Adalimumab is an active pharmaceutical ingredient in the Tumor Necrosis Factor Alpha (Tnf-Alpha) Inhibitors group (L04AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 22, 2025[1]
Rheumatoid arthritis Hyrimoz in combination with methotrexate, is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
CACanada· Health Canada
40 products
Uses
CAOfficial regulatory label· revised January 7, 2026[2]
2 Recommended Dose and Dosage Adjustment 04/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS ..............................................................................................................
7 2 CONTRAINDICATIONS ................................................................................................. 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 8 4 DOSAGE AND ADMINISTRATION.................................................................................
EUEuropean Union· EMA
11 products
Uses
EUOfficial regulatory label· revised May 7, 2026[3]
Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
1). Humira has not been studied in patients aged less than 2 years. 1). Paediatric plaque psoriasis Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Paediatric Crohn's disease 3 Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Drug interactions
Known interactions involving Adalimumab. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 307. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB045200244 · revised April 22, 2025
[2]Health Canada (DPD) · 02258595 · revised January 7, 2026
[3]European Medicines Agency · EMEA/H/C/000481 · revised May 7, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
1). Adalimumab has not been studied in patients aged less than 2 years. 1). Axial spondyloarthritis Ankylosing spondylitis (AS) Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Axial spondyloarthritis without radiographic evidence of AS Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 1) and to improve physical function.
Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
2). Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Ulcerative colitis Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
How to take
GBOfficial regulatory label· revised April 22, 2025[1]
Hyrimoz treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hyrimoz is indicated. 4). Patients treated with Hyrimoz should be given the Patient Reminder Card.
After proper training in injection technique, patients may self-inject with Hyrimoz if their physician determines that it is appropriate and with medical follow-up as necessary. , corticosteroids and / or immunomodulatory agents) should be optimised.
Posology Rheumatoid arthritis The recommended dose of Hyrimoz for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Hyrimoz.
Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hyrimoz. 1. In monotherapy, some patients who experience a decrease in their response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Hyrimoz may be available in other strengths and/or presentations depending on the individual treatment needs.
Dose interruption There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis The recommended dose of Hyrimoz for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Psoriasis The recommended dose of Hyrimoz for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Hyrimoz 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose. Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Beyond 16 weeks, patients with inadequate response to Hyrimoz 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. 1). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Hyrimoz may be available in other strengths and/or presentations depending on the individual treatment needs. Hidradenitis suppurativa The recommended Hyrimoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as two 80 mg injections or four 40 mg injections in one day or as one 80 mg injection or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as one 80 mg injection or two 40 mg injections in one day).
Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as one 80 mg injection or two 40 mg injections in one day). Antibiotics may be continued during treatment with Hyrimoz, if necessary.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hyrimoz. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
1). 1). Hyrimoz may be available in other strengths and/or presentations depending on the individual treatment needs. Crohn’s disease The recommended Hyrimoz induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 80 mg at Week 0 followed by 40 mg at Week 2.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at Week 0 (given as two 80 mg injections or four 40 mg injections in one day or as one 80 mg injection or two 40 mg injections per day for two consecutive days), followed by 80 mg at Week 2 (given as one 80 mg injection or two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped Hyrimoz and signs and symptoms of disease recur, Hyrimoz may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 22, 2025[1]
Summary of the safety profile Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period. 4 % for control-treated patients. The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body’s defence against infection and cancer. Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) and frequency in table 7 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency seen among the various indications has been included. 8. g. optic neuritis, Guillain-Barré syndrome)1) System Organ Class Frequency Adverse Reaction Common Visual impairment, conjunctivitis, blepharitis, eye swelling Eye disorders Uncommon Diplopia Common VertigoEar and labyrinth disorders Uncommon Deafness, tinnitus Common Tachycardia Uncommon Myocardial infarction1), arrhythmia, congestive heart failure Cardiac disorders* Rare Cardiac arrest Common Hypertension, flushing, haematoma Vascular disorders Uncommon Aortic aneurysm, vascular arterial occlusion, thrombophlebitis Common Asthma, dyspnoea, cough Uncommon Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1) Respiratory, thoracic and mediastinal disorders* Rare Pulmonary fibrosis1) Very common Abdominal pain, nausea and vomiting Gastrointestinal disorders Common […]
GBOfficial regulatory label· Warnings and precautions· revised April 22, 2025[1]
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients taking TNF-antagonists are more susceptible to serious infections.
Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hyrimoz. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.
Treatment with Hyrimoz should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Hyrimoz should be considered prior to initiating therapy (see Other opportunistic infections).
