For Patients & Caregivers

Get to know OTULFI® (ustekinumab-aauz)

OTULFI® (ustekinumab-aauz) is an FDA-approved biosimilar to Stelara® (ustekinumab) used for treatment of patients with the following conditions:

Plaque Psoriasis

Psoriatic Arthritis

Crohn’s Disease

Ulcerative Colitis

Typically, doctors will prescribe OTULFI after someone has already not responded to a different medication. 

In conditions treated by OTULFI, your body may be producing two proteins, interleukin 12 (IL-12) and interleukin 23 (IL-23), at higher-than-normal levels, which may result in inflammation and pain. OTULFI works by blocking the activity of IL-12 and IL-23 proteins, which has been shown to reduce inflammation, pain, swelling, and help with skin symptoms. 

OTULFI can be given in the clinic by a healthcare provider or at home as a self-administered subcutaneous injection. 

Your healthcare provider will determine the appropriate setting and administration method for your specific condition.

 
Administered by your healthcare provider: 
Vial for IV infusion

For patients with Crohn's disease and ulcerative colitis only, an intravenous (IV) infusion may be given by your healthcare provider for your first dose. The medicine is administered using a needle placed in a vein in your arm. The infusion process will take place in your physician's office or at an infusion center and will take about 1 hour. Follow-up doses will be given through a pre-filled syringe. 

Vial for IV infusion

For patients with Crohn's disease and ulcerative colitis only, an intravenous (IV) infusion may be given by your healthcare provider for your first dose. The medicine is administered using a needle placed in a vein in your arm. The infusion process will take place in your physician's office or at an infusion center and will take about 1 hour. Follow-up doses will be given through a pre-filled syringe. 

Vial for subcutaneous injection 

For patients with plaque psoriasis and psoriatic arthritis only, your medicine will be given as an injection under your skin by your healthcare provider. The injection is prepared and delivered in your physician's office. 

Vial for subcutaneous injection 

For patients with plaque psoriasis and psoriatic arthritis only, your medicine will be given as an injection under your skin by your healthcare provider. The injection is prepared and delivered in your physician's office. 

Administered by you:

Single-use pre-filled syringes
(45 mg and 90 mg) 

You will receive your medicine by injection under the skin using the pre-filled syringe, which is a syringe that comes with medicine inside. The syringes come in 45 mg and 90 mg sizes. 

Single-use pre-filled syringes
(45 mg and 90 mg) 

You will receive your medicine by injection under the skin using the pre-filled syringe, which is a syringe that comes with medicine inside. The syringes come in 45 mg and 90 mg sizes. 

It is important to read the Instructions for Use that come with your OTULFI prescription about how to prepare and inject a dose of OTULFI, and how to properly dispose of used needles and syringes. The syringe, needle, and vial must never be reused. Throw away any unused portion of OTULFI. 

Images are for illustrative purposes only.

  • OTULFI must be refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton 
  • Do not freeze 
  • Store OTULFI vials upright 
  • A single pre-filled syringe may be stored at room temperature at or below 30°C (86°F) for a single maximum period of up to 30 days 
  • Once a syringe has been stored at room temperature, do not return it to the refrigerator 
  • Protect the vials and syringes from light by storing them in the original pack 

Take the missed dose as soon as you remember, then resume your usual dosing routine. Do not take 2 doses to make up for a missed one. If you’re unsure when to take your next dose, talk with your healthcare provider for guidance. 

Talk to your healthcare provider if you or your caregiver have any questions about OTULFI. 

A biosimilar is a medicine that is highly similar to the original product (also called "reference product") with no clinically meaningful differences in safety, purity, or effectiveness.

OTULFI® (ustekinumab-aauz) and Stelara® (ustekinumab) are similar in the following ways:

  • Both made from living cells
  • Work in the body in the same way
  • Equally safe and effective

Why are biosimilars important?

  • Help reduce costs for patients and healthcare systems
  • Increase availability to more patients in need
  • Encourage innovation in health care

"FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference [original] product."

—US Food and Drug Administration

Filename
KabiCare-Biosimilars-Patient-Brochure-3285.pdf
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1 MB
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pdf
Download the Understanding Biosimilars Brochure

KabiCare Patient Support Program

Fresenius Kabi provides you access to KabiCare, a comprehensive patient support program 

Our experts work closely with you to help simplify your treatment journey, including enrolling in KabiCare, navigating insurance coverage and financial assistance, securing access to medication, offering disease education, injection training, refill reminders, and more.

Once enrolled, you’ll have access to a wide range of materials, including:


     Enrollment Support

    


     Financial support*

    


     Insurance support

    


     Clinical support

    

*Eligibility criteria apply.

