Adalimumab

Indications

Adalimumab is used for: Rheumatoid arthritis, Ankylosing spondylitis; Psoriatic arthritis, Crohn's disease; Ulcerative colitis, Plaque psoriasis, Juvenile Rheumatoid Arthritis

Adult Dose

Subcutaneous Rheumatoid arthritis, Ankylosing spondylitis; Psoriatic arthritis Adult: 40 mg as a single dose every other wk. 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. Plaque psoriasis Adult: Initially, 80 mg. Maintenance: 40 mg every other wk beginning 1 wk after 1st dose.

Child Dose

Subcutaneous Juvenile Rheumatoid Arthritis Reduction of signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis <2 years or <10 kg: Safety and efficacy not established >2 years 10 kg to <15 kg: 10 mg SC q2wk 15 kg to <30 kg: 20 mg SC q2wk >30 kg: 40 mg SC q2wk Crohn Disease >6 years (17 kg to <40 kg) Induction: 80 mg SC on Day 1 (administer as two 40 mg injections in one day); THEN 2 weeks later (Day 15) give 40 mg Maintenance (beginning Week 4 [Day 29]): 20 mg SC q2wk >6 years (>40 kg) Induction: 160 mg SC on Day 1 (administer as four 40 mg injections in one day or as two 40 mg injection per day for two consecutive days); THEN 2 weeks later (Day 15) give 80 mg (as two 40 mg injections in one day) Maintenance (beginning Week 4 [Day 29]):40 mg SC q2wk

Renal Dose

Administration

Instruct patients using the pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided Injections should occur at separate sites in the thigh or abdomen; rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard

Contra Indications

None listed on FDA-approved label.

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. 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. Lactation: Limited data from published literature indicate that adalimumab is present in low levels in human milk and is not likely to be absorbed by a breastfed infant

Pregnancy-Lactation

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.

Adverse Effects

Side effects of Adalimumab : >10% Injection site pain (12-20%),Upper respiratory tract infection (URTI) (17%),Increased creatine phosphokinase (15%),Headache (12%),Rash (12%),Sinusitis (11%) 1-10% Nausea (9%),Urinary tract infection (UTI) (8%),Abdominal pain (7%),Flulike syndrome (7%),Hyperlipidemia (7%),Back pain (6%),Hypercholesterolemia (6%),Hematuria (5%),Hypertension (5%),Increased alkaline phosphatase (5%) <1% Allergic reactions,Hematologic disorder (leukopenia, thrombocytopenia, pancytopenia, aplastic anemia) 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.

Mechanism of Action

Adalimumab is a recombinant DNA-derived human Ig G1 monoclonal antibody. It binds to human tumour necrosis factor alfa (TNF-alpha), thus interfering w/ cytokine-driven inflammatory processes.