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OMVYENCE is a brand name for Infliximab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 7.1.3 Pediatrics, 8.2.1 Clinical Trial Adverse Reactions - Pediatrics, 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS.) The safety and efficacy of Omvyence™ has not been established in pediatric patients with Crohn’s disease <9 years of age or with ulcerative colitis <6 years of age. The safety and efficacy of…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 INDICATIONS ................................................................................................................... 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 5 CONTRAINDICATIONS ...................................................................................................
5 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 6 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 3 Reconstitution .......................................................................................................... 4 Administration ..........................................................................................................
5 Missed Dose .......................................................................................................... 10 OVERDOSAGE ..............................................................................................................
, Infusion-related Reactions). 4 Drug-Drug Interactions Concurrent Use of Omvyence™ with other Biological Therapeutics The combination of Omvyence™ with other biological therapeutics used to treat the same conditions as Omvyence™, including anakinra or abatacept, is not recommended (see 7 WARNINGS AND PRECAUTIONS, Risk of Infections).
0 Page 48 of 118 Live Vaccines/Therapeutic Infectious Agents It is recommended that live vaccines not be given concurrently with Omvyence™. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 12 months following birth.
1 Pregnant Women). 2 Breast-feeding). It is recommended that therapeutic infectious agents not be given concurrently with Omvyence™ (see 7 WARNINGS AND PRECAUTIONS). , TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab, the formation of CYP450 enzymes could be normalized.
, cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. Interactions with other drugs have not been established. 5 Drug-Food Interactions Interactions with food have not been established.
6 Drug-Herb Interactions Interactions with herbal products have not been established. 7 Drug-Laboratory Test Interactions Interactions with laboratory tests have not been established. 1 Mechanism of Action Infliximab is a chimeric IgG1κ monoclonal antibody with an approximate molecular weight of 149,100 daltons.
It is composed of human constant and murine variable regions. Infliximab binds specifically to human tumour necrosis factor alpha (TNFα) with an association constant of 1010 M-1. Infliximab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
, Risk of Infections). 2 Clinical Trial Adverse Reactions, Congestive Heart Failure). • Patients with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions RISK OF INFECTIONS Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving Omvyence™.
Some of these infections have been fatal. Patients must be evaluated for the risk of tuberculosis, including latent tuberculosis, prior to initiation of Omvyence™. This evaluation should include a detailed medical history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
e. tuberculin skin test and chest x- ray (if indicated), should be performed in all patients. Prescribers are reminded of the risk of false negative tuberculin skin test results especially in patients who are severely ill or immunocompromised.
Treatment of latent tuberculosis infection should be initiated prior to therapy with Omvyence™ (see 7 WARNINGS AND PRECAUTIONS, Risk of Infections). Hepatosplenic T-cell Lymphoma Postmarketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blockers including Omvyence™.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with or immediately prior to a TNF-blocker. The vast majority of Omvyence™ cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were reported in adolescent or young adult males (see 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).
2 Clinical Trial Adverse Reactions, Congestive Heart Failure). The results of a randomized study evaluating the use of Omvyence™ in patients with heart failure (NYHA Functional Class III/IV) suggested higher mortality in patients who received 10 mg/kg Omvyence™, and higher rates of cardiovascular adverse events at doses of 5 mg/kg and 10 mg/kg.
Driving and Operating Machinery Omvyence™ may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of Omvyence™. Hematologic There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including Omvyence™.
Caution should be exercised in patients treated with Omvyence™ who have a current or past history of significant cytopenias. g. persistent fever, bruising, bleeding, pallor). Discontinuation of Omvyence™ therapy should be considered in patients with confirmed significant hematologic abnormalities.
0 Page 16 of 118 Hepatic/Biliary/Pancreatic Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Omvyence™. Isolated cases of liver failure resulting in liver transplantation or death have occurred.
A causal relationship between Omvyence™ and these events has not been established. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or ALT elevations 5 times the upper limit of normal develop, Omvyence™ should be discontinued immediately, and a thorough investigation of the abnormality should be undertaken.
, surface antigen positive). Patients should be tested for hepatitis B virus (HBV) infection before initiating treatment with immunosuppressants, including Omvyence™. For patients who test positive for hepatitis B surface antigen, consultation with a health professional with expertise in the treatment of hepatitis B is recommended.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 Page 49 of 118 Infliximab neutralises the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralise TNFβ (lymphotoxin α), a related cytokine that utilises the same receptors as TNFα.
