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KabiCare Patient Support Program forOTULFI® (ustekinumab-aauz)

OTULFI® (ustekinumab-aauz) is an FDA-approved biosimilar to Stelara® (ustekinumab) that addresses patients’ and prescribers’ core needs.1

Approved in 2025, OTULFI is indicated for::

  • Moderate to severe plaque psoriasis in adults and children 6 years of age or older
  • Active psoriatic arthritis in adults and children 6 years of age or older
  • Crohn’s Disease in adults
  • Ulcerative colitis in adults

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

Do not take OTULFI if you are allergic to ustekinumab products or any of the ingredients in OTULFI.

For more information about OTULFI and our other Biosimilars, please visit our website: BioSpecialized (Opens in a New Window)

Reference 1: OTULFI (ustekinumab-aauz) injection prescribing information. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2023

Please see the Full Prescribing information for OTULFI (ustekinumab-aauz) (PDF Opens in a New Window).

Important Safety Information

Program Support Areas

Learn more about the program support for OTULFI (ustekinumab-aauz) offered through KabiCare by selecting an area of support below:

KabiCare is here to offer you support and assistance, from diagnosis through your treatment and care.

There are several ways to enroll in the programs provided by KabiCare. Your healthcare provider can enroll you in the KabiCare Patient Support Program, or you can download the enrollment form (PDF Opens in a New Window) and begin completing it yourself. Your completed enrollment form can be submitted to KabiCare online, by phone, or by fax. Once enrolled, you can opt-in for Nurse Support and note any communication preferences that the KabiCare Patient Support Guide should be aware of.

Click here to download the enrollment form. (PDF Opens in a New Window)

Who is Your Patient Support Guide?

Your KabiCare Patient Support Guide is someone who will be available to support you through the enrollment process and will work closely with you and your healthcare provider(s) to help navigate your insurance, financial assistance, and medication access needs to simplify your treatment journey. Getting answers to your questions is just a phone call away at 1-833-KABICARE (1-833-522-4227)

Welcome Call

Once enrollment is complete you will receive a Welcome Call from a Patient Support Guide who will review your insurance information with you and provide you with more information about additional KabiCare resources available to you.

How To Enroll

KabiCare can help you navigate insurance processes and provide information related to your insurance coverage. After enrollment in KabiCare is complete and you have received a Welcome Call from a Patient Support Guide, you will have an opportunity to review your benefits and discuss other patient support program offerings you may be eligible to receive. Your Patient Support Guide is trained to assist you with questions about the KabiCare support programs available to you.

KabiCare can also help make sure your prescription gets to the right specialty pharmacy based on your healthcare provider’s preference or your insurance plan requirements.

Bridge to Therapy Program

The Bridge to Therapy Program ensures that you can receive OTULFI without delay while you are waiting for insurance approval. Eligibility* criteria apply.

*Eligibility criteria apply. Patients are not eligible for Bridge to Therapy Program support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

KabiCare can help with enrolling you into additional assistance programs.

Commercial Copay Support

If you have commercial or private insurance, you may be eligible** for the copay program that lowers your out-of-pocket costs to as little as $0/month for treatment with an annual maximum. You will have a choice to enroll in the full KabiCare Patient Support Program, or just simply enroll in OTULFI Copay Support.

Enroll in the full Program (PDF Opens in a New Window)

Enroll in the Copay Program ONLY

Patient Assistance Program

If you do not have insurance or do not have coverage for your medication, you may be eligible for additional assistance through the Patient Assistance Program* or through independent nonprofit patient assistance programs. Eligibility criteria apply.ŧ

*Terms and Conditions apply.

**Eligibility criteria paply. Patients are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

‡Eligibility for resources provided by independent nonprofit patient assistance program sis based on the nonprofits’ criteria. Fresenius Kabi has no control over these programs.

Financial Assistance Resources

Non-Profit Foundations for Financial Assistance

Nurse Support

Once enrolled, KabiCare Nurse Educators are available to help you make sense of your disease, treatment and medication as prescribed by your doctor. Nurse Educators will also be available to provide injection training for you by phone or telehealth.

Nurse support provided by KabiCare is not meant to replace discussions with a healthcare provider regarding a patient’s care and treatment.

Helpful Resources

We have selected resources and links to useful websites that may be beneficial to you.

KabiCare Program Resources

Useful Website Links

Non-Profit Foundations for Financial Assistance

National Patient Organizations

Healthcare Professional Speaking with a Patient

Why Enroll in KabiCare?

KabiCare is here to offer you support and assistance, from diagnosis through your treatment and care.

There are several ways to enroll in the programs provided by KabiCare. Your healthcare provider can enroll you online in the KabiCare Patient Support Program or by fax. Once enrolled, patients can note any communication preferences that the KabiCare Patient Support Guide should be aware of.

Talk to your doctor today about enrolling in KabiCare.

Expand

Important Safety Information for OTULFI® (ustekinumab-aauz) – Patient

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 the Medication Guide, including Serious Side Effects, for more Important Safety Information. (PDF Opens in a New Window).

Important Safety Information for OTULFI® (ustekinumab-aauz) – Patient

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 the Medication Guide, including Serious Side Effects, for more Important Safety Information. (PDF Opens in a New Window).