Adalimumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Crohn's disease
Adult: For moderately to severely active cases in patients who had an inadequate response to conventional therapy, or lost response to or are intolerant to infliximab: Induction: 80 mg, followed by 40 mg after 2 weeks. Alternatively, 160 mg on Day 1 (given as four 40 mg inj in 1 day, or as two 40 mg inj daily for 2 consecutive days), followed by 80 mg 2 weeks later on Day 15 (given as two 40 mg inj in 1 day). Maintenance: 40 mg every other week starting Day 29. If necessary, may increase dose to 40 mg weekly or 80 mg every other week according to individual response. Review therapy if there is no response within 12 weeks.
Child: For moderately to severely active cases in patients who had an inadequate response to conventional therapy including primary nutrition treatment, a corticosteroid and/or an immunomodulator, or are intolerant to or have contraindications for such treatments: ≥6 years weighing <40 kg: Induction: 40 mg on Day 1, then 20 mg 2 weeks later on Day 15. If a more rapid response is needed (with higher risk of adverse effects), may administer 80 mg on Day 1, then 40 mg 2 weeks later on Day 15. Maintenance: 20 mg every other week starting Day 29. In patients with insufficient response, dose may be increased to 20 mg weekly; ≥40 kg: Induction: 80 mg on Day 1, then 40 mg 2 weeks later on Day 15. If a more rapid response is needed (with higher risk of adverse effects), may administer 160 mg on Day 1 (given as 160 mg in 1 day, or as 80 mg daily for 2 consecutive days), then 80 mg 2 weeks later on Day 15. Maintenance: 40 mg every other week starting Day 29. In patients with insufficient response, dose may be increased to 40 mg weekly, or 80 mg every other week. Review therapy if there is no response within 12 weeks. Dosage recommendations may vary among individual products or between countries (refer to detailed product guidelines).

Subcutaneous
Ulcerative colitis
Adult: For moderately to severely active cases in patients who had an inadequate response to conventional treatment including corticosteroids and 6-mercaptopurine or azathioprine, or are intolerant to or have contraindications for such therapies: Induction: 160 mg on Day 1 (given as four 40 mg inj in 1 day, or as two 40 mg inj daily for 2 consecutive days), then 80 mg 2 weeks later on Day 15 (given as two 40 mg inj in 1 day). Maintenance: 40 mg every other week starting Day 29. If necessary, may increase dose to 40 mg weekly or 80 mg every other week according to individual response. Review therapy if there is no response within 8 weeks.
Child: For moderately to severely active cases in patients who had an inadequate response to conventional treatment including corticosteroids and 6-mercaptopurine or azathioprine, or are intolerant to or have contraindications for such therapies: ≥6 years weighing <40 kg: Induction: 80 mg on Day 1 (given as two 40 mg inj in 1 day), then 40 mg 2 weeks later on Day 15. Maintenance: 40 mg every other week or 20 mg weekly starting Day 29; ≥40 kg: 160 mg on Day 1 (given as four 40 mg inj in 1 day, or two 40 mg inj daily for 2 consecutive days), then 80 mg 2 weeks later on Day 15 (given as two 40 mg inj in 1 day). Maintenance: 80 mg every other week or 40 mg weekly starting Day 29. Review therapy if there is no response within 8 weeks. Dosage recommendations may vary among individual products or between countries (refer to detailed product guidelines).

Subcutaneous
Non-radiographic axial spondyloarthritis
Adult: For severe cases but with objective signs of inflammation by elevated CRP and/or MRI in patients who had an inadequate response to or are intolerant to NSAIDs: 40 mg every other week as a single dose. Review therapy if there is no response within 12 weeks.

Subcutaneous
Ankylosing spondylitis
Adult: For active cases in patients who had an inadequate response to conventional therapy: 40 mg every other week as a single dose. Review therapy if there is no response within 12 weeks. Treatment guidelines may vary among individual products or between countries (refer to specific product recommendations).

Subcutaneous
Rheumatoid arthritis
Adult: For moderately to severely active cases in patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs): As monotherapy or in combination with methotrexate or other DMARDs: 40 mg every other week as a single dose. When used as monotherapy, may increase dose to 40 mg weekly, or 80 mg every other week. Review therapy if there is no response within 12 weeks. Treatment guidelines may vary among individual products or between countries (refer to specific product recommendations).

Subcutaneous
Psoriatic arthritis
Adult: As monotherapy or in combination with DMARDs in patients with an inadequate response to previous DMARD treatment: 40 mg every other week as a single dose. Review therapy if there is no response within 12 weeks.

Subcutaneous
Enthesitis-related arthritis
Child: For active cases in patients who had an inadequate response to or are intolerant to conventional therapy: ≥6 years weighing 15 to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week. Doses are given via SC inj.

