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.

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.

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

• rheumatoid arthritis (moderate to severe) in adults to reduce the signs and symptoms of RA, slow the progression of structural damage, and improve physical function.
• juvenile idiopathic arthritis (moderate to severe polyarticular) for children 2 years and older, to reduce the signs and symptoms of moderately to severely active polyarticular JIA.
• psoriatic arthritis in adults to be used to reduce the signs and symptoms of psoriatic arthritis, slow the progression of structural damage, and improve physical function.
• ankylosing spondylitis in adults to reduce signs and symptoms with active AS.
• hidradenitis suppurativa (moderate to severe) in adults and children 12 years and older.
• Crohn’s disease (moderate to severe) in adults and children 6 years of age and older.
• ulcerative colitis (chronic moderate to severe) in adults. It is not known if Idacio is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• plaque psoriasis (moderate chronic and severe) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• uveitis (UV) which is non-infectious intermediate, posterior, and panuveitis, for adult patients.

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.

• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is made of heavy-duty plastic, that can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out.
• It should also be leak-resistant, and properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

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 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:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (Idacio can cause hepatitis B to come back or get worse);
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk of getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Idacio. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common;
• diabetes;
• heart failure;
• any numbness or tingling or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• if you are scheduled to have major surgery; or
• if you have recently received or are scheduled to receive any vaccine.

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.

Common Idacio side effects

Common side effects of Idacio may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, and sore throat;
• rash; or
• redness, bruising, itching, or swelling where the injection was given.

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:

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also, call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

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

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:

• Idacio pen (40 mg/0.8 mL)
• Single-dose prefilled syringe (40 mg/0.8 mL)

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.

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

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).

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:

• abatacept, etanercept;
• anakinra;
• azathioprine, 6-mercaptopurine; or
• certolizumab, golimumab, infliximab, rituximab.

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.

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.

• Store this medicine in its original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze. Do not use if the liquid is cloudy, discolored, contains flakes or particles, or has been frozen, even if it has thawed.
• If you are traveling, carefully follow all patient instructions for storing your medicine during travel.
• Do NOT shake. Do not drop or crush, the prefilled syringe is made of glass.
• Avoid extreme heat or cold.
• If needed, for example when you are traveling, you may also store syringes at room temperature up to 77°F (25°C) for up to 28 days. Store Idacio in the original carton until used to protect it from light. Discard Idacio if it has been kept at room temperature and not been used within 28 days. Record the date you first remove syringes from the refrigerator in the spaces provided on the syringe carton.
• Do not use Idacio after the expiration date on the carton, pen, or prefilled syringe.

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

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.

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.

View Abrilada information in detail.

Amjevita (adalimumab-atto) - Amgen Inc.

View Amjevita information in detail.

Cyltezo (adalimumab-adbm) - Boehringer Ingelheim Pharmaceuticals, Inc.

View Cyltezo information in detail.

Hadlima (adalimumab-bwwd) - Samsung Bioepis Co., Ltd.

View Hadlima information in detail.

Hulio (adalimumab-fkjp) - Biocon Biologics Inc.

View Hulio information in detail.

Hyrimoz (adalimumab-adaz) - Sandoz Inc.

View Hyrimoz information in detail.

Simlandi (adalimumab-ryvk) - Alvotech USA Inc.

View Simlandi information in detail.

Yuflyma (adalimumab-aaty) - CELLTRION, Inc.

View Yuflyma information in detail.

Yusimry (adalimumab-aqvh) - Emerge Bioscience Pte. Ltd.

View Yusimry 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

Idacio (adalimumab-aacf) - Fresenius Kabi USA, LLC

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.