Hadlima Injection Dosage

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended subcutaneous dosage of HADLIMA 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 HADLIMA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HADLIMA to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis

The recommended subcutaneous dosage of HADLIMA 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 HADLIMA.

The only dosage form for HADLIMA that allows weight-based dosing for pediatric patients below 30 kg is the single-dose glass vial for institutional use only.

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

Crohn’s Disease

Adults

The recommended subcutaneous dosage of HADLIMA for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with HADLIMA. Azathioprine, 6- mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HADLIMA if necessary.

Pediatrics

The recommended subcutaneous dosage of HADLIMA for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below:

The only dosage form for HADLIMA that allows weight-based dosing for pediatric patients below 40 kg is the single-dose glass vial for institutional use only.

Ulcerative Colitis

Adults

The recommended subcutaneous dosage of HADLIMA for adult patients with ulcerative colitis is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dosage of 40 mg every other week.

Discontinue HADLIMA in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with HADLIMA. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with HADLIMA if necessary.

Plaque Psoriasis ​or Adult Uveitis

The recommended subcutaneous dosage of HADLIMA for adult patients with plaque psoriasis (Ps) ​or Uveitis (UV) 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 adalimumab products in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies.

​2.6 Hidradenitis Suppurativa

​The recommended subcutaneous dosage of HADLIMA for adult patients with hidradenitis suppurativa (HS) is an initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Begin 40 mg weekly or 80 mg every other week dosing two weeks later (Day 29).

Monitoring to Assess Safety

Prior to initiating HADLIMA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].

General Considerations for Administration

HADLIMA is intended for use under the guidance and supervision of a physician. A patient may self-inject HADLIMA or a caregiver may inject HADLIMA using either the HADLIMA PushTouch or HADLIMA prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.

HADLIMA PushTouch or prefilled syringe can be taken out of the refrigerator for about 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap of PushTouch or prefilled syringe while allowing it to reach room temperature.

Carefully inspect the solution in the HADLIMA PushTouch, HADLIMA prefilled syringe, or HADLIMA single-dose institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HADLIMA does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe [see How Supplied/Storage and Handling (16)].

Instruct patients using the HADLIMA PushTouch or HADLIMA 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.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

The HADLIMA single-dose 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.