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KabiCare Patient Support Program forOTULFI® (ustekinumab-aauz)

Otufi PackagingOTULFI® (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

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

Reference 1: OTUFLI (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 offered through KabiCare by selecting an area of support below:

Patient Support Guide

Our Patient Support Guides can assist with the enrollment process and provide appropriate information regarding patient insurance coverage, copay assistance, and other support programs. Our online portal keeps you up to date on the progress for any claim or Prior Authorization (PA) issues.

Welcome Call

After enrolling in the program, your patient will receive a Welcome Call from a Patient Support Guide to help answer any questions about the product, disease-state information, and other resources available to patients through KabiCare.

Learn More About How to Enroll or Download The Enrollment Form Here (PDF Opens in a New Window)

Benefits Investigation

Once a patient is enrolled, KabiCare conducts the benefits investigation on behalf of the patient to confirm insurance coverage details. The information is provided to you, your practice, and your patient to aid in patient access.

Prior Authorizations Support

If a prior authorization is required by insurance, the Patient Support Guide will alert your office of the requirement and confirm the submission method preferred by the payer. The Patient Support Guide will work closely with you and your staff to ensure the appropriate information is shared with the payer.

Claims Appeals Support

Should a claim or prior authorization be denied, a KabiCare Patient Support Guide will assist as you prepare the documentation needed to support an appeal.

  1. Download Sample Letter of Medical Necessity (PDF Opens in a New Window)
  2. Download Sample Letter of Appeal (PDF Opens in a New Window)

Obtaining a determination from the insurance company is sometimes delayed for any number of reasons. Field Reimbursement Managers will be available to help identify and overcome obstacles in an effort to prevent any further delays.

Billing and Coding Support

Get connected with a Field Reimbursement Manager who is available to share updates in payer coverage and help answer your questions about billing and coding.

Download: Access and Reimbursement Guide (PDF Opens in a New Window)

Bridge to Therapy Program Enrollment

The Bridge to Therapy Program provides commercially insured patients access to treatment without delay while they are waiting for insurance approval. Eligibility criteria apply**.

**Eligibility criteria apply. 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.

Specialty Pharmacy Support

If you enrolled your patient, or the patient enrolled themselves into the KabiCare Patient Support Program, and a specialty pharmacy was not selected, the Patient Support Guides can help ensure your patient’s prescription is triaged to an appropriate specialty pharmacy.

Commercial Copay Support

If your patient has commercial or private insurance, they may be eligible** for the copay program that lowers their out-of-pocket costs to as little as $0/month for treatment with an annual maximum. Your patient 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 your patient in the Copay Program ONLY

Patient Assistance Program

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

*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 your patient make sense of their disease, treatment and medication as prescribed by you. Nurse Educators will also be available to provide injection training for your patients 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.

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

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

Infections

Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.

Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:

  • Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections
  • Psoriatic arthritis: cholecystitis
  • Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis
  • Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis

Avoid initiating treatment with OTULFI (ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of OTULFI (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with OTULFI (ustekinumab-aauz).

Discontinue OTULFI (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with OTULFI (ustekinumab-aauz).

Avoid administering OTULFI (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering OTULFI (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of OTULFI (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Closely monitor patients receiving OTULFI (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment.

Malignancies

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.

The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving OTULFI (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue OTULFI (ustekinumab-aauz).

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.

Monitor all patients treated with OTULFI (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue OTULFI (ustekinumab-aauz).

Immunizations

Prior to initiating therapy with OTULFI (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with OTULFI (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with OTULFI (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving OTULFI (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of OTULFI (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue OTULFI (ustekinumab-aauz) and institute appropriate treatment.

Most Common Adverse Reactions

The most common adverse reactions (≥3%) seen in patients treated with OTULFI (ustekinumab-aauz) are:

  • Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue
  • Crohn’s disease, induction: vomiting
  • Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis
  • Ulcerative colitis, induction: nasopharyngitis
  • Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indications

  • Adult patients with:
    • Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
    • Active psoriatic arthritis
    • Moderately to severely active Crohn’s disease
    • Moderately to severely active ulcerative colitis
  • Pediatric patients ≥6 years of age with:
    • Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
    • Active psoriatic arthritis

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

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

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

Infections

Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.

Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:

  • Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections
  • Psoriatic arthritis: cholecystitis
  • Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis
  • Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis

Avoid initiating treatment with OTULFI (ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of OTULFI (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with OTULFI (ustekinumab-aauz).

Discontinue OTULFI (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with OTULFI (ustekinumab-aauz).

Avoid administering OTULFI (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering OTULFI (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of OTULFI (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Closely monitor patients receiving OTULFI (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment.

Malignancies

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.

The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving OTULFI (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue OTULFI (ustekinumab-aauz).

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.

Monitor all patients treated with OTULFI (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue OTULFI (ustekinumab-aauz).

Immunizations

Prior to initiating therapy with OTULFI (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with OTULFI (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with OTULFI (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving OTULFI (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of OTULFI (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue OTULFI (ustekinumab-aauz) and institute appropriate treatment.

Most Common Adverse Reactions

The most common adverse reactions (≥3%) seen in patients treated with OTULFI (ustekinumab-aauz) are:

  • Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue
  • Crohn’s disease, induction: vomiting
  • Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis
  • Ulcerative colitis, induction: nasopharyngitis
  • Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indications

  • Adult patients with:
    • Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
    • Active psoriatic arthritis
    • Moderately to severely active Crohn’s disease
    • Moderately to severely active ulcerative colitis
  • Pediatric patients ≥6 years of age with:
    • Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
    • Active psoriatic arthritis

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