Adalimumab-fkjpdosage

Administer by subcutaneous injection Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

Adults: 40 mg every other week.

Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis: Pediatric Weight 2 Years of Age and Older Recommended Dosage 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn’s Disease:

Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.

Pediatric Patients 6 Years of Age and Older: Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis:

Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). Plaque Psoriasis or Adult Uveitis:

Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa:

Adults: o Day 1: 160 mg (given in one day or split over two consecutive days) o Day 15: 80 mg o Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

2.1 Rheumatoid

Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of Adalimumab-fkjp 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 Adalimumab-fkjp. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of Adalimumab-fkjp to 40 mg every week or 80 mg every other week.

2.2 Juvenile

Idiopathic Arthritis The recommended subcutaneous dosage of Adalimumab-fkjp 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 Adalimumab-fkjp. Pediatric Weight (2 Years of Age and older) Recommended Dosage 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week There is no dosage form for Adalimumab-fkjp that allows weight-based dosing for pediatric patients below 15 kg. 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.

2.3 Crohn’s

Disease Adults The recommended subcutaneous dosage of Adalimumab-fkjp 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 Adalimumab-fkjp. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with Adalimumab-fkjp if necessary. Pediatrics The recommended subcutaneous dosage of Adalimumab-fkjp for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below: Pediatric Weight Recommended Dosage Days 1 through 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week

2.4 Ulcerative

Colitis Adults The recommended subcutaneous dosage of Adalimumab-fkjp 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 Adalimumab-fkjp 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 Adalimumab-fkjp. Azathioprine and 6-mercaptopurine (6-MP) may be continued during treatment with Adalimumab-fkjp if necessary.

2.5 Plaque Psoriasis or

Adult Uveitis The recommended subcutaneous dosage of Adalimumab-fkjp 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 Adults The recommended subcutaneous dosage of Adalimumab-fkjp 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).

2.7 Monitoring to

Assess Safety Prior to initiating Adalimumab-fkjp and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection.

2.8 General

Considerations for Administration Adalimumab-fkjp is intended for use under the guidance and supervision of a physician. A patient may self-inject Adalimumab-fkjp or a caregiver may inject Adalimumab-fkjp using either the Adalimumab-fkjp 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. Adalimumab-fkjp can be taken out of the refrigerator for 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the Adalimumab-fkjp Pen or prefilled syringe for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. Adalimumab-fkjp does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe. Instruct patients using the Adalimumab-fkjp Pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the 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.