Important Safety Information
Indications

INDICATIONS

  • IDACIO 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 active rheumatoid arthritis. IDACIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

  • IDACIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. IDACIO can be used alone or in combination with methotrexate.

  • IDACIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IDACIO can be used alone or in combination with non-biologic DMARDs.

  • IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

  • IDACIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • IDACIO is indicated for the 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. IDACIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  • IDACIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
    Limitations of Use
    The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with IDACIO® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue IDACIO® 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 IDACIO® use and during therapy. Initiate treatment for latent TB prior to IDACIO® 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 antifungal 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.

Carefully consider the risks and benefits of treatment with IDACIO® prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Treatment with IDACIO® should not be initiated in patients with an active infection, including localized infections.

Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.

Discontinue IDACIO® if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with IDACIO®, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of adalimumab products with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

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 been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants

  • Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.

  • In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.

  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with IDACIO®.

  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.

  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of IDACIO® and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including IDACIO®, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV.

In patients who develop HBV reactivation, stop IDACIO® and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of IDACIO® therapy in this situation and monitor patients closely.

NEUROLOGICAL REACTIONS

Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.

Exercise caution in considering the use of IDACIO® in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of IDACIO® should be considered if any of these disorders develop.

HEMATOLOGICAL REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping IDACIO® if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on IDACIO® should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating IDACIO® therapy. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

INDICATIONS

  • Rheumatoid Arthritis (RA): 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): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

  • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

  • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.

  • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.

    Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

  • Plaque Psoriasis (PsO): 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.

Please see full Prescribing Information, including boxed WARNING, for IDACIO® (adalimumab-aacf).

Dosing & Administration

A DOSING SCHEDULE IDENTICAL TO HUMIRA’S

Patients transitioning to IDACIO® (adalimumab-aacf) can keep the same subcutaneous route of administration they used with Humira® (adalimumab).1,2 For them, and for patients who may be initiating treatment, IDACIO offers two citrate-free administration routes and room-temperature storage of up to 28 days.1

IDACIO (adalimumab-aacf) offers the same 40 mg dosing as Humira (adalimumab)1,a,b

Adult Rheumatology Patients

The recommended subcutaneous dosage of IDACIO for adult patients with the following indications1:

Indication Recommended Dosage
Rheumatoid Arthritisb 40 mg every other week
Psoriatic Arthritis 40 mg every other week
Ankylosing Spondylitis 40 mg every other week

aThere is no dosage form for IDACIO that allows weight-based dosing for pediatric patients below 40 kg.

bIn treatment of Rheumatoid Arthritis, some patients not taking concomitant Methotrexate may drive additional benefit from increasing their dosage of IDACIO to 40 mg every week or 80 mg every other week.

Pediatric Rheumatology Patients

The recommended subcutaneous dosage of IDACIO for patients 2 years of age and older based on body weight1:

Indication Pediatric Weight Recommended Dosage
Polyarticular Juvenile Idiopathic Arthritis 30 kg (66 lbs) and greater 40 mg every other week

IDACIO (adalimumab-aacf) offers the same 40 mg dosing as Humira (adalimumab)1,a,b

Adult Gastroenterology Patients

The recommended subcutaneous dosage of IDACIO for adult patients with ulcerative colitis or adult and pediatric patients with Crohn’s disease:

Indication Recommended Dosage
Day 1 Day 15 Starting on Day 29
Ulcerative Colitis 160 mgc 80 mg 40 mg every other week
Crohn’s disease (adult patients and pediatric patients 88 lbs (40 kg) and greater) 160 mgc 80 mg 40 mg every other week

aIDACIO is not currently approved in indications for which Humira maintains regulatory exclusivity protection: moderate to severe ulcerative colitis in pediatric patients 5 years and older, moderate to severe hidradenitis suppurativa in patients 12 years and older, and non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years and older.

bThere is no dosage form for IDACIO that allows weight-based dosing for pediatric patients below 40 kg.

cGiven as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days.

