Adalimumab Dosage

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Usual Adult Dose for Ankylosing Spondylitis

40 mg subcutaneously every other week

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Rheumatoid Arthritis

40 mg subcutaneously every other week

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Psoriatic Arthritis

40 mg subcutaneously every other week

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Crohn's Disease - Acute

Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Crohn's Disease - Maintenance

Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Ulcerative Colitis

Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.

The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Plaque Psoriasis

Initial dose: 80 mg subcutaneously.
Maintenance dose: 40 mg subcutaneously every other week, starting one week after initial dose.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

4 to 17 years:

Limited data are available for adalimumab treatment in pediatric patients with a weight below 15 kg.

15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week

Greater than or equal to 30 kg (66 lbs): 40 mg every other week

Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment with adalimumab.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

In the controlled portions of clinical trials of all the TNF-blocking agents, more cases of lymphoma have been observed among patients receiving TNF blockers compared to control patients. In the controlled portions of clinical trials of some TNF-blocking agents, including adalimumab, more cases of malignancies have been observed among patients receiving TNF blockers compared to controls. During the controlled portions of adalimumab trials in patients with moderately to severely active rheumatoid arthritis, two lymphomas were observed among 1380 adalimumab treated patients versus zero among 690 control patients (mean duration of controlled treatment approximately 7 months). In the controlled and open-label portions of these clinical trials of adalimumab in rheumatoid arthritis patients, ten lymphomas were observed in 2468 patients over 4870 patient-years of therapy. During the controlled portions of adalimumab trials in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and plaque psoriasis, malignancies, other than lymphoma and non-melanoma (basal cell and squamous cell) skin cancer, were observed at a rate of 0.6/100 patient-years among adalimumab-treated patients versus a rate of 0.4 /100 patient-years among control patients (median duration of treatment of 5.5 months for adalimumab-treated patients and 3.9 months for control-treated patients). The rate of non-melanoma (basal cell and squamous cell) skin cancers was 0.9/100 patient-years among adalimumab-treated patients and 0.3/100 patient-years among control patients. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma and the role of TNF blockers in the development of malignancy is unknown.

On May 3, 2008, the FDA issued an early communication about an ongoing safety review to inform healthcare professionals that the agency is investigating a possible link between the use of TNF blockers and the development of lymphoma and other cancers in children and young adults. Reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immunosuppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Until the review is completed, prescribers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

In postmarketing experience, anaphylaxis has been reported rarely following adalimumab administration. In clinical trials of adalimumab, allergic reactions overall (including allergic rash, anaphylactoid reaction, fixed drug reaction, nonspecific drug reaction, urticaria) have been observed in approximately 1% of patients. Adalimumab should be discontinued immediately and appropriate measures initiated if an anaphylactic reaction or other serious allergic reaction occurs.

Rare reports of pancytopenia including aplastic anemia have been reported with TNF alpha-blocking agents. Adverse events of the hematologic system, including medically significant cytopenias (such as thrombocytopenia, leukopenia) have been infrequently reported with adalimumab.

Adalimumab has been associated with serious infections, sepsis, and fatalities, many of which occurred in patients on concomitant immunosuppressive therapy. Immunosuppressive therapy and rheumatoid arthritis may predispose patients to infections, tuberculosis, and invasive opportunistic fungal infections.

Therapy should not be initiated in patients with active infections, including chronic or localized infections. Patients who develop infections during therapy should be monitored closely and adalimumab should be discontinued if a serious infection develops. Caution is recommended in patients with a history of recurrent infections, other conditions which may predispose to infections, or patients who have lived in regions with endemic tuberculosis and histoplasmosis.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including adalimumab. Clinical studies of another TNF blocker, a higher rate of serious CHF-related adverse events was observed. Caution should be exercised when using adalimumab in patients who have heart failure and these patients should be closely monitored.

Adalimumab has been associated with signs and symptoms suggestive of demyelinating disease. Caution is recommended in patients with preexisting or recent onset CNS demyelinating disorders.

The first injection should be performed under medical supervision. Patients or caregivers should be instructed in proper injection techniques, and syringe and needle disposal.

Tuberculosis has been reported. The incidence of tuberculosis reactivation was higher with larger than recommended doses. A tuberculin tine test should be administered before initiation of therapy and patients should be advised to seek medical attention if they experience signs or symptoms of a tuberculosis infection (e.g., persistent cough, weight loss, low grade fever). Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection both prior to initiating adalimumab and during therapy.

The safety and efficacy of adalimumab has not been established in immunosuppressed patients. TNF blocking agents may affect host defenses against infections and malignancies.

Live virus vaccines should not be given concurrently with adalimumab.

The formation of autoantibodies and lupus-like syndrome may occur. Adalimumab should be discontinued if symptoms of a lupus-like syndrome occur.

Patients should be advised to report any signs of new or worsening medical conditions such as heart disease, neurological disease, or autoimmune disorders. Patients should be advised to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever.

Dialysis

Data not available

Other Comments

To monitor outcomes of pregnant women exposed to adalimumab, a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972.

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