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PRESCRIBING INFORMATION (PI)

HUMIRA (adalimumab) 20 mg and 40 mg solution for injection in pre-filled syringe; 40 mg and 80 mg solution for injection in pre-filled pen.

Refer to Summary of Product Characteristics (SmPC) before prescribing.

PRESENTATIONS: Each single dose 0.2 ml pre-filled syringe contains 20 mg of adalimumab for subcutaneous injection. Each single dose 0.4 ml pre-filled syringe or 0.4 ml pre-filled pen contains 40 mg of adalimumab for subcutaneous injection. Each single dose 0.8 ml pre-filled pen contains 80 mg of adalimumab for subcutaneous injection.

INDICATIONS: Humira in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including MTX has been inadequate and for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. For the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in combination with MTX in patients from the age of 2 years who have had an inadequate response to one or more DMARDs. Can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. For the treatment of active enthesitis-related arthritis (ERA) in patients 6 years and above: with inadequate response to, or intolerance to conventional therapy. For the treatment of severe ankylosing spondylitis (AS) in patients with inadequate response to conventional therapy. For the treatment of severe axial spondyloarthritis without radiographic evidence of AS (nr-AxSPA) in adults with objective signs of inflammation (elevated CRP and/or MRI), and an inadequate response to, or intolerance to nonsteroidal anti-inflammatory drugs. For the treatment of active and progressive psoriatic arthritis (PsA) in adults with inadequate response to DMARDs. For the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. For the treatment of severe chronic plaque psoriasis from 4 years of age with an inadequate response to or are inappropriate candidates for topical and phototherapies. For the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years and above with inadequate response to conventional systemic HS therapy. For the treatment of moderately to severely active Crohn’s Disease (CD) in adults with no response despite a full and adequate course of, intolerance to, or contraindication for, a corticosteroid and/or an immunosuppressant therapy. For the treatment of moderately to severely active Crohn’s Disease (CD) in patients 6 years and over with inadequate response to, intolerance to, or contraindication for conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator. For the treatment of moderately to severely active ulcerative colitis (UC) in adults with inadequate response to, intolerance to, or contraindication for, conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). For the treatment of moderately to severely active UC in paediatric patients (from 6-17 yrs) 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. For the treatment of non-infectious intermediate, posterior, uveitis and panuveitis in adults with inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. For the treatment of chronic non-infectious anterior uveitis in patients 2 years and above with inadequate response to or intolerance to conventional therapy, or in whom conventional therapy is inappropriate.

DOSAGE AND ADMINISTRATION: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of the treatment. Patients should be given a patient reminder card. After proper training in injection technique, patients may self-inject with the treatment if their physician determines that it is appropriate and with medical follow-up as necessary. During treatment, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised. Posology: RA: 40 mg single dose every other week (EOW). Concomitant MTX should be continued. In monotherapy, patients may require 40 mg every week or 80 mg EOW if they experience a decrease in clinical response. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. pJIA: 10 kg to < 30 kg 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. ERA in patients 6 years and above: 15 kg to < 30 kg: 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. PsA, AxSpA, AS: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Plaque Psoriasis: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment beyond 16 weeks should be reconsidered if no clinical response in that time. Beyond 16 weeks, patients with inadequate response to 40 mg EOW may benefit from an increase in dosage to 40 mg every week or 80 mg EOW. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered. Paediatric Plaque Psoriasis: 15 kg to < 30 kg: 20 mg initial dose at week 0, followed by 20 mg EOW from week 1. If > 30 kg 40 mg initial dose at week 0 followed by 40 mg EOW from week 1. HS, adults: 160 mg dose initially at Day 1, followed by 80 mg two weeks later at Day 15. Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg EOW. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. HS, adolescents 12 years and above ≥30 kg: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. If there is inadequate response to 40 mg EOW, an increase in dosing frequency to 40 mg every week or 80 mg EOW may be considered. Treatment beyond 12 weeks should be reconsidered if no improvement in that time. Evaluate periodically the benefit and risk of continued long-term treatment. CD: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW. If decrease in clinical response, can increase dosing frequency to 40 mg every week or 80 mg EOW. Patients with no response by Week 4 may benefit from continued maintenance therapy to Week 12. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Paediatric CD, 6 years and above < 40 kg: Induction: 40 mg dose at Week 0, followed by 20 mg at Week 2. For a more rapid response: 80 mg at Week 0, followed by 40 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 20 mg dose EOW. If insufficient response, consider an increase in dosing frequency to 20 mg every week. If ≥ 40 kg: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg dose at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW. If insufficient response, consider an increase in dosing frequency to 40 mg every week or 80 mg EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. UC: Induction: 160 mg dose at Week 0, followed by 80 mg at Week 2. Maintenance: 40 mg dose EOW. If insufficient response, consider an increase in dosing frequency to 40 mg every week or 80 mg EOW. Treatment beyond 8 weeks should be reconsidered if no clinical response in that time. Paediatric UC from 6-17 years: Induction: < 40 kg, 80 mg at Week 0 and 40 mg at Week 2. Maintenance 40 mg EOW. Induction ≥ 40 kg, 160 mg at Week 0 and 80 mg at Week 2. Maintenance 80 mg EOW. Paediatric patients who reach 18 yrs should continue on prescribed maintenance dose. Continued therapy beyond 8 weeks should be reconsidered in patients not showing signs of response. Uveitis: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Paediatric uveitis, 2 years and above: Dosage: < 30 kg: 20 mg dose EOW in combination with MTX. Optional 40 mg loading dose one week prior to start of maintenance therapy. No clinical data in use of loading dose < 6 years of age. If ≥ 30 kg: 40 mg dose EOW in combination with MTX. Optional 80 mg loading dose one week prior to start of maintenance therapy. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Special Populations: Elderly: No dose adjustment is required. Renal and/or hepatic impairment: Humira has not been studied in these patient populations. No dose recommendations can be made.