IDACIO (adalimumab-aacf) offers the same 40 mg dosing as Humira (adalimumab)1,a-c

Adult Dermatology Patients

The recommended subcutaneous dosage of IDACIO for adult patients with Plaque psoriasis1:

Indication Recommended Dosage
Day 1 Starting on Day 8
Plaque Psoriasis 80 mg 40 mg every other week

aIDACIO is not currently approved in indications for which Humira maintains regulatory exclusivity protection: moderate to severe ulcerative colitis in pediatric patients 5 years and older, moderate to severe hidradenitis suppurativa in patients 12 years and older, and non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years and older.

bThere is no dosage form for IDACIO that allows weight-based dosing for pediatric patients below 40 kg.

cIDACIO prefilled administration options are not available in 80 mg dosage.

Patient-centered administration

With updated features and longer temperature storage capacity for patient flexibility, IDACIO offers a choice of administration and practice options,1 whether for first-time patients or those switching from Humira.

IDACIO pre-filled autoinjector pen1

offering built-in simplicity

IDACIO Physioject Pre-filled Autoinjector Pen
IDACIO pre-filled syringe1

designed with patients in mind

IDACIO Pre-filled Syringe
Table comparing IDACIO device features to Humira and Amjevita devices
Table comparing IDACIO device features to Humira and Amjevita devices

INNOVATIVE DESIGNS

IDACIO’s pre-filled autoinjector pen and syringe are designed to offer patients safety, ease of handling, and simplicity.1 Citrate-free, they provide updated features that meet the needs of patients and practices.1

Explore device features

THE SAME DOSING REGIMEN AND SHELF LIFE AS HUMIRA—WITH TWO WEEKS’ LONGER STORAGE AT ROOM TEMPERATURE.

Both the pre-filled autoinjector pen and syringe feature a 29-gauge needle for user comfort and room-temperature storage for up to 28 days.1 Both devices have syringe plunger stoppers and needle covers that are not made with natural rubber latex.1

Yellow-circled illustration of a calendar with text: “28”
Yellow-circled illustration with text: “Citrate free”

READY TO LEARN MORE?

Discover the details about how to correctly administer IDACIO using the pre-filled autoinjector pen or pre-filled syringe.

View pen instruction for use (IFU) video

Download pen IFU

MUSIC: Up & Under Throughout

VO: This demonstration video provides only supplementary information for the administration of IDACIO.

SUPERS: Demonstration video provides only supplementary information for the administration of IDACIO (adalimumab-aacf)

VO: It is not a substitute for reading the medication guide accompanying IDACIO for important information you need to know for preparation and injection.

Text on Screen: This is NOT a substitute for reading the IDACIO medication guide

VO: This video demonstrates the administration of IDACIO with the active ingredient adalimumab using a prefilled pen.

You’ve been prescribed IDACIO, which is available as a pre-filled pen as well as a pre-filled syringe with a dosage of 40 milligrams to be injected.

In this video you will learn the correct way to inject using a prefilled pen.

VO: Instructions for use

IDACIO single dose prefilled pen.

Before we go over the steps to self-administer using a prefilled pen, there are a few things to consider.

Text on Screen: Instructions for use

IDACIO®

Single dose prefilled pen (adalimumab-aacf) for subcutaneous injection 40 mg/0.8 mL

VO: It’s important to follow instructions so that you inject IDACIO correctly.

Do not share your prefilled pen with another person as you may give them an infection or get an infection from them.

Do not try to reuse the prefilled pen. It’s only for one-time, single-dose use.

Do not try to inject IDACIO yourself until you understand the instructions for use.

Do not use an IDACIO prefilled pen to give IDACIO to a child who weighs less than 66 pounds.

Do not insert your fingers into the opening of the safety guard.

Do not use the prefilled pen if the new carton is open or damaged.

Do not use a prefilled pen that has been frozen or left in direct sunlight.

Text on Screen: DOs and DON'Ts

Don’t share your IDACIO prefilled pen with others

Don’t reuse your IDACIO prefilled pen

Don’t try to inject IDACIO yourself until you understand all instructions

Don’t give IDACIO to a child weighing less than 66lbs

Don’t insert your fingers into the safety guard

Don’t use a prefilled pen if the new carton is open or damaged

Don’t use a prefilled pen that has been frozen or left in direct sunlight

VO: Do call your healthcare provider or pharmacist if you drop or crush the prefilled pen—do not use it.

Do talk to your healthcare provider to be sure you understand IDACIO dosing instructions or if you or your caregiver have any questions about the right way to inject IDACIO.

Text on Screen: DOs and DON'Ts

Do call your healthcare provider or pharmacist if you drop or crush the IDACIO prefilled pen

Do talk to your healthcare provider to ensure you understand IDACIO dosing instructions

VO: Let’s take a moment to talk about storing your IDACIO prefilled pen.

