breathing; hives; swelling of face, lips, tongue, or throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

November 21, 2014

Health Canada has issued new restrictions concerning the use of Stelara® (ustekinumab). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Allergic reaction: In rare cases, some people may develop a serious allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, seek immediate medical attention.

Allergy shots: This medication may affect allergy shots. If you are receiving or have received allergy shots, especially for severe allergic reactions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune system and infections: Ustekinumab may lower your ability to fight infections and may increase the risk of infections and reactivate inactive infections. Your doctor may test for tuberculosis before starting this medication.

Your doctor will do regular tests of immune system function while you are using this medication. If you develop a severe infection, contact your doctor as soon as possible.

Latex: The needle cover on the pre-filled syringe contains dry natural rubber (a form of latex). If you are allergic to latex, talk to your doctor before using the pre-filled syringe.

Malignancies (cancer): Ustekinumab may increase the risk of cancer. If you have cancer or have had cancer in the past, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like ustekinumab. If you have had a previous episode of RPLS, ustekinumab may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Serious infections: Ustekinumab can affect the way your body’s natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking ustekinumab with other medications that reduce the body’s ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

If you have an active infection, you should not use this medication until the infection resolves.

Serious skin conditions: There have been reports of rare serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis) in people receiving ustekinumab. If you experience redness and shedding of skin over most of the entire area of the body, contact your doctor immediately.

Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using ustekinumab. If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking ustekinumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children 12 years of age and younger with psoriasis. The safety and effectiveness of using this medication have not been established for children less than 18 years of age with Crohn’s disease.

What other drugs could interact with this medication?

There may be an interaction between ustekinumab and any of the following:

  • abciximab
  • belimumab
  • denosumab
  • echinacea
  • fingolimod
  • immunosuppressants (e.g., prednisone, dexamethasone, chemotherapy, azathioprine, tacrolimus, cyclosporine)
  • infliximab
  • leflunomide
  • live vaccines (e.g., BCG, measles, mumps, rubella; chickenpox; polio, meningococcal)
  • natalizumab
  • pimecrolimus
  • roflumilast
  • tacrolimus
  • tofacitinib
  • trastuzumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Stelara

Verona, Italy, June 6, 2012 – New efficacy and safety data from the Phase 3 PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with STELARA® (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Among responders receiving STELARA 45 mg or 90 mg and randomized to continue maintenance therapy through five years, 79 and 81 percent of patients, respectively, experienced at least a 75 percent improvement in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75) at the end of the treatment period. Investigators also reported a consistent benefit-to-risk profile for STELARA through five years and observed treatment with the biologic therapy to be generally well-tolerated with rates of adverse events (AEs), including infections, malignancies and cardiovascular events, remaining stable over time. The data were presented today at the 9th Annual European Academy of Dermatology and Venereology Spring Symposium in Verona, Italy.

“These data are important to the professional dermatology community as we now have five-year data—the longest continuous study evaluating a biologic in the treatment of psoriasis—that reinforce our understanding of STELARA efficacy and safety as a therapeutic option,” said Alexa Kimball, MD, MPH, Associate Professor, Harvard Medical School, Department of Dermatology, Massachusetts General Hospital and lead study investigator. “STELARA continues to be an important option for dermatologists in the treatment of moderate to severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease who might be candidates for biologic therapy.”

In the PHOENIX 1 study, patients were randomized to receive placebo or STELARA 45 mg or 90 mg at weeks 0 and 4. Following assessment of PASI 75 at week 12, the primary endpoint, STELARA-treated patients continued to receive treatment every 12 weeks. At week 40, PASI 75 responders were re-randomized to receive maintenance therapy with STELARA or to withdraw from treatment and only receive retreatment with loss of response. More than two-thirds (n=517) of all STELARA-treated patients (n=753) in PHOENIX 1 continued to receive STELARA through the last scheduled five-year dose. Among the responders who continued treatment from week 40 through the end of the study, 48 and 59 percent had PASI 90 in the STELARA 45 mg and 90 mg groups, respectively, with up to five years of treatment. Efficacy was similarly maintained in an overall analysis of the study population, with 63 and 72 percent of all PHOENIX 1 participants achieving PASI 75, and 40 and 49 percent achieving PASI 90, of those individuals receiving STELARA 45 mg or 90 mg, respectively.

