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Adalimumab Dosage

Applies to the following strength(s): 40 mg/0.8 mL ; 10 mg/0.2 mL ; 20 mg/0.4 mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for Ankylosing Spondylitis

40 mg subcutaneously every other week

In the treatment of rheumatoid arthritis, some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency to 40 mg every week.

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

Uses: Moderate to severe rheumatoid arthritis, as monotherapy, or in combination with methotrexate, psoriatic arthritis (PsA), ankylosing spondylitis (AS)

Usual Adult Dose for Rheumatoid Arthritis

40 mg subcutaneously every other week

In the treatment of rheumatoid arthritis, some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency to 40 mg every week.

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

Uses: Moderate to severe rheumatoid arthritis, as monotherapy, or in combination with methotrexate, psoriatic arthritis (PsA), ankylosing spondylitis (AS)

Usual Adult Dose for Psoriatic Arthritis

40 mg subcutaneously every other week

In the treatment of rheumatoid arthritis, some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency to 40 mg every week.

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

Uses: Moderate to severe rheumatoid arthritis, as monotherapy, or in combination with methotrexate, psoriatic arthritis (PsA), ankylosing spondylitis (AS)

Usual Adult Dose for Crohn's Disease - Acute

-Initial dose: 160 mg subcutaneously on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15)
-Maintenance dose: Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week

Comments:
-Aminosalicylates and/or corticosteroids may be continued during treatment.
-Azathioprine, 6-mercaptopurine (6-MP), or methotrexate (MTX) may be continued during treatment if necessary.
-Treatment beyond one year in Crohn's Disease has not been established.
-Treatment in ulcerative colitis should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Usual Adult Dose for Crohn's Disease - Maintenance

-Initial dose: 160 mg subcutaneously on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15)
-Maintenance dose: Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week

Comments:
-Aminosalicylates and/or corticosteroids may be continued during treatment.
-Azathioprine, 6-mercaptopurine (6-MP), or methotrexate (MTX) may be continued during treatment if necessary.
-Treatment beyond one year in Crohn's Disease has not been established.
-Treatment in ulcerative colitis should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Usual Adult Dose for Ulcerative Colitis

-Initial dose: 160 mg subcutaneously on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15)
-Maintenance dose: Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week

Comments:
-Aminosalicylates and/or corticosteroids may be continued during treatment.
-Azathioprine, 6-mercaptopurine (6-MP), or methotrexate (MTX) may be continued during treatment if necessary.
-Treatment beyond one year in Crohn's Disease has not been established.
-Treatment in ulcerative colitis should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Usual Adult Dose for Plaque Psoriasis

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

Comments:
-Treatment beyond one year has not been studied.

Uses: Moderate to severe chronic plaque psoriasis

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

2 years of age and older:

10 kg (22 pounds) to less than 15 kg (33 pounds):10 mg subcutaneously every other week

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

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

Comments:
-Safety and efficacy has not been established patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
-Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment.

Uses: To reduce symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients 2 years of age and older, used alone or in combination with methotrexate.

Usual Pediatric Dose for Crohn's Disease - Acute

6 years of age and older:

17 kg (37 pounds) to less than 40 kg (88 pounds):
-Initial dose: 80 mg subcutaneously on Day 1 (administered as two 40 mg injections in one day); and 40 mg subcutaneously two weeks later (on Day 15)
-Maintenance dose: 20 mg subcutaneously every other week

Greater than or equal to 40 kg (88 pounds):
-Initial dose: 160 mg subcutaneously on Day 1 (administered as four injections in one day or as two 40 mg injections per day for two consecutive days); and 80 mg subcutaneously two weeks later (on Day 15) (administered as two 40 mg injections in one day)
-Maintenance dose: 40 mg subcutaneously every other week

Uses: To reduce symptoms and induce and maintain clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Usual Pediatric Dose for Crohn's Disease - Maintenance

6 years of age and older:

17 kg (37 pounds) to less than 40 kg (88 pounds):
-Initial dose: 80 mg subcutaneously on Day 1 (administered as two 40 mg injections in one day); and 40 mg subcutaneously two weeks later (on Day 15)
-Maintenance dose: 20 mg subcutaneously every other week

Greater than or equal to 40 kg (88 pounds):
-Initial dose: 160 mg subcutaneously on Day 1 (administered as four injections in one day or as two 40 mg injections per day for two consecutive days); and 80 mg subcutaneously two weeks later (on Day 15) (administered as two 40 mg injections in one day)
-Maintenance dose: 40 mg subcutaneously every other week

Uses: To reduce symptoms and induce and maintain clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
-SERIOUS INFECTIONS: There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. This drug should be discontinued if a patient develops a serious infection or sepsis during treatment. A test should be performed for latent TB; if positive, treatment for TB should be started prior to starting therapy with this drug. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.
MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescents and young adults with inflammatory bowel disease treated with TNF blockers.

-PEDIATRIC CROHN'S DISEASE: Safety and effectiveness have not been established in patients younger than 6 years.
-PEDIATRIC POLYARTICULAR JIA: Safety and effectiveness have not been established in patients younger than 2 years.

Consult WARNINGS section of additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Following adequate training in subcutaneous injection technique, patients may self-inject adalimumab. Self-injection sites include the thigh or abdomen.
-Injection sites should be rotated and adalimumab should not be injected into areas where the skin is tender, bruised, red, or hard.

Storage requirements:
-Adalimumab should be refrigerated at 2 C to 8 C and kept from freezing.
-If necessary, single adalimumab prefilled syringes or pens may be stored at room temperature (below 25 C) and protected from light for up to 14 days. Once removed from the refrigerator for storage at room temperature, the syringe must be used within 14 days or discarded, regardless of whether it is returned to the refrigerator or not.

General:
-There is an increased risk of lymphoma in rheumatoid arthritis patients with long standing, highly active, inflammatory disease.
-Use of live vaccines should be avoided during therapy.

Monitoring:
Cardiovascular: Signs and symptoms of new or worsening congestive heart failure
Hematologic: Blood dyscrasias
Immunologic: Infections and development of autoantibodies
Neurologic: New onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease
Oncologic:
-Lymphomas or other malignancies, particularly in rheumatoid arthritis patients, patients with a history of malignancy, COPD patients, and patients with a history of heavy smoking
-Patients with a medical history of extensive immunosuppressant therapy and psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment.

Patient advice:
-Patients using a prefilled pen or syringe should be instructed to inject the full amount in the device.
-If removing the syringe from the refrigerator for room temperature storage, record the date of removal so as to allow the syringe to be discarded after the maximum of 14 days if not used.

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