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Adalimumab-adbm is as safe and effective as Humira® for your patients

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Adalimumab-adbm, the first ever interchangeable* biosimilar to Humira®, is the exact same medicine as CYLTEZO®

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Adalimumab-adbm is made in the US

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO, refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

Adalimumab-adbm: Made in the US and interchangeable* with Humira

Adalimumab-adbm is the first ever interchangeable biosimilar to Humira.* Adalimumab-adbm and CYLTEZO® are the exact same medicine. They are both manufactured in the US by Boehringer Ingelheim, one of the largest producers of biologic medicines in the world.

Learn more about the CYLTEZO Switching Study

Savings with the CareConnect4MeTM
Adalimumab-adbm Copay Program

The CARECONNECT4ME Adalimumab-adbm Copay Program may help eligible patients with commercial insurance—including through health insurance exchanges, federal employee plans, or state employee plans—pay as little as $0 per fill of Adalimumab-adbm. Terms and conditions apply.

Learn how to save

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO, refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

Frequently asked questions

About Adalimumab-adbm and CYLTEZO

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CYLTEZO or Adalimumab-adbm is an FDA-approved biosimilar to Humira (adalimumab), developed and manufactured by Boehringer Ingelheim.1,2,*

According to the FDA, a biosimilar is a biological product that has been proven to be highly similar to a reference product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency.3

Adalimumab-adbm is indicated for:2

  • Rheumatoid arthritis (RA) – Moderate to severe RA in adults
  • Psoriatic arthritis (PsA)
  • Ankylosing spondylitis (AS)
  • Crohn’s disease (CD) – Moderate to severe CD in adults and pediatric patients ≥6 years
  • Plaque psoriasis (PsO) – Moderate to severe chronic PsO in adults
  • Hidradenitis suppurativa (HS disease) – Moderate to severe HS in adults and adolescents 12 years of age and older
  • Juvenile idiopathic arthritis (JIA) – Moderate to severe polyarticular JIA in patients ≥2 years
  • Uveitis – Noninfectious intermediate, posterior, and panuveitis in adults and pediatric patients ≥2 years

These indications allow for the use of Adalimumab-adbm in clinical practice across a spectrum of autoimmune conditions. For full Prescribing Information and a complete list of indications, healthcare professionals are encouraged to refer to Adalimumab-adbm full Prescribing Information and CYLTEZO full Prescribing Information.1,2

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO, refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

References

  1. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/prescribing-information

  2. Adalimumab-adbm [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://content.boehringer-ingelheim.com/DAM/3cac0533-fd57-40a4-87bc-b0810145b210/adalimumab-adbm-us-pi.pdf

  3. U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for Industry. April 2015. Accessed October 10, 2025. https://www.fda.gov/media/82647/download

Boehringer Ingelheim offers insurers Adalimumab-adbm, which is 81% off Humira wholesale acquisition cost (WAC), and CYLTEZO, which is 5% off Humira WAC. While insurance will ultimately determine which product your patient receives, Adalimumab-adbm and CYLTEZO are the exact same medicine.

Adalimumab-abdm (or CYLTEZO) is not a generic; it is an FDA-approved biosimilar and interchangeable* biologic to Humira (adalimumab).1-3 Generics are exact chemical copies of small-molecule drugs. By contrast, biosimilars are large, complex molecules derived from living cells and are demonstrated to be highly similar to the reference biologic, with no clinically meaningful differences in terms of safety, purity, or efficacy.2

Adalimumab-adbm has been evaluated to confirm structural and functional similarity to Humira, including through analytical, nonclinical, and clinical comparisons, as per FDA biosimilar standards.2-6 It is also the first adalimumab biosimilar approved as interchangeable with Humira.6,7

Adalimumab-adbm offers healthcare providers a clinically equivalent and potentially cost-effective alternative to Humira for managing approved indications, including conditions such as HS or RA.8

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO, refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

References

  1. Adalimumab-adbm [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://content.boehringer-ingelheim.com/DAM/3cac0533-fd57-40a4-87bc-b0810145b210/adalimumab-adbm-us-pi.pdf

  2. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/prescribing-information

  3. Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77(6):914-921.

