Prescription medicine
Adalimumab-adbm Brand names: Cyltezo
Adalimumab-adbm (Cyltezo) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $639.19 per pen (Adalimumab-adbm(cf) pen 40 mg/0.4 mL) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the adalimumab-adbm FDA label on DailyMed (effective May 22, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the BLA 761058 record on Drugs@FDA; every adalimumab-adbm label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY.
See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue CYLTEZO if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting CYLTEZO. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): 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 occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageCYLTEZO is a tumor necrosis factor (TNF) blocker 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.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- August 25, 2017 Cyltezo, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $639.19 per pen Adalimumab-adbm(cf) pen 40 mg/0.4 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 213 through July 30, 2026
What is adalimumab-adbm used for?
From the label: indications and usageCYLTEZO is a tumor necrosis factor (TNF) blocker 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. ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) Reducing signs and symptoms in adult patients with active ankylosing spondylitis. […]
Conditions named in the indications of adalimumab-adbm's FDA labels, with every medicine labeled for each:
From other adalimumab-adbm labelsPsoriasis: 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. …
Rheumatoid arthritis: Rheumatoid Arthritis CYLTEZO 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 …
Crohn's disease and ulcerative colitis: Crohn's Disease CYLTEZO is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
Source: FDA drug label (Cyltezo), Boehringer Ingelheim Pharmaceuticals, Inc., effective May 22, 2026 (SPL set 115ea79b-7209-7f19-b35d-36ec0828fbf5), via openFDA; the full label on DailyMed
What does the patient leaflet for adalimumab-adbm say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CYLTEZO?CYLTEZO is a medicine that affects your immune system. CYLTEZO can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting CYLTEZO. Your doctor should check you closely for signs and symptoms of TB during treatment with CYLTEZO. You should not start taking CYLTEZO if you have any kind of infection unless your doctor says it is okay. Before starting CYLTEZO, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes. have TB, or have been in close contact with someone with TB. were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use CYLTEZO. […]
From the patient leaflet: How should I store CYLTEZO?Store CYLTEZO in the refrigerator at 36°F to 46°F (2°C to 8°C). Store CYLTEZO in the original carton until use to protect it from light. Do not freeze CYLTEZO. Do not use CYLTEZO if frozen, even if it has been thawed. Refrigerated CYLTEZO may be used until the expiration date printed on the CYLTEZO carton, dose tray, pen, or prefilled syringe. Do not use CYLTEZO after the expiration date. If needed, for example when you are traveling, you may also store CYLTEZO at room temperature up to 77°F (25°C) for up to 14 days. Store CYLTEZO in the original carton until use to protect it from light. Throw away CYLTEZO if it has been kept at room temperature and not been used within 14 days. Record the date you first remove CYLTEZO from the refrigerator in the spaces provided on the carton and dose tray. Do not store CYLTEZO in extreme heat or cold. […]
Source: FDA drug label (Cyltezo), Boehringer Ingelheim Pharmaceuticals, Inc., effective May 22, 2026 (SPL set 115ea79b-7209-7f19-b35d-36ec0828fbf5), via openFDA; the full label on DailyMed
Is there a generic for adalimumab-adbm (Cyltezo)?
No generic adalimumab-adbm is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for adalimumab-adbm (Cyltezo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $639.19 per pen (Adalimumab-adbm(cf) pen 40 mg/0.4 mL). The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Adalimumab-adbm(cf) pen 40 mg/0.4 mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Adalimumab-adbm(cf) pen 40 mg/0.4 mL | Generic | $639.19 per pen | n/a | n/a |
| Adalimumab-adbm(cf) pen 40 mg/0.8 mL | Generic | $639.58 per pen | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the adalimumab-adbm label say about other medicines?
The adalimumab-adbm label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | drug interactions | DRUG INTERACTIONS Abatacept: Increased risk of serious infection. |
| Adalimumab | boxed warning | SERIOUS INFECTIONS Patients treated with adalimumab products, including CYLTEZO, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ]. |
| Anakinra | drug interactions | In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of CYLTEZO with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions (5.7 … |
| Azathioprine | boxed warning | Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of CYLTEZO in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rituximab | drug interactions | A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. |
| Theophylline | drug interactions | Upon initiation or discontinuation of CYLTEZO in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Warfarin | drug interactions | Upon initiation or discontinuation of CYLTEZO in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
Source: FDA drug label (Cyltezo), Boehringer Ingelheim Pharmaceuticals, Inc., effective May 22, 2026 (SPL set 115ea79b-7209-7f19-b35d-36ec0828fbf5), via openFDA; the full label on DailyMed
What do FAERS reports show for adalimumab-adbm?
The FDA Adverse Event Reporting System holds 213 reports that list adalimumab-adbm among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 21 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Adalimumab-adbm side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other