Humira (Adalimumab) - Indications and Dosage

INDICATIONS AND USAGE

HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. HUMIRA can be used alone or in combination with MTX or other DMARDs.

DOSAGE AND ADMINISTRATION

The recommended dose of HUMIRA for adult patients with rheumatoid arthritis is 40 mg administered every other week as a subcutaneous injection. MTX, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with HUMIRA. Some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of HUMIRA to 40 mg every week.

HUMIRA is intended for use under the guidance and supervision of a physician. Patients may self-inject HUMIRA if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in injection technique.

The solution in the 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 pre-filled syringes 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.

Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red or hard (see PATIENT INFORMATION LEAFLET).

Instructions For Activating the Needle Stick Device: Cartons for institutional use contain a syringe and needle with a needle protection device (see HOW SUPPLIED). To activate the needle stick protection device after injection, hold the syringe in one hand and, with the other hand, slide the outer protective shield over the exposed needle until it locks into place.

STORAGE AND STABILITY

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

HOW SUPPLIED

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

PATIENT USE SYRINGE CARTON

HUMIRA is dispensed 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 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-3799-02.

INSTITUTIONAL USE SYRINGE CARTON

Each carton contains two alcohol preps and one dose tray. Each dose tray consists of a single-use, 1 mL pre-filled glass syringe with a fixed 27 gauge ½ inch needle (with a needle stick protection device) providing 40 mg (0.8 mL) of HUMIRA. The NDC number is 0074-3799-01.