IDACIO SOLUTION FOR INJECTION FOR PAEDIATRIC USE 40MG/0.8ML VIAL

INJECTION, SOLUTION

**DOSAGE AND ADMINISTRATION** **ADULTS** **Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis** The recommended dose of adalimumab for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis 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. **Crohn’s Disease**  In case there is a need for a more rapid response to therapy, the regimen 160mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., 6-mercaptopurine and azathioprine) may be continued during treatment with adalimumab. Patients usually respond within the induction phase. However, if a patient does not show any response, available data do not sufficiently support further adalimumab treatment. **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 four injections in one day or as two injections per day for two consecutive days) and 80mg 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 dosing frequency to 40mg adalimumab every 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. **Plaque Psoriasis** The recommended dose of adalimumab for adult patients with plaque psoriasis is an initial dose of 80mg, followed by 40mg 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 may benefit from an increase in dosing frequency to 40 mg every week. Response should be periodically evaluated (for example, every 12 weeks). Patients with continued inadequate response should discontinue treatment. If an adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40mg fortnightly. **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 as two 40 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week. 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. Should treatment need to be interrupted, adalimumab 40mg every week may be re-introduced. In patients without any benefit after 12 weeks of treatment, continued therapy should be reconsidered. **Uveitis** Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with adalimumab. 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. It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis. **PEDIATRICS** **Juvenile Idiopathic Arthritis** **Polyarticular Juvenile Idiopathic Arthritis** Adalimumab has not been studied in children with polyarticular juvenile idiopathic arthritis aged less than 2 years. **Polyarticular Juvenile Idiopathic Arthritis** The recommended dose of adalimumab for patients from 2 years of age with polyarticular juvenile idiopathic arthritis (JIA) is based on body weight (Table 32). MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with adalimumab.  Adalimumab has not been studied in patients with polyarticular juvenile idiopathic arthritis 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 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 33).  Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years. **Pediatric Crohn's Disease** **Patients < 40kg body weight:**  In case there is a need for a more rapid response to therapy, the induction regimen 80mg at week 0 (dose can be administered as two injections in one day), 40mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. Some patients may benefit from increasing the frequency to weekly if a disease flare or an inadequate response is experienced during maintenance dosing. **Patients ≥ 40kg body weight:**  In case there is a need for a more rapid response to therapy, the induction regimen 160mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. Some patients may benefit from increasing the frequency to weekly if a disease flare or an inadequate response is experienced during maintenance dosing. Adalimumab has not been studied in children with Crohn’s disease aged less than 6 years. **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 34). adalimumab is administered via subcutaneous injection.  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. There is no relevant use of adalimumab in children aged less than 4 years in this indication. **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 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 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 Uveitis** The recommended dose of adalimumab for pediatric patients 2 years of age and older with chronic non-infectious anterior uveitis is based on body weight (Table 35). Adalimumab is administered via subcutaneous injection. Adalimumab may be available in different strengths and/or presentations. In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.  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 an adalimumab loading dose in children <6 years of age (see section Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. **Pediatric Ulcerative Colitis** The recommended dose of adalimumab for patients from 5 to 17 years of age with ulcerative colitis is based on body weight (Table 36). Adalimumab is administered via subcutaneous injection.  Continued therapy beyond 8 weeks should be carefully considered in patients not showing signs of response within this time period. There is no relevant use of adalimumab in children aged less than 5 years in this indication. **Pediatric Use** Adalimumab has not been studied in children less than 2 years of age and there are limited data on adalimumab treatment in children with weight < 10kg. 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, adolescent hidradenitis suppurativa, pediatric uveitis and pediatric ulcerative colitis 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. **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.