Generic name: ADALIMUMAB 10mg in 0.2mL; ISOPROPYL ALCOHOL 0.70mL in 1mL
Dosage form: injection
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Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended dose of HUMIRA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with HUMIRA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of HUMIRA to 40 mg every week.
Juvenile Idiopathic Arthritis
The recommended dose of HUMIRA for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.
(2 years of age and older)
|10 kg (22 lbs) to <15 kg (33 lbs)||10 mg every other week
(10 mg Prefilled Syringe)
|15 kg (33 lbs) to <30 kg (66 lbs)||20 mg every other week
(20 mg Prefilled Syringe)
|≥30 kg (66 lbs)||40 mg every other week
(HUMIRA Pen or 40 mg Prefilled Syringe)
Adult Crohn’s Disease
The recommended HUMIRA dose regimen for adult patients with Crohn’s disease (CD) is 160 mg initially 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). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with HUMIRA. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HUMIRA if necessary. The use of HUMIRA in CD beyond one year has not been evaluated in controlled clinical studies.
Pediatric Crohn’s Disease
|Pediatric Patients||Induction Dose||Maintenance Dose
Starting at Week 4 (Day 29)
|17 kg (37 lbs) to < 40 kg (88 lbs)||
|≥ 40 kg (88 lbs)||
The recommended HUMIRA dose regimen for adult patients with ulcerative colitis (UC) is 160 mg initially 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). Two weeks later (Day 29) continue with a dose of 40 mg every other week.
Only continue HUMIRA in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with HUMIRA. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with HUMIRA if necessary.
The recommended dose of HUMIRA for adult patients with plaque psoriasis (Ps) is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of HUMIRA in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies.
Monitoring to Assess Safety
Prior to initiating HUMIRA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].
General Considerations for Administration
HUMIRA is intended for use under the guidance and supervision of a physician. A patient may self-inject HUMIRA or a caregiver may inject HUMIRA using either the HUMIRA Pen or prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
If more comfortable, you may leave HUMIRA at room temperature for about 15 to 30 minutes before injecting. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the HUMIRA Pen, prefilled syringe, or single-use institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HUMIRA does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe. NOTE: Instruct patients sensitive to latex not to handle the needle cover of the syringe because it contains dry rubber (latex).
The HUMIRA single-use institutional use vial is for administration within an institutional setting only, such as a hospital, physician’s office or clinic. Withdraw the dose using a sterile needle and syringe and administer promptly by a healthcare provider within an institutional setting. Only administer one dose per vial. The vial does not contain preservatives; therefore, discard unused portions.
More about Humira (adalimumab)
- Humira Pen
- Humira Pen Crohn's Disease Starter Package
- Humira Pen Crohns Disease/Ulcerative Colitis Starter Package
- Humira (Advanced Reading)
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- Crohn's Disease, Maintenance
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- Crohn's Disease, Acute
- Juvenile Idiopathic Arthritis
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