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ABRILADA 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 Abrilada and the reference biologic drug Humira. Abrilada (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyartic ular 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.
Pediatric Crohn’s Disease. 2 Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Crohn’s Disease. The majority (102/192) of pediatric patients with Crohn’s disease studied were 13 to 17 years of age weighing ≥ 40 kg. 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 Abrilada in these patients has been determined based on pharmacokinetic/ pharmacodynamic modeling and simulation. 2 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. 2 Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Ulcerative Colitis.
Safety and effectiveness in pediatric patients with ulcerative colitis less than 5 years of age have not been established. 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). Sex No sex-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
ABRILADA Product Monograph Page 10 of 194 Ethnic Origin No differences in immunoglobulin clearance would be expected among ethnicities. 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. See (10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Disease States).
1 Adverse Reaction Overview, Infections). The benefits and risks of treatment with Abrilada 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.
Pediatric Crohn’s Disease. 2 Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Crohn’s Disease. The majority (102/192) of pediatric patients with Crohn’s disease studied were 13 to 17 years of age weighing ≥ 40 kg. 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 Abrilada in these patients has been determined based on pharmacokinetic/ pharmacodynamic modeling and simulation. 2 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. 2 Recommended Dosage and Dosage Adjustment, Pediatrics, Pediatric Ulcerative Colitis.
Safety and effectiveness in pediatric patients with ulcerative colitis less than 5 years of age have not been established. Geriatrics Evidence from clinical studies and experience suggests that use of adalimumab in the geriatric population is not associated with differences in effectiveness.
4 Geriatrics). 2 CONTRAINDICATIONS Abrilada is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. 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, Serious Warnings and Precautions, Infections). Patients with moderate to severe heart failure (NYHA class III/IV).
See (7 WARNINGS AND PRECAUTIONS, Cardiovascular, Patients with Congestive Heart Failure). ABRILADA Product Monograph Page 8 of 194 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 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.
Abrilada is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. 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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Concomitant Medications Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with adalimumab. When treated with adalimumab as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dose intensity to adalimumab 40 mg every week.
2 Recommended Dose and Dosage Adjustment Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Abrilada for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1). Abrilada is administered every other week via subcutaneous injection.
Abrilada 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. Abrilada Dose for Patients with Polyarticular JIA Patient Weight Dosing Regimen 10 kg to < 30 kg* 20 mg every other week ≥ 30 kg 40 mg every other week *A dose of 10 mg every other week can be considered for patients weighing 10 to <15 kg.
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 adalimumab in children aged < 2 years in this indication.
ABRILADA Product Monograph Page 11 of 194 Pediatric Crohn’s Disease The recommended Abrilada induction dose regimen for pediatric patients with severely active Crohn’s disease and moderately active Crohn’s disease with no response to conventional therapy is 160 mg at Week 0, followed by 80 mg at Week 2 administered by subcutaneous injection.
The first dose of 160 mg can be given in one day (four 40 mg injections) or split over two consecutive days (two 40 mg injections each day). The second dose of 80 mg at Week 2 is given as two 40 mg injections in one day. The recommended Abrilada maintenance dose regimen is 20 mg every other week beginning at Week 4.
For pediatric patients who experience a disease flare or non-response, dose escalation to 40 mg every other week may be considered. 5 Clinical Trials – Reference Biologic Drug. The use of adalimumab in pediatric patients with Crohn’s disease ages 13 to 17 has been evaluated up to one year in clinical studies.
If a patient has not responded by Week 12, continued therapy should be carefully reconsidered. Adolescent Hidradenitis Suppurativa The recommended Abrilada 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 Abrilada 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 Abrilada if necessary. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Pediatric Uveitis The recommended […]
No dose adjustment is needed for this population. 4 Geriatrics). Sex No sex-related pharmacokinetic differences were observed after correction for a patient’s body weight. Healthy volunteers and patients with rheumatoid arthritis displayed similar adalimumab pharmacokinetics.
ABRILADA Product Monograph Page 10 of 194 Ethnic Origin No differences in immunoglobulin clearance would be expected among ethnicities. 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. See (10 CLINICAL PHARMACOLOGY, 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 adalimumab. When treated with adalimumab as monotherapy, some rheumatoid arthritis patients who experience a decrease in their response to adalimumab 40 mg every other week may benefit from an increase in dose intensity to adalimumab 40 mg every week.
2 Recommended Dose and Dosage Adjustment Pediatrics Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Abrilada for patients with polyarticular JIA from 2 years of age is based on body weight (Table 1). Abrilada is administered every other week via subcutaneous injection.
Abrilada 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. Abrilada Dose for Patients with Polyarticular JIA Patient Weight Dosing Regimen 10 kg to < 30 kg* 20 mg every other week ≥ 30 kg 40 mg every other week *A dose of 10 mg every other week can be considered for patients weighing 10 to <15 kg.
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 adalimumab in children aged < 2 years in this indication.
ABRILADA Product Monograph Page 11 of 194 Pediatric Crohn’s Disease The recommended Abrilada induction dose regimen for pediatric patients with severely active Crohn’s disease and moderately active Crohn’s disease with no response to conventional therapy is 160 mg at Week 0, followed by 80 mg at Week 2 administered by subcutaneous injection.
The first dose of 160 mg can be given in one day (four 40 mg injections) or split over two consecutive days (two 40 mg injections each day). The second dose of 80 mg at Week 2 is given as two 40 mg injections in one day. The recommended Abrilada maintenance dose regimen is 20 mg every other week beginning at Week 4.
For pediatric patients who experience a disease flare or non-response, dose escalation to 40 mg every other week may be considered. 5 Clinical Trials – Reference Biologic Drug. The use of adalimumab in pediatric patients with Crohn’s disease ages 13 to 17 has been evaluated up to one year in clinical studies.
If a patient has not responded by Week 12, continued therapy should be carefully reconsidered. Adolescent Hidradenitis Suppurativa The recommended Abrilada 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 […]
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 Abrilada 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 Abrilada should be considered prior to initiating therapy.
See (7 WARNINGS AND PRECAUTIONS, Infections, Other Opportunistic Infections). As with other TNF-blockers, patients should be monitored closely for infections (including tuberculosis) before, during and after treatment with Abrilada.
Patients who develop a new infection while undergoing treatment with Abrilada should be monitored closely and undergo a complete diagnostic evaluation. Administration of Abrilada 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 Abrilada 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 (