Adalimumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Rheumatoid arthritis 40 mg as a single dose every other wk. May increase to wkly dosing when used as monotherapy. Ankylosing spondylitis; Psoriatic arthritis 40 mg as a single dose every other wk. Plaque psoriasis Initial: 80 mg. Maintenance: 40 mg every other wk beginning 1 wk after 1st dose. Crohn’s disease; Ulcerative colitis Moderate to severe active disease: Initial: 160 mg (given as four 40-mg inj in 1 day or as two 40-mg inj for 2 consecutive days), then 80 mg 2 wk after the initial dose. Maintenance: 40 mg every other wk, may increase to 40 mg wkly if needed. Review treatment if no response w/in 8 or 12 wk of therapy.
Dosage Details
Subcutaneous
Rheumatoid arthritis
Adult: 40 mg as a single dose every other wk. May increase to wkly dosing when used as monotherapy.

Subcutaneous
Ankylosing spondylitis, Psoriatic arthritis
Adult: 40 mg as a single dose every other wk.

Subcutaneous
Plaque psoriasis
Adult: Initially, 80 mg. Maintenance: 40 mg every other wk beginning 1 wk after 1st dose.

Subcutaneous
Juvenile idiopathic arthritis
Child: ≥4 yr 15 to <30 kg: 20 mg every other wk; ≥30 kg: 40 mg every other wk.

Subcutaneous
Crohn's disease, Ulcerative colitis
Adult: Moderate to severe active disease: Initially, 160 mg (given as four 40-mg inj in 1 day or as two 40-mg inj for 2 consecutive days), then 80 mg 2 wk after the initial dose (day 15). Maintenance: After 2 wk (day 29), 40 mg every other wk, may increase to 40 mg wkly if needed. Review treatment if no response w/in 8 (ulcerative colitis) or 12 (Crohn’s disease) wk of therapy.
Special Precautions
Patient w/ pre-existing or recent onset central or peripheral nervous system demyelinating disorders, heart failure or decreased left ventricular function; at risk of hepatitis B virus (HBV) infection. Reactivation and new onset of TB infection. Patient who travelled to or resided in regions where TB is endemic. Elderly. Pregnancy and lactation.
Adverse Reactions
Upper resp tract infection, pulmonary and extrapulmonary (e.g. disseminated) TB, nasopharyngitis, sinusitis, headache, pyrexia, musculoskeletal pain, CVA, pulmonary embolism, DVT, alopecia, inj site reactions (itching, erythema, haemorrhage, pain or swelling), hepatobiliary disorders, liver failure, sarcoidosis, Merkel cell carcinoma, new or worsening psoriasis (all sub-types e.g. pustular and palmoplantar). Rarely, pancytopenia, aplastic anaemia, central and peripheral demyelinating events, lupus and related conditions, Stevens-Johnson syndrome.
Potentially Fatal: Sepsis, opportunistic infections, TB, HBV reactivation, other malignancies (e.g. leukaemia, lymphoma, hepatosplenic T-cell lymphoma), haematological, neurological and autoimmune reactions, anaphylaxis, angioneurotic oedema.
MonitoringParameters
Perform tuberculin skin test and HBV screening prior to treatment. Monitor for signs and symptoms of infection prior to, during and following treatment.
Drug Interactions
Increased risk of serious infections w/ other biologic disease-modifying antirheumatic drugs (e.g. abatacept, anakinra), rituximab. May increase immunosuppressant effect w/ tocilizumab, live vaccines.
Action
Description: Adalimumab is a recombinant DNA-derived human Ig G1 monoclonal antibody. It binds to human tumour necrosis factor alfa (TNF-α), thus interfering w/ cytokine-driven inflammatory processes.
Pharmacokinetics:
Absorption: Bioavailability: 64%. Time to peak plasma concentration: Approx 3-8 days.
Distribution: It crosses the placenta; enters breast milk. Volume of distribution: 4.7-6 L.
Excretion: Mean terminal half-life: Approx 2 wk.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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