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Cyltezo

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Cyltezo

Cyltezo_EN

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cyltezo

Property Description
Active Ingredient Adalimumab-adbm
Form Solution for injection (prefilled syringe/pen)
Pharmacological Class Tumor Necrosis Factor (TNF) Blocker
RX/OTC Status Prescription-Only Medicine (Rx)
Manufacturer Boehringer Ingelheim Pharmaceuticals, Inc.
Origin Biologic (Recombinant monoclonal antibody)

Cyltezo is a biological product designated as Adalimumab-adbm that belongs to the Tumor Necrosis Factor (TNF) Blocker class. It is approved as an interchangeable biosimilar to the reference biologic, Humira. The interchangeability status is a unique feature of Cyltezo, meaning it is expected to produce the same clinical result as the reference product when substituted at the pharmacy level. This drug is clinically recognized for its ability to provide therapeutic equivalence to the originator biologic, offering patients a reliable alternative treatment option. Cyltezo is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., and is available only as a Prescription-Only Medicine (Rx).

Composition, Formulation, and General Purpose

The active component in Cyltezo is the Adalimumab protein, a fully human monoclonal antibody that acts as an immunosuppressant. The medication is supplied as a sterile solution for injection in a single-use prefilled pen or syringe for subcutaneous administration. This injectable format is necessary because, as a large, complex protein produced via recombinant DNA technology, Adalimumab would be broken down if administered orally. Its formulation is often citrate-free, a feature designed to enhance patient comfort during injection. Its general purpose is to provide systemic control over chronic, inappropriate inflammation by neutralizing the excessive TNFalpha protein signals, a strategy widely supported by extensive pharmacological studies.

Regulatory References

  1. Adalimumab-adbm Prescribing Information (NIH DailyMed)

What side effects are possible with Cyltezo?

Possible Side Effects and Safety Information

The official safety profile for Cyltezo (adalimumab-adbm) is structured by governmental regulatory documents, classifying potential adverse reactions by frequency and physiological system. This classification helps define the medicine's risk profile from common occurrences to serious, rare events.

Frequency-Classified Adverse Reactions

Adverse reactions are classified based on their observed incidence in clinical use and official safety data:

  • Very Common (occurring in ge 1/10 patients) include Infections (such as upper respiratory tract infection) and Injection site reactions (e.g., pain, redness, or swelling).
  • Common (occurring in ge 1/100 to < 1/10 patients) include Headache, Rash, and various blood and lymphatic system changes like Leukopenia.
  • Uncommon and Rare events, which are less frequent, include serious conditions such as Liver failure, certain Demyelinating Disorders, and Pancytopenia.

Serious Adverse Reactions and Safety Constraints

The regulatory label explicitly documents the potential for serious adverse reactions, which primarily affect the Infections and Neoplasms system-organ classes. These include warnings for Serious Infections (e.g., reactivation of Tuberculosis (TB), bacterial sepsis, fungal infections) and the risk of Malignancy (including Lymphoma and Hepatosplenic T-cell Lymphoma).

Safety Restrictions define specific conditions for use. The drug is contraindicated if a patient has an active infection or moderate-to-severe heart failure. Furthermore, specific Monitoring Requirements are noted, such as mandatory TB testing prior to initiation and continued monitoring for Hepatitis B Virus (HBV) reactivation in carriers, which are essential components of the established safety framework.

Overdose and Emergency Response

Overdose and when to seek help

This section details the officially documented overdose information for Cyltezo (Adalimumab-adbm) as described in regulatory labeling.

Overdose Scope and Management

Feature Official Regulatory Statement
Documented Manifestations No specific clinical symptoms of acute overdose are documented in the regulatory label. Dose-limiting toxicity was not observed in clinical trials up to high doses.
Immediate Action Required The patient is instructed to call a healthcare professional immediately if an overdose is suspected.
Supportive Management Management of a suspected overdose is required to consist of symptomatic and supportive treatment.
Antidote Information No specific antidote for Adalimumab-adbm overdose is known or documented.

Overdose Classification and Monitoring

Classification Official Regulatory Statement
Severity Classification Dose-limiting toxicity was not established at the highest tested doses.
Monitoring Requirements Patients who have received an overdose must be monitored closely for any signs or symptoms of adverse reactions or effects.

Resulting Overdose Structure

Official overdose statements:

  • No dose-limiting toxicity was documented in clinical studies using the active component at elevated doses.
  • Management is limited to symptomatic and supportive treatment.
  • Patients must be closely monitored for adverse effects.

