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SIMLANDI is a brand name for Adalimumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between SimlandiTM (adalimumab injection) and the reference biologic drug HUMIRA®. Simlandi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dosage and Dosage Adjustment, Pediatrics, Polyarticular Juvenile Idiopathic Arthritis . Safety and effectiveness in pediatric patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg have not been established.
2 Recommended Dosage and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa. There are no clinical trials with adalimumab in adolescent patients with hidradenitis suppurativa (HS). The dosage of adalimumab in these patients has been determined based on pharmacokinetic/ pharmacodynamic modeling and simulation.
Pediatric Uveitis See 4 DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Uveitis. Safety and effectiveness in pediatric patients with uveitis less than 2 years of age have not been established.
Very limited data are available for pediatric patients with uveitis between 2 and < 3 years of age. Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab in the geriatric population is not associated with differences in effectiveness.
No dose adjustment is needed for this population. 4 Geriatrics (>65 years of age,).
Gender Product Monograph (Biosimilar) Simlandi 11 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
Race No differences in immunoglobulin clearance would be expected among races. From limited data in non-Caucasians, no important kinetic differences were observed for adalimumab. Dosage adjustment is not required. Hepatic Insufficiency No pharmacokinetic data are available in patients with hepatic impairment.
No dose recommendation can be made. Renal Insufficiency No pharmacokinetic data are available in patients with renal impairment. No dose recommendation can be made. Disease States Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
3 Pharmacokinetics, Special Populations and Conditions, Disease States). Concomitant Medications Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with Simlandi.
, Adverse Drug Reaction Overview, Infections). The benefits and risks of treatment with Simlandi should be carefully considered before initiating therapy. Pediatric Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including adalimumab.
See 7 WARNINGS AND PRECAUTIONS, Malignancies, Malignancies in Pediatric Patients and Young Adults). 2 Recommended Dosage and Dosage Adjustment, Pediatrics, Polyarticular Juvenile Idiopathic Arthritis . Safety and effectiveness in pediatric patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg have not been established.
2 Recommended Dosage and Dosage Adjustment, Pediatrics, Adolescent Hidradenitis Suppurativa. There are no clinical trials with adalimumab in adolescent patients with hidradenitis suppurativa (HS). The dosage of adalimumab in these patients has been determined based on pharmacokinetic/ pharmacodynamic modeling and simulation.
Pediatric Uveitis See 4 DOSAGE AND ADMINISTRATION, Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Uveitis. Safety and effectiveness in pediatric patients with uveitis less than 2 years of age have not been established.
Very limited data are available for pediatric patients with uveitis between 2 and < 3 years of age. Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab in the geriatric population is not associated with differences in effectiveness.
No dose adjustment is needed for this population. 4 Geriatrics (>65 years of age,).
Gender Product Monograph (Biosimilar) Simlandi 11 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 No gender-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
4 Geriatrics (>65 years of age). 2 CONTRAINDICATIONS • Patients with known hypersensitivity to adalimumab or any of its components. For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
See (3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Infections and 7 WARNINGS AND PRECAUTIONS). • Patients with moderate to severe heart failure (NYHA class III/IV). See ( 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Patients with Congestive Heart Failure ).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Hepatosplenic T-cell Lymphoma Very rare post-marketing reports of hepatosplenic T-cell lymphoma (HSTCL), a rare aggressive lymphoma that is often fatal, have been identified in patients treated with adalimumab.
Most of the patients had prior infliximab therapy as well as concomitant azathioprine or 6-mercaptopurine use for Crohn’s disease. The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
The causal association of HSTCL with adalimumab is not clear.
Infections Product Monograph (Biosimilar) Simlandi 9 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 Serious infections due to bacterial, mycobacterial, invasive fungal (disseminated or extrapulmonary histoplasmosis, aspergillosis, coccidiodomycosis), viral, parasitic, or other opportunistic infections have been reported in patients receiving tumor necrosis factor (TNF) - blocking agents.
Sepsis, rare cases of tuberculosis, candidiasis, listeriosis, legionellosis and pneumocystis have also been reported with the use of TNF -blocking agents, including adalimumab. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicemia.
• Patients with known hypersensitivity to adalimumab or any of its components. For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Patients with severe infections such as sepsis, tuberculosis and opportunistic infections.
See (
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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When treated with Simlandi as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to Simlandi 40 mg every other week may benefit from an increase in dose intensity to Simlandi 40 mg every week.
2 Recommended Dose and Dosage Adjustment Note: See Table 3 at the end of this section for available presentations of Simlandi for each indication in pediatrics and adults.
Product Monograph (Biosimilar) Simlandi 12 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Simlandi for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1).
Simlandi is administered every other week via subcutaneous injection only in patients who require the full 40 mg dose. A 40 mg autoinjector and a 40 mg pre-filled syringe of Simlandi are available for patients to administer a full 40 mg dose.
