Adalimumab-fkjp Clinical Profile

Prescribing Adalimumab-fkjp means not really changing a whole lot.

Built with patients in mind

With the easy-to-use 2-click Adalimumab-fkjp prefilled pen, starting treatment is as simple as “click, click, go!”1
No buttons to push—patients simply remove the cap and push the device against the skin to trigger their injection.2

Adalimumab-fkjp is also available in 20 mg/0.4 mL and 40 mg/0.8 mL prefilled syringes.

orange-checkmark (1)

Protective Cap

Covers needle for patient safety

orange-checkmark (1)

Citrate Free

Minimizes injection site pain

orange-checkmark (1)

Viewing Window

Shows progress of injection

orange-checkmark (1)

2 Audible Clicks

Confirms start and end of injection

orange-checkmark (1)

Plastic Design

Reduces breakage concerns

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Made Without Natural Rubber Latex

Reduces hypersensitivity reactions

Keep on treating with Adalimumab-fkjp

Adalimumab-fkjp is a recombinant human IgG1 monoclonal antibody (mAb) that blocks TNF-α.2 Sound familiar? Because Adalimumab-fkjp works the same way as Humira, you can continue helping your patients manage a wide range of autoimmune and inflammatory conditions.2

Adalimumab-fkjp Indications*
Moderate to Severe chronic

Plaque Psoriasis

in adults

Moderate to Severe

Ulcerative Colitis

in adults

ACTIVE

Ankylosing Spondylitis

in adults

Moderate to Severe

Rheumatoid Arthritis

in adults

Moderate to Severe

Crohn’s Disease

in adults and children 6 years and older

Moderate to Severe

Hidradenitis Suppurativa

in adults

MODERATE TO SEVERE POLYARTICULAR

Juvenile Idiopathic Arthritis

in children 2 years and older

NON-INFECTIOUS

Uveitis

in adults

ACTIVE

Psoriatic Arthritis

in adults

*Click here for full indications.

Biosimilars aren’t just what we do—they’re all we do

Each year, biosimilars save the US healthcare system over $5 billion.*3 By expanding the availability of high-quality biosimilars such as Adalimumab-fkjp here and around the world, Biocon Biologics 
can make a meaningful difference for patients and those charged with their care.

Robust Pipeline

More than 20 biosimilars approved or in development

Strong Portfolio

9 biosimilars launched across global markets

Wide Impact

5.5 million patients served in over 100 countries

Learn more about Biocon Biologics here. external icon

*Estimates of reductions in direct spending on biologic drugs from 2014 through 2024.

The proof behind Adalimumab-fkjp

Adalimumab-fkjp meets the rigorous biosimilar approval standards of the FDA

COMPARATIVE CLINICAL STUDIES to help ensure no clinically meaningful differences3
CLINICAL PHARMACOLOGY STUDIES to show similarity in human PK/PD/immunogenicity profiles3
NONCLINICAL STUDIES to evaluate biosimilar toxicity and safety profiles3
ANALYTICAL STUDIES to support structural and functional similarity to reference product3
  • An application for a proposed biosimilar generally must include information showing that the proposed product is biosimilar to a reference product3
  • The process typically requires analytical studies, nonclinical (animal) studies, clinical pharmacology (pharmacokinetics), and one or more clinical studies3
  • For more information about the FDA approval process, please visit the FDA biosimilars review and approval page

PD=pharmacodynamic; PK=pharmacokinetic.

Extrapolation

After biosimilarity is confirmed by the totality of evidence, scientific justification may be used to support extrapolation to certain other approved indication(s) of a reference biologic.4

Totality of Evidence

+

Scientific Justification

=

Extrapolation to Additional Indications

Adalimumab-fkjp has 2-year switching data

The comparative clinical data required for FDA biosimilar approval were evaluated for an extended period—including the effects of single- and double-switching treatment in a defined population.3

  • There was no long-term clinically meaningful difference between Adalimumab-fkjp and Humira with respect to safety, efficacy, and immunogenicity3
  • There was no impact of switching and double switching between the 2 drugs3

Click below to expand and view the evidence.

