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RENFLEXIS 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: Indications have been granted on the basis of similarity between Renflexis® and the reference biologic drug Remicade®. RENFLEXIS® (Infliximab for Injection) is indicated for: • use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and…
Verbatim from this product's HC label. Tap a section to expand.
) The safety and efficacy of infliximab for injection 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 infliximab for injection in pediatric patients with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and in juvenile rheumatoid arthritis have not been established.
2 Geriatrics Geriatrics (≥65 years of age): Evidence from clinical studies suggests that the use in geriatric population is associated with no overall differences in safety and efficacy. In rheumatoid arthritis clinical trials (ATTRACT) and plaque psoriasis trials, no overall differences were observed in the effectiveness or safety in 181 patients with rheumatoid arthritis and 75 patients with plaque psoriasis, aged 65 or older compared to younger patients although the incidence of serious adverse events in patients aged 65 or older was higher in both infliximab for injection and control groups compared to younger patients.
In Crohn’s disease, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis studies, there were insufficient numbers of patients aged 65 and over to determine whether they respond differently from patients aged 18 to 64.
2 Clinical Trial Adverse Reactions, Infections). 2 CONTRAINDICATIONS • Patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, Risk of Infections). 2 Clinical Trial Adverse Reactions, Congestive Heart Failure).
• Patients with a history of hypersensitivity to infliximab for injection, to other murine proteins, or to any of the excipients. For a complete listing, see
The adverse drug reaction profiles reported in clinical studies that compared Renflexis® to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview The most common adverse drug reactions reported from both clinical trials and post-marketing reports are infections, allergic reactions and infusion-related reactions. Less common adverse drug reactions from these sources which may be serious and clinically relevant include hepatobiliary events (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic), demyelinating disorders (see 7 WARNINGS AND PRECAUTIONS, Neurologic), and lymphoma (see 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).
One of the most common reasons for discontinuation of treatment in clinical trials was infusion-related reactions (dyspnea, flushing, headache and rash) (see 7 WARNINGS AND PRECAUTIONS, Immune). Adverse events have been reported in a higher proportion of rheumatoid arthritis patients receiving the 10 mg/kg dose than the 3 mg/kg dose, however, no differences were observed in the frequency of adverse events between the 5 mg/kg dose and the 10 mg/kg dose in patients with Crohn’s disease or ulcerative colitis and between the 3 mg/kg and 5 mg/kg dose in patients with plaque psoriasis.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Description of Data Sources The data described herein reflect the exposure infliximab for injection in 5561 patients in adequate and well-controlled studies.
, Risk of Infections). 2 Clinical Trial Adverse Reactions, Congestive Heart Failure). • Patients with a history of hypersensitivity to infliximab for injection, to other murine proteins, or to any of the excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
3 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 Renflexis®.
Some of these infections have been fatal. Patients must be evaluated for the risk of tuberculosis, including latent tuberculosis, prior to initiation of Renflexis®. This evaluation should include a detailed medical history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
e. 3 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 Renflexis® (see 7 WARNINGS AND PRECAUTIONS, Risk of Infections).
Hepatosplenic T-cell lymphoma Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blockers including infliximab for injection. 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 infliximab for injection 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).
• Patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, Risk of Infections). 2 Clinical Trial Adverse Reactions, Congestive Heart Failure). • Patients with a history of hypersensitivity to infliximab for injection, to other murine proteins, or to any of the excipients.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Infliximab in Canada.
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Infliximab for injection was studied in patients with rheumatoid arthritis (1304 patients exposed), juvenile rheumatoid arthritis (117 patients exposed), Crohn’s disease (1566 patients exposed, including 1427 adult and 139 pediatric patients), ulcerative colitis (544 patients exposed, including 484 adults and 60 children), plaque psoriasis (1373 patients exposed), psoriatic arthritis (293 patients exposed), ankylosing spondylitis (347 patients exposed) and other conditions (17 patients exposed), primarily in double-blind, placebo-controlled trials.
In general, integration of data in the following sections is based on clinical trials in rheumatoid arthritis and adult Crohn’s disease. 5 Clinical trials – reference biologic drug for a description of the individual studies conducted in each indication.
