HIGHLIGHT
Idacio

Idacio Dosage/Direction for Use

adalimumab

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
ADULTS: 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 apondylitis and non-radiographic axial apondyloarthritis) is 40mg 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 dosing frequency of adalimumab to 40mg every week or 80 mg every other week (optional).
Plaque Psoriasis: The recommended dose of adalimumab for adult patients is an initial dose of 80mg administered subcutaneously, followed by 40mg 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 adequate response after 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 160mg at Week 0 (dose can be administered as 160mg (four injections) in one day or as 80mg (two injections) per day for two consecutive days) and 80 mg at Week 2. After induction treatment, the recommended dose is 40mg 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 40mg 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 four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given a two 40 mg injections in one day). 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.
Ongoing evidence of benefit, potential loss of response and the risks of treatment in patients continuing adalimumab beyond 12 weeks should be periodically evaluated (for example, after a further 12 weeks and every 6 months thereafter). In the two pivotal studies, the primary measure of efficacy was hidradenitis suppurativa clinical response (HiSCR), defined as ≥ 50% reduction from baseline in total abscess and inflammatory nodule (AN) count, with no observed increase in either abscess or draining fistula counts (see Section 5.1 Pharmacodynamic Properties, Clinical trials for hidardenitis suppurativa).
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.
PEDIATRICS: Juvenile Idiopathic Arthritis: Polyarticular Juvenile Idiopathic Arthritis: The recommended dose of adalimumab for patients 2 years of age with polyarticular juvenile idiopathic arthritis (JIA) is based on body weight (Table 27). Adalimumab is administered every other week via subcutaneous injection. (See Table 27.)

Click on icon to see table/diagram/image

Adalimumab has not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
Available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
There is no relevant use of adalimumab in children aged less than 2 years in this indication.
Enthesitis-Related Arthritis: The recommended dose of adalimumab for patients from 6 years of age with enthesitis-related arthritis is based on body weight (Table 28). Adalimumab is administered every other week via subcutaneous injection. (See Table 28.)

Click on icon to see table/diagram/image

Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Pediatric Crohn's Disease: The recommended dose of adalimumab for patients from 6 to 17 years of age with Crohn's disease is based on body weight (Table 29). Adalimumab is administered via subcutaneous injection. (See Table 29.)

Click on icon to see table/diagram/image

Continued therapy should be carefully considered in a subject not responding by week 12. There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Pediatric Plaque Psoriasis: The recommended adalimumab dose for patients from 4 to 17 years of age with plaque psoriasis is based on body weight (Table 30). Adalimumab is administered via subcutaneous injection. (See Table 30.)

Click on icon to see table/diagram/image

Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period. If retreatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed. The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
There is no relevant use of adalimumab in children aged less than 4 years in this indication.
Pediatric Uveitis: The recommended dose of adalimumab for pediatrics patients 2 years of age and older with chronic non-infectious uveitis is based on body weight (Table 31). Adalimumab is administered via subcutaneous injection.
In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate. (See Table 31.)

Click on icon to see table/diagram/image

When adalimumab is initiated, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of adalimumab loading dose in children < 6 years of age (see Pharmacology: Pharmacokinetics under Actions).
There is no relevant use of adalimumab in children aged less than 2 years in this indication.
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis.
Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg): There are no clinical trials with adalimumab in adolescent patients with hidradenitis suppurativa (HS). The posology of adalimumab in these patients has been determined from pharmacokinetic modeling and simulation.
The recommended adalimumab dose in adolescent patients from 12 years of age weighing at least 30 kg with hidradenitis suppurativa is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.
In adolescent patients with inadequate response to adalimumab 40 mg every other week, an increase in dosing frequency to 40 mg every week or 80 mg every other week may be considered.
Antibiotics may be continued during treatment with adalimumab if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with adalimumab.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Should treatment be interrupted, adalimumab may be re-introduced as appropriate.
The benefit and risk of continued long-term treatment should be periodically evaluated. There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Pediatric Use: Adalimumab has not been studied in children less than 2 years of age.
The safety and efficacy of adalimumab in pediatric patients for indications other than juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis), pediatric Crohn's disease, pediatric plaque psoriasis, pediatric 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 theses subjects and younger subjects. No dose adjustment is needed for this population.
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 with any other medicine.
Any unused product or waste material should be disposed of in accordance with local requirements.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in