Simlandi Dosage

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

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

Juvenile Idiopathic Arthritis

The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI.

There is no dosage form for SIMLANDI that allows weight-based dosing for pediatric patients below 30 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.

Crohn’s Disease

Adults

The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2)] or MTX may be continued during treatment with SIMLANDI if necessary.

Pediatrics

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

There is no dosage form for SIMLANDI that allows weight-based dosing for pediatric patients below 40 kg.

Ulcerative Colitis

Adults

The recommended subcutaneous dosage of SIMLANDI for adult patients with ulcerative colitis (UC) 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 SIMLANDI 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 SIMLANDI. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2)] may be continued during treatment with SIMLANDI if necessary.

Plaque Psoriasis or Adult Uveitis

The recommended subcutaneous dosage of SIMLANDI 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.

Hidradenitis Suppurativa

Adults

The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1)] .

General Considerations for Administration

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

SIMLANDI 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, do not use the product. SIMLANDI does not contain preservatives; therefore, discard unused portions of drug remaining from the autoinjector.

Instruct patients using the SIMLANDI autoinjector 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.