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Simlandi is indicated for:
Rheumatoid Arthritis (RA): reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Simlandi can be used alone or in combination with methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis (JIA): in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older, weighing ≥ 30 kg, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Simlandi can be used as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.
Psoriatic Arthritis (PsA): reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients. Simlandi can be used in combination with methotrexate (MTX) in patients who do not respond adequately to methotrexate alone.
Ankylosing Spondylitis (AS): reducing the signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Adult Crohn’s Disease (CD): 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, including corticosteroids and/or immunosuppressants. Simlandi 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.
Adult Ulcerative Colitis (UC): treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies. The efficacy of Simlandi in patients who have lost response to or were intolerant to TNF blockers has not been established.
Hidradenitis Suppurativa (HS): treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).
Plaque Psoriasis (Ps): treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, Simlandi should be used after phototherapy has been shown to be ineffective or inappropriate.
Adult Uveitis: treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.
Pediatric Uveitis: treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age, weighing ≥ 30 kg, who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Please consult the product monograph at https://pdf.hres.ca/dpd_pm/00064183.pdf for important information relating to Contraindications regarding hypersensitivity to adalimumab or its components, severe infections, and heart failure. The most serious warning and precautions regarding hepatoplenic T-cell lymphoma, infections, and pediatric malignancy. Other relevant warnings and precautions regarding concomitant administration with other biologic DMARDs or other TNF antagonists, surgery, congestive heart failure, pancytopenia, symptoms suggestive of a lupus-like syndrome, demyelinating disease, and serious allergic reactions. Conditions of clinical use, adverse reactions, drug interactions and dosing instructions
The Product Monograph is also available by calling JAMP Pharma Group Medical Information service at 1 866-399-9091 #2.
1. Nash P, Vanhoof J, Hall S, et al. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2016;3(2):257-270. doi:10.1007/s40744-016-0041-3