Adalimumab slowly absorbed and distributed, and reaches its maximum serum concentration after approximately 5 days. The absolute bioavailability of adalimumab with a single subcutaneous injection of 40 mg of 64%. The distribution and excretion : The distribution with a single intravenous injection is from 4.7 to 6.0 liter, indicating that the adalimumab substantially uniform distribution in the blood and extravascular fluids. Adalimumab is displayed slowly , a clearance is typically less than 12 ml / h. Testosterone gel is an average of two weeks and ranged from 10 to 20 days. The clearance , and do not change significantly when administered dose of 0.25-10 mg / kg, and the half-life is similar to the case of intravenous and subcutaneous administration of the drug. Adalimumab concentration in synovial fluid of rheumatoid arthritis patients is from 31 to 96% of the serum.
Pharmacokinetics adalimumab at steady state
equilibrium concentrations after subcutaneous application adalimumab 40mg once every two weeks in patients with rheumatoid arthritis at the end of the dosing interval are about 5 mg / ml (without the simultaneous methotrexate) and 8.9 ug / ml (compared to simultaneous use of methotrexate). With increasing doses of adalimumab in a range of 20, 40 and 80 mg once every two weeks and once per week subcutaneously observed almost linear increase in serum adalimumab concentrations in testosterone gel the end of the dosing interval. With prolonged use (over 2 years) adalimumab clearance does not change.
In the appointment of 40 mg adalimumab monotherapy once in 2 weeks average equilibrium minimum concentration of the drug in patients with psoriasis was 5 ug / ml.
There was a trend to increased clearance of adalimumab depending on the weight the body and the presence of antibodies to adalimumab.
for patients with Crohn’s disease, with a starting dose of 160 mg Humira at 0 week and followed by a dose of 80 mg for 2 weeks, adalimumab reaches its maximum serum concentration (approximately 12 ug / ml) for 2 th and 4 th week. In patients with Crohn’s disease equilibrium concentration observed (approximately 7 mg / ml) in the 24th and 56th weeks of maintenance therapy with 40 mg of adalimumab every 2 weeks.
Special populations Elderly Age has minimal effect on the clearance of adalimumab. Gender , testosterone gel race differences pharmacokinetic parameters (adjusted for body weight) in patients of different sex and race were found. hepatic and renal failure. Data on the pharmacokinetics of adalimumab in patients with impaired hepatic or renal function there.
- Moderate to severe active rheumatoid arthritis (as monotherapy or in combination with methotrexate or other disease modifying anti);
- Active psoriatic arthritis (as monotherapy or in combination with methotrexate or other disease modifying anti);
- The active ankylosing spondylitis;
- Crohn’s disease (moderate to severe) with an inadequate response to conventional therapy or ineffective (or decrease efficiency) of infliximab;
- Chronic plaque psoriasis (moderate and severe) as shown systemic therapy or phototherapy, and when other systemic therapy options are not optimal.
- Juvenile idiopathic arthritis in patients from 13 to 17 years as monotherapy or in combination with methotrexate.
- Hypersensitivity to adalimumab or any of its auxiliary components
- Children under the age of 18 years, except for patients 13 to 17 years with juvenile idiopathic arthritis.
- Infectious diseases, including tuberculosis
- Chronic heart failure III-IV functional class testosterone gel.
- Joint reception with drugs anakinra and abatacept.