Subcutaneous
Polyarticular juvenile idiopathic arthritis
Child: As monotherapy or in combination with methotrexate in patients who had an inadequate response to 1 or more DMARDs: ≥2 years weighing 10 to <30 kg: 20 mg every other week; ≥30 kg: 40 mg every other week. Doses are given via SC inj. Review therapy if there is no response within 12 weeks. Dosage recommendations may vary among individual products or between countries (refer to detailed product guidelines).

Subcutaneous
Chronic non-infectious anterior uveitis
Child: In combination with methotrexate in patients who had an inadequate response to or are intolerant to conventional treatment, or in whom conventional therapy is inappropriate: ≥2 years weighing <30 kg: Initially, 40 mg loading dose given 1 week before maintenance therapy starts. Maintenance: 20 mg every other week; ≥30 kg: Initially, 80 mg loading dose given 1 week before maintenance therapy starts. Maintenance: 40 mg every other week. Doses are given via SC inj.

Subcutaneous
Plaque psoriasis
Adult: For moderate to severe chronic cases in patients who are candidates for systemic therapy or phototherapy, or when other systemic therapies are less appropriate: Initially, 80 mg as a single dose, followed by 40 mg every other week starting 1 week after the initial dose. Review therapy if there is no response within 16 weeks. If response is inadequate beyond 16 weeks, may increase dose to 40 mg weekly or 80 mg every other week. Once adequate response is achieved, subsequently reduce dose to 40 mg every other week.
Child: For severe chronic cases in patients who had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy: ≥4 years weighing 15 to <30 kg: Initially, 20 mg, followed by 20 mg every other week beginning 1 week after the initial dose; ≥30 kg: Initially, 40 mg, followed by 40 mg every other week starting 1 week after the initial dose. Review therapy if there is no response within 16 weeks.

Subcutaneous
Hidradenitis suppurativa
Adult: For moderate to severe active cases in patients with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy: Initially, 160 mg at Day 1 (given as four 40 mg inj in 1 day, or as two 40 mg inj daily for 2 consecutive days), followed by 80 mg 2 weeks later at Day 15 (given as two 40-mg inj in 1 day). Maintenance: 40 mg weekly, or 80 mg every other week (given as two 40-mg inj in 1 day) starting Day 29. Review therapy if there is no response within 12 weeks.
Child: For moderate to severe active cases in patients with an inadequate response to conventional systemic HS therapy: ≥12 years weighing ≥30 kg: Initially, 80 mg at Day 1. Maintenance: 40 mg every other week starting Day 8. In patients with inadequate response, may increase the maintenance dose to 40 mg weekly, or 80 mg every other week. Review therapy if there is no response within 12 weeks.