Resources for OTULFI

Watch this video to learn how to administer OTULFI (45 mg pre-filled syringe)

Watch this video to learn how to administer OTULFI (90 mg pre-filled syringe)

 

 

Download OTULFI resource materials

Filename
OTULFI-Patient-Brochure-5769.pdf
Size
4 MB
Format
pdf
OTULFI Patient Brochure
Filename
KabiCare-Biosimilars-Patient-Brochure-3285.pdf
Size
1 MB
Format
pdf
Understanding Biosimilars Brochure
Important Safety Information

What is OTULFI (ustekinumab-aauz)?
OTULFI is a prescription medicine use to treat:

  • Moderate-to-severe psoriasis (PsO) in adults and children 6 years and older who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
  • Active psoriatic arthritis (PsA) in adults and children 6 years and older
  • Moderately to severely active Crohn’s disease (CD) in adults 18 years and older
  • Moderately to severely active ulcerative colitis (UC) in adults 18 years and older

It is not known if OTULFI is safe and effective in children less than 6 years of age.

OTULFI is contraindicated in patients with clinically significant hypersensitivity to
ustekinumab products or to any of the excipients in OTULFI.

OTULFI is a prescription medicine that affects your immune system and can increase your chance of having serious side effects including:

Serious Infections
OTULFI may lower your ability to fight infections and may increase your risk of infections. While taking OTULFI, 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 OTULFI and monitor for signs and symptoms of TB when being treated with OTULFI
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with OTULFI

You should not begin treatment with OTULFI if you have any kind of infection unless your doctor says it is okay.

Before starting OTULFI, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweats, or chills
    • muscle aches
    • shortness of breath
    • cough
    • blood in phlegm
    • weight loss
    • feeling very tired
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
  • have any open cuts or 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 with TB

After starting OTULFI, call your doctor right away if you have any symptoms of an infection (see above). These may include signs of infections such as chest infections, skin infections, or shingles that could have serious complications. OTULFI can make it more likely for you 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 some serious infections that can spread throughout the body and cause death. People who take OTULFI may also be more likely to get these infections.

Cancers
OTULFI 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 before starting treatment with OTULFI.
Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving OTULFI. Tell your doctor if you have any new skin growths.

Posterior Reversible Encephalopathy Syndrome (PRES)
PRES is a rare condition that affects the brain and can cause death. If PRES is found early and treated, most people recover. The cause of PRES is not known. 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 during treatment with OTULFI. Stop using OTULFI and get medical help right away if you have any symptoms of a serious allergic reaction such as swelling of your face, eyelids, tongue, or throat; feeling faint; chest tightness; or skin rash.

Lung Inflammation
There have been some cases of lung inflammation in people who receive OTULFI. These cases may be serious and may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with OTULFI.

Before receiving OTULFI, tell your doctor about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed above for serious infections, cancers, or PRES
  • ever had an allergic reaction to OTULFI or any of its ingredients (ask your doctor if you are not sure)
  • have recently received or are scheduled to receive a vaccine
    • People who take OTULFI should not receive live vaccines
    • Tell your doctor if anyone in your house needs a live vaccine
    • The viruses used in some types of live 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 receiving OTULFI or one year after you stop receiving OTULFI
  • have any new or changing lesions within psoriasis areas or on normal skin
  • receive or have received phototherapy for your psoriasis
  • are receiving or have received allergy shots, especially for serious allergic reactions
  • are pregnant or plan to become pregnant
    • It is not known if OTULFI can harm your unborn baby
    • You and your doctor should decide together if you will receive treatment with OTULFI
  • received OTULFI while you were pregnant; it is important that you tell your baby’s healthcare provider before your baby receives any vaccinations
  • are breastfeeding or plan to breastfeed; OTULFI can pass into your breast milk
  • talk to your doctor about the best way to feed your baby if you receive OTULFI

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 and keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed OTULFI:

  • Use OTULFI exactly as your doctor tells you to
  • OTULFI is intended for use under the guidance and supervision of your doctor.
    • In children 6 years and older, it is recommended that OTULFI be administered by a healthcare provider
    • If your doctor decides that you or a caregiver may give your injections of OTULFI at home, you should receive training on the right way to prepare and inject OTULFI
    • Your doctor will determine the right dose of OTULFI for you, the amount for each injection, and how often you should receive it
      • Do not try to inject OTULFI yourself until you or your caregiver have been shown how to inject OTULFI by your doctor or nurse


Common side effects of OTULFI include:

  • nasal congestion
  • sore throat
  • runny nose
  • upper respiratory infections
  • fever
  • headache
  • tiredness
  • itching
  • nausea
  • vomiting
  • redness at the injection site
  • vaginal yeast infections
  • urinary tract infections
  • sinus infection
  • bronchitis
  • diarrhea
  • stomach pain
  • joint pain

These are not all of the possible side effects with OTULFI. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Fresenius Kabi at 1-800-551-7176.

Please see Full Prescribing Information and Medication Guide, including Serious Side Effects, for more Important Safety Information.

Indications

Adults & children 6 years+ with 
moderate to severe

OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adults and pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Adults & children 6 years+ with active

OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adults and pediatric patients ≥6 years of age with active psoriatic arthritis.

Adults with moderately to severely active

OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderately to severely active Crohn’s disease.

Adults with moderately to severely active

OTULFI (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderately to moderately to severely active ulcerative colitis.