Relative Frequency of Adverse Drug Reactions Adverse events occurring at a frequency of at least 5% in infliximab for injection-treated adult patients with rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and ulcerative colitis are shown in Table 3.
Adverse events occurring at a frequency of at least 5% in infliximab for injection-treated pediatric patients with Crohn’s disease or ulcerative colitis are shown in Table 4. Adverse events occurring at a frequency of ≥1% to <5% in infliximab for injection-treated adult patients are shown in Table 5.
Adverse events occurring at a frequency of ≥1% to <5% in infliximab for injection-treated pediatric patients with Crohn’s disease or ulcerative colitis are shown in Table 6. 1 Clinical Trial Adverse Reactions - Pediatrics, Juvenile Rheumatoid Arthritis.
In general, the adverse events in pediatric patients with Crohn’s disease or ulcerative colitis who received infliximab for injection were similar in frequency and type to those seen in adult patients with Crohn’s disease or ulcerative colitis respectively.
1 Clinical Trial Adverse Reactions - Pediatrics, Crohn’s Disease and Ulcerative Colitis. RENFLEXIS® Page 23 of 110 Unclassified / Non classifié Table 3. 8%) System-organ class/preferred term Respiratory system disorders URTI 22% 29% 15% 23% 14% 49% 17% 18% 16% 25% 13% 24% Pharyngitis 7% 12% 6% 13% 5% 20% 6% 10% 4% 9% 4% 10% Sinusitis 7% 13% 6% 9% 1% 11% 5% 9% 3% 8% 4% 11% Coughing 7% 12% 6% 7% 3% 13% 4% 6% 1% 5% 1% 7% Rhinitis 4% 8% 5% 6% 5% 21% 2% 4% 1% 6% 2% 4% Bronchitis 8% 9% 3% 5% 1% 8% 3% 4% 2% 4% 3% 6% Gastro-intestinal system disorders Nausea 19% 19% 25% 21% 9% 11% 9% 11% 4% 8% 6% 5% Abdominal pain 7% 12% 17% 24% 4% 16% 13% 12% 1% 4% 2% 5% Diarrhea 11% 11% 7% 9% 5% 20% 5% 5% 2% 5% 3% 2% Vomiting 6% 7% 13% 12% 4% 6% 7% 6% 1% 3% 2% 1% Dyspepsia 6% 9% 2% 6% 4% 4% 2% 3% 1% 2% 2% 2% Skin and appendages disorders Rash 5% 9% 6% 10% 7% 10% 8% 8% 1% 2% 0% 2% Pruritus 2% 6% 3% 6% 7% 12% 4% 6% 4% 9% 3% 6% Body as a whole-general disorders Pain 7% 7% 6% 13% 5% 29% 12% 11% 5% 10% 1% 4% Fatigue 6% 8% 13% 14% 4% 15% 8% 10% 2% 7% 3% 4% Musculo-skeletal system disorders Arthralgia 6% 7% 8% 15% 1% 8% 10% 15% 2% 10% 2% 4% RENFLEXIS® Page 24 of 110 Unclassified / Non classifié RA studies CD studies AS studies UC […]
Pediatric Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including infliximab for injection (see 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).
4 Administration. RENFLEXIS® Page 7 of 110 Unclassified / Non classifié All patients administered Renflexis® 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 Organon HarmonyTM Infusion Network has been established to facilitate the administration of Renflexis®. This network consists of clinics located across Canada that are staffed by qualified healthcare professionals specially trained in the administration of Renflexis® infusions.
4 Administration. Rheumatoid Arthritis The recommended dose of Renflexis® 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. Renflexis® 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 infliximab for injection 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 Renflexis® 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 Renflexis® 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 healthcare professional’s clinical assessment, measurement of infliximab for injection trough levels and titers of antibodies to infliximab for injection should be taken into account before considering dose adjustment.
Crohn’s Disease RENFLEXIS® Page 8 of 110 Unclassified / Non classifié Adults The recommended dose of Renflexis® 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.
For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg. […]