Patients who develop a new infection while undergoing treatment with Hyrimoz should be monitored closely and undergo a complete diagnostic evaluation. Administration of Hyrimoz should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Physicians should exercise caution when considering the use of Hyrimoz in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Serious infections Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported. Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 22, 2025[1]
1. 4). 4).
This is not medical advice. Consult a qualified healthcare professional.
1 Clinical Trial Adverse Reactions – Pediatrics..................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................... 1 Less Common Clinical Trial Adverse Reactions – Pediatrics .............................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................. 5 Post-Market Adverse Reactions..............................................................................
68 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .......................................................................................
76 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 77 PART II: SCIENTIFIC INFORMATION ......................................................................................
78 13 PHARMACEUTICAL INFORMATION ........................................................................... 78 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ............................................................................... […]
How to take
CAOfficial regulatory label· revised January 7, 2026[2]
2 Recommended Dose and Dosage Adjustment 04/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 5 1 INDICATIONS ..............................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised January 7, 2026[2]
Reports of serious allergic reactions, including anaphylaxis, have been received following Humira administration. If an anaphylactic reaction or other serious allergic reactions occur, administration of Humira should be discontinued immediately and appropriate therapy initiated.
The Humira Pen and the pre-filled syringe are available with a 29 gauge ½ inch needle and a black needle cover that does not contain latex. See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Immune Autoimmunity Treatment with Humira may result in the formation of autoantibodies and rarely, in the development of a lupus-like syndrome.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira, treatment should be discontinued. 1 Adverse Reaction Overview, Autoantibodies. Immunosuppression The possibility exists for TNF-blocking agents, including Humira, to affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
In a study of 64 patients with rheumatoid arthritis who were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T- and B-cells and NK-cells, monocyte/macrophages, and neutrophils.
The impact of treatment with Humira on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. 1 Adverse Reaction Overview, Infections and Malignancies. HUMIRA (adalimumab injection) Page 21 of 176 Immunizations In a randomized, double-blind, placebo-controlled study in 226 adult rheumatoid arthritis patients treated with Humira, antibody responses to concomitant pneumococcal and influenza vaccines were assessed.
Protective antibody levels to the pneumococcal antigens were achieved by 86% of patients in the Humira group compared to 82% in the placebo group. A total of 37% of Humira-treated patients and 40% of placebo-treated patients achieved at least a 2-fold increase in antibody titer to at least three out of five pneumococcal antigens.
In the same study, 98% of patients in the Humira group and 95% in the placebo group achieved protective antibody levels to the influenza antigens. A total of 52% of Humira- treated patients and 63% of placebo-treated patients achieved at least a 4-fold increase in antibody titer to at least two out of three influenza antigens.
It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Humira therapy. Patients on Humira may receive concurrent vaccinations, except for live vaccines.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following the mother’s last Humira injection during pregnancy.
1 Pregnant Women. Infections Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira. , disseminated) tuberculosis. Before initiation, during and after treatment with Humira, patients should be evaluated for active and inactive (“latent”) tuberculosis infection with a tuberculin skin test.
Treatment of latent tuberculosis infections should be initiated prior to therapy with Humira. When tuberculin skin testing is performed for latent tuberculosis infection, an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guérin (BCG).
If active tuberculosis is diagnosed, Humira therapy must not be initiated. The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or who had close contact with a person with active tuberculosis.
If latent infection is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylactic treatment, in accordance with the Canadian Tuberculosis Standards and Centers for Disease Control and Prevention guidelines, before the initiation of Humira.
Use of anti-tuberculosis prophylactic treatment should also be considered before the initiation of Humira in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
The decision to initiate anti-tuberculosis therapy in these patients should only be made after taking into account both the risk for latent tuberculosis infection and the risks of anti-tuberculosis therapy. If necessary, consultation should occur with a physician with expertise in the treatment of tuberculosis.
HUMIRA (adalimumab injection) Page 22 of 176 Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients receiving Humira. Also, active tuberculosis has developed in patients receiving Humira whose screening for latent tuberculosis infection was negative, and some patients who have been successfully treated for active tuberculosis have redeveloped active tuberculosis while being treated with TNF- blocking agents.
Patients receiving Humira should be monitored for signs and symptoms of active tuberculosis, particularly because tests for latent tuberculosis infection may be falsely negative. The risk of false negative tuberculin skin test results should be considered, especially in patients who are severely ill or immunocompromised.