Keep it in the original carton to protect from light

And store it in a refrigerator set between 36 and 46 degrees Fahrenheit or 2 and 8 degrees Celsius.

Do not freeze IDACIO.

Do not use IDACIO if frozen, even if it has been thawed.

Text on Screen: Storing IDACIO prefilled pens

Keep in original carton

Refrigerate between 36–46°F (2–8°C)

Do not freeze

Do not use if frozen, even once thawed

VO: Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton, dose tray, or pen.

Do not use after expiration.

Text on Screen: Storing IDACIO prefilled pens

Refrigerated IDACIO may be used until expiration date

Do not use IDACIO after the expiration date

VO: If needed, like when traveling, an IDACIO prefilled pen can be stored at room temperature for up to 28 days.

Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton.

Text on Screen: Storing IDACIO prefilled pens

A prefilled pen can be stored at room temperature between 68–77°F (36–46°C) for up to 28 days

Record the dates IDACIO is removed from the refrigerator on the carton

VO: Keep the IDACIO prefilled pen, injection supplies, and all other medicines out of the reach and sight of children.

Text on Screen: Storing IDACIO prefilled pens

Keep away from children

VO: Throw away the IDACIO prefilled pen in a sharps disposal container if

It has been kept at room temperature and not used within 28 days

Or if it’s been stored in extreme heat or cold.

Do not use IDACIO if the liquid is cloudy, discolored, or has flakes or particles in it.

Text on Screen: Throw away IDACIO prefilled pen if it has:

Been kept at room temperature, but not used within 28 days

Been stored in extreme heat or cold

Cloudy or discolored liquid, or there are visible flakes or particles

VO: Let’s get familiar with your prefilled pen before we go over the 8 steps to successful injection.

Here we see a cap that covers the needle for injection of the drug.

A window in which you can see the drug

And the injection button for administering the dose.

Do not remove the needle cap until you’re ready to inject.

Text on Screen: Your prefilled pen

Before Use

Needle cap

Transparent syringe housing, syringe plunger, needle

Label area (IDACIO, dose, expiration date)

Injector body

Injection button

VO: Once the needle cap is off the pen, like after use, you’ll see the needle, a safety guard that’s extended, and syringe plunger.

Do not use the device if the pen is like this before use.

Text on Screen: Your prefilled pen

Your prefilled pen

After Use

Needle

Safety Guard—Extended

Syringe Plunger—Final Position

VO: Now that you’re familiar with the prefilled pen, let’s go over the first step: preparing for your injection.

Find a clean, flat surface in a well-lit area. Whether you’re using a table or countertop, this is where you’ll gather the necessary supplies: a cotton ball, alcohol swab, and prefilled pen, along with a sharps disposal container that’s open, ready for use.

Text on Screen: Gather supplies

VO: Once everything’s in place, remove the IDACIO carton from your refrigerator.

Then check the expiration date on the side of the box. Do not use if the date has passed.

Next, remove 1 prefilled pen from the original box by placing 2 fingers on its label area and pulling straight up.

Place the prefilled pen on the countertop alongside your other supplies and let it sit for 15 to 30 minutes at room temperature before using as injecting cold medicine may be painful.

Text on Screen:Remove carton

Check expiration date

Remove prefilled pen

Leave prefilled pen at room temp for 15-30 minutes

VO: Return the remaining pen in its original carton to the refrigerator.

Text on Screen:Return remaining pen in original carton to refrigerator

VO: The next step? Washing your hands.

Wash them well with soap and water.

Then dry your hands with a clean towel.

Gloves do not replace the need for washing hands.

Text on Screen: Step 2: Wash hands

Use soap and water

Dry with a clean towel

Warning: Gloves do not replace the need for washing hands

VO: Step 3: Checking your prefilled pen.

It’s important to look at the transparent syringe housing to make sure that the liquid inside is clear and colorless to pale yellow as well as free of particles and flakes.

Make sure that the syringe isn’t cracked or damaged.

Next, check the prefilled pen label to make sure that the name on it says IDACIO and that the expiration date hasn’t passed.