Biological activities attributed to TNFα include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, and induction of acute phase reactants and other liver proteins.
Cells expressing transmembrane TNFα bound by infliximab can be lysed in vitro by complement or effector cells. Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays utilising human fibroblasts, endothelial cells, neutrophils, B and T lymphocytes, and epithelial cells.
Anti-TNFα antibodies reduce disease activity in a cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab prevents disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα, and, when administered after disease onset, facilitates eroded joints to heal.
2 Pharmacodynamics Preclinical Infliximab binds to the soluble and transmembrane forms of TNFα with high affinity and blocks the interaction of TNFα with its receptors, thereby neutralising the biological activity of TNFα. Cells expressing transmembrane TNFα can be lysed in vitro by complement or effector cell- mediated mechanisms after infliximab binds.
Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays utilising human fibroblasts, endothelial cells, neutrophils B and T lymphocytes, and epithelial cells. Infliximab specifically neutralises TNFα-induced cell cytotoxicity but not lymphotoxin α.
Lymphotoxin α is a cytokine that shares 30% homology with TNFα and utilises the same receptors as TNFα. Species cross-reactivity of infliximab is limited to human and chimpanzee TNFα. In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
In a transgenic mouse (Tg197) that constitutively expresses human TNFα, infliximab administered twice weekly at 5 mg/kg or once weekly at 10 mg/kg prevents the development of polyarthritis by Week 10, demonstrating that infliximab neutralises TNFα in vivo.
Clinical Elevated concentrations of TNFα have been found in the joints of rheumatoid arthritis patients, in the joints of psoriatic arthritis patients, in the skin lesions of plaque psoriasis patients, and in the stools of Crohn’s disease and ulcerative colitis patients.
This correlates with elevated disease activity. In rheumatoid arthritis, treatment with Omvyence™ reduced infiltration of […]
Pediatric Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Omvyence™ (see 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).
4 Administration. 0 Page 7 of 118 All patients administered Omvyence™ should be observed for at least 1-2 hours post-infusion for side effects. 2 Clinical Trial Adverse Reactions, Infusion-related Reactions). 5 Post-Market Adverse Reactions), considering the long half-life of infliximab.
The BioAdvance® Network has been established to facilitate the administration of Omvyence™. BioAdvance® Network clinics are staffed by qualified healthcare professionals specially trained in the administration of Omvyence™ infusions and are available across Canada.
Information about the BioAdvance® Network and location of the nearest BioAdvance® Network clinic can be obtained by calling Janssen Inc. Medical Information at: 1-800-567-3331. 4 Administration. Rheumatoid Arthritis The recommended dose of Omvyence™ is 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter.
Omvyence™ should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg and/or treating as often as every 4 weeks. Duration of treatment needed to achieve a response after dose escalation is not known.
However, higher doses of Omvyence™ were associated with a slightly higher proportion of patients experiencing adverse events (97% for the 3 mg/kg dose given every 8 weeks vs. 100% for the 10 mg/kg dose given every 4 weeks), including infections (84% for the 3 mg/kg dose given every 8 weeks vs.
91% for the 10 mg/kg dose given every 4 weeks). Ankylosing Spondylitis The recommended dose of Omvyence™ is 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks thereafter.
Ulcerative Colitis The recommended dose of Omvyence™ is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by 5 mg/kg every 8 weeks thereafter, for the treatment of adults and pediatric patients (≥6 years of age) with moderately to severely active ulcerative colitis.
In some adult patients, consideration may be given to adjusting the dose up to 10 mg/kg to sustain clinical response and remission. Some adult patients may not benefit from dose escalation. In addition to the health professional’s clinical assessment, measurement of infliximab trough levels and titers of antibodies to infliximab should be taken into account before considering dose adjustment.
Crohn’s Disease Adults:
The recommended dose of Omvyence™ is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderate to severe, active Crohn’s disease. 0 Page 8 of 118 response, consideration […]
Chronic carriers of hepatitis B should be appropriately evaluated prior to the initiation of Omvyence™ therapy and monitored closely during treatment and for several months following discontinuation of therapy. Immune To minimize the incidence of hypersensitivity reactions, including infusion reactions and serum sickness-like reactions, Omvyence™ should be administered as regular maintenance therapy after an induction regimen at weeks 0, 2 and 6 (see