Pharmacokinetics (PK) highly similar1

Results from a Phase I, randomized, double-blind, parallel-group study compared the pharmacokinetic profile of the Biocon Biologic’s biosimilar adalimumab, Adalimumab-fkjp, with reference adalimumab sourced from the European Union and the US. A total of 180 healthy subjects (170 men 
and 10 women of non-childbearing potential) were enrolled.1

  • Adalimumab-fkjp has a PK profile similar to EU-approved and US-licensed adalimumab reference products1
  • Adalimumab-fkjp was well tolerated by healthy volunteers in this Phase I PK study, 
with a safety profile similar to that 
of its reference product3

EU=European Union

Adalimumab-fkjp pharmacokinetics compared to Humira

a

Efficacy highly similar during double-blind phase2,3

A randomized, double-blind (DB), phase 3, 24-week study compared the efficacy, safety, and immunogenicity of Adalimumab-fkjp with Humira in patients with moderate-to-severe rheumatoid arthritis (RA) inadequately controlled with methotrexate. Patients who completed the DB study were enrolled in the open-label extension (OLE) study and re-randomized 2:1 to receive Adalimumab-fkjp or Humira; two-thirds continued on the same treatment and one-third switched for 30 weeks. Then all patients received Adalimumab-fkjp for a total duration of 2 years.2,3

a

a

Safety profile highly similar during double-blind phase2,3

  • Data shown refer to the same 24-week, double-blind trial as the efficacy data; please see the study design under the efficacy section
  • Adalimumab-fkjp and the adalimumab reference product have similar clinical safety profiles2

AEs=adverse events; TB=tuberculosis;
TEAE=treatment-emergent adverse event;
TESAE=treatment-emergent serious adverse event.

Adalimumab-fkjp safety profile compared to Humira

a

  • The Adalimumab-fkjp and Humira analysis included 673.7 patient-years and 175.4 patient-years, respectively3
  • Safety of Adalimumab-fkjp was comparable to Humira and maintained over long-term treatment during the open-label extension study, even when patients were switched between Adalimumab-fkjp and Humira3
  • Please see the study design under the efficacy section
Adalimumab-fkjp safety profile compared to Humira
a

*Related or possibly related to study drug.

Immunogenicity highly similar during double-blind phase2

  • Data shown refer to the same 24-week, double-blind trial as the efficacy data; please see the study design under the efficacy section
  • Proportion of patients with anti-drug antibodies (ADA+) was similar between Adalimumab-fkjp and Humira groups at Week 242
Adalimumab-fkjp immunogenicity (ADA+) compared to Humira
a
  • Neutralizing anti-drug antibodies (ADAs) did not increase in any sequence during the study3
  • Switching treatment between Humira and Adalimumab-fkjp did not impact ADA response3
  • Please see the study design under the efficacy section

Adalimumab-fkjp immunogenicity (ADA+) compared to Humira

a

graph

Adalimumab-fkjp keeps it familiar

Prescribing Adalimumab-fkjp means not really changing a whole lot.
Especially the dosing you’ve come to expect with Humira.1,2

Administering Adalimumab-fkjp

  • Dosing is similar to Humira—no new doses or dosing schedule to learn1,2
  • Adalimumab-fkjp is intended for use under the guidance and supervision of a physician. A patient may self-inject Adalimumab-fkjp or a caregiver may inject Adalimumab-fkjp using either the Adalimumab-fkjp Pen or prefilled syringe if a physician determines that it is appropriate, after proper training in subcutaneous injection technique1
  • Prior to initiating Adalimumab-fkjp and periodically during therapy, evaluate patients for active tuberculosis and test for 
latent infection1
  • If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time1
  • There is no dosage form of Adalimumab-fkjp that allows weight-based dosing for pediatric patients weighing less than 15 kg (or 33 lb)1
  • Your patients may receive Adalimumab-fkjp injection
Image of prefilled pen

Prefilled Pen

  • Injection: 40 mg/0.8 mL in a single-dose pen
  • 2-step process with audible clicks and no buttons assures correct use, even for patients with disabilities
  • Does not need to be mixed or prepared
  • Medicine is injected automatically; patients never see the needle
Image of prefilled syringe

Prefilled Syringe

  • Injection: 40 mg/0.8 mL in a single-dose prefilled plastic syringe
  • Injection: 20 mg/0.4 mL in a single-dose prefilled plastic syringe

Adalimumab-fkjp helps you get going and keep going

See how similar transitioning to Adalimumab-fkjp will be for your current Humira patients.1,2

Click on the therapeutic area below to reveal Adalimumab-fkjp-specific dosing for each indication.

