Abrilada Dosage/Direction for Use

Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis (Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis): The recommended dose of Adalimumab for adult patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) is 40 mg administered every other week as a single dose via subcutaneous injection. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics or other DMARDs may be continued during treatment with Adalimumab.
In rheumatoid arthritis, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of Adalimumab to 40 mg every week or 80 mg every other week (optional).
Plaque Psoriasis: The recommended dose of Adalimumab for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Beyond 16 weeks, patients with inadequate response to Adalimumab 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage. If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Crohn's disease: The recommended Adalimumab induction dose regimen for adult patients with severe Crohn's Disease is 80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as 160 mg in one day or as 80 mg per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped Adalimumab and signs and symptoms of disease recur, Adalimumab may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.
Some patients who experience decrease in their response may benefit from an increase in dosage to 40 mg Adalimumab every week or 80 mg every other week.
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period. During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Ulcerative Colitis: The recommended Adalimumab induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (dose can be administered as 160 mg in one day or as 80 mg per day for two consecutive days) and 80 mg at Week 2. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., 6-mercaptopurine and azathioprine) may be continued during treatment with Adalimumab. During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Some patients who experience decrease in their response may benefit from an increase in dosage to 40 mg Adalimumab every week or 80 mg every other week.
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. Adalimumab should only be continued in patients who have responded during the first 8 weeks of therapy.
Hidradenitis Suppurativa: The recommended Adalimumab dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as 160 mg in one day or as 80 mg per day for two consecutive days), followed by 80 mg two weeks later at Day 15. Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week. Antibiotics may be continued during treatment with Adalimumab if necessary.
Should treatment need to be interrupted, Adalimumab may be re-introduced.
In patients without any benefit after 12 weeks of treatment, prescriber should consider to discontinue the treatment.
Uveitis: The recommended dose of Adalimumab for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with Adalimumab alone. Treatment with Adalimumab can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Adalimumab.
Preparation of Adalimumab: Adalimumab is intended for use under the guidance and supervision of a physician. Patients may self inject adalimumab if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in injection technique.
Sites for self-injection include thigh or abdomen. Injection sites should be rotated. New injections should never be given into areas where the skin is tender, bruised, red or hard.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Adalimumab should not be mixed in the same syringe or vial with any other medicine. Any unused product or waste material should be disposed of in accordance with local requirements.
Paediatric Use: Adalimumab has not been studied in children less than 2 years of age.
The safety and efficacy of Adalimumab in paediatric patients for indications other than juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis), paediatric Crohn's disease, paediatric plaque psoriasis, paediatric uveitis and adolescent hidradenitis suppurativa have not been established.
Geriatric Use: Of the total number of subjects in clinical studies of Adalimumab, 9.4% were 65 years and over while approximately 2.0% were 75 and over. No overall differences in effectiveness were observed between these subjects and younger subjects. No dose adjustment is needed for this population.