Connection to the overall overdose profile: The official regulatory profile for Cyltezo defines overdose by the absence of specific acute clinical manifestations, based on high dose tolerability in trials. This mandates that the management strategy focuses entirely on professional assessment, close monitoring for adverse reactions, and supportive treatment, requiring the patient to contact a healthcare provider immediately upon suspicion of an excess dose.

Therapeutic Uses of Cyltezo

Main Uses and Indications

Cyltezo is a biological medication classified as a tumor necrosis factor (TNF) blocker. It is used to manage several chronic inflammatory conditions by targeting a specific protein in the body that causes inflammation. The primary uses for this medication include:

Rheumatoid Arthritis

Cyltezo is used to reduce signs and symptoms, induce major clinical response, and inhibit the progression of structural damage in adults with moderately to severely active rheumatoid arthritis. It may be used alone or in combination with other medications like methotrexate.

Psoriatic Arthritis

For adults with active psoriatic arthritis, the medication is used to reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function. It can be used as monotherapy or with non-biologic disease-modifying antirheumatic drugs (DMARDs).

Ankylosing Spondylitis

Cyltezo is indicated for reducing signs and symptoms in adults with active ankylosing spondylitis, a type of arthritis that primarily affects the spine.

Crohn's Disease

The medication is used for the treatment of moderately to severely active Crohn's disease in both adults and pediatric patients 6 years of age and older. It helps to reduce signs and symptoms and to achieve and maintain clinical remission.

Ulcerative Colitis

Cyltezo is used in adults with moderately to severely active ulcerative colitis to help achieve and maintain clinical remission when certain other medications have not worked well enough.

Plaque Psoriasis

Adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy may use Cyltezo. It is generally prescribed for those whose condition affects large areas of the body or sensitive areas where topical treatments are insufficient.

Juvenile Idiopathic Arthritis

Cyltezo is used to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Hidradenitis Suppurativa

This medication is used to treat moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition, in adult patients.

Benefits and Clinical Goals

The primary benefit of Cyltezo is its ability to interfere with the inflammatory process at a molecular level. By binding to TNF-alpha, the medication helps to:

  • Reduce Inflammation: It targets the underlying cause of swelling, pain, and stiffness in joints and tissues.
  • Prevent Structural Damage: In conditions like rheumatoid and psoriatic arthritis, it can slow the progression of bone and joint destruction.
  • Improve Physical Function: By managing symptoms, the medication often helps patients maintain their ability to perform daily activities.
  • Maintain Remission: In gastrointestinal conditions like Crohn's disease and ulcerative colitis, the goal is to heal the intestinal lining and prevent symptom flare-ups over the long term.

Eligibility and Restrictions for Use

Eligibility for Cyltezo (Adalimumab-adbm): Official Regulatory Status

Official regulatory documents define strict criteria for the use of Cyltezo, primarily focused on managing risks associated with its immunosuppressive effects. This information is derived solely from government-approved labeling.

Absolute Contraindications

Cyltezo is contraindicated and must not be used in patients with a known severe hypersensitivity or allergic reaction to Adalimumab or any of the product's components. Initiation of therapy is also contraindicated if a patient has an active serious infection, such as active tuberculosis (TB) or sepsis, until the infection is fully controlled.

Age and Population Restrictions

Population Group Eligibility Status Regulatory Requirement
Adults Generally Approved Approved for all indications.
Pediatric Patients Conditional Use Approved age varies by condition: ge 2 years (JIA/Uveitis), ge 6 years (Crohn's Disease), ge 12 years (HS).
Older Adults (ge 65) Conditional Use Greater sensitivity may be possible, requiring monitoring.
Pregnancy Restricted Use only if clearly needed.
Lactation Restricted Clinical decision required between mother and physician.

Other Use Limitations

Use is not recommended in combination with other biologic disease-modifying antirheumatic drugs (DMARDs) or TNF blockers. Patients must be tested for latent TB prior to starting treatment, and if positive, treatment for TB must be initiated before Cyltezo. Caution is required for patients with pre-existing conditions like heart failure or demyelinating disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Cyltezo (Adalimumab-adbm)