  4. Hanauer S, Liedert B, Balser S, et al. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn’s disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6(10):816-825.

  5. Menter A, Arenberger P, Balser S, et al. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized phase III VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021;21(1):87-96.

  6. Menter A, et al. Switching between adalimumab reference product and BI 695501 in patients with chronic plaque psoriasis (VOLTAIRE-X): a randomized controlled trial. Am J Clin Dermatol. 2022;23:719-728.

  7. Boehringer Ingelheim. Press release: MPR-US-101912. US FDA approves Cyltezo (adalimumab-adbm) as first interchangeable biosimilar with Humira. October 15, 2021. Accessed October 10, 2025. https://www.boehringer-ingelheim.com/us/media/press-releases/cyltezo-adalimumab-adbm-first-interchangeable-biosimilar-bi-us

  8. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: Initial experience and future potential. RAND Corporation; 2017. Accessed October 10, 2025. https://www.rand.org/pubs/perspectives/PE264.html

About Biologics and Biosimilars

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Interchangeability goes beyond biosimilarity. While all interchangeable biologics are biosimilars, not all biosimilars are interchangeable. For a biosimilar to receive this designation, the FDA may require additional evidence from switching studies that show patients can alternate between the reference product and the biosimilar without any loss of efficacy, increased safety concerns, or heightened immunogenicity risk.1-3

This interchangeability designation by the FDA means that pharmacists may substitute certain biosimilars (such as Adalimumab-adbm) for the reference product (like Humira) without prescriber intervention, depending on individual state laws.1,3 This supports expanded access to biologic therapy and may help reduce treatment costs for patients and healthcare systems alike.

References

  1. U.S. Food and Drug Administration. 9 things to know about biosimilars and interchangeable biosimilars. Updated June 2024. Accessed October 10, 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  2. Cohen HP, Blauvelt A, Rifkin RM, et al. Switching reference medicines to biosimilars: A systematic literature review of clinical outcomes. Drugs. 2018;78(4):463-478. doi:10.1007/s40265-018-0881-y

  3. CYLTEZO [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://pro.boehringer-ingelheim.com/us/products/cyltezo/bipdf/prescribing-information

Yes, Adalimumab-adbm is interchangeable* with Humira,1-3 and Adalimumab-adbm and CYLTEZO are the exact same medicine. 

The FDA granted low-concentration CYLTEZO (50 mg/mL) its interchangeable status on October 15, 2021, based on results from the VOLTAIRE-X study.1 Data showed that switching several times between CYLTEZO and Humira resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety.1,2

The FDA further granted interchangeability status to high-concentration CYLTEZO (100 mg/mL) on May 20, 2025. This FDA approval was based, in part, on data from the clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of Adalimumab-adbm.3

What this means for your clinical practice*:

You can confidently consider Adalimumab-adbm as a safe and effective substitute for Humira, supported by robust data from the VOLTAIRE-X trial and the FDA’s interchangeability standards.2,4 Adalimumab-adbm and CYLTEZO are the exact same medicine.

Pharmacist-level substitution may occur where state laws allow, potentially streamlining treatment pathways and reducing delays in access to therapy.4,5

The interchangeability designation may also reduce administrative burden by limiting the need for prior authorizations or step therapy adjustments and can facilitate broader patient access to adalimumab treatment, especially in chronic inflammatory conditions.5,6

*The FDA first approved CYLTEZO as an interchangeable biosimilar (50 mg/mL) to Humira on October 15, 2021. CYLTEZO (100 mg/mL) was approved as an interchangeable biosimilar to Humira on May 20, 2025. For more information on interchangeability for CYLTEZO, refer to the FDA’s resource on biosimilars and interchangeability, the Purple Book: https://purplebooksearch.fda.gov/.

