Common Questions About Crohn’s Disease
Crohn's disease is an autoimmune condition. Even though the exact cause of Crohn’s disease is unknown, potential drivers of Crohn’s disease have been linked to a combination of several factors, including your immune system, genetics, and the environment. Learn more about how STELARA® works.
Your doctor will prescribe a Crohn's disease treatment based on many factors, including how severe your disease is, your age, and your medical history. Some common treatments include:
These drugs work in the GI tract to decrease inflammation
Oral, topical, or intravenously infused drugs used to suppress the immune system
Oral or injectable drugs that modify or weaken the immune system to reduce inflammation
Some can treat bacterial infections in the GI tract
The newest type of therapy, biologics are injectables or infusions that target inflammation that may cause Crohn's disease symptoms
*Recommended by the American College of Gastroenterology Practice Guidelines for the treatment of Crohn’s disease but it is not approved by the FDA for the treatment of this condition.
Learn more about the available options in the treatment of Crohn's disease.
Common Questions About STELARA®
STELARA® is a prescription medicine used to treat adults 18 years and older with moderately to severely active Crohn’s disease who have already taken other medicine that did not work well enough or they could not tolerate it.
The recommended treatment regimen for STELARA® is a single intravenous (IV) infusion of the amount of medication based on your body weight administered through a needle placed in a vein by a medical professional at week 0, followed by a 90-mg injection given under the skin as directed by your doctor at week 8 and then every 8 weeks thereafter. The injection is administered by a healthcare provider or self-injected only after proper training. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject STELARA®. Do not try to inject yourself until you or your caregiver has been properly trained by a healthcare provider.
STELARA® treatment begins with a single intravenous (IV) infusion of the amount of medication based on your body weight administered by a medical professional in a comfortable setting at week 0. This is followed by a 90-mg injection given under the skin as directed by your doctor at week 8 and then every 8 weeks thereafter. The injection is administered by a healthcare provider or self-injected only after proper training. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject STELARA®. Do not try to inject yourself until you or your caregiver has been properly trained by a healthcare provider.
Only your doctor can decide how long you will need to continue treatment with STELARA®.
The active ingredient in STELARA® is called ustekinumab. The other ingredients are sucrose, L-histidine and L-histidine monohydrochloride monohydrate, and polysorbate 80 for prefilled syringes and EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and sucrose for intravenous infusion. STELARA® is manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403.
Janssen Biotech is a world leader in biomedical research and development that continues to discover and deliver innovative biologic treatments such as STELARA®. To learn more, please visit Janssen.com.
STELARA® is a prescription medicine that targets your immune system, and may increase your chances of serious side effects including infections, cancer, serious allergic reactions and a rare condition called reversible posterior leukoencephalopathy syndrome.
In clinical studies, the most common side effects were upper respiratory infections, headache, tiredness, joint pain, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site.
You should not receive a live vaccine while taking STELARA®. Before receiving STELARA®, tell your doctor if you have recently received or are scheduled to receive an immunization (vaccine). 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®.
Everyone responds to treatment differently.
Clinical studies included patients who were new to, had experience with, or did not respond to biologics.* Of the patients who were new to, or had experience with biologics, the majority found relief from their Crohn's disease symptoms in just 6 weeks after the one-time intravenous (IV) infusion of STELARA®, with noticeable improvement as early as 3 weeks. Additionally, the majority of those continuing treatment with STELARA® subcutaneous maintenance doses were in remission through the end of the one-year study.
STELARA® is not right for everyone. Only your doctor can decide if STELARA® is right for you. Individual results may vary.
STELARA® is not right for everyone. Only your doctor can decide if STELARA® is right for you. Individual results may vary.
*Tumor necrosis factor blocker (anti-TNF agent).
How STELARA® Works
STELARA® is a biologic. Biologics are medications that are genetically engineered from products of living organisms, such as proteins, genes, or antibodies. They target enzymes and proteins that may cause inflammation.
There are many different naturally occurring proteins in the body that contribute to inflammation. Patients with Crohn's disease are found to have elevated levels of two of these proteins, IL-12 and IL-23, that may be associated with gastrointestinal inflammation in Crohn's disease.
STELARA® is the first and only Crohn’s disease medicine that works by targeting IL-12 and IL-23, which are thought to be associated with gastrointestinal inflammation in Crohn's disease.
STELARA® is not for everyone; only your doctor can decide if it’s right for you. STELARA® is a prescription medicine that affects your immune system. It can increase your chances of having serious side effects including infections, cancer, serious allergic reactions and a rare condition called reversible posterior leukoencephalopathy syndrome. Please read the Important Safety Information below and the Medication Guide for STELARA® to learn more about these and other risks for STELARA®. Discuss any questions you have with your doctor.