Interaction scope

Property Description (Strictly from Regulatory Labels)
Medicinal product categories with documented interactions: Other Biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), Cytokine Modulators, Live Vaccines, Immunosuppressants.
Specific interacting medicines (if explicitly listed): Anakinra, Abatacept, Methotrexate (MTX), Azathioprine (AZA), 6-Mercaptopurine (6-MP).
Mechanistic basis of interactions (only if stated in label): Pharmacodynamic Interaction (additive immunosuppression risk); Pharmacokinetic Interaction (MTX may reduce clearance of Adalimumab-adbm); Indirect Pharmacokinetic Effect (restoration of CYP450 enzyme activities).
Timing-based interaction rules (if applicable): If Hepatitis B Virus (HBV) reactivation occurs, Cyltezo must be discontinued and antiviral therapy must be initiated.
Population-specific interaction notes (if applicable): Increased risk for Hepatosplenic T-cell Lymphoma (HSTCL) when combined with AZA or 6-MP in pediatric and young adult patients with Inflammatory Bowel Disease (IBD).
Interaction-related restrictions: Combination with Anakinra, Abatacept, and Other TNF Blockers is not recommended. Co-administration with Live Vaccines must be avoided.

Interaction classifications (high-level)

Property Description (Strictly from Regulatory Labels)
Interaction severity classification (as defined in official documents): Contraindicated Combinations (Biologic DMARDs, Live Vaccines); Clinically Significant Association (Immunosuppressants/HSTCL risk); Known Pharmacokinetic Interaction (MTX exposure increase).
Regulatory basis (EMA / FDA / etc.): Official U.S. Food and Drug Administration (FDA) Prescribing Information; European Medicines Agency (EMA) Summary of Product Characteristics (SmPC).
Interaction-context constraints (as defined in official documents): Administration of live vaccines to infants exposed to the drug in utero may need to be delayed.

Resulting interaction structure

Official interaction statements:

  • Co-administration with cytokine modulators Anakinra or Abatacept is not recommended due to an elevated risk of serious infection without added therapeutic benefit.
  • Concurrent use with Live Vaccines must be avoided to prevent vaccine-induced infection.
  • The use of Methotrexate (MTX) results in a pharmacokinetic interaction that increases the serum exposure of Adalimumab-adbm.
  • In young patients, the combination with Azathioprine or 6-Mercaptopurine is associated with an increased risk of Hepatosplenic T-cell Lymphoma (HSTCL).
  • Changes in inflammation levels may indirectly affect CYP450 enzyme activity, which can alter the concentration of co-administered CYP substrates.

Connection to the overall interaction profile (2–4 sentences):

The regulatory documents establish the interaction profile primarily through pharmacodynamic restrictions, prohibiting the combination with other potent immunosuppressive biologics and live vaccines due to documented risk. The profile also formally notes specific drug-drug interactions, such as the exposure-modifying effect of Methotrexate and the cautionary association with certain immunosuppressants in specific patient populations, as stated in official labeling.

Mechanism of Action

Cyltezo (Adalimumab-adbm) acts by neutralizing the pro-inflammatory protein Tumor Necrosis Factor alpha ( TNF-alpha) through direct, high-affinity binding. This molecular interaction prevents TNF-alpha from engaging its specific receptors on cell surfaces. Because TNF-alpha is a central upstream component of the inflammatory process, its blockade directly dampens excessive signaling within the broader cytokine network, which results in decreased activity of the cytokine-mediated inflammatory response. The neutralization of TNF-alpha suppresses key intracellular cascades, notably the Nuclear Factor kappa-light-chain-enhancer of activated B-cells ( NF-kappa B) and Mitogen-Activated Protein Kinase (MAPK) pathways. This inhibition reduces the sustained cellular production of downstream inflammatory proteins and enzymes, such as those that contribute to tissue degradation. Consequently, the mechanism reduces the expression of adhesion molecules on blood vessel walls, thereby reducing the extravasation of leukocytes into tissues. This biological activity is constrained by the potential for the body to develop anti-drug antibodies (ADAs), which can neutralize the drug and functionally limit the duration of the TNF-alpha blockade mechanism over time.

Dosage and Administration Information

Administration Route and Dosage Patterns

Cyltezo is administered as a subcutaneous injection using the provided prefilled pen or syringe. The medication is delivered in a two-phase regimen, consisting of a higher-dose induction period followed by a consistent, long-term maintenance schedule.

The typical maintenance dose for adults across most approved indications, such as Rheumatoid Arthritis (RA) and Psoriatic Arthritis, is 40 mg every other week. Initial, high-dose loading regimens, such as 160 mg followed by 80 mg, are prescribed for conditions like Crohn's Disease and Hidradenitis Suppurativa to initiate therapy.

