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Humira

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Humira

Humira

INDICATIONS

Rheumatoid Arthritis

HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis

HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

Psoriatic Arthritis

HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis

HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn's Disease

HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Ulcerative Colitis

HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies].

Plaque Psoriasis

HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

HUMIRA is administered by subcutaneous injection.

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 pediatric patients 4 to 17 years of age 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.

Pediatric Patients (4 to 17 years) Dose
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)

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

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] 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.

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] 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 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].

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.

HOW SUPPLIED

Dosage Forms And Strengths

  • Pen
    Injection: A single-use pen (HUMIRA Pen), containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA.
  • Prefilled Syringe
    Injection: A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA.Injection: A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 20 mg (0.4 mL) of HUMIRA.
  • Institutional Use Vial
    Injection: A single-use, glass vial, providing 40 mg (0.8 mL) of HUMIRA for institutional use only.

Storage And Handling

HUMIRA® (adalimumab) is supplied as a preservative-free, sterile solution for subcutaneous administration. The following packaging configurations are available.

HUMIRA Pen Carton

HUMIRA is dispensed in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-4339-02.

HUMIRA Pen – Crohn's Disease/Ulcerative Colitis Starter Package

HUMIRA is dispensed in a carton containing 6 alcohol preps and 6 dose trays (Crohn's Disease/Ulcerative Colitis Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-4339-06.

HUMIRA Pen – Psoriasis Starter Package

HUMIRA is dispensed in a carton containing 4 alcohol preps and 4 dose trays (Psoriasis Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-4339-07.

Prefilled Syringe Carton – 40 mg

HUMIRA is dispensed in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-3799-02.

Pediatric Prefilled Syringe Carton – 20 mg

HUMIRA is supplied for pediatric use only in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-use, 1 mL pre-filled glass syringe with a fixed 27 gauge ½ inch needle, providing 20 mg (0.4 mL) of HUMIRA. The NDC number is 0074-9374-02.

Institutional Use Vial Carton – 40 mg

HUMIRA is supplied for institutional use only in a carton containing a single-use, glass vial, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-3797-01.

Storage and Stability

Do not use beyond the expiration date on the container. HUMIRA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. When traveling, store HUMIRA in a cool carrier with an ice pack. Protect the prefilled syringe from exposure to light. Store in original carton until time of administration.

AbbVie Inc. North Chicago, IL 60064, U.S.A. Content revised 01/2013

Last reviewed on RxList: 10/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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