HULIO SOLUTION FOR INJECTION 40 MG/0.8 ML IN PRE-FILLED SYRINGE

MYLAN PHARMACEUTICALS PTE. LTD.

ZUELLIG PHARMA PTE. LTD.

Therapeutic

Prescription Only

INJECTION, SOLUTION

**Posology and method of administration** Posology **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 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. **Crohn’s Disease**  In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given 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. Some patients who experience a decrease in their response may benefit from an increase in dosage to 40 mg Adalimumab every week or 80mg every other week. 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 160 mg at Week 0 (given 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. **Plaque Psoriasis** The recommended dose of Adalimumab for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg 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 dosage to 40 mg every week or 80 mg every other 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 dosage, 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 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. 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 40 mg 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. Paediatric population Hulio is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen. It is not possible to administer Hulio to paediatric patients that require less than a full 40 mg dose. If a dose other than 40 mg is required, other adalimumab products offering such an option should be used. _Juvenile idiopathic arthritis_ 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 26). MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with Adalimumab. Adalimumab may be available in different strengths and/or presentations.  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 10kg. 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 Hulio for patients from 6 years of age with enthesitis-related arthritis is based on body weight (Table 27). Hulio may be available in different strengths and/or presentations.  Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years. _Paediatric plaque psoriasis_ The recommended Adalimumab dose for patients from 4 to 17 years of age with plaque psoriasis based on body weight (Table 28). Adalimumab is administered via subcutaneous injection. Adalimumab may be available in different strengths and/or presentations.  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 for this indication. _Adolescent hidradenitis suppurativa_ 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 modelling 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. Adalimumab may be available in different strengths and/or presentations. In adolescent patients with inadequate response to Adalimumab 40 mg every other week, an increase in dosage 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. Adalimumab may be available in other presentations depending on the individual treatment needs. _Paediatric 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. Adalimumab may be available in different strengths and/or presentations.  Patients 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_ Adalimumab has not been studied in children with Crohn’s disease aged less than 6 years. _Paediatric Uveitis_ The recommended dose of Adalimumab for paediatric patients 2 years of age and older with chronic non-infectious anterior uveitis is based on body weight (Table 30). 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 therapy 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 Adalimumab loading dose in children < 6 years of age. 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 Use** Adalimumab has not been studied in children less than 2 years of age and there are limited data on Hulio 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 and pediatric uveitis have not been established. **Geriatric Use** Of the total number of subjects in clinical studies of Hulio, 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. Method of administration Hulio is administered by subcutaneous injection.