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any excipients; Active tuberculosis (TB) or other severe infections such as sepsis and opportunistic infections; Moderate to severe heart failure (NYHA class III/IV).

SPECIAL WARNINGS AND PRECAUTIONS: Infections: Patients taking TNF-antagonists are more susceptible to serious infections, especially if lung function is impaired. Monitor for infections, including TB, before, during and for 4 months after treatment. Do not initiate treatment during an active infection, until infection is controlled. Consider risk/benefit prior to treatment in patients exposed to TB or who have travelled in areas of high risk of TB or endemic mycoses. Evaluate new infections during treatment and monitor closely. Stop treatment if new serious infection or sepsis and treat appropriately. Exercise caution in patients with a history of recurring infections or who are predisposed to infections, including the use of concomitant immunosuppressive medications. Serious infections: Serious infections, including those associated with hospitalisation or death, were reported in patients receiving treatment. TB: Reactivation and new onset TB, both pulmonary and extra-pulmonary (disseminated), were reported. Screen all patients before therapy initiation for active or inactive (latent) TB. Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients. If latent TB is suspected, consult physician with appropriate expertise and follow local treatment recommendations for prophylaxis prior to initiation of treatment. Despite prophylaxis, TB reactivation has occurred on Humira. If active TB is diagnosed, do not initiate treatment. Other opportunistic infections: Opportunistic infections were observed in patients receiving Humira. Stop treatment in patients with signs and symptoms of such infections. Consult with physician with appropriate expertise for diagnosis and administration of empiric antifungal therapy in these patients. Hepatitis B reactivation: Reactivation of HBV has occurred in chronic carriers (surface antigen positive). Patients should be tested for HBV infection before initiating treatment. HBV carriers should consult a specialist physician and be closely monitored for reactivation of HBV infection throughout therapy and for several months following termination of treatment. If reactivation occurs, stop treatment and initiate appropriate anti-viral and supportive treatment. Neurological events: Caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. Discontinuation of treatment should be considered if any of these disorders develop. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to initiation of treatment and regularly during treatment, to assess for pre-existing or developing central demyelinating disorders. Allergic reactions: Reports of serious allergic reactions including anaphylaxis received. For serious allergic or anaphylactic reaction, stop treatment immediately and initiate appropriate therapy. Immunosuppresion: In a study of 64 patients with rheumatoid arthritis that 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-, B-, NK-cells, monocyte/macrophages, and neutrophils. Malignancies and lymphoproliferative disorders: A possible risk has been reported of malignancy, including lymphomas and leukaemia, in all patients, including paediatric patients, treated with Tumour Necrosis Factor (TNF) antagonists. Examine all patients, especially those with a medical history of extensive immunosuppressant or PUVA treatment, for non-melanoma skin cancer prior to and during treatment; caution in COPD patients, and in patients with increased risk for malignancy due to heavy smoking. Consider the potential risk with the combination of AZA or 6-MP and Humira (hepatosplenic T-cell lymphoma has occurred). Risk of hepatosplenic T-cell lymphoma cannot be excluded. Caution in patients with a history of malignancy. Risk of developing dysplasia or colon cancer is unknown. Patients with UC, history of dysplasia or colon carcinoma, to be screened for dysplasia before and during treatment. Haematologic reactions: Adverse events of the haematologic system were reported. Patients should seek immediate medical attention if signs and symptoms of blood dyscrasias develop while on treatment. Vaccinations: Patients may receive concurrent vaccinations, except for live vaccines. Bring paediatric patients up to date with all immunisations prior to initiating treatment. Congestive heart failure: See contraindications. Caution is advised with mild heart failure (NYHA class I/II). Discontinue treatment if new or worsening symptoms of congestive heart failure. Autoimmune processes: Autoimmune antibodies may form and treatment should be stopped if development of a lupus-like syndrome with positive antibodies against double-stranded DNA. Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. Small bowel obstruction: Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment. Available data suggest that Humira does not worsen or cause strictures. Surgery: Consider the long half-life of Humira for planned surgical procedures. Monitor closely for infections. Elderly patients: Serious infections were higher in patients over 65 years of age, some of which had a fatal outcome. Consider risk of infections in these patients.