Text on Screen: Step 3:

Check your prefilled pen

Make sure that the:

Liquid is clear, colorless to pale yellow, and free of particles and flakes

Syringe isn’t cracked or damaged

Name on the pen says IDACIO

Expiration date hasn’t passed

VO: Do not use the prefilled pen

if the label doesn’t have IDACIO on it or the expiration date has passed, don’t use it if the liquid’s cloudy or colored, or if the liquid has particles or flakes in it

Don’t use the pen if it looks damaged.

With any of these issues, dispose of the pen in a sharps disposal container and call your healthcare provider or pharmacist.

Text on Screen: Do not use the pen if the:

Label does not have IDACIO on it or expiration date has passed

Liquid is cloudy, colored, or has particles or flakes

Device looks damaged

Throw away the pen in sharps disposal container and call your healthcare provider or pharmacist

VO: Now for step 4: Choosing the injection site.

You have 2 options:

Either your stomach, about 2 inches, that’s approximately 5 centimeters, away from the bellybutton, or the front of your thighs.

No matter which site you choose, make sure it’s at least 1 inch or approximately 2 and a half centimeters from the last place you injected IDACIO to reduce the chance of redness, irritation, or other skin problems.

Text on Screen: Step 4: Choose the injection site

Options:

1) Stomach

2) Thighs

Inject at least 1" (~2.5 cm) from the last site

VO: Don’t inject IDACIO into skin that is sore, tender, bruised, red, hard, or scarred, or where you have stretch marks or tattoos.

And if you have psoriasis, do not inject into any lesions or red, thick, raised, or scaly patches.

Finally, don’t inject through clothing.

Text on Screen: Don’t inject into:

  • Sore, bruised, red, hard, or scarred skin
  • Stretch marks or tattoos.
  • Lesions or red, thick, raised, or scaly patches if you have psoriasis

Do not inject through clothes

VO: Next, we’ll have you clean the injection site using an alcohol swab.

Wipe the skin of your injection site with an alcohol swab using a circular motion.

Let the skin dry before injecting.

Don’t blow on or touch the injection site again after cleaning it.

Text on Screen: Step 5: Clean the injection site

Use alcohol swab in a circular motion

Let skin dry before injecting

VO: Now you’re ready to administer the injection.

Hold the pen upwards with one hand and remove the needle cap with the other by pulling the cap straight off.

Careful not to twist or touch the safety guard. You may see a few drops of liquid at the needle tip, which is normal.

Dispose of the needle cap in the sharps disposal container.

Position the pen so that you can see the transparent syringe housing.

Place your thumb above, but not touching, the yellow injection button.

Place the pen straight and flat against your skin at a 90-degree angle.

Text on Screen: Step 6: Give your injection

Remove needle cap

Position pen so syringe housing is visible and thumb is above yellow injection button

Angle pen at 90° so it’s straight and flat against skin

VO: Administer the injection by pushing and holding the pen firmly against your skin until the safety guard is fully pushed down, which will unlock the injection button.

Now push the injection button with your thumb until you hear a loud “click,” which means the injection’s started.

Continue holding the pen firmly.

Watch the syringe plunger to make sure it moves all the way down to the bottom of the syringe housing.

Make sure that all the liquid has been injected.

Continue holding the pen for 5 seconds before lifting it from the skin.

Once moved away from the site, the safety guard slides back into place.

If there’s blood or liquid on the injection site, gently press a cotton ball on the skin.

Text on Screen: Step 6: Give your injection

Push and hold pen firmly against skin until safety guard is fully pushed down, unlocking the injection button

Push injection button until there’s a loud “click”

Continue to hold pen firmly

Watch syringe plunger to ensure it moves down to the bottom of syringe

Keep holding for 5 seconds

Press cotton ball or gauze on injection site without rubbing

VO: Now that the injection’s been given, let’s dispose of the pen.

Put your used pen in an FDA-cleared sharps disposal container right after use.

If you don’t have a sharps disposal container, you can use a household container made of heavy-duty plastic.

Make sure it can be closed with a tight-fitting, puncture-resistant lid so that sharps can’t come out and it can stay upright and stable during use.

It must be leak-resistant and properly labeled to warn of hazardous waste inside.

Text on Screen: Step 7: Dispose of your prefilled pen

Place used pen in an FDA-cleared sharps disposal container after use

Or

A household container that’s:

  • Made of heavy-duty plastic
  • Puncture-resistant with a tight-fitting lid
  • Leak-resistant
  • Labeled with hazardous waste warning

VO: Keep your sharps disposal container out of the reach of children

Do not dispose of prefilled pens in household trash or recycling.

