Adalimumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Hong Kong prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Monitoring Parameters

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.

MIMS Class

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

References

Anon. Adalimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/09/2014.

Buckingham R (ed). Adalimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/09/2014.

Humira Injection, Solution (Abbvie Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 30/09/2014.

Humira Injection. U.S. FDA. https://www.fda.gov/. Accessed 30/09/2014.

Joint Formulary Committee. Adalimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/09/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Adalimumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 30/09/2014.

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