, persistent cough, wasting/weight […]
CAOfficial regulatory label· Warnings and precautions· revised January 7, 2026[2]
, Cardiovascular, Patients with Congestive Heart Failure. HUMIRA (adalimumab injection) Page 8 of 176 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Hepatosplenic T-Cell Lymphoma Very rare post-marketing reports of hepatosplenic T-cell lymphoma (HSTCL), a rare aggressive lymphoma that is often fatal, have been identified in patients treated with Humira.
Most of the patients had prior infliximab therapy as well as concomitant azathioprine or 6-mercaptopurine use for Crohn’s disease. The potential risk with the combination of azathioprine or 6-mercaptopurine and Humira should be carefully considered.
The causal association of HSTCL with Humira is not clear. Infections Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidioidomycosis), viral, parasitic, or other opportunistic infections have been reported in patients receiving tumor necrosis factor (TNF)-blocking agents.
Sepsis, rare cases of tuberculosis, candidiasis, listeriosis, legionellosis and pneumocystis have also been reported with the use of TNF-blocking agents, including Humira. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicemia.
Hospitalization or fatal outcomes associated with infections have been reported. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Treatment with Humira should not be initiated in patients with active infections, including chronic or localized infections, until infections are controlled. In patients who have been exposed to tuberculosis, and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy.
See 7 WARNINGS AND PRECAUTIONS, Infections, Other Opportunistic Infections. As with other TNF-blockers, patients should be monitored closely for infections (including tuberculosis) before, during and after treatment with Humira. Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised January 7, 2026[2]
● Patients with known hypersensitivity to Humira or any of its components. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. ● Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
See
This is not medical advice. Consult a qualified healthcare professional.
Paediatric Uveitis Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
How to take
EUOfficial regulatory label· revised May 7, 2026[3]
Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. 4). Patients treated with Humira should be given the Patient Reminder Card.
After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary. , corticosteroids and/or immunomodulatory agents) should be optimised.
Posology Paediatric population Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Humira is administered every other week via subcutaneous injection. Table 1. Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight Dosing Regimen 10 kg to < 30 kg 20 mg every other week ≥ 30 kg 40 mg every other week Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Continued therapy should be carefully reconsidered in a patient not responding within this time period. There is no relevant use of Humira in patients aged less than 2 years for this indication. Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
Enthesitis-related arthritis 4 The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). Humira is administered every other week via subcutaneous injection. Table 2.
Humira Dose for Patients with Enthesitis-Related Arthritis Patient Weight Dosing Regimen 15 kg to < 30 kg 20 mg every other week ≥ 30 kg 40 mg every other week Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric plaque psoriasis The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Humira is administered via subcutaneous injection. Table 3. Humira Dose for Paediatric Patients with Plaque Psoriasis Patient Weight Dosing Regimen 15 kg to < 30 kg Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose ≥ 30 kg Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed. The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. There is no relevant use of Humira in children aged less than 4 years for this indication.
Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric Crohn's disease The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 4).
Humira is administered via subcutaneous injection. 5 Table 4. Humira Dose for Paediatric Patients with Crohn’s disease Patient Weight Induction Dose Maintenance Dose Starting at Week 4 < 40 kg • 40 mg at week 0 and 20 mg at week 2 In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: • 80 mg at week 0 and 40 mg at week 2 20 mg every other week ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2 In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: • 160 mg at week 0 and 80 mg at week 2 40 mg every other week Patients who experience insufficient response may benefit from an increase in dosage: • < 40 kg: 20 mg every week • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
There is no relevant use of Humira in children aged less than 6 years for this indication. Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric Uveitis The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Humira is administered via subcutaneous injection. In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate. Table 5. Humira Dose for Paediatric Patients with Uveitis Patient Weight Dosing Regimen < 30 kg 20 mg every other week in combination with methotrexate ≥ 30 kg 40 mg every other week in combination with methotrexate When Humira therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
2). 6 There is no relevant use of Humira in children aged less than 2 years in this indication. 1). Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Renal and/or hepatic impairment Humira has not been studied in these patient populations.
No dose recommendations can be made. Method of […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 7, 2026[3]
Summary of the safety profile Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period. 4% for control treated patients. 13 The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Serious adverse reactions have been reported for Humira. TNF-antagonists, such as Humira affect the immune system and their use may affect the body’s defence against infection and cancer. Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of Humira.
Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency seen among the various indications has been included. 8. g. optic neuritis, Guillain-Barré syndrome) 1) Eye disorders Common Visual impairment, conjunctivitis, blepharitis, eye swelling Uncommon Diplopia Ear and labyrinth disorders Common Vertigo Uncommon Deafness, tinnitus 16 System Organ Class Frequency Adverse Reaction Cardiac disorders* Common Tachycardia Uncommon Myocardial infarction1), arrhythmia, congestive heart failure Rare Cardiac arrest Vascular disorders Common Hypertension, flushing, haematoma Uncommon Aortic aneurysm, vascular arterial occlusion, thrombophlebitis Respiratory, thoracic and mediastinal disorders* Common Asthma, dyspnoea, cough Uncommon Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1) Rare Pulmonary fibrosis1) Gastrointestinal disorders Very common Abdominal pain, […]
EUOfficial regulatory label· Warnings and precautions· revised May 7, 2026[3]
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients taking TNF -antagonists are more susceptible to serious infections.
Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.
Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Other opportunistic infections).
Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation. Administration of Humira should be discontinued if a patient develops a new serious infection or sepsis and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Physicians should exercise caution when considering the use of Humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
7 Serious infections Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira.
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported. Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 7, 2026[3]
1. 4). 4).
This is not medical advice. Consult a qualified healthcare professional.
e. disseminated) tuberculosis. Before initiation of therapy with Hyrimoz, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply). It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
3). In all situations described below, the benefit / risk balance of therapy should be very carefully considered. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. If latent tuberculosis is diagnosed, appropriate treatment must be started with anti- tuberculosis prophylaxis treatment before the initiation of Hyrimoz, and in accordance with local recommendations.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hyrimoz in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
, persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hyrimoz. Other opportunistic infections Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes. For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and / or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Hyrimoz should be promptly discontinued.
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections. e. surface antigen positive). Some cases have had a fatal outcome.
Patients should be tested for HBV infection before initiating treatment with Hyrimoz. For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Carriers of HBV who require treatment with Hyrimoz should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several […]
Administration of Humira should be discontinued if a patient develops a serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated. Physicians should exercise caution when considering the use of Humira in patients with a history of recurrent infection or with underlying conditions which may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.
1 Adverse Reaction Overview, Infections. The benefits and risks of treatment with Humira should be carefully considered before initiating therapy. Pediatric Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Humira.
See 7 WARNINGS AND PRECAUTIONS, Malignancies, Malignancies in Pediatric Patients and Young Adults. 1 Dosing Considerations Pediatrics Polyarticular Juvenile Idiopathic Arthritis See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Pediatrics, Polyarticular Juvenile Idiopathic Arthritis.
Safety and effectiveness in pediatric patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg have not been established. Pediatric Crohn’s Disease See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Pediatrics, Pediatric Crohn’s Disease.
The majority (102/192) of pediatric patients with Crohn’s disease studied were 13 to 17 years of age weighing ≥ 40 kg. Adolescent Hidradenitis Suppurativa See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa.
There are no clinical trials with Humira in adolescent patients with hidradenitis suppurativa (HS). The dosage of Humira in these patients has been determined based on pharmacokinetic/pharmacodynamic modeling and simulation. Pediatric Uveitis See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Pediatrics, Pediatric Uveitis.
Safety and effectiveness in pediatric patients with uveitis less than 2 years of age have not been established. Very limited data are available for pediatric patients with uveitis between 2 and < 3 years of age. Pediatric Ulcerative Colitis See 4 DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Ulcerative Colitis.
Safety and effectiveness in pediatric patients with ulcerative colitis less than 5 years of age have not been established. HUMIRA (adalimumab injection) Page 10 of 176 Geriatrics Evidence from clinical studies and experience suggests that use of Humira in the geriatric population is not associated with differences in effectiveness.
No dose adjustment is needed for this population. A brief discussion can be found under 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics. Gender No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight.
Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics. Race No differences in immunoglobulin clearance would be expected among races. From limited data in non- Caucasians, no important kinetic differences were observed for adalimumab.
Dosage adjustment is not required. Hepatic Insufficiency No pharmacokinetic data are available in patients with hepatic impairment. No dose recommendation can be made. Renal Insufficiency No pharmacokinetic data are available in patients with […]
e. disseminated) tuberculosis. Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply). It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
3). In all situations described below, the benefit/risk balance of therapy should be very carefully considered. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Humira and in accordance with local recommendations.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Humira in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Humira.
, persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Humira. Other opportunistic infections Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes. 8 For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Humira should be promptly discontinued.
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections. e. surface antigen positive). Some cases have had a fatal outcome.
Patients should be tested for HBV infection before initiating treatment with Humira. For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. […]