Subcutaneous
Non-infectious intermediate uveitis, Noninfectious panuveitis, Non-infectious posterior uveitis
Adult: In patients who had an inadequate response to corticosteroids, those in need of corticosteroid-sparing, or in whom corticosteroid therapy is inappropriate: Initially, 80 mg as a single dose, followed by 40 mg every other week starting 1 week after the initial dose. Some guidelines recommend initiating treatment in combination with corticosteroids and/or other non-biologic immunomodulatory agents. Evaluate patients yearly to determine if continued long-term treatment is necessary.
Contraindications
Active infection including localised infections, active TB, and severe infections (e.g. sepsis, opportunistic infections); moderate to severe heart failure (NYHA class III/IV). Concurrent administration of live vaccines.
Special Precautions
Patient with history of opportunistic infections, chronic or recurrent infection, underlying conditions predisposing to infection (e.g. advanced or poorly controlled diabetes); pre-existing or recent-onset central or peripheral nervous system demyelinating disorders, COPD, mild heart failure (NYHA class I/II) or decreased left ventricular function; history or known malignancy (other than successfully treated non-melanoma skin cancer), history of significant haematologic abnormalities. HIV-positive patients and HBV carriers. Patients exposed to TB and those who resided in or travelled to areas with endemic TB or mycoses. Patients undergoing surgery and heavy smokers. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: New-onset or worsening of heart failure; antibody formation. Rarely, anaphylaxis or other serious hypersensitivity reactions, autoimmune disorders (e.g. lupus-like syndrome), new-onset or exacerbation of demyelinating disease (e.g. optic neuritis, multiple sclerosis, peripheral demyelinating disease, including Guillain-Barre syndrome); haematologic disorders (e.g. pancytopenia, aplastic anaemia).
Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, leucocytosis, neutropenia, agranulocytosis, coagulation and bleeding disorders.
Cardiac disorders: Tachycardia, chest pain.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Conjunctivitis, blepharitis, eye inflammation, visual impairment.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, dyspepsia, GERD.
General disorders and administration site conditions: Inj site reactions (e.g. pain, pruritus, swelling, bleeding), flu-like symptoms, oedema, pyrexia, impaired healing.
Infections and infestations: Herpes simplex or zoster infection.
Investigations: Positive ANA titre; increased creatine phosphokinase, uric acid, blood lactate dehydrogenase, and liver enzymes.
Metabolism and nutrition disorders: Hypercholesterolaemia, hyperlipidaemia, dehydration, hypokalaemia, hypocalcaemia, hyperglycaemia, hypophosphataemia.
Musculoskeletal and connective tissue disorders: Back or musculoskeletal pain, muscle spasm.
Neoplasms benign, malignant and unspecified: Benign neoplasm.
Nervous system disorders: Headache, paraesthesia, migraine.
Psychiatric disorders: Insomnia, anxiety, mood alteration, depression.
Renal and urinary disorders: Haematuria, renal impairment, UTI.
Respiratory, thoracic and mediastinal disorders: Sinusitis, upper and lower respiratory tract infection, pharyngitis, nasopharyngitis, asthma, dyspnoea, cough.
Skin and subcutaneous tissue disorders: Skin rash, alopecia, pruritus, onychoclasis, hyperhidrosis, urticaria, new-onset or worsening of psoriasis.
Vascular disorders: Hypertension, flushing, haematoma.
Potentially Fatal: Serious infections such as active TB (including reactivation of latent TB), invasive fungal infections (e.g. aspergillosis, blastomycosis, histoplasmosis, candidiasis, coccidioidomycosis, pneumocystosis), and bacterial, viral or other opportunistic infections (including listeriosis and legionellosis); leukaemia, lymphomas (e.g. hepatosplenic T-cell lymphoma) and other malignancies. Rarely, hepatitis B virus (HBV) reactivation.
Patient Counseling Information
This drug may cause vertigo and visual impairment, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform active and latent TB screening prior to initiation and during therapy. Evaluate for HBV infection prior to initiation of therapy. Examine for the presence of non-melanoma skin cancer, particularly for patients with history of extensive immunosuppressant treatment or psoriasis patients with history of psoralen and ultraviolet A (PUVA) radiation therapy. Obtain CBC with differential and complete metabolic panel at baseline. Closely monitor for signs and symptoms of infection, TB (including patients who tested negative for latent TB before therapy initiation), HBV infection (in HBV carriers), blood dyscrasias, hypersensitivity reactions, lupus-like syndrome, or malignancies during and after treatment.
Drug Interactions
May reduce the serum concentrations of warfarin, theophylline and ciclosporin.
Potentially Fatal: May increase the risk of vaccine-associated infections with live vaccines. Increased risk of serious infections with other biologic DMARDs (e.g. anakinra, abatacept, rituximab) and other TNF-α antagonists or immunosuppressants (e.g. corticosteroids, methotrexate).
Action
Description: Adalimumab is a recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibody. It specifically binds to human tumour necrosis factor-α (TNF-α) and then blocks its interaction with p55 and p75 cell surface TNF receptors, thus interfering with cytokine-driven inflammatory processes.
Pharmacokinetics:
Absorption: Slowly absorbed following SC administration. Absolute bioavailability: 64%. Time to peak plasma concentration: Approx 3-8 days.
Distribution: Crosses the placenta and enters breast milk. Concentrated in the synovial fluid (31-96% of serum). Volume of distribution: 4.7-6 L.
Excretion: Terminal elimination half-life: Approx 2 weeks (range: 10-20 days).
Storage
Store between 2-8°C. Do not freeze. Protect from light. If necessary (e.g. when travelling), a pre-filled syringe or pre-filled pen may be stored up to 25°C for up to 14 days. Protect from light. Discard if not used within 14 days.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
AbbVie Limited. Humira Solution for Injection data sheet 21 February 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 16/05/2022.

Anon. Adalimumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 16/05/2022.

Anon. Adalimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/03/2022.

Buckingham R (ed). Adalimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/05/2022.

Humira 20 mg Solution for Injection in Pre-filled Syringe (AbbVie Ltd). MHRA. https://products.mhra.gov.uk. Accessed 08/03/2022.

Humira 40 mg Solution for Injection in Pre-filled Syringe and Pre-filled Pen (AbbVie Ltd). MHRA. https://products.mhra.gov.uk. Accessed 08/03/2022.

Humira Injection, Solution (Abbvie Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 16/05/2022.

Humira Solution for Injection in Pre-filled Pen 40 mg/0.4 mL (AbbVie Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 16/05/2022.

Joint Formulary Committee. Adalimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/05/2022.

Disclaimer: This information is independently developed by MIMS based on Adalimumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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