Hulio

/ Dexcel

The treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which the drug is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment.
Patients treated with adalimumab should be given the ‘Patient safety information card’.
After proper training in injection technique, patients may self-inject with Hulio if their physician determines that it is appropriate and with medical follow-up as necessary.
During treatment, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Rheumatoid arthritis:
The recommended dose for adult patients is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with adalimumab.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with adalimumab. In monotherapy, some patients who experience a decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis:
The recommended dose is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Psoriasis:
The recommended dose 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.
Hidradenitis suppurativa (HS):
The recommended dose regimen for adult patients 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 or 80 mg every other week (given as two 40 mg injections in one day). 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 the treatment.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, adalimumab 40 mg every week or 80 mg every other week may be re-introduced.
Crohn’s disease:
The recommended induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg injections in one day), followed by a maintenance dose of 40 mg every other week via subcutaneous injection beginning at Week 4.
Aminosalicylates, corticosteriods and/or immunomodulatory agents (e.g. 6-mercaptopurine and azathioprine) may be continued during treatment with adalimumab.
Some patients who experience decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dosage to 40 mg Hulio 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.
Ulcerative colitis:
The recommended induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40 mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Some patients who experience decrease in their 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.
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. Adalimumab therapy should not be continued in patients failing to respond within this time period.
Uveitis:
The recommended dose for adult patients 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 can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Intestinal Behcet’s disease:
The initial dose for adult patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later. From four weeks after the initial dose, 40 mg is administered every other week.
See prescribing information for full details.

Rheumatoid arthritis:
Adalimumab in combination with methotrexate is indicated for:
• The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
•The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Hulio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Axial spondyloarthritis:
Ankylosing spondylitis (AS): Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Axial spondyloarthritis without radiographic evidence of AS: Adalimumab is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels, who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs.
Psoriatic arthritis:
Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Psoriasis:
Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Hidradenitis suppurativa (HS):
Adalimumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Crohn’s disease:
Adalimumab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Adalimumab is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative colitis:
Adalimumab is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Uveitis:
Adalimumab is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Intestinal Behcet’s disease:
Adalimumab is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.

• Hypersensitivity to the active substance or to any of the excipients.
• Active tuberculosis or other severe infections such as sepsis, and opportunistic infections.
• Moderate to several heart failure (NYHA class III/IV).

Infections, serious infections, tuberculosis and other opportunistic infections, hepatitis B reactivation, neurological events, allergic reactions, immunosuppression, malignancies and lymphoproliferative disorders, hematologic reactions, vaccinations, congestive heart failure, autoimmune processes, concurrent admiration of biological DMARDS or TNF-antagonists, surgery, small bowel obstruction, elderly (higher risk for serious infections). See prescribing information for full details.

The most commonly (very common) reported adverse reactions are infections and infestations such as respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), leukopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, rash (including exfoliative rash), injection site reactions (including injection site erythema), headache and musculoskeletal pain, abdominal pain, nausea and vomiting, elevated liver enzymes.
See prescribing information for full details.

Adalimumab has been studied in rheumatoid arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate. Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy. Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab.
The combination with anakinra is not recommended.
The combination with abatacept is not recommended.

Women of child bearing potential and pregnancy:
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last treatment.
Breast feeding:
Adalimumab can be used during breastfeeding.

No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.