ADULTS

MAINTENANCE

ADULTS

40 mg/0.8 mL

every other week

Indication: Adalimumab-fkjp 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1

ADULTS

MAINTENANCE

ADULTS

40 mg/0.8 mL

every other week

Indication: Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs.1

ADULTS

MAINTENANCE

ADULTS

40 mg/0.8 mL

every other week

Indication: Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.1

MAINTENANCE

CHILDREN ≥2 years

15 kg (33 lbs) to
<30 kg (66 lbs)

20 mg/0.4 mL

every other week

≥30 kg (66 lbs)

40 mg/0.8 mL

every other week

CHILDREN ≥2 years
15 kg (33 lbs) to
<30 kg (66 lbs)
≥30 kg (66 lbs)

MAINTENANCE

ADULTS

20 mg/0.4 mL

every other week

40 mg/0.8 mL

every other week

There is no dosage form for Adalimumab-fkjp that allows weight-based dosing for pediatric patients below 15 kg.

Adalimumab products have not been studied in patients with polyarticular juvenile idiopathic arthritis less than 2 years of age or in patients with a weight below 10 kg.

Indication: Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate.1

ADULTS

INDUCTION

ADULTS

Day 1:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 8:

40 mg/0.8 mL

every other week

Indication: Indication: Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs.1

ADULTS

MAINTENANCE

ADULTS

40 mg/0.8 mL

every other week

Indication: Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs.1

ADULTS

INDUCTION

ADULTS

Day 1:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 8:

40 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

Indication: Adalimumab-fkjp 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. Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.1

ADULTS

INDUCTION

ADULTS

Day 1:

160 mg/0.8 mL*
>

Day 15:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 29:

40 mg/0.8 mL

every week

or
80 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

*Given in 1 day or split over 2 consecutive days.

Indication: Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.1

ADULTS

INDUCTION

ADULTS

Day 1:

160 mg/0.8 mL*
>

Day 15:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 29:

40 mg/0.8 mL

every other week
CHILDREN ≥6 years

17 kg (37 lbs) to <40 kg (88 lbs)

Day 1:

80 mg/0.8 mL
>

Day 15:

40 mg/0.8 mL

Day 29:

20 mg/0.8 mL

every other week

≥40 kg (88 lbs)

Day 1:

160 mg/0.8 mL*
>

Day 15:

80 mg/0.8 mL

Day 29:

40 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

*Given in 1 day or split over 2 consecutive days.

Indication: Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.1

INDUCTION

ADULTS

Day 1:

160 mg/0.8 mL*
 >

Day 15:

80 mg/0.8 mL
CHILDREN ≥6 years

17 kg (37 lbs) to
<40 kg (88 lbs)

Day 1:

80 mg/0.8 mL
 >

Day 15:

40 mg/0.8 mL

≥40 kg (88 lbs)

Day 1:

160 mg/0.8 mL*
 >

Day 15:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 29:

40 mg/0.8 mL

every other week
CHILDREN ≥6 years

17 kg (37 lbs) to
<40 kg (88 lbs)

Day 29:

20 mg/0.8 mL

every other week

≥40 kg (88 lbs)

Day 29:

40 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

*Given in 1 day or split over 2 consecutive days.

Indication: Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.1

ADULTS

INDUCTION

ADULTS

Day 1:

160 mg/0.8 mL*
>

Day 15:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 29:

40 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

Discontinue Adalimumab-fkjp in adult patients without evidence of clinical remission by 8 weeks (Day 57) of therapy.

*Given in 1 day or split over 2 consecutive days.

Indication: Adalimumab-fkjp is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.1

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.1

ADULTS

INDUCTION

ADULTS

Day 1:

80 mg/0.8 mL

MAINTENANCE

ADULTS

Day 8:

40 mg/0.8 mL

every other week

Current adalimumab patients do not need to repeat induction dose—initiate Adalimumab-fkjp as next scheduled dose.