References

  1. Boehringer Ingelheim. Press release: MPR-US-101912. US FDA approves Cyltezo (adalimumab-adbm) as first interchangeable biosimilar with Humira. October 15, 2021. Accessed October 10, 2025. https://www.boehringer-ingelheim.com/us/media/press-releases/cyltezo-adalimumab-adbm-first-interchangeable-biosimilar-bi-us.

  2. Menter A, et al. Switching between adalimumab reference product and BI 695501 in patients with chronic plaque psoriasis (VOLTAIRE-X): A randomized controlled trial. Am J Clin Dermatol. 2022 Aug 7;23(5):719-728. doi: 10.1007/s40257-022-00708-w

  3. Boehringer Ingelheim. Press release: MPR-US-103133 (5/24). US FDA approves Boehringer Ingelheim’s high-concentration, citrate-free formulation of CYLTEZO (adalimumab-adbm) injection. May 1, 2024. Accessed October 10, 2025. https://www.boehringer-ingelheim.com/us/fda-approves-additional-formulation-biosimilar

  4. U.S. Food and Drug Administration. 9 things to know about biosimilars and interchangeable biosimilars. Updated June 2024. Accessed October 10, 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  5. Blackstone EA, Fuhr JP Jr. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469-478.

  6. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: Initial experience and future potential. RAND Corporation; 2017. Accessed October 10, 2025. https://www.rand.org/pubs/perspectives/PE264.html

Prescribing Adalimumab-adbm

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When selecting an adalimumab biosimilar, you should evaluate:

  • FDA-approved interchangeability status

    The interchangeability designation supports that switching between a biosimilar and the reference will not result in clinically meaningful differences in efficacy, safety, or immunogenicity. This can streamline treatment pathways, especially for patients requiring long-term biologic therapy.1

  • Indication match with patient’s diagnosis

    This ensures that the treatment is appropriate and supported by clinical evidence for the intended condition.2

  • Real-world data on switching and patient satisfaction

    Real-world evidence and clinical trials play an important role in understanding the long-term safety and effectiveness of biosimilars. Additionally, real-world data on patient satisfaction, including ease of switching and the experience of lower treatment costs, can further support decision-making. Also consider the patient’s preference for treatment options, including the potential for greater adherence or satisfaction with a more affordable therapy.1

  • Patient support programs

    Choosing a biosimilar with strong manufacturer support programs (eg, financial assistance, educational resources, nurse support) can be crucial in improving treatment outcomes and patient adherence. These programs can reduce the administrative burden for both you and your patients and improve patient outcomes by enhancing access to therapy and encouraging adherence.3

References

  1. Mayden KD, et al. Biosimilars in the United States: Considerations for Oncology Advanced practitioners. J Adv Pract Oncol. 2015 Mar 1;6(2):108-116.

  2. Mysler E, et al. Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience? Drugs. 2021;81(16):1859-1879. doi: 10.1007/s40265-021-01610-1

  3. Småstuen CM, et al. OP0070-HPR. Is patients’ satisfaction with being switched to a biosimilar medication associated with their level of health literacy? Results from a Norwegian user survey. Ann Rheum Dis. 2018;77(suppl 2):86.

Biosimilars such as Adalimumab-adbm provide several advantages for you and your patients, particularly in the management of chronic immune-mediated conditions:

  • Comparable clinical performance to the reference product

    Adalimumab-adbm has demonstrated no clinically meaningful differences in efficacy, safety, purity, and immunogenicity compared to Humira, as required by the FDA’s rigorous biosimilar approval pathway.1,2

  • Potential cost savings for the healthcare system and patients

  • Improved access to biologic therapy

Lower costs and increased market availability of biosimilars can expand access to advanced biologic treatments for patients who may have previously faced affordability barriers—especially critical in chronic inflammatory diseases such as RA, HS, and Crohn’s disease.1,3

These benefits align with biosimilarity standards established by both the FDA and the World Health Organization (WHO) and are increasingly supported by 
real-world evidence and postmarketing surveillance data from global clinical use.

