Drug Detail:Hulio (Adalimumab [ ay-da-lim-ue-mab ])
Generic Name: ADALIMUMAB 20mg in 0.4mL; ISOPROPYL ALCOHOL 0.70mg in 1mL
Dosage Form: subcutaneous injection
Drug Class: TNF alfa inhibitors
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended subcutaneous dosage of HULIO 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 HULIO. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HULIO to 40 mg every week or 80 mg every other week.
Juvenile Idiopathic Arthritis
The recommended subcutaneous dosage of HULIO 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 HULIO.
|
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 HULIO 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.
Crohn’s Disease
Adults
The recommended subcutaneous dosage of HULIO 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 HULIO. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HULIO if necessary.
Pediatrics
The recommended subcutaneous dosage of HULIO 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 |
Ulcerative Colitis
Adults
The recommended subcutaneous dosage of HULIO 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 HULIO 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 HULIO. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with HULIO if necessary.
Plaque Psoriasis
The recommended subcutaneous dosage of HULIO 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.
2.6 Hidradenitis Suppurativa
Adults
The recommended subcutaneous dosage of HULIO 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 HULIO and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].
General Considerations for Administration
HULIO is intended for use under the guidance and supervision of a physician. A patient may self-inject HULIO or a caregiver may inject HULIO using either the HULIO 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.
HULIO 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 HULIO Pen or prefilled syringe for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HULIO does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe.
Instruct patients using the HULIO Pen or 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.