INTERACTIONS: Antibody formation was lower when given together with MTX in comparison with use as monotherapy. Combination of Humira with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF-antagonists is not recommended.

FERTILITY, PREGNANCY AND LACTATION: Women of childbearing potential: Should consider the use of adequate contraception and continue its use for at least 5 months after the last treatment. Pregnancy: Humira should only be used during pregnancy if clearly needed. No administration of live vaccines (e.g., BCG) to infants exposed to Humira in utero for 5 months following mother’s last Humira treatment during pregnancy. Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn. Breast-feeding: Humira can be used during breast-feeding. Fertility: Preclinical data on fertility effects of adalimumab are not available.

ABILITY TO DRIVE AND USE MACHINES: May have a minor influence on the ability to drive and use machines. Vertigo and visual impairment may occur following administration of Humira.

UNDESIRABLE EFFECTS:

See SmPC for full list of adverse events. Undesirable effects are presented in order of decreasing seriousness in each section.

Very common ≥ 1/10 including serious: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), leukopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, elevated liver enzymes, rash (including exfoliative rash), musculoskeletal pain, injection site reaction (including injection site erythema).

Common ≥ 1/100 to < 1/10 including serious: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections, skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm, leucocytosis, thrombocytopenia, hypersensitivity, allergies (including seasonal allergy), hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration, mood alterations (including depression), anxiety, insomnia, paraesthesias (including hypoesthesia), migraine, nerve root compression, visual impairment, conjunctivitis, blepharitis, eye swelling, vertigo, tachycardia, hypertension, flushing, haematoma, asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome, worsening or new onset of psoriasis (including palmoplantar pustular psoriasis), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia, pruritus, muscle spasms (including blood creatine phosphokinase increased), renal impairment, haematuria, chest pain, oedema, pyrexia, coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased, impaired healing.

Serious also include: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis, pneumonia, pyelonephritis, septic arthritis and septicaemia. Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis. Lymphoma solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma, Idiopathic thrombocytopenic purpura, sarcoidosis, vasculitis, cerebrovascular accident, tremor, neuropathy, diplopia, deafness, tinnitus, myocardial infarction, arrhythmia, congestive heart failure, aortic aneurysm, vascular arterial occlusion, thrombophlebitis, pulmonary embolism, interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion ,pancreatitis, dysphagia, face oedema, cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased, night sweats, scar, rhabdomyolysis, systemic lupus erythematosus, nocturia, erectile dysfunction and inflammation.

MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/NHS LIST PRICE:

20 mg (for 2 pre-filled syringes) Great Britain (GB) PLGB 41042/0024, Northern Ireland (NI) EU/1/03/256/022: £352.14, 40 mg (for 2 pre-filled pens) GB PLGB 41042/0025 NI EU/1/03/256/017:£704.28, 40 mg (for 2 pre-filled syringes) GB PLGB 41042/0095, NI EU/1/03/256/013, £704.28, 80 mg (for 1 pre-filled pen) GB PLGB 41042/0026, NI EU/1/03/256/021: £704.28

LEGAL CLASSIFICATION: POM

MA HOLDER: Further information available from Abbvie Ltd, Maidenhead, SL6 4UB.

DATE OF REVISION: May 2024

DOCUMENT NUMBER: HUMI-UK-00003-C/HUMIRA-PI 048

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on [email protected]

 

 

UK-RISN-240351. Date of preparation: June 2024.