September 4, 2015
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Humira

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Humira




Indications
Dosage
How Supplied

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 patients 2 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.

Adult 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.

Pediatric Crohn's Disease

HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining 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.

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 (6-MP). 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 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.

Patients (2 years of age and older) Dose
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)

HUMIRA has not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

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] 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

The recommended HUMIRA dose regimen for pediatric patients 6 years of age and older with Crohn's disease (CD) is based on body weight as shown below:

Pediatric Patients Induction Dose Maintenance Dose Starting at Week 4 (Day 29)
17 kg (37 lbs) to < 40 kg (88 lbs)
  • 80 mg on Day 1 (administered as two 40 mg injections in one day); and
  • 40 mg two weeks later (on Day 15)
  • 20 mg every other week
≥ 40 kg (88 lbs)
  • 160 mg 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 two weeks later (on Day 15) (administered as two 40 mg injections in one day)
  • 40 mg every other week

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 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).

Instruct patients using the HUMIRA Pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the Instructions for Use [see Instructions for Use].

Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

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.

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.
    Injection: A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 10 mg/0.2 mL of HUMIRA.
  • Single-Use 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 Prefilled Syringe - Pediatric Crohn's Disease Starter Package (6 count)
HUMIRA is dispensed in a carton containing 6 alcohol preps and 6 dose trays (Pediatric Starter Package). 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 0074-3799-06.

HUMIRA Prefilled Syringe - Pediatric Crohn's Disease Starter Package (3 count)
HUMIRA is dispensed in a carton containing 4 alcohol preps and 3 dose trays (Pediatric Starter Package). 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 0074-3799-03.

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.

Prefilled Syringe Carton - 20 mg
HUMIRA is supplied 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.

Prefilled Syringe Carton - 10 mg
HUMIRA is supplied 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 10 mg/0.2 mL of HUMIRA. The NDC number is 0074-6347-02.

Single-Use 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. Store in original carton until time of administration to protect from light.

If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. HUMIRA should be discarded if not used within the 14-day period. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.

Do not store HUMIRA in extreme heat or cold.

Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A. US License Number 1889. 03-B077. Revised: Dec 2014

Last reviewed on RxList: 8/13/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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