When your sharps disposal container is almost full, you’ll need to follow your local guidelines for the right way to dispose of the container.

Text on Screen: Keep your sharps disposal container out of the reach of children

Do not dispose of pens in household trash or recycling

When sharps disposal container is almost full, follow local guidelines for proper container disposal

VO: And the final step: document the injection site to help you remember when and where on your body to give the next injection.

Record the date administered.

Note whether the injection site was your stomach or right or left thigh.

Text on Screen: Step 8: Document your injection site

Record administration date

Note injection site

VO: Thank you for watching this video on IDACIO.

If you have any further questions, please contact your healthcare practitioner.

Text on Screen: Thank you for watching

If you have any questions, contact your healthcare practitioner

View syringe instruction for use (IFU) video

Download syringe IFU

MUSIC: Up & Under Throughout

VO: This demonstration video provides only supplementary information for the administration of IDACIO.

Text on Screen: Demonstration video provides only supplementary information for the administration of IDACIO (adalimumab-aacf)

VO: It is not a substitute for reading the medication guide accompanying IDACIO for important information you need to know for preparation and injection.

Text on Screen: This is NOT a substitute for reading the IDACIO medication guide

VO: This video demonstrates the administration of IDACIO with the active ingredient adalimumab using a single dose prefilled syringe.

You’ve been prescribed IDACIO, which is available as a prefilled syringe as well as a prefilled pen with a dosage of 40 milligrams to be injected.

In this video you will learn the correct way to inject using a prefilled syringe.

VO: Instructions for use…

IDACIO single dose prefilled syringe.

Before we go over the steps to self-administer using a prefilled syringe, there are a few things to consider.

Text on Screen: Instructions for use

IDACIO®

Single dose prefilled syringe (adalimumab-aacf) for subcutaneous injection 40 mg/0.8 mL

VO: It’s important to follow instructions so that you inject IDACIO correctly.

Do not share your prefilled syringe with another person as you may give them an infection or get an infection from them.

Do not try to reuse the prefilled syringe. It’s only for one-time, single-dose use.

Do not try to inject IDACIO yourself until you understand the instructions for use.

Do not use an IDACIO prefilled syringe to give IDACIO to a child weighing less than 66 pounds.

Do not use the prefilled syringe if the new carton is open or damaged.

Do not use a prefilled syringe that has been frozen or left in direct sunlight.

Text on Screen: DOs and DON’TS

Don’t share your IDACIO prefilled syringe with others

Don’t reuse your IDACIO prefilled syringe

Don’t try to inject IDACIO yourself until you understand all instructions

Don’t give IDACIO to a child weighing less than 66 lbs (30 kg)

Don’t use a prefilled syringe if the new carton is open or damaged

Don’t use a prefilled syringe that has been frozen or left in direct sunlight

VO: Do call your healthcare provider or pharmacist if you drop or crush the prefilled syringe — do not use it.

Do talk to your healthcare provider to be sure you understand IDACIO dosing instructions or if you or your caregiver have any questions about the right way to inject IDACIO.

Text on Screen: DOs and DON’TS

Do call your healthcare provider or pharmacist if you drop or crush the IDACIO prefilled syringe as it is glass

Do talk to your healthcare provider to ensure you understand IDACIO dosing instructions

VO: Let’s take a moment to talk about storing your IDACIO prefilled syringe.

Keep it in the original carton to protect from light and store it in a refrigerator set between 36 and 46 degrees Fahrenheit or 2 and 8 degrees Celsius.

Do not freeze IDACIO.

Do not use IDACIO if frozen, even if it has been thawed.

Text on Screen: Storing IDACIO prefilled syringes

Keep in original carton

Refrigerate between 36–46°F(2–8°C)

Do not freeze

Do not use if frozen, even once thawed

VO: Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton or syringe.

Do not use after expiration.

If needed, like when traveling, an IDACIO prefilled syringe can be stored at room temperature for up to 28 days.

Text on Screen: Storing IDACIO prefilled syringes

Refrigerated IDACIO may be used until expiration date

Do not use IDACIO after the expiration date

A prefilled syringe can be stored at room temperature up to 77°F (25°C) for up to 28 days

VO: Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton.

