Prescription medicine
Adalimumab-aacf Brand names: Idacio
Adalimumab-aacf (Idacio) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the adalimumab-aacf FDA label on DailyMed (effective January 30, 2026, Fresenius Kabi USA, LLC); the BLA 761255 record on Drugs@FDA; every adalimumab-aacf label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 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 IDACIO 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 IDACIO. 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 IDACIO 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 usageIDACIO 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
- December 13, 2022 Idacio, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 300 through July 30, 2026
What is adalimumab-aacf used for?
From the label: indications and usageIDACIO 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. Juvenile 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-aacf's FDA labels, with every medicine labeled for each:
From other adalimumab-aacf 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 (Idacio), Fresenius Kabi USA, LLC, effective January 30, 2026 (SPL set 43de75ac-1a37-4609-9edd-68bda2448a47), via openFDA; the full label on DailyMed
What does the patient leaflet for adalimumab-aacf 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 IDACIO?IDACIO is a medicine that affects your immune system. IDACIO 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 IDACIO. Your healthcare provider should check you closely for signs and symptoms of TB during treatment with IDACIO. You should not start taking IDACIO if you have any kind of infection unless your healthcare provider says it is okay. Before starting IDACIO, tell your healthcare provider 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 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 IDACIO. […]
From the patient leaflet: How should I store IDACIO?Store IDACIO in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store IDACIO in the original carton until use to protect it from light. Do not freeze IDACIO . Do not use IDACIO if frozen, even if it has been thawed. Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton. Pen or prefilled syringe. Do not use IDACIO after the expiration date. If needed, for example when you are traveling, you may also store IDACIO at room temperature up to 77°F (25°C) for up to 28 days. Store IDACIO in the original carton until use, to protect it from light. Throw away IDACIO if it has been kept at room temperature and not been used within 28 days. Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton. Do not store IDACIO in extreme heat or cold. […]
Source: FDA drug label (Idacio), Fresenius Kabi USA, LLC, effective January 30, 2026 (SPL set 43de75ac-1a37-4609-9edd-68bda2448a47), via openFDA; the full label on DailyMed
Is there a generic for adalimumab-aacf (Idacio)?
No generic adalimumab-aacf is approved (Drugs@FDA, October 8, 2026).
- 2022 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the adalimumab-aacf label say about other medicines?
The adalimumab-aacf label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name adalimumab-aacf. 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 IDACIO 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 IDACIO 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 IDACIO 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 IDACIO 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 IDACIO 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 (Idacio), Fresenius Kabi USA, LLC, effective January 30, 2026 (SPL set 43de75ac-1a37-4609-9edd-68bda2448a47), via openFDA; the full label on DailyMed
What do FAERS reports show for adalimumab-aacf?
The FDA Adverse Event Reporting System holds 300 reports that list adalimumab-aacf 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 147 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 else is labeled for the same conditions as adalimumab-aacf?
9 other medicines are given the same way (subcutaneous) and in the same FDA class as adalimumab-aacf or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adalimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Methotrexate | Rheumatoid arthritis, Psoriasis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Adalimumab-ryvk | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $499.12 per unit 40 mg/0.4 mL autoinjector | A presentation being discontinued |
| Etanercept | Rheumatoid arthritis, Psoriasis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Sarilumab | Rheumatoid arthritis | none listed | $2,075.30 per mL 200 mg/1.14 mL pen injection | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
| Certolizumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $6,094.02 per syringe 2x200 mg/mL syringe kit | No current entry |
Every medicine labeled for the same conditions as adalimumab-aacf
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to adalimumab-aacf
- 9 medicines for the same use
- Adalimumab-aacf side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other