Loading…
IDACIO 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: , Polyarticular Juvenile Idiopathic Arthritis 2026-01 1 INDICATIONS, Crohn’s Disease 2026-01 1 INDICATIONS, Pediatric Uveitis 2026-01 1 INDICATIONS, 1.1 Pediatrics 2026-01 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Consideration, Pediatrics 2026-01 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 2026-01 IDACIO® (adalimumab injection) – Product Monograph Page 3 of 135 5 OVERDOSAGE............................................................................................................. 14
Reports of serious allergic reactions, including anaphylaxis, have been received following adalimumab injection administration. If an anaphylactic reaction or other serious allergic reactions occur, administration of Idacio should be discontinued immediately and appropriate therapy initiated.
Idacio pre-filled syringe and auto-injector are available with a 29 Gauge, 12 mm thin wall steel needle protected by a rigid needle shield. All contents of the prefilled syringe carton or auto-injector carton (including syringe or auto-injector, accessories and packaging) are latex-free.
See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Immune Autoimmunity Treatment with adalimumab injection may result in the formation of autoantibodies and rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Idacio, treatment should be discontinued.
1 Adverse Reaction Overview, Autoantibodies. IDACIO® (adalimumab injection) – Product Monograph Page 17 of 135 Immunosuppression The possibility exists for TNF-blocking agents, including adalimumab injection, to affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
In a study of 64 patients with rheumatoid arthritis who were treated with adalimumab injection, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B-cells and NK-cells, monocyte/macrophages, and neutrophils.
The impact of treatment with adalimumab injection on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. 1 Adverse Reaction Overview, Infections and Malignancies. Immunizations In a randomized, double-blind, placebo-controlled study in 226 adult rheumatoid arthritis patients treated with adalimumab injection, antibody responses to concomitant pneumococcal and influenza vaccines were assessed.
3 Pediatrics 2026-01 IDACIO® (adalimumab injection) – Product Monograph Page 3 of 135 5 OVERDOSAGE............................................................................................................. 14 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................
14 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
2 Breast-feeding ....................................................................................................... 3 Pediatrics ...............................................................................................................
4 Geriatrics ............................................................................................................... 22 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions.............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics ..........................................................
3 Less Common Clinical Trial Adverse Reactions....................................................... 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..................................................................................................
5 Post-Market Adverse Reactions ............................................................................. 58 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions.......................................................................................
• Patients with known hypersensitivity to Idacio or to 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.
Other brands of Adalimumab in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Protective antibody levels to the pneumococcal antigens were achieved by 86% of patients in the adalimumab injection group compared to 82% in the placebo group. A total of 37% of adalimumab injection-treated patients and 40% of placebo-treated patients achieved at least a 2-fold increase in antibody titer to at least three out of five pneumococcal antigens.
In the same study, 98% of patients in the adalimumab injection group and 95% in the placebo group achieved protective antibody levels to the influenza antigens. A total of 52% of adalimumab injection-treated patients and 63% of placebo-treated patients achieved at least a 4-fold increase in antibody titer to at least two out of three influenza antigens.
It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Idacio therapy. Patients on Idacio may receive concurrent vaccinations, except for live vaccines.
No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab injection. Administration of live vaccines to infants exposed to adalimumab injection in utero is not recommended for five months following the mother’s last Idacio injection during pregnancy.
1 Pregnant Women. Infections Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab injection. , disseminated) tuberculosis. Before initiation, during and after treatment with adalimumab injection, patients should be evaluated for active and inactive (“latent”) tuberculosis infection with a tuberculin skin test.
Treatment of latent tuberculosis infections should be initiated prior to therapy with Idacio. When tuberculin skin testing is performed for latent tuberculosis infection, an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guérin (BCG).
If active tuberculosis is diagnosed, Idacio therapy must not be initiated. The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or travelled to countries with a high prevalence of tuberculosis or who had close contact with a person with active tuberculosis.
If latent infection is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylactic treatment, in accordance with the Canadian Tuberculosis Standards and Centers for Disease Control and Prevention guidelines, before the initiation of Idacio.
Use IDACIO® (adalimumab injection) – Product Monograph Page 18 of 135 of anti-tuberculosis prophylactic treatment should also be considered before the initiation of Idacio in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
The decision to initiate anti-tuberculosis therapy in these patients should only be made after taking into account both the risk for latent tuberculosis infection and the risks of anti- tuberculosis therapy. If necessary, consultation should occur with a physician with expertise in the treatment of tuberculosis.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients receiving adalimumab injection. Also, active tuberculosis has developed in patients receiving adalimumab injection whose screening for latent tuberculosis infection was negative, and some patients who have been successfully treated for active tuberculosis have redeveloped active tuberculosis while being treated with TNF-blocking agents.
Patients receiving Idacio should be monitored for signs and […]
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions .........................................................................
61 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .............................................................................................
2 Pharmacodynamics ................................................................................................ 3 Pharmacokinetics ...................................................................................................
62 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 65 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 65 IDACIO® (adalimumab injection) – Product Monograph Page 4 of 135 PART II: SCIENTIFIC INFORMATION ........................................................................................
66 13 PHARMACEUTICAL INFORMATION ............................................................................. 66 14 CLINICAL TRIALS .........................................................................................................
5 Clinical Trials - Reference Biologic Drug ................................................................. 131 IDACIO® (adalimumab injection) – Product Monograph Page 5 of 135 PART I: HEALTH PROFESSIONAL INFORMATION Idacio® (adalimumab injection) is a biosimilar biologic drug (biosimilar) to Humira® (adalimumab injection).
A biosimilar is a biologic drug that was granted authorization based on a demonstration of similarity to a version previously authorized in Canada, known as the reference biologic drug. 1 INDICATIONS Idacio is indicated for: Rheumatoid Arthritis • 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.
Idacio can be used alone or in combination with methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs). When used as first-line treatment in recently diagnosed patients who have not been previously treated with MTX, Idacio should be given in combination with MTX.
[…]