Keep the IDACIO prefilled syringe, injection supplies, and all other medicines out of the reach and sight of children.

Text on Screen: Storing IDACIO prefilled syringes

Record the dates IDACIO is removed from the refrigerator on the carton

Keep away from children

VO: Throw away the IDACIO prefilled syringe in an FDA-cleared sharps disposal container if it has been kept at room temperature and not used within 28 days or if it’s been stored in extreme heat or cold.

Do not use IDACIO if the liquid is cloudy, discolored, or has flakes or particles in it.

Text on Screen: Throw away IDACIO prefilled syringe if it has:

Been kept at room temperature, but not used within 28 days

Been stored in extreme heat or cold

Cloudy or discolored liquid, or there are visible flakes or particles

VO: Let’s get familiar with your prefilled syringe before we go over the 8 steps to successful injection.

Here we see the cap covering the needle for injection of the drug.

A clear needle guard with a liquid-filled syringe barrel inside that allows you to see the drug, the label and the plunger and finger grip for administering the dose.

Do not remove the needle cap until you’re ready to inject.

Text on Screen: Your prefilled syringe

Before Use

Needle cap

Clear needle guard with liquid-filled syringe barrel inside

Label area

(IDACIO, dose, expiration date)

Plunger and finger grip

VO: Once the needle cap is off the syringe like after use you’ll see the clear needle guard covering the needle a needle guard spring that’s extended and the syringe plunger.

Do not use the device if the syringe is like this before use.

Text on Screen: Your prefilled syringe

After Use

Clear needle guard covering the needle

Needle guard with spring extended

Plunger

VO: Now that you’re familiar with the prefilled syringe, let’s go over the first step: preparing for injection.

Find a clean, flat surface in a well-lit area. Whether you’re using a table or countertop, this is where you’ll gather the necessary supplies…A cotton ball, alcohol swab, and prefilled syringe along with a sharps disposal container that’s open, ready for use.

Text on Screen: Step 1:

Prepare for injection

Gather supplies

VO: Once everything’s in place remove the IDACIO carton from your refrigerator.

Then check the expiration date on the side of the box. Do not use if the date has passed.

Next, remove 1 prefilled syringe from the original box by placing 2 fingers on the middle of the clear needle guard and pulling straight up.

Don’t pick up the syringe by the plunger or needle cap as it could damage the syringe or activate the clear needle guard.

Text on Screen: Remove carton

Check expiration date

Remove prefilled syringe

VO: Place the prefilled syringe on the countertop alongside your other supplies

Return the remaining syringe in its original carton to the refrigerator.

Let the syringe sit on the counter for 15 to 30 minutes at room temperature before using as injecting cold medicine may be painful.

Text on Screen: Return remaining syringe in original carton to refrigerator

Leave prefilled syringe at room temp for 15-30 minutes

VO: Step 2: Checking your prefilled syringe.

It’s important to look at the clear window on the back of the syringe to make sure that the liquid inside is clear and colorless to pale yellow as well as free of particles and flakes.

Make sure that the syringe, needle guard, and needle cap aren’t cracked or damaged.

Check that the needle cap is securely attached.

Next, look at the label to make sure the name on it says IDACIO and that the expiration date hasn’t passed.

Text on Screen: Step 2:

Check your prefilled syringe

Make sure that the:

Liquid is clear, colorless to pale yellow, and free of particles and flakes

Syringe, clear needle guard, and needle cap aren’t cracked or damaged

Needle cap is securely attached

Name on the syringe says IDACIO

Expiration date hasn’t passed

VO: Do not use the prefilled syringe if the label doesn’t have IDACIO on it or the expiration date has passed…

Don’t use it if the liquid’s cloudy or colored or if the liquid has particles or flakes in it.

Don’t use the syringe if it looks damaged or the needle guard spring is extended.

With any of these issues, dispose of the syringe in a sharps disposal container and call your healthcare provider or pharmacist.

Text on Screen: Do not use the syringe if the:

Label does not have IDACIO on it or expiration date has passed

Liquid is cloudy, colored, or has particles or flakes

Device looks damaged

Needle guard spring is extended

Throw away the syringe in sharps disposal container and call your healthcare provider or pharmacist

VO: The next step? Washing your hands.

Wash them well with soap and water.

Then dry your hands with a clean towel.

Gloves do not replace the need for washing hands.