Preparation and Use Constraints

Administration must adhere to specific preparation requirements. The product should be removed from refrigeration and allowed to warm for 15 to 30 minutes to reach room temperature before the injection. The injection site, usually the thigh or abdomen, requires rotation with each dose to ensure proper use. The high-dose 160 mg initial dose must be administered as multiple separate injections.

Population-Specific and Timing Rules

Dosing for pediatric patients, including those with Juvenile Idiopathic Arthritis and Pediatric Crohn's Disease, is determined by specific weight bands, diverging from the fixed adult dose. If a scheduled dose is missed, the dose should be administered as soon as possible and then the standard dosing frequency resumed from that time forward.

The overall protocol dictates a chronic use pattern, but continuation of therapy for adult Ulcerative Colitis patients is conditional upon documented evidence of clinical remission after eight weeks of treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cyltezo

The clinical evaluation for Cyltezo (Adalimumab-adbm) centers on demonstrating its similarity and interchangeability with the reference biological medicine, Humira, according to regulatory assessments. The evidence is derived from advanced laboratory assessments and dedicated comparative clinical trials in specific patient populations, as part of the regulatory review to assess the totality of evidence for Cyltezo.

Evidence for Use in Rheumatoid Arthritis

Research explored how Cyltezo was evaluated in adult patients with moderately to severely active rheumatoid arthritis (RA) through Randomized Controlled Trials (RCTs) designed for direct comparison. Researchers focused on measuring outcomes related to physical discomfort, such as the measurement of changes in signs and symptoms of RA. Researchers also examined whether the patterns related to structural joint damage progression were monitored for comparison between the two products. Findings describe patterns of symptom evolution that appeared similar in the observed populations.

Evidence for Use in Plaque Psoriasis and the Interchangeability Studies

Cyltezo was studied for use in dedicated comparative RCTs involving adult patients with moderate to severe plaque psoriasis. The evidence for this indication was supplemented by specialized switching studies that monitored the patients’ immune response. The findings from these trials fulfilled the necessary data requirements for the regulatory designation of Cyltezo as an interchangeable biosimilar.

Evidence for Other Approved Conditions (Extrapolation)

For other approved uses, including Crohn's disease, ulcerative colitis, and psoriatic arthritis, the evidence supporting Cyltezo is supported by the regulatory principle of extrapolation. This means that high-level analytical and pharmacokinetic data demonstrated structural and functional similarity. Equivalent drug concentration in the body was reported by studies, and based on this, efficacy findings from one sensitive indication were relied upon for extrapolation to other indications by regulators.

Key Studies & References

  1. NIH/MedlinePlus: Adalimumab Injection

Frequently Asked Questions (FAQ)

Common questions about Cyltezo (FAQ)

Q: How long does it typically take to see potential results from Cyltezo?

A: Studies and official information indicate that a therapeutic response is generally observed within about 12 weeks of starting treatment for conditions like Rheumatoid Arthritis. If a response is not seen by this timeframe, healthcare providers may re-evaluate the continuation of therapy.

Q: Can Cyltezo be used by children?

A: Yes, the medicine is approved for use in pediatric patients for certain specific conditions. The approved age varies by condition, such as starting from age 2 for Juvenile Idiopathic Arthritis. For children, the appropriate amount of medicine is based on their weight.

Q: Can Cyltezo be taken during pregnancy?

A: Official guidance states that Cyltezo is to be used during pregnancy only if clearly needed. A clinical decision is involved in weighing the potential benefits of using the medicine for the mother against any potential risks to the developing fetus.

Q: Are there risks associated with using Cyltezo while breastfeeding?

A: Official product information indicates that a clinical decision is required from a healthcare professional. This decision involves balancing the importance of the medicine for the mother's health with the potential effects on the breastfed child.

Q: What happens if I miss a scheduled dose of Cyltezo?

A: Regulatory documents describe that if a dose is missed, the dose is to be administered as soon as it is noticed. The subsequent instruction is to resume the regular dosing schedule and frequency from that point forward.

Q: Does Cyltezo interact with herbal supplements?

A: Official labeling primarily addresses interactions with specific prescription medicines and live vaccines. While specific interactions with herbal supplements are not officially listed, discussion with a healthcare professional regarding all products being taken is typically recommended.

Q: What is the purpose of the citrate-free formulation of Cyltezo?

A: Cyltezo is manufactured to be citrate-free. This formulation feature is intended to reduce the potential for pain and stinging that may be experienced at the injection site, which can be associated with citrate.

Q: Can Cyltezo cause changes in mood or mental state?

