Adalimab 40

Rheumatoid arthritis, Ankylosing spondylitis; Psoriatic arthritis, Crohn's disease; Ulcerative colitis, Plaque psoriasis, Juvenile Rheumatoid Arthritis

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

Subcutaneous Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis Adult: 40 mg as a single dose every other wk. May increase to wkly dosing when used as monotherapy. 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.

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

None listed on FDA-approved label.

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.

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

>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.

Pregnancy Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/Mother-To-Baby HUMIRA Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn disease (CD) Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease matched comparison cohort The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant Clinical consideration Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity Adverse pregnancy outcomes include preterm delivery (ie, <37 weeks gestation), low birth weight (ie, <2500 g) infants, and small for gestational age at birth Fetal/neonatal adverse reaction Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab in utero owing to possible effect on infant immune system Lactation Limited data from case reports in published literature describe presence of adalimumab in human milk at infant doses of 0.1-1% of maternal serum level; there are no reports of adverse effects of adalimumab on breastfed infant and no effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

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.