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Idacio

Generic name: adalimumab-aacf
Dosage form: Idacio pen (40 mg/0.8 mL)
Drug class: TNF alfa inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Dec 12, 2024.

What is Idacio?

Idacio (adalimumab-aacf) is a biosimilar of Humira, which is a TNF alfa blocker used to reduce pain, inflammation, and skin symptoms in autoimmune conditions. Idacio is used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis.

Idacio is a biosimilar to Humira, biosimilars are biologic medicines that are a very close copy to the original product made by another company. It is not an interchangeable biosimilar. Idacio is available as an autoinjector or a prefilled syringe and is citrate-free.

Idacio received FDA approval on December 13, 2022.

How does Idacio work?

Idacio works by blocking tumor necrosis factor (TNF), a protein involved in causing inflammation; this helps to reduce pain, inflammation, and skin symptoms of these conditions.

Idacio is used to treat chronic autoimmune conditions. Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor is involved in causing inflammation in autoimmune disorders, so Idacio blocking TNF reduces the symptoms of these conditions.

What is Idacio used for?

Idacio is an FDA-approved medicine to be used for: 

Idacio side effects

Common Idacio side effects

Common side effects of Idacio may include:

Get emergency medical help if you have any of these signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Serious Idacio side effects

Call your doctor right away if you have any symptoms of lymphoma:

Also, call your doctor at once if you have:

Older adults may be more likely to develop infections or certain types of cancer while using Idacio.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings

Idacio affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with Idacio, tell your doctor if you have signs of infection, such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for tuberculosis (TB) before starting to take this medicine and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting certain types of cancer, such as non-melanoma skin cancer, leukemia, or lymphomas,  may be increased for children and adults taking TNF-blockers.

Anti-drug antibodies may develop which can affect how effective Idacio is. Your healthcare provider will monitor you for these.

Do not take Idacio if you are allergic to the active ingredient adalimumab or to any of the inactive ingredients. 

Before taking this medicine

Before using Idacio, tell your doctor if you have signs of infection - fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Idacio should only be used in age groups for the specific conditions it is FDA-approved to treat. Before starting treatment, children using Idacio should be current on all childhood immunizations.

Tell your doctor if you have ever had:

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common in certain areas of the world.

Idacio may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

It is not known whether Idacio will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used this medicine while you were pregnant, especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using Idacio. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

How should I use Idacio?

Use Idacio exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use Idacio exactly as directed.

Idacio is injected under the skin (subcutaneous injection) using a prefilled pen or a prefilled syringe.

The dose schedule for Idacio will depend on the severity and the condition that you are treating. Follow your doctor's dosing instructions very carefully.

A healthcare provider will teach you how to use this medicine by yourself properly. Do not use Idacio if you do not fully understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

Do not use this Idacio if you have any signs of an infection. Call your doctor for instructions.

Prepare your injection only when you are ready to give it. Do not use Idacio if it looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Leave the prefilled pen or prefilled syringe at room temperature for 15 to 30 minutes to allow it to warm up.  Do not warm the Prefilled Syringe using heat sources such as hot water or a microwave.

Do not shake your pen. Shaking can damage your medicine.

Choose an injection site. You may inject into the front of your thigh and your abdomen except for the 2 in (5 cm) around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1 inch (3 cm) away from the injection site you used before.

Do NOT inject in skin that is red, hard, tender, damaged, bruised, or scarred, and do NOT inject through your clothes.

Idacio affects your immune system, so you may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Dispose of used needles and syringes or used Pens in an FDA-cleared sharps disposal container immediately after use.

Idacio Dosing information

The dose and frequency of Idacio given depend on age, severity, and the condition being treated. Click the link below for more information on specific dosing schedules.

Idacio is available as:

Entyvio, Otezla, Cimzia, Stelara, Taltz, Ilumya, Cosentyx, prednisone, naproxen, methotrexate

What happens if I miss a dose?

If you forget to take your dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject Idacio call your doctor or pharmacist. 

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Idacio?

Do not inject into skin that is bruised, red, tender, or hard.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Idacio. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What other drugs will affect Idacio?

Some drugs should not be used together with Idacio. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this injection, especially:

Avoid the use of live vaccines.

This list is not complete. Other drugs may interact with Idacio, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed.

Does Idacio interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Idacio Package Insert

Review the Idacio Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ingredients

Active ingredient: adalimumab-aacf.

Inactive ingredients:  glacial acetic acid, trehalose, polysorbate 80, sodium chloride, and Water for Injection. Sodium hydroxide is added as necessary to adjust pH. 

The syringe plunger stopper and needle cover are not made with natural rubber latex.

Available as Idacio 40 mg/0.8 mL pen, Idacio 40 mg/0.8 mL prefilled syringe, and Idacio 40 mg/0.8 mL institutional use vial kit.

Storage

Manufacturer

Manufactured by: Fresenius Kabi USA, LLC Lake Zurich, IL 60047, U.S.A.

Idacio Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Idacio.