A: Official adverse reaction reports include central nervous system disorders (such as demyelinating disorders) as potential uncommon or rare events. However, changes in mood or mental state are not typically listed among the most common side effects reported in official documents.

Q: Can I switch from another adalimumab product to Cyltezo?

A: Cyltezo has the regulatory designation of an interchangeable biosimilar. This designation means it is expected to produce the same clinical result as its reference product and may be substituted at the pharmacy without the need for the prescribing doctor’s authorization, based on state laws.

Q: What does 'biosimilar' mean in simple terms?

A: A biosimilar product is officially described as being highly similar to an original FDA-approved biologic medicine. It means there are no clinically meaningful differences between the two products regarding safety, purity, or effectiveness.

Q: How is Cyltezo different from other medicines that treat the same conditions?

A: Cyltezo is an interchangeable biosimilar of the reference product, Humira, meaning it is structurally and functionally highly similar. Its interchangeable status is its primary distinction from other non-interchangeable biologic medicines or traditional (non-biologic) treatments for the same conditions.

Q: Will I feel Cyltezo working right away?

A: Because the medicine works by gradually reducing inflammation signals in the body, its effects are generally not felt immediately after the first dose. Clinical improvement is typically expected to be achieved over the first several weeks or months of treatment.

Q: Why are there different versions of adalimumab?

A: The different versions exist because regulatory pathways allow for the approval of new, highly similar biological products called biosimilars. This process is intended to increase competition and provide more treatment options for patients.

Q: Is it normal to feel tired after starting Cyltezo?

A: While fatigue or general tiredness is not classified as a very common side effect on its own, it can sometimes be a symptom associated with serious infections. Official warnings note that serious infections are a potential adverse reaction, and any new or worsening fatigue may be appropriate to discuss with a healthcare provider.

Q: Can a patient travel with Cyltezo?

A: Yes, official guidelines allow for travel. If necessary, the product may be kept out of the refrigerator for a single period of up to 14 days at temperatures up to 77 F (25 C). If the product is not used within the 14-day period, it must be discarded and is not intended to be returned to refrigeration.

Q: Is it safe to get vaccines while using Cyltezo?

A: Official labeling states that live vaccines must be avoided while using Cyltezo due to the risk of infection. Non-live vaccines may be administered, but the body's immune response to them might be reduced due to the action of Cyltezo.

Q: Does Cyltezo affect fertility?

A: Studies performed in animals with adalimumab found no evidence of impairment of fertility. However, specific human data on the medicine’s effect on fertility are limited.

Q: What research evidence supports the use of Cyltezo for Crohn's disease?

A: The approval for Crohn's disease is supported by dedicated comparative studies (like the VOLTAIRE-CD trial). These studies specifically evaluated the medicine's similarity to the reference product in patients with moderately to severely active Crohn's disease.

Q: Does Cyltezo affect liver function?

A: Yes, regulatory documents include warnings regarding the potential for new or worsening autoimmune hepatitis and the risk of Hepatitis B Virus (HBV) reactivation in carriers. Rare cases of serious liver failure have also been reported with the drug class.

Q: What is the 'no-substitution' rule for biosimilars like Cyltezo?

A: This rule applies to non-interchangeable biosimilars. However, Cyltezo has the interchangeable status, meaning it can be substituted for the reference product at the pharmacy without the prescriber's permission, depending on state laws.

Q: What kind of monitoring is needed while on Cyltezo?

A: Mandatory monitoring includes a TB test before starting the medicine. Additionally, ongoing monitoring is needed for potential HBV reactivation in carriers, as well as for signs of new infections, malignancies, and heart failure.

How should Cyltezo be stored and disposed of?

How to Store and Dispose of Cyltezo

Official regulatory guidelines mandate specific storage and handling requirements to maintain the integrity of Cyltezo (adalimumab-adbm).

Storage Requirements

Condition Requirement
Temperature Store in a refrigerator between 36°F to 46°F (2°C to 8°C).
Prohibited Do not freeze. Do not use the product if it has been frozen.
Handling Do not shake the product. Keep in the original carton to protect it from light until use.
Stability May be stored out of the refrigerator for a single period of up to 14 days at a temperature up to 77°F (25°C). The product must be discarded if not used within this 14-day period and cannot be returned to refrigeration.

Disposal Instructions

Used Cyltezo Pens and syringes must be immediately placed into an FDA-cleared sharps disposal container. This container must be kept safely out of the reach of children. Disposal of the full sharps container must comply with federal, state, and local requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Equivalent of Cyltezo found in:

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