Indication: Adalimumab-fkjp is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.1

References: 1. Hulio. Product information. European Medicines Agency; 2022. Accessed March 20, 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/hulio 2. Hulio. Product information. Health Canada; 2022. Accessed March 20, 2023. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99197 3. Data on file. Biocon Biologics Inc; 2023. 4. US Food and Drug Administration. Biosimilars: review and approval. 2022. Accessed April 24, 2023. https://www.fda.gov/drugs/biosimilars/review-and-approval 5. Adalimumab-fkjp. Prescribing Information. Biocon Biologics Inc; 2025. 6. HUMIRA. Prescribing information. AbbVie Inc; 2024.

Important Safety Information and Indications

Serious infections

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

Discontinue Adalimumab-fkjp if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-fkjp use and during therapy. Initiate treatment for latent TB prior to Adalimumab-fkjp use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with Adalimumab-fkjp 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 Adalimumab-fkjp, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start Adalimumab-fkjp during an active infection, including localized infections
  • Patients older than 65 years, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate 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-fkjp 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. Postmarketing 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 (6-MP) 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 Adalimumab-fkjp 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 Adalimumab-fkjp.
  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general US 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 a serious allergic reaction occurs, stop Adalimumab-fkjp and institute appropriate therapy.

Hepatitis b virus reactivation

  • Use of TNF blockers, including HULIO, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after Adalimumab-fkjp treatment.
  • Discontinue Adalimumab-fkjp and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming Adalimumab-fkjp after HBV treatment.

Neurologic reactions

  • TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering Adalimumab-fkjp for patients with these disorders; discontinuation of Adalimumab-fkjp should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

Hematologic 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 Adalimumab-fkjp if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new-onset congestive heart failure (CHF) have been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; 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 Adalimumab-fkjp should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating Adalimumab-fkjp therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or liveattenuated vaccines in infants exposed to Adalimumab-fkjp 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: Adalimumab-fkjp 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
  • Juvenile Idiopathic Arthritis: Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate.
  • Psoriatic Arthritis: Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs.
  • Ankylosing Spondylitis: Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Crohn’s Disease: Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis: Adalimumab-fkjp 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.
  • Plaque Psoriasis: Adalimumab-fkjp 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. Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Uveitis: Adalimumab-fkjp is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Important Safety Information and Indications

Serious infections

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

Discontinue Adalimumab-fkjp if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-fkjp use and during therapy. Initiate treatment for latent TB prior to Adalimumab-fkjp use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with Adalimumab-fkjp 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 Adalimumab-fkjp, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start Adalimumab-fkjp during an active infection, including localized infections
  • Patients older than 65 years, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate 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-fkjp 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. Postmarketing 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 (6-MP) 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 Adalimumab-fkjp 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 Adalimumab-fkjp.
  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general US 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 a serious allergic reaction occurs, stop Adalimumab-fkjp and institute appropriate therapy.

Hepatitis b virus reactivation

  • Use of TNF blockers, including Adalimumab-fkjp, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after Adalimumab-fkjp treatment.
  • Discontinue Adalimumab-fkjp and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming Adalimumab-fkjp after HBV treatment.

Neurologic reactions

  • TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering Adalimumab-fkjp for patients with these disorders; discontinuation of Adalimumab-fkjp should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

Hematologic 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 Adalimumab-fkjp if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new-onset congestive heart failure (CHF) have been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; 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 Adalimumab-fkjp should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating Adalimumab-fkjp therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or liveattenuated vaccines in infants exposed to Adalimumab-fkjp 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: Adalimumab-fkjp 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
  • Juvenile Idiopathic Arthritis: Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate.
  • Psoriatic Arthritis: Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs.
  • Ankylosing Spondylitis: Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Crohn’s Disease: Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis: Adalimumab-fkjp 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.
  • Plaque Psoriasis: Adalimumab-fkjp 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. Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Uveitis: Adalimumab-fkjp is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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Indications

Rheumatoid Arthritis: Adalimumab-fkjp 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis: Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate.

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

Ankylosing Spondylitis: Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: Adalimumab-fkjp 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.

Plaque Psoriasis: Adalimumab-fkjp 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.Adalimumab-fkjp should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

Uveitis: Adalimumab-fkjp is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.