Humira (adalimumab) - AbbVie Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Autoinjector 40 mg/0.8 mL
Autoinjector 80 mg/0.8 mL
Pre-Filled Syringe 10 mg/0.1 mL
Pre-Filled Syringe 10 mg/0.2 mL Discontinued
Pre-Filled Syringe 20 mg/0.2 mL
Pre-Filled Syringe 20 mg/0.4 mL Discontinued
Pre-Filled Syringe 40 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL
Pre-Filled Syringe 80 mg/0.8 mL
Single-Dose Vial 40 mg/0.8 mL

View Humira information in detail.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Abrilada (adalimumab-afzb) - Pfizer Inc.
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 10 mg/0.2 mL Discontinued
Pre-Filled Syringe 20 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL
Single-Dose Vial 40 mg/0.8 mL

View Abrilada information in detail.

Amjevita (adalimumab-atto) - Amgen Inc.
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 10 mg/0.2 mL
Pre-Filled Syringe 20 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL

View Amjevita information in detail.

Cyltezo (adalimumab-adbm) - Boehringer Ingelheim Pharmaceuticals, Inc.
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 10 mg/0.2 mL
Pre-Filled Syringe 20 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL

View Cyltezo information in detail.

Hadlima (adalimumab-bwwd) - Samsung Bioepis Co., Ltd.
Formulation type Strength
Pre-Filled Syringe 40 mg/0.8 mL
Single-Dose Vial 40 mg/0.8 mL

View Hadlima information in detail.

Hyrimoz (adalimumab-adaz) - Sandoz Inc.
Formulation type Strength
Pre-Filled Syringe 10 mg/0.1 mL
Pre-Filled Syringe 10 mg/0.2 mL Discontinued
Pre-Filled Syringe 20 mg/0.2 mL
Pre-Filled Syringe 20 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL
Pre-Filled Syringe 80 mg/0.8 mL

View Hyrimoz information in detail.

Simlandi (adalimumab-ryvk) - Alvotech USA Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.4 mL

View Simlandi information in detail.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Amjevita (adalimumab-atto) - Amgen Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Autoinjector 80 mg/0.8 mL
Pre-Filled Syringe 20 mg/0.2 mL
Pre-Filled Syringe 40 mg/0.4 mL
Pre-Filled Syringe 80 mg/0.8 mL

View Amjevita information in detail.

Cyltezo (adalimumab-adbm) - Boehringer Ingelheim Pharmaceuticals, Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.4 mL

View Cyltezo information in detail.

Hadlima (adalimumab-bwwd) - Samsung Bioepis Co., Ltd.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 40 mg/0.4 mL

View Hadlima information in detail.

Hulio (adalimumab-fkjp) - Biocon Biologics Inc.
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 20 mg/0.4 mL
Pre-Filled Syringe 40 mg/0.8 mL

View Hulio information in detail.

Hyrimoz (adalimumab-adaz) - Sandoz Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Autoinjector 40 mg/0.8 mL
Autoinjector 80 mg/0.8 mL
Pre-Filled Syringe 40 mg/0.4 mL

View Hyrimoz information in detail.

Idacio (adalimumab-aacf) - Fresenius Kabi USA, LLC
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 40 mg/0.8 mL
Single-Dose Vial 40 mg/0.8 mL
Simlandi (adalimumab-ryvk) - Alvotech USA Inc.
Formulation type Strength
Pre-Filled Syringe 20 mg/0.2 mL
Pre-Filled Syringe 80 mg/0.8 mL

View Simlandi information in detail.

Yuflyma (adalimumab-aaty) - CELLTRION, Inc.
Formulation type Strength
Autoinjector 40 mg/0.4 mL
Autoinjector 80 mg/0.8 mL
Pre-Filled Syringe 20 mg/0.2 mL
Pre-Filled Syringe 40 mg/0.4 mL
Pre-Filled Syringe 80 mg/0.8 mL

View Yuflyma information in detail.

Yusimry (adalimumab-aqvh) - Hong Kong King-Friend Industrial Company Limited
Formulation type Strength
Autoinjector 40 mg/0.8 mL
Pre-Filled Syringe 40 mg/0.8 mL

View Yusimry information in detail.

Popular FAQ

What are biosimilar drugs and how do they compare to biologics?

A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. One example is Amjevita (adalimumab-atto), the first biosimilar approved for Humira (adalimumab) in 2016. Continue reading

Can you take Humira with antibiotics?

You can take Humira with an antibiotic if your doctor has prescribed both of these medications for you. There may be some antibiotics that are not safe to take with Humira, so do not start taking any antibiotic without prior approval from your doctor. Continue reading

Cosentyx vs Humira: How do they compare?

Both Cosentyx and Humira are available as subcutaneous injections (which means given under the skin) and may be used to treat certain inflammatory conditions such as plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and ankylosing spondylitis. Cosentyx is also available as an IV injection that can be administered by a healthcare provider. After an initial loading dose, Humira is given every two weeks and Cosentyx every four weeks. Continue reading

Skyrizi vs Humira for plaque psoriasis - How do they compare?

In a head-to-head clinical study between Skyrizi and Humira, researchers found that Skyrizi was better than Humira at clearing moderate-to-severe plaque psoriasis in adults. At 16 weeks, 72% of patients given Skyrizi achieved 90% clearer skin compared to 47% of patients given Humira, a statistically significant outcome. Continue reading

Is Amjevita interchangeable with Humira?

Amjevita is not yet interchangeable with Humira, and the pharmacist must get approval from your doctor before they can substitute it for Humira. To date, the approved interchangeable biosimilars for Humira are Abrilada, Cyltezo, Hyrimoz, and Simlandi, according to the FDA Purple Book as of April 2024. Continue reading

More FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.