Idacio Injection Dosage
Generic name: ADALIMUMAB 40mg in 0.8mL; ISOPROPYL ALCOHOL 0.75g
Dosage form: injection, solution
Drug class: TNF alfa inhibitors
Medically reviewed by Drugs.com. Last updated on Oct 15, 2024.
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended subcutaneous dosage of IDACIO 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 IDACIO. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of IDACIO to 40 mg every week or 80 mg every other week.
Juvenile Idiopathic Arthritis
The recommended subcutaneous dosage of IDACIO 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 IDACIO.
Pediatric Weight (2 Years of Age and older) |
Recommended Dosage |
10 kg (22 lbs) to less than 15 kg (33 lbs) |
10 mg every other week |
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 |
The only dosage form for IDACIO that allows weight-based dosing for pediatric patients below 30 kg is the single-dose glass vial kit 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 IDACIO 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 IDACIO. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with IDACIO if necessary.
Pediatrics
The recommended subcutaneous dosage of IDACIO 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 |
The only dosage form for IDACIO that allows weight-based dosing for pediatric patients below 40 kg is the single-dose glass vial kit for institutional use only
Ulcerative Colitis
Adults
The recommended subcutaneous dosage of IDACIO 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 IDACIO 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 IDACIO. Azathioprine and 6-mercaptopurine (6-MP) may be continued during treatment with IDACIO if necessary.
Plaque Psoriasis or Adult Uveitis
The recommended subcutaneous dosage of IDACIO 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 IDACIO 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 IDACIO and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection.
General Considerations for Administration
IDACIO Pen or prefilled syringe is intended for use under the guidance and supervision of a physician. A patient may self-inject IDACIO or a caregiver may inject IDACIO using either the IDACIO 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.
IDACIO may 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 IDACIO Pen, or prefilled syringe or 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. IDACIO does not contain preservatives. Therefore, discard unused portions of drug remaining in the syringe.
Instruct patients using the IDACIO 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.
The IDACIO syringe plunger stopper and needle cover are not made with natural rubber latex.
The IDACIO single-dose institutional use vial kit is for administration within an institutional setting only, such as a hospital, physician’s office, or clinic. Withdraw the dose using the vial adapter, the sterile syringe and needle provided. Only administer one dose per vial. The vial does not contain preservatives; discard unused portion.
The IDACIO vial and syringe stopper are not made with natural rubber latex.
Read these Administration Instructions before using the Idacio Vial kit.
IDACIO is supplied in a carton containing 1 sterile single-use syringe, 1 sterile needle, 1 vial adapter, 2 alcohol preps and 1 glass vial providing 40 mg/0.8 mL of IDACIO (Figure A)
The contents of the Idacio Vial Kit are for single-dose (one-time) use only. Discard unused portion.
Prior to Administration
- •
- Remove the Idacio Vial Kit from the refrigerator and let it sit at room temperature for at least 30 minutes.
- •
- Check the expiration date.
- •
- Remove Vial Kit contents from the carton and inspect for damage.
Do not use if any kit component or packaging has been damaged.
- •
- Check the vial contents to make sure that the liquid is clear, colorless, and free of particles and flakes.
Note: Prepare syringe just prior to administration and inject immediately. Do not store Idacio in the syringe.
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