Prescription medicine
Adalimumab-fkjp Brand names: Hulio
Adalimumab-fkjp (Hulio) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the adalimumab-fkjp FDA label on DailyMed (effective January 12, 2026, Biocon Biologics Inc); the BLA 761154 record on Drugs@FDA; every adalimumab-fkjp label on DailyMed.
Highlights of the record
FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-fkjp are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Adalimumab-fkjp 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-fkjp use and during therapy. Initiate treatment for latent TB prior to Adalimumab-fkjp 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. […]
Used for
From the label: indications and usageAdalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- July 6, 2020 Hulio, Mylan Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 46,053 through July 30, 2026
What is adalimumab-fkjp used for?
From the label: indications and usageAdalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA. J uvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. […]
Conditions named in the indications of adalimumab-fkjp's FDA labels, with every medicine labeled for each:
From other adalimumab-fkjp labelsCrohn's disease and ulcerative colitis: Crohn’s Disease (CD) ( 1.5 ): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Psoriasis: Plaque Psoriasis (Ps) ( 1.7 ): 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.
Source: FDA drug label (Adalimumab), BLA761154 (Mylan Pharms Inc), as published by Biocon Biologics Inc, effective January 12, 2026 (SPL set 5cde907d-6747-0e62-db25-1718ee717fe7), via openFDA; the full label on DailyMed
What does the patient leaflet for adalimumab-fkjp 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 Adalimumab-fkjp?Adalimumab-fkjp is a medicine that affects your immune system. Adalimumab-fkjp 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 healthcare provider should test you for TB before starting Adalimumab-fkjp. • Your healthcare provider should check you closely for signs and symptoms of TB during treatment with Adalimumab-fkjp. You should not start taking Adalimumab-fkjp if you have any kind of infection unless your healthcare provider says it is okay. Before starting Adalimumab-fkjp, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection such as: o fever, sweats, or chills o muscle aches o cough o shortness of breath o blood in phlegm o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinate more often than normal o feel very tired o 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 healthcare provider 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 Adalimumab-fkjp. […]
From the patient leaflet: How should I store Adalimumab-fkjp?Store Adalimumab-fkjp in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store Adalimumab-fkjp in the original carton until use to protect it from light. • Do not freeze Adalimumab-fkjp. Do not use Adalimumab-fkjp if frozen, even if it has been thawed. • Refrigerated Adalimumab-fkjp may be used until the expiration date printed on the Adalimumab-fkjp carton, dose tray, Pen or prefilled syringe. Do not use Adalimumab-fkjp after the expiration date. • If needed, for example when you are traveling, you may also store Adalimumab-fkjp at room temperature up to 77°F (25°C) for up to 14 days. Store Adalimumab-fkjp in the original carton until use to protect it from light. • Throw away Adalimumab-fkjp if it has been kept at room temperature and not been used within 14 days. • Record the date you first remove Adalimumab-fkjp from the refrigerator in the spaces provided on the carton and dose tray. […]
Source: FDA drug label (Adalimumab), BLA761154 (Mylan Pharms Inc), as published by Biocon Biologics Inc, effective January 12, 2026 (SPL set 5cde907d-6747-0e62-db25-1718ee717fe7), via openFDA; the full label on DailyMed
Is there a generic for adalimumab-fkjp (Hulio)?
No generic adalimumab-fkjp is approved (Drugs@FDA, October 8, 2026).
- 2020 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the adalimumab-fkjp label say about other medicines?
The adalimumab-fkjp label names 10 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 | 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 Adalimumab-fkjp with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions … |
| Adalimumab | boxed warning | SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-fkjp 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 Adalimumab-fkjp with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions … |
| 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 Adalimumab-fkjp 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 … |
| Mercaptopurine | warnings and precautions | The potential risk with the combination of azathioprine or 6- mercaptopurine and Adalimumab-fkjp should be carefully considered. |
| 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 Adalimumab-fkjp 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 … |
| Warfarin | drug interactions | Upon initiation or discontinuation of Adalimumab-fkjp 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 … |
Source: FDA drug label (Adalimumab), BLA761154 (Mylan Pharms Inc), as published by Biocon Biologics Inc, effective January 12, 2026 (SPL set 5cde907d-6747-0e62-db25-1718ee717fe7), via openFDA; the full label on DailyMed
What do FAERS reports show for adalimumab-fkjp?
The FDA Adverse Event Reporting System holds 46,053 reports that list adalimumab-fkjp among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,734 are coded as a death and 16,373 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. Reports rose sharply in 2024 (8,764, against a median of 2,819 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Adalimumab-fkjp side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other