Hyrimoz Injection Dosage

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

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

Juvenile Idiopathic Arthritis

The recommended subcutaneous dosage of HYRIMOZ 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 HYRIMOZ.

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 HYRIMOZ 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 HYRIMOZ. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HYRIMOZ if necessary.

Pediatrics

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

Ulcerative Colitis

Adults

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

Plaque Psoriasis

The recommended subcutaneous dosage of HYRIMOZ for adult patients with plaque psoriasis (Ps) 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.

Monitoring to Assess Safety

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

General Considerations for Administration

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

You may leave HYRIMOZ at room temperature for about 15 to 30 minutes before injecting. Do not remove the cap while allowing it to reach room temperature. Carefully inspect the solution in the HYRIMOZ single-dose prefilled Sensoready Pen or HYRIMOZ single-dose prefilled syringe for particulate matter and discoloration prior to subcutaneous administration. The solution should be clear, colorless or slightly yellowish. Do not use a prefilled syringe or prefilled Sensoready Pen if the solution is cloudy, discolored, or has flakes or particles in it. HYRIMOZ does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe.

Instruct patients using the HYRIMOZ single-dose prefilled Sensoready Pen and the HYRIMOZ single-dose prefilled syringe to inject the full amount 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.