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HULIO 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: , 1.1 Pediatrics 10/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 10/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 10/2021 7 WARNINGS AND PRECAUTIONS 10/2021 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 10/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 10/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .................................................................................................................
4 Pediatrics ............................................................................................................... 6 Geriatrics ...............................................................................................................
7 2 CONTRAINDICATIONS .................................................................................................. 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................ 7 4 DOSAGE AND ADMINISTRATION ................................................................................
8 Dosing Considerations ........................................................................................... 8 Recommended Dose and Dosage Adjustment..................................................... 10 Administration ......................................................................................................
15 Missed Dose ........................................................................................................ 15 5 OVERDOSAGE.............................................................................................................
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). 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 Hulio should be discontinued immediately and appropriate therapy initiated.
The Hulio Pen and the pre-filled syringe are available with a 29 gauge ½ inch needle and a cap that is not made with natural rubber latex. See (6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Hulio® (adalimumab injection) Product Monograph Page 19 of 165 Immune Autoimmunity Treatment with Hulio 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 Hulio, treatment should be discontinued. 1 Adverse Drug Reaction Overview, Autoantibodies). Immunosuppression The possibility exists for TNF-blocking agents, including Hulio, to affect host defences 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 Hulio on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. 1 Adverse Drug 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 10/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS .............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .................................................................................................................
4 Pediatrics ............................................................................................................... 6 Geriatrics ...............................................................................................................
7 2 CONTRAINDICATIONS .................................................................................................. 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................ 7 4 DOSAGE AND ADMINISTRATION ................................................................................
8 Dosing Considerations ........................................................................................... 8 Recommended Dose and Dosage Adjustment..................................................... 10 Administration ......................................................................................................
15 Missed Dose ........................................................................................................ 15 5 OVERDOSAGE.............................................................................................................
16 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 16 7 WARNINGS AND PRECAUTIONS ............................................................................... 17 Special Populations .............................................................................................
• Patients with known hypersensitivity to Hulio (adalimumab injection) or any of its components. For a complete listing, see the (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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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 Hulio therapy. Patients on Hulio 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 Hulio injection during pregnancy.
1 Pregnant Women). Hulio® (adalimumab injection) Product Monograph Page 20 of 165 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 Hulio, 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 Hulio.
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, Hulio therapy must not be initiated.
The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or traveled 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 Hulio.
Use of anti-tuberculosis prophylactic treatment should also be considered before the initiation of Hulio 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 Hulio should be monitored for signs and symptoms of active tuberculosis, particularly because tests for latent tuberculosis infection may be falsely […]
26 8 ADVERSE REACTIONS ............................................................................................... 26 Adverse Reaction Overview ................................................................................. 26 Clinical Trial Adverse Reactions...........................................................................
49 Less Common Clinical Trial Adverse Reactions (<1%) ........................................ 61 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................
62 Post-Market Adverse Reactions ........................................................................... 63 9 DRUG INTERACTIONS ................................................................................................ 64 Serious Drug Interactions ....................................................................................
64 Drug Interactions Overview .................................................................................. 65 Drug-Behavioural Interactions .............................................................................. 65 Hulio® (adalimumab injection) Product Monograph Page 3 of 165 Drug-Drug Interactions.........................................................................................
65 Drug-Food Interactions ........................................................................................ 66 Drug-Herb Interactions......................................................................................... 66 Drug-Laboratory Test Interactions........................................................................
66 10 CLINICAL PHARMACOLOGY ...................................................................................... 66 Mechanism of Action ........................................................................................ 66 Pharmacodynamics ..........................................................................................
67 Pharmacokinetics ............................................................................................. 68 11 STORAGE, STABILITY AND DISPOSAL ..................................................................... 71 12 SPECIAL HANDLING INSTRUCTIONS........................................................................
71 PART II: SCIENTIFIC INFORMATION ..................................................................................... 73 13 PHARMACEUTICAL INFORMATION ........................................................................... 73 14 CLINICAL TRIALS ........................................................................................................
74 Comparative Trial Design and Study Demographics ........................................ 74 Comparative Study Results .............................................................................. 77 Immunogenicity ................................................................................................
78 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG..................................... 79 15 […]