Adverse events were evaluated in more than 753 ustekinumab-treated patients with a total 3,104 patient-years (PY) of follow-up. Rates of AEs (221 and 209 per 100 PY), serious AEs (5.3 and 5.4 per 100 PY) and infections (84 and 82 per 100 PY) in the STELARA 45 mg and 90 mg treatment groups, respectively, remained stable over time. Rates of serious infection (1.03 per 100 PY), non-melanoma skin cancer (0.45 per 100 PY), malignancy other than non-melanoma skin cancer (0.48 per 100 PY), and major adverse cardiovascular events (0.35 per 100 PY) in combined STELARA groups were similarly consistent over the five-year period. No new safety signals were reported with the increased duration of exposure.

As part of a post-marketing commitment with the United States Food and Drug Administration (FDA) for safety surveillance of STELARA, Janssen Biotech, Inc. is conducting the PSOriasis Longitudinal Assessment Registry (PSOLAR). PSOLAR is an international, multicenter, prospective, observational study evaluating long-term safety and clinical outcomes for patients receiving (or eligible to receive) treatment for psoriasis with biologics and/or conventional systemic agents in academic and community-based settings. Patients completing PHOENIX 1 are being transitioned into PSOLAR when possible to continue collection of long-term safety data.

About Psoriasis
Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques can crack and bleed, and may occur anywhere on the body. The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world’s population is living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About PHOENIX 1
The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension (PHOENIX 1) evaluated the efficacy and safety of STELARA in the treatment of 766 patients with chronic plaque psoriasis for up to five years. Patients were randomized to receive subcutaneously administered STELARA or placebo. Patients randomized to receive STELARA received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of STELARA at weeks 12 and 16 and every 12 weeks thereafter. Some patients inadequately responding to STELARA at weeks 28 and 40 were eligible to switch to every 8 week dosing. The primary endpoint of the study was the proportion of patients achieving PASI 75 at week 12. Patients responding to STELARA through week 40 were randomized to continue maintenance treatment with their original dose of STELARA through the end of the study or to withdraw from treatment and only receive retreatment upon loss of response. After week 76, subjects continued on treatment in a long-term extension for up to 5 years.

About STELARA
STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.

In its 2012 Consensus Guidelines for the Management of chronic Plaque Psoriasis, the National Psoriasis Foundation supports the choice of STELARA as a first-line systemic therapy for moderate to severe plaque psoriasis. For more information about STELARA, visit www.STELARAinfo.com.

Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to the product in the United States. The Janssen pharmaceutical companies maintain exclusive worldwide marketing rights to STELARA, which is currently approved for the treatment of moderate to severe plaque psoriasis in 65 countries.

Important Safety Information
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

  • Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and 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 that 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.

Cancer
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. 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, and vision problems.

Serious Allergic Reactions
Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor if you:

  • have any of the conditions or symptoms listed above for serious infections, cancer, or RPLS
  • 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®. Non-live vaccinations received while taking STELARA® may not fully protect you from disease.
  • are receiving or have received allergy shots, especially for serious allergic reactions
  • ever had an allergic reaction to STELARA®
  • receive phototherapy for your psoriasis
  • have any other medical conditions
  • are pregnant or plan 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 to 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

Common side effects of STELARA® include: upper respiratory infections, headache, and tiredness

These are not all of the side effects with STELARA®. Tell your doctor about any side effect that bothers you or does not go away. Ask your doctor or pharmacist for more information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Medication Guide for STELARA® and discuss any questions you have with your doctor.

About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy ofinnovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world. Follow us on Twitter at www.twitter.com/JanssenUS.

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Media Contacts:
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Janssen Biotech, Inc.
Office: 215-628-7010
Mobile: 215-620-0111

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Janssen Biotech, Inc.
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Investor Contacts:
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Johnson & Johnson
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Stelara Side Effects

Generic Name: ustekinumab

Medically reviewed by Drugs.com. Last updated on Dec 11, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about ustekinumab. Some of the dosage forms listed on this page may not apply to the brand name Stelara.

In Summary

More frequent side effects include: headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ustekinumab: parenteral injection

Warning

REMS:

FDA approved a REMS for ustekinumab to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of ustekinumab and consists of the following: communication plan. See the FDA REMS page ().

Side effects include:

Patients with psoriasis: Nasopharyngitis, upper respiratory tract infection, headache, fatigue, diarrhea, back pain, dizziness, pharyngolaryngeal pain, pruritus, injection site erythema, myalgia, depression.

Patients with psoriatic arthritis: Arthralgia, nausea, dental infections.