Text on Screen: Step 3:

Wash hands

Use soap and water

Dry with a clean towel

Warning: Gloves do not replace the need for washing hands

VO: Now for step 4: Choosing the injection site.

You have 2 options…

Either your stomach, about 2 inches—that’s approximately 5 centimeters—away from the bellybutton or the front of your thighs.

No matter which site you choose make sure it’s at least 1 inch or approximately 2 and a half centimeters from the last place you injected IDACIO to reduce the chance of redness, irritation, or other skin problems.

Don’t inject IDACIO into skin that is sore, tender, bruised, red, hard, or scarred... or where you have stretch marks or tattoos.

And if you have psoriasis, do not inject into any lesions or red, thick, raised, or scaly patches.

Finally, don’t inject through clothing.

Text on Screen: Step 4:

Choose the injection site

Options:

1) Stomach

2) Thighs

Inject at least 1" (~2.5 cm) from the last site

Don’t inject into:

• Sore, bruised, red, hard, or scarred skin

• Stretch marks or tattoos.

• Lesions or red, thick, raised, or scaly patches if you have psoriasis

Do not inject through clothes

VO: Next we’ll have you clean the injection site using an alcohol swab.

Wipe the skin of your injection site with an alcohol swab using a circular motion.

Let the skin dry before injecting.

Don’t blow on or touch the injection site again after cleaning it.

Text on Screen: Step 5:

Clean the injection site

Use alcohol swab in a circular motion

Let skin dry before injecting

VO: Now you’re ready to administer the injection.

Hold the syringe in one hand.

With your other hand, gently remove the needle cap and dispose of it in the sharps disposal container.

Don’t touch the needle with your fingers or let the needle touch anything.

Hold the body of the prefilled syringe between the thumb and index finger… like a pencil.

Don’t pull back on the plunger.

Text on Screen: Step 6:

Give your injection

Remove and discard needle cap

Hold syringe like a pencil

VO: With your free hand, gently squeeze the area of the cleaned skin and hold it firmly.

Using a quick dart-like motion, insert the needle into the squeezed skin at a 45-degree angle.

Once the needle’s in, let go of the skin.

Slowly push the plunger all the way in until all liquid is injected and the syringe is empty.

The plunger must be pushed all the way down to ensure the full dose has been injected and the safety system activated.

Do not remove the needle from the skin when the plunger is pushed all the way down.

Text on Screen: Squeeze and hold cleaned skin

Angle syringe at 45° and insert needle

Push plunger all the way in until syringe is empty

Watch syringe plunger move down to the bottom for full dose

VO: Slowly remove your thumb from the plunger.

This allows the needle to move up into the clear needle guard and cover the entire needle.

If there’s blood or liquid on the injection site, gently press a cotton ball on the skin.

Text on Screen: Remove thumb from plunger so needle moves into clear needle guard

Press cotton ball or gauze on injection site without rubbing

VO: Now that the injection’s been given, let’s dispose of the syringe.

Put your used syringe in an FDA-cleared sharps disposal container right after use.

If you don’t have a sharps disposal container, you can use a household container made of heavy-duty plastic.

Make sure it can be closed with a tight-fitting, puncture-resistant lid so that sharps can’t come out and it can stay upright and stable during use.

It must be leak-resistant and properly labeled to warn of hazardous waste inside.

Text on Screen: Step 7:

Dispose of your used syringe

Place used syringe in an FDA-cleared sharps disposal container after use

Or

A household container that’s:

  • Made of heavy-duty plastic
  • Puncture-resistant with a tight-fitting lid
  • Leak-resistant
  • Labeled with hazardous waste warning

VO: Keep your sharps disposal container out of the reach of children.

Do not dispose of prefilled syringes in household trash or recycling.

When your sharps disposal container is almost full, you’ll need to follow your local guidelines for the right way to dispose of the container.

Text on Screen: Keep your sharps disposal container out of the reach of children

Do not dispose of syringes in household trash or recycling

When sharps disposal container is almost full, follow local guidelines for proper container disposal

VO: And the final step… document the injection site to help you remember when and where on your body to give the next injection.

Record the date administered.

Note whether the injection site was on your stomach or on the right or left thigh.

Text on Screen: Step 8:

Document your injection site

Record administration date

Note injection site

VO: Thank you for watching this video on IDACIO.

