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Humira (Adalimumab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 disease-modifying anti-rheumatic drugs (DMARDs).

Psoriatic Arthritis

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

Ankylosing Spondylitis

HUMIRA is indicated for reducing signs and symptoms in 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.

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, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with HUMIRA. In rheumatoid arthritis, some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency of HUMIRA to 40 mg every week.

Crohn’s Disease

The recommended HUMIRA dose regimen for adult patients with Crohn’s disease is 160 mg initially at 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, corticosteroids, and/or immunomodulatory agents (e.g., 6-mercaptopurine and azathioprine) may be continued during treatment with HUMIRA. The use of HUMIRA in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

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.

The solution in the HUMIRA Pen or prefilled syringe should be carefully inspected visually for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, the product should not be used. HUMIRA does not contain preservatives; therefore, unused portions of drug remaining from the syringe should be discarded. NOTE: The needle cover of the syringe contains dry rubber (latex), which should not be handled by persons sensitive to this substance.

Patients using the HUMIRA Pen or prefilled syringe should be instructed to inject the full amount in the syringe (0.8 mL), which provides 40 mg of HUMIRA, according to the directions provided in the Patient Information Leaflet [see Patient Counseling Information].

Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red or hard.

DOSAGE FORMS AND STRENGTHS

  • Pen

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

A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of HUMIRA.

HOW SUPPLIED/STORAGE AND HANDLING

HUMIRA® (adalimumab) is supplied in prefilled syringes 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 gauge½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-4339-02.

  • HUMIRA Pen – Crohn's Disease Starter Package

HUMIRA is dispensed in a carton containing 6 alcohol preps and 6 dose trays (Crohn’s Disease Starter Package). Each dose tray consists of a single-use pen, containing a 1 mL prefilled glass syringe with a fixed 27 gauge½ inch needle, providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-4339-06.

  • 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.

  • Storage and Stability

Do not use beyond the expiration date on the container. HUMIRA must be refrigerated at 2 to 8° C (36 to 46° F). DO NOT FREEZE. Protect the prefilled syringe from exposure to light. Store in original carton until time of administration.

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