The 40 mg autoinjector and 40 mg pre -filled syringe are not designed to deliver a portion of the full 40 mg dose and must not be used in pediatric patients requiring less than the full 40 mg dose. Simlandi can be used in combination with methotrexate or as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.
Table 1. Simlandi Dose for Patients with Polyarticular JIA Patient Weight Dosing Regimen > 30 kg 40 mg every other week Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Efficacy and safety in patients who do not respond by Week 16 have not been established.
There is no relevant use of Simlandi in children aged <2 years in this indication. Adolescent Hidradenitis Suppurativa The recommended Simlandi dose regimen for adolescent patients with HS (12 to 17 years of age weighing ≥ 30 kg) 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 Simlandi 40 mg every other week, an increase in dosing frequency to 40 mg every week may be considered. 5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG, Pediatric, Adolescent Hidradenitis Suppurativa).
Antibiotics may be continued during treatment with Simlandi if necessary. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Pediatric Uveitis Product Monograph (Biosimilar) Simlandi 13 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 The recommended dose of Simlandi in combination with methotrexate for pediatric patients with chronic non-infectious anterior uveitis 2 years of age and older is based on body weight (Table 2).
Simlandi is administered every other week via subcutaneous injection only in patients who require the full 40 mg dose. A 40 mg autoinjector and a 40 mg pre-filled syringe of SIMLANDI are available for patients to administer a full 40 mg dose.
The 40 mg autoinjector and 40 mg pre -filled syringe are not designed to deliver a portion of the full 40 mg dose and must not be use d in pediatric patients requiring less than the full 40 mg dose. In pediatric uveitis, there is no experience in the treatment with Simlandi without concomitant treatment with methotrexate.
Table […]
Race No differences in immunoglobulin clearance would be expected among races. From limited data in non-Caucasians, no important kinetic differences were observed for adalimumab. Dosage adjustment is not required. Hepatic Insufficiency No pharmacokinetic data are available in patients with hepatic impairment.
No dose recommendation can be made. Renal Insufficiency No pharmacokinetic data are available in patients with renal impairment. No dose recommendation can be made. Disease States Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
3 Pharmacokinetics, Special Populations and Conditions, Disease States). Concomitant Medications Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with Simlandi.
When treated with Simlandi as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to Simlandi 40 mg every other week may benefit from an increase in dose intensity to Simlandi 40 mg every week.
2 Recommended Dose and Dosage Adjustment Note: See Table 3 at the end of this section for available presentations of Simlandi for each indication in pediatrics and adults.
Product Monograph (Biosimilar) Simlandi 12 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Simlandi for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1).
Simlandi is administered every other week via subcutaneous injection only in patients who require the full 40 mg dose. A 40 mg autoinjector and a 40 mg pre-filled syringe of Simlandi are available for patients to administer a full 40 mg dose.
The 40 mg autoinjector and 40 mg pre -filled syringe are not designed to deliver a portion of the full 40 mg dose and must not be used in pediatric patients requiring less than the full 40 mg dose. Simlandi can be used in combination with methotrexate or as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.
Table 1. Simlandi Dose for Patients with Polyarticular JIA Patient Weight Dosing Regimen > 30 kg 40 mg every other week Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Efficacy and safety in patients who do not respond by Week 16 have not been established.
There is no relevant use of Simlandi in children aged <2 years in this indication. Adolescent Hidradenitis Suppurativa The recommended Simlandi dose regimen for adolescent patients with HS (12 to 17 years of age weighing ≥ 30 kg) 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 Simlandi 40 mg every other week, an increase in dosing frequency to 40 mg every week may be considered. 5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG, Pediatric, Adolescent Hidradenitis Suppurativa).
Antibiotics may be continued during treatment with Simlandi if necessary. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Pediatric Uveitis Product Monograph (Biosimilar) Simlandi 13 Schedule D:
Biosimilar Biologic Drug Adalimumab injection February 02, 2024 The recommended dose of Simlandi in combination with methotrexate for pediatric patients with chronic non-infectious anterior uveitis 2 years of age and older is based on body weight (Table 2).
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Hospitalization or fatal outcomes associated with infections have been reported. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Treatment with Simlandi should not be initiated in patients with active infections, including chronic or localized infections, until infections are controlled. In patients who have been exposed to tuberculosis, and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Simlandi should be considered prior to initiating therapy.
See (7 WARNINGS AND PRECAUTIONS, Infections, Tuberculosis, Other Opportunistic Infections). As with other TNF-blockers, patients should be monitored closely for infections (including tuberculosis) before, during and after treatment with Simlandi.
Patients who develop a new infection while undergoing treatment with Simlandi should be monitored closely and undergo a complete diagnostic evaluation. Administration of Simlandi should be discontinued if a patient develops a serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated.
Physicians should exercise caution when considering the use of Simlandi in patients with a history of recurrent infection or with underlying conditions which may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.
See (7 WARNINGS AND PRECAUTIONS, Infections, Tuberculosis) and (