If you have any further questions, please contact your healthcare practitioner.

Text on Screen: Thank you for watching

If you have any questions, contact your healthcare practitioner

Text on Screen: [ISI]

[COPYRIGHT]

[INTERNAL REF CODE]

WITH ERGONOMIC, EASY-TO-READ DEVICES AND ROOM-TEMPERATURE STORAGE FOR UP TO 28 DAYS, IDACIO OFFERS THE SAME DOSING REGIMEN AS HUMIRA.1

Comprehensive support for your patients

Fresenius Kabi is proud to provide broad support for all our products. For IDACIO, we offer resources to help support patient access to therapy including resources to navigate insurance, financial assistance, nursing, and therapeutic needs and simplify the treatment journey. To learn more, start here.

Discover IDACIO support

INDICATIONS

  • IDACIO 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 active rheumatoid arthritis. IDACIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

  • IDACIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. IDACIO can be used alone or in combination with methotrexate.

  • IDACIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IDACIO can be used alone or in combination with non-biologic DMARDs.

  • IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

  • IDACIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • IDACIO is indicated for the 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. IDACIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  • IDACIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
    Limitations of Use
    The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with IDACIO® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue IDACIO® 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 IDACIO® use and during therapy. Initiate treatment for latent TB prior to IDACIO® 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 antifungal 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.

Carefully consider the risks and benefits of treatment with IDACIO® prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Treatment with IDACIO® should not be initiated in patients with an active infection, including localized infections.

Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.

Discontinue IDACIO® if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with IDACIO®, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of adalimumab products with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

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 been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants

  • Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.

  • In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.

  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with IDACIO®.

  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.

  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of IDACIO® and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including IDACIO®, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV.

In patients who develop HBV reactivation, stop IDACIO® and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of IDACIO® therapy in this situation and monitor patients closely.

NEUROLOGICAL REACTIONS

Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.

Exercise caution in considering the use of IDACIO® in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of IDACIO® should be considered if any of these disorders develop.

HEMATOLOGICAL REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping IDACIO® if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on IDACIO® should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating IDACIO® therapy. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

INDICATIONS

  • Rheumatoid Arthritis (RA): 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): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

  • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

  • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.

  • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.

    Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

  • Plaque Psoriasis (PsO): 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.

Please see full Prescribing Information, including boxed WARNING, for IDACIO® (adalimumab-aacf).

Important Safety Information
Indications

INDICATIONS

  • IDACIO 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 active rheumatoid arthritis. IDACIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

  • IDACIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. IDACIO can be used alone or in combination with methotrexate.

  • IDACIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IDACIO can be used alone or in combination with non-biologic DMARDs.

  • IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

  • IDACIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • IDACIO is indicated for the 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. IDACIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  • IDACIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
    Limitations of Use
    The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with IDACIO® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue IDACIO® 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 IDACIO® use and during therapy. Initiate treatment for latent TB prior to IDACIO® 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 antifungal 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.

Carefully consider the risks and benefits of treatment with IDACIO® prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Treatment with IDACIO® should not be initiated in patients with an active infection, including localized infections.

Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.

Discontinue IDACIO® if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with IDACIO®, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of adalimumab products with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

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 been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants

  • Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.

  • In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.

  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with IDACIO®.

  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.

  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of IDACIO® and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including IDACIO®, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.

Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV.

In patients who develop HBV reactivation, stop IDACIO® and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of IDACIO® therapy in this situation and monitor patients closely.

NEUROLOGICAL REACTIONS

Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.

Exercise caution in considering the use of IDACIO® in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of IDACIO® should be considered if any of these disorders develop.

HEMATOLOGICAL REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.

Consider stopping IDACIO® if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on IDACIO® should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating IDACIO® therapy. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

INDICATIONS

  • Rheumatoid Arthritis (RA): 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): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

  • Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

  • Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.

  • Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.

    Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

  • Plaque Psoriasis (PsO): 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.

Please see full Prescribing Information, including boxed WARNING, for IDACIO® (adalimumab-aacf).

References:

  1. IDACIO® (adalimumab-aacf) injection prescribing information. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2022.
  2. HUMIRA injection [package insert]. North Chicago, IL. AbbVie Inc.
  3. AMJEVITA™ (adalimumab-atto) injection prescribing information. Thousand Oaks, CA: Amgen Inc. 2022.