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ERELZI is a brand name for Etanercept, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Erelzi (etanercept) is indicated for: • Treatment of moderately to severely active rheumatoid arthritis (RA) in adults. Treatment is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. Erelzi can be…
Verbatim from this product's HC label. Tap a section to expand.
). 2 Geriatrics Four hundred and eighty RA patients in clinical studies were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. One hundred thirty-eight patients with PsO in clinical studies were age 65 or older.
No overall differences in effectiveness were observed between younger and older patients with psoriasis. 4 Geriatrics). 2 CONTRAINDICATIONS Erelzi 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
3 Less common Trial adverse reactions). Patients have frequently presented with disseminated rather than localized disease. 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 Erelzi should not be initiated in patients with an active infection, including clinically important localized infections. The risks and benefits of treatment should be considered prior to initiating therapy in patients: • With chronic or recurrent infection; • Who have been exposed to tuberculosis; • With a history of an opportunistic infection; • Who have resided or traveled in areas of endemic tuberculosis or mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; • With underlying conditions that may predispose them to infection such as advanced or poorly controlled diabetes.
Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving etanercept, including patients who have previously received treatment for latent or active tuberculosis. Patients should be evaluated according to the Canadian Tuberculosis Standards guidelines for tuberculosis risk factors and tested for latent infection prior to initiating Erelzi and during therapy as appropriate.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immuno-compromised. If active tuberculosis is diagnosed, Erelzi therapy should not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment should be started with anti-tuberculosis therapy before the initiation of Erelzi.
In this situation, the benefit/risk balance of Erelzi therapy should be very carefully considered. Anti-tuberculosis therapy should also be considered prior to initiation of Erelzi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.
3 Pediatrics). Only pediatric patients weighing 63 kg (138 pounds) or more, who do not require weight-based dosing, can be treated with the Erelzi 50 mg prefilled syringe or the Erelzi 50 mg SensoReady® Pen. Patients weighing less than 63 kg should be accurately dosed on a mg/kg basis with other etanercept products.
(See 4 DOSAGE AND ADMINISTRATION). 2 Geriatrics Four hundred and eighty RA patients in clinical studies were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
One hundred thirty-eight patients with PsO in clinical studies were age 65 or older. No overall differences in effectiveness were observed between younger and older patients with psoriasis. 4 Geriatrics). 2 CONTRAINDICATIONS Erelzi 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, or at risk of, sepsis syndrome, such as immunocompromised and HIV+ patients. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Infections • Serious infections leading to hospitalization or death, including sepsis, tuberculosis (TB), invasive fungal and other opportunistic infections, have been observed with the use of TNF-blocking agents including etanercept.
Cases of TB may be due to reactivation of latent TB infection or to new infection. • Treatment with Erelzi should not be initiated in patients with active infections including TB, chronic or localized infections. Administration of Erelzi should be discontinued if a patient develops a serious infection or sepsis.
• Physicians also should exercise caution when considering the use of Erelzi in patients with a history of recurring or latent infections, including TB, or with underlying conditions, which may predispose patients to infections, such as advanced or poorly controlled diabetes.
Erelzi 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, or at risk of, sepsis syndrome, such as immunocompromised and HIV+ patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Patients should be monitored for the development of signs and symptoms of infection during and after treatment with Erelzi, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Tests for latent tuberculosis infection may be falsely negative while on therapy with Erelzi. Product Monograph Erelzi (Etanercept) Page 10 of 78 Tuberculosis should be strongly considered in patients who develop a new infection during Erelzi treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.
Histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking TNF-blockers, including etanercept. This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness.
Appropriate empiric antifungal therapy may be initiated while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
Erelzi should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Erelzi should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and antimicrobial therapy should be initiated, as appropriate.
In post-marketing studies of patients with juvenile idiopathic arthritis, serious infections have been reported in approximately 3% of patients. 8%). General Parenteral administration of any biologic product should be attended by appropriate precautions in case an allergic or untoward reaction occurs.
Allergic reactions associated with administration of etanercept during clinical trials have been reported in < 2% of patients. If any serious allergic or anaphylactic reaction occurs, administration of Erelzi should be discontinued immediately and appropriate therapy initiated.
Concurrent etanercept and anakinra treatment Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and etanercept with no added clinical benefit compared to etanercept alone. Because of the nature of the adverse events seen with combination of etanercept and anakinra therapy, the combination of etanercept and anakinra is not recommended (see
• Before starting treatment with Erelzi, all patients should be evaluated for both active and inactive (‘latent’) TB. If inactive (‘latent’) TB is diagnosed, treatment for latent TB should be started with anti-TB therapy before the initiation of Erelzi.
• Patients should be monitored for the development of signs and symptoms of infection during and after treatment with Erelzi, including the possible development of tuberculosis in patients Product Monograph Erelzi (Etanercept) Page 6 of 78 who tested negative for latent tuberculosis infection prior to initiating therapy (see 7 WARNING AND PRECAUTION, Serious and Opportunistic Infections).
Malignancies • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including etanercept (see further detail in Malignangies/Pediatric Patients section below).
1 Dosing Considerations Erelzi (etanercept) is intended for use under the guidance and supervision of a physician who has sufficient knowledge of RA, JIA, PsA, AS, or PsO and who has fully familiarized themselves with the efficacy/safety profile of Erelzi.
Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in measurement of the correct dose and injection technique. 2 Recommended Dose and Dosage Adjustment General A 50 mg dose should be given as one subcutaneous (SC) injection.
A 50 mg dose can also be given as two 25 mg SC injections. When administering Erelzi as two 25 mg injections in adults or children, the injections should be given either on the same day once weekly or 3 or 4 days apart. Adult RA, Psoriatic Arthritis, and Ankylosing Spondylitis Patients The recommended dose of Erelzi for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 50 mg per week.
Methotrexate, glucocorticoids, salicylates, non-steroidal anti- inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Erelzi. Based on a study of 50 mg etanercept twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week are not recommended.
Adult Plaque Psoriasis Patients The recommended starting dose of Erelzi for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week.
A maintenance dose of 50 mg given twice weekly has also been shown to be efficacious. Pediatric Patients (Juvenile Idiopathic Arthritis or Plaque Psoriasis) Erelzi should be administered by, or under the supervision of, a responsible adult.
8 mg/kg per week (up to a maximum of 50 mg per week). Only pediatric patients weighing 63 kg (138 pounds) or more, who do not require weight-based dosing, can be treated with the Erelzi 50 mg prefilled syringe or the Erelzi 50 mg SensoReady® Pen.
Patients weighing less than 63 kg should be accurately dosed on a mg/kg basis with other etanercept products. In Juvenile Idiopathic Arthritis, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or Product Monograph Erelzi (Etanercept) Page 7 of 78 analgesics may be continued during treatment with Erelzi.
Concurrent use with methotrexate and higher doses of Erelzi have not been studied in pediatric patients. 4 Administration Preparation of Erelzi Using the Single-use Prefilled Syringe or Single-use Prefilled SensoReady® Pen: Before injection, […]