For Healthcare Professionals

Applies to ustekinumab: intravenous solution, subcutaneous solution

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain

Uncommon (0.1% to 1%): Nasal congestion

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Facial palsy

Other

Common (1% to 10%): Fatigue

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea

Musculoskeletal

Common (1% to 10%): Back pain, myalgia, arthralgia

Local

Common (1% to 10%): Injection site erythema, pain, bruising, irritation

Uncommon (0.1% to 1%): Injection site reactions (including hemorrhage, hematoma, induration, swelling, and pruritus)

Dermatologic

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation

Rare (less than 0.1%): Exfoliative dermatitis

Postmarketing reports: Erythrodermic psoriasis

Psychiatric

Common (1% to 10%): Depression

Oncologic

Common (1% to 10%): Malignancies (1.7%)

Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)

Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)

Immunologic

Very common (10% or more): Infections (up to 27%)

Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections

Uncommon (0.1% to 1%): Cellulitis, herpes zoster, viral upper respiratory tract infection

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

2. Cerner Multum, Inc. “Australian Product Information.” O 0

3. “Product Information. Stelara (ustekinumab).” Centocor Inc, Malvern, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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FDA Approves STELARA® (Ustekinumab) for Treatment of Moderate-to-Severe Crohn’s Disease

NEW YORK, NY – The Crohn’s & Colitis Foundation released the following statement today after the U.S. Food & Drug Administration announced its approval of STELARA® (ustekinumab), a biologic therapy from Janssen Biotech, Inc., for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) earlier this week. STELARA will be available for use in adult patients with Crohn’s disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker. It has also been approved for use in patients who failed or were intolerant to treatment with one or more TNF blockers.

“Because of the individual nature of these diseases, what works for one patient may not work for another. That is why it is so critical that our Crohn’s patients have many different treatment options available to them,” said Michael Osso, President & CEO of the Crohn’s & Colitis Foundation. “The approval of STELARA is extremely important for patients living with moderate-to-severe Crohn’s disease. Many of these patients have exhausted available treatments, and STELARA gives them another option to hopefully, induce remission, help manage their disease, and improve their quality of life.”

STELARA® is the first biologic therapy for Crohn’s disease targeting Interleukin-12 and Interleukin-23 cytokines, which play a key role in inflammatory and immune responses.

“The role of cytokines in regulating the immune system’s response to inflammation has been the subject of significant research. Through our robust grant-funding program, the Foundation has funded a number of preliminary research studies into the importance of cytokines in the treatment of IBD,” Osso said. “We will continue to fund research into cytokines and other potential therapeutic targets in order to yield additional discoveries and new treatments for IBD patients.”

STELARA® is the only treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg , 390 mg , or 520 mg ) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control. The first dose of STELARA® is an induction dose, administered intravenously, under the supervision of a healthcare professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a healthcare professional or self-injected by the patient after proper training.

About Crohn’s Disease

Crohn’s disease is a painful, medically incurable disease that attacks the digestive system. Crohn’s disease may attack anywhere along the digestive tract, from mouth to anus. Symptoms may include abdominal pain, persistent diarrhea, rectal bleeding, fever, and weight loss. Many patients require numerous hospitalizations and surgery. Most people develop the diseases between the ages of 15 and 35; however the incidence is increasing in children.

About STELARA® (ustekinumab)

STELARA® is a prescription medicine used to treat moderately to severely active Crohn’s disease in adult patients (18 years and older) who have already taken other medicine that did not work well enough or they could not tolerate it.

Important Safety Information for STELARA®

STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections

STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®. If your doctor feels that you are at risk for TB, you may be treated for TB before and 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 that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.

Cancers

STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.

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, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor if you:

  • Have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
  • Ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
  • Are allergic to latex. The needle cover on the prefilled syringe contains latex.
  • 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®.
  • Have any new or changing lesions within psoriasis areas or on normal skin.
  • Are receiving or have received allergy shots, especially for serious allergic reactions.
  • Receive or have received phototherapy for your psoriasis.
  • Have any other medical conditions.
  • Are pregnant or plan 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. Talk to your doctor about the best way to feed your baby if you take STELARA®.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed STELARA®:

  • Use STELARA® exactly as prescribed by your doctor.
  • If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Do not try to inject STELARA® yourself until you or your caregiver has been shown how to inject STELARA® by your doctor or nurse.

Common side effects of STELARA® include: upper respiratory infections, headache, tiredness, joint pain, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA®.

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