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In rheumatoid arthritis, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of AMGEVITA to 40 mg every week or 80 mg every other week (optional).
Plaque Psoriasis: The recommended dose of AMGEVITA 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 AMGEVITA 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 AMGEVITA 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 AMGEVITA and signs and symptoms of disease recur, AMGEVITA 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 AMGEVITA 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 AMGEVITA 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 AMGEVITA. 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 AMGEVITA 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 AMGEVITA 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 AMGEVITA if necessary.
Should treatment need to be interrupted, AMGEVITA 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 AMGEVITA 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 AMGEVITA alone. Treatment with AMGEVITA 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 AMGEVITA.
Paediatrics: Juvenile idiopathic arthritis: Polyarticular Juvenile Idiopathic Arthritis: The recommended dose of AMGEVITA for patients from 2 years of age with polyarticular juvenile idiopathic arthritis (JIA) is based on body weight (Table 5). AMGEVITA is administered every other week via subcutaneous injection. (See Table 5.)
Click on icon to see table/diagram/imageAMGEVITA 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 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 AMGEVITA in children aged less than 2 years in this indication. AMGEVITA may be available in other strengths and/or presentations depending on the individual treatment needs.
Enthesitis-Related Arthritis: The recommended dose of AMGEVITA for patients from 6 years of age with enthesitis-related arthritis is based on body weight (Table 6). AMGEVITA is administered every other week via subcutaneous injection.
AMGEVITA may be available in different strengths and/or presentations. (See Table 6.)
Click on icon to see table/diagram/imageAMGEVITA has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Pediatric Crohn's Disease: The recommended dose of AMGEVITA for patients from 6 to 17 years of age with Crohn's disease is based on body weight (Table 7). AMGEVITA is administered via subcutaneous injection. AMGEVITA may be available in different strengths and/or presentations. (See Table 7.)
Click on icon to see table/diagram/imagePatients who experience insufficient response may benefit from an increase in dosage: < 40 kg: 20 mg every week, ≥ 40 kg: 40 mg every week or 80 mg every other week.
Continued therapy should be carefully considered in a subject not responding by week 12. There is no relevant use of AMGEVITA in children aged less than 6 years for this indication.
AMGEVITA may be available in other strengths and/or presentations depending on the individual treatment needs.
Paediatric Plaque Psoriasis: The recommended AMGEVITA dose for patients from 4 to 17 years of age with plaque psoriasis is based on body weight (Table 8). AMGEVITA is administered via subcutaneous injection. AMGEVITA may be available in different strengths and/or presentations. (See Table 8.)
Click on icon to see table/diagram/imageContinued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
If retreatment with AMGEVITA is indicated, the previously mentioned guidance on dose and treatment duration should be followed.
The safety of AMGEVITA in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
There is no relevant use of AMGEVITA in children aged less than 4 years in this indication.
Paediatric Uveitis: The recommended dose of AMGEVITA for paediatric patients 2 years of age and older with chronic non-infectious uveitis is based on body weight (Table 9). AMGEVITA is administered via subcutaneous injection. AMGEVITA may be available in other strengths and/or presentations.
In paediatric uveitis, there is no experience in the treatment with AMGEVITA without concomitant treatment with methotrexate. (See Table 9.)
Click on icon to see table/diagram/imageWhen AMGEVITA 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 a AMGEVITA loading dose in children < 6 years of age (see Pharmacology: Pharmacokinetics under Actions).
There is no relevant use of AMGEVITA 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.
Preparation of AMGEVITA: AMGEVITA is intended for use under the guidance and supervision of a physician. Patients may self-inject AMGEVITA 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.
AMGEVITA 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: AMGEVITA has not been studied in children less than 2 years of age.
The safety and efficacy of AMGEVITA 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 and paediatric uveitis 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.