Common Questions About Infusion
The infusion lasts at least one hour, so before you're done texting, tweeting, and planning a hangout with your friends, you'll be finished and on your way home.
There are a few things you'll need to bring to your appointment, as well as a few items that can make you more comfortable or help pass the time. You can download a comprehensive checklist here.
STELARA® Injection Support
The first step in self-injecting is for you and your doctor to decide if self-injection is right for you. If your doctor decides that you or a caregiver may be able to 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 have been shown the right way to give the injections by your doctor or nurse. Please note that your first dose will always be given at the doctor’s office. Click here to watch a video overview of self-injecting STELARA®.
Please read the Important Safety Information below and the Medication Guide for STELARA® to learn more about these and other risks for STELARA®. Discuss any questions you have with your doctor.
Your prefilled syringe should look clear and colorless to light yellow with few white particles. Do not use the prefilled syringe if the liquid looks frozen, discolored, cloudy, or contains large particles. If you have any questions about what is normal and what is not, call 877-CarePath (877-227-3728).
As far as injection sites go, you can use your buttocks, the front of your thigh, or around your stomach. Either site is equally good. Just remember, the 2-inch radius around your belly button is off limits. If you’ve got someone there to help you out, the outer area of your upper arm is also an option. Do not inject into an area that is tender, bruised, red, or hard.
If you see a small amount of blood or liquid where you injected, that is normal. Just press a cotton ball or gauze pad to it, if needed. Do not rub. If you want, you can cover the area with an adhesive bandage.
If your doctor decides that a caregiver or a friend may give your injections at home, he or she should receive training on the right way to prepare and inject STELARA®. He or she should not inject you until trained by a healthcare provider.
Our Nurse Navigators are available to answer your questions about the injection process. For assistance, call Janssen CarePath for STELARA® at 877-CarePath (877-227-3728). You can also watch our self-injection overview video on our Injection Support page.
Put the used syringe in an approved puncture-resistant container (sharps disposal container) right away after use. Do not throw away loose syringes in your household trash. Follow your community’s guidance for the right way to dispose of your sharps container. Always keep the sharps disposal container out of the reach of children.
Free Syringe Disposal Program
We offer a Safe Returns® program, providing a free sharps container in a postage-paid return package for easy syringe disposal. You can opt into Safe Returns® by enrolling in the patient support program or by calling Janssen CarePath for STELARA® at 877-CarePath (877-227-3728).
For more information about safe sharps disposal and specific information about your state’s disposal guidelines, go to the FDA’s website at: FDA.gov/safesharpsdisposal.
Do not miss any doses of STELARA®. If you forget to use STELARA® at your scheduled time, call your healthcare provider.
STELARA® Storage and Stability
STELARA® must be stored in the refrigerator between 36°F to 46°F (2°C to 8°C) (but NOT in the freezer compartment). STELARA® should not be frozen or shaken. Keep the product in the original carton to protect it from light until the time of use. If your STELARA® has been stored outside of the recommended temperature ranges, contact your healthcare provider. If the expiration date has passed, do not use it. If the expiration date has passed, call your doctor or pharmacist, or call 1-800-JANSSEN (1-800-526-7736) for help.
Common Questions About Cost Savings & Insurance Coverage
Understanding your insurance coverage can be tricky. Since coverage policies can vary from plan to plan, it’s important to check if your pharmacy and medical benefits cover STELARA®. Janssen CarePath Care Coordinators can help you learn about and verify your insurance benefits. They’ll also help explain your potential out-of-pocket medication costs for STELARA®. You can contact Janssen CarePath for STELARA® at 877-CarePath (877-227-3728), Monday-Friday, 8 AM to 8 PM ET. Please have your insurance information available when you call.
If you use private or commercial health insurance to pay for a portion of your medication costs for STELARA®, the Janssen CarePath Savings Program may help lower your out-of-pocket costs including co-pay, deductible, and co-insurance medication costs. If you qualify, your out-of-pocket costs will be just $5 for each dose* with a $20,000 maximum program benefit per calendar year.
A Janssen CarePath Care Coordinator can provide you with more details and see if you are able to participate.
You are encouraged to call Janssen CarePath to get information about how to get help paying for STELARA®. You can contact them at 877-CarePath (877-227-3728) or Stelara.JanssenCarePathSavings.com. Please have your insurance information ready.
For more information about help paying for STELARA®, visit cost support options.
If you're delayed or denied treatment from your insurance provider, we may be able to help. Contact 877-CarePath (877-227-3728) and ask about the Janssen Link Program.
*Not valid for patients enrolled in Medicare, Medicare Part D, or Medicaid. Visit Stelara.JanssenCarePathSavings.com for full eligibility requirements.