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 eva luated in controlled clinical studies.
Ulcerative Colitis
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.
Plaque Psoriasis
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 eva luated in controlled clinical studies.
Monitoring to Assess Safety
Prior to initiating Humira and periodically during therapy, eva luate 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 if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
Carefully inspect the solution in the Humira Pen or prefilled syringe 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).
Instruct patients using the Humira Pen or prefilled syringe to inject the full amount in the syringe (0.8 mL), which provides 40 mg of Humira, according to the directions provided in the Instructions for Use [see Instructions for Use].
Instruct patients (15 kg to <30 kg) using the pediatric pre-filled syringe, or their caregivers, to inject the full amount in the syringe (0.4 mL), which provides 20 mg of Humira, according to the directions provided in the Instructions for Use.
Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.
The Humira institutional use vial is for use and 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.
Dosage Forms and Strengths
•Pen
Injection: A single-use pen (Humira Pen), containing a 1 mL prefilled glass syringe with a fixed 27