References

  1. Adalimumab-adbm [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2025. Accessed October 10, 2025. https://content.boehringer-ingelheim.com/DAM/3cac0533-fd57-40a4-87bc-b0810145b210/adalimumab-adbm-us-pi.pdf

  2. U.S. Food and Drug Administration. 9 things to know about biosimilars and interchangeable biosimilars. Updated June 2024. Accessed October 10, 2025. https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars

  3. IGBA. Embracing science with confidence: Adopting the Revised 2022 WHO Biosimilars Guideline. 2022. Accessed October 10, 2025. https://www.igbamedicines.org/doc/Embracing-Science-with-Confidence-9-11-2022.pdf

CARECONNECT4ME Adalimumab-adbm Copay Program

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Eligible, commercially insured patients may pay as little as $0 per dispense of Adalimumab-adbm. Once enrolled, patients will receive all details for the CARECONNECT4ME Adalimumab-adbm Copay Program at the email address they provide during enrollment. Please see Terms and Conditions.

The Boehringer Ingelheim Cares Foundation (BI Cares) is an independent, nonprofit organization with a mission to improve patient lives and strengthen our communities. BI Cares provides medicines free of charge to eligible patients who are uninsured. For more information on the BI Cares Foundation, call 1-855-297-5904 or visit www.boehringer-ingelheim.us/our-responsibility/patient-assistance-program.

Patients can call 1-855-297-5904 or visit www.boehringer-ingelheim.us/our-responsibility/patient-assistance-program for more information. Based on eligibility criteria, patients should locate and submit the application for CYLTEZO.

INDICATIONS FOR Adalimumab-adbm (adalimumab-adbm) injection, for subcutaneous use

Rheumatoid Arthritis: Adalimumab-adbm is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-adbm can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 

Juvenile Idiopathic Arthritis: Adalimumab-adbm is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adbm can be used alone or in combination with methotrexate. 

Psoriatic Arthritis: Adalimumab-adbm is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adbm can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis: Adalimumab-adbm is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: Adalimumab-adbm is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: Adalimumab-adbm is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use:
The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis: Adalimumab-adbm is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adbm should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: Adalimumab-adbm is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: Adalimumab-adbm is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION FOR Adalimumab-adbm (adalimumab-adbm) injection, for subcutaneous use

This important information also applies to CYLTEZO® (adalimumab-adbm) injection for subcutaneous use.

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with adalimumab products, including Adalimumab-adbm, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue Adalimumab-adbm if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-adbm use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adbm use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with Adalimumab-adbm prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with Adalimumab-adbm, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start Adalimumab-adbm during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of Adalimumab-adbm with other biologic DMARDS (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with Adalimumab-adbm.
  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

Hypersensitivity Reactions

  • Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop Adalimumab-adbm and institute appropriate therapy.

Hepatitis B Virus Reactivation

  • Use of TNF blockers, including Adalimumab-adbm, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after Adalimumab-adbm treatment. Discontinue Adalimumab-adbm and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming Adalimumab-adbm after HBV treatment.

Neurologic Reactions

  • TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering Adalimumab-adbm for patients with these disorders; discontinuation of Adalimumab-adbm should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.

Hematological Reactions

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping Adalimumab-adbm if significant hematologic abnormalities occur.

Congestive Heart Failure

  • Worsening or new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab. Exercise caution when using Adalimumab-adbm in patients who have heart failure and monitor them carefully.

Autoimmunity

  • Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome or autoimmune hepatitis. Discontinue treatment if symptoms of a lupus-like syndrome or autoimmune hepatitis develop.

Immunizations

  • Patients on Adalimumab-adbm should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating Adalimumab-adbm therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

CL-AA-100002 OCT 2025

Please see Prescribing Information for Adalimumab-adbm, including Boxed Warning, and Medication Guide. Please see Prescribing Information for CYLTEZO, including Boxed Warning, and Medication Guide.