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RYMTI 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: Indications have been granted on the basis of similarity between RYMTI and the reference biologic drug ENBREL. RYMTI (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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations RYMTI 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 RYMTI.
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 RYMTI 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 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis Patients The recommended dose of RYMTI for adult patients with RA, PsA, or AS is 50 mg per week.
Methotrexate, glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with RYMTI. 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 RYMTI 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 RYMTI Page 7 of 87 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) RYMTI 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 RYMTI 50 mg pre-filled syringe or pre-filled auto-injector.
RYMTI is not suitable to deliver accurate dosing to pediatric patients less than 63 kg. In JIA, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with RYMTI. Concurrent use with methotrexate and higher doses of etanercept have not been studied in pediatric patients.
The adverse drug reaction profiles reported in clinical studies that compared RYMTI 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 Adverse Reactions in Adult Patients with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Plaque Psoriasis Etanercept has been studied in 1442 patients with RA who have been followed for over 6 years, including 225 patients who have been followed for more than 10 years.
etanercept has been studied in 169 adult patients with PsA for up to 24 months, in 222 patients with AS for up to 48 months and in 1864 adult patients with PsO for up to 36 months. Etanercept has over four million patient-years of post-market exposure.
Among patients with RA treated in placebo-controlled studies, serious adverse events occurred at a frequency of 4% in 349 patients treated with etanercept compared to 5% of 152 placebo- treated patients. In a subsequent study (Study III), serious adverse events occurred at a frequency of 6% in 415 patients treated with etanercept compared to 8% of 217 methotrexate- treated patients.
In long-term open-label studies in adults with RA, there were no new or unexpected serious adverse events reported. Among adult patients with PsA, serious adverse events occurred at a frequency of 4% in 101 patients treated with etanercept compared to 4% of 104 placebo-treated patients.
5% among etanercept and placebo-treated patients in the first 3 months of treatment. However, in patients greater than 65 years of age treated with etanercept 50 mg twice weekly, serious adverse events occurred at a higher rate than in younger patients.
In long-term open-label trials of adult PsO, serious non-infectious adverse events were infrequent and exposure-adjusted event rates generally remained stable throughout etanercept treatment. Although data for patients aged 65 or greater in the long -term trials are limited, adverse events, including serious adverse events, occurred at a higher frequency for patients treated with 50 mg twice weekly.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. Serious and Opportunistic Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic (including protozoal), or other opportunistic pathogens have been reported in patients receiving TNF-blocking agents.
Tuberculosis, histoplasmosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, legionellosis, listeriosis, and pneumocystosis have been reported (see ADVERSE REACTIONS/Infections section). 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 RYMTI should not be initiated in patients with an active infection, including clinically important localized infections.
0 mL) and 50 mg/mL prefilled auto- injector pen glycine, sucrose, sodium chloride, sodium dihydrogen phosphate dihydrate, trisodium citrate dihydrate, water for injection RYMTI Page 9 of 87 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 RYMTI and during therapy as appropriate.
RYMTI 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 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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3 Administration Preparation of RYMTI Using the Single -use Prefilled Syringe or Single-use Prefilled Auto-injector pen: Before injection, allow RYMTI to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle cap while allowing the prefilled syringe o r autoinjector to reach room temperature.
Prior to administration, visually inspect the solution for particulate matter and discolouration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discoloured or cloudy, or if foreign particulate matter is present.
4 Missed Dose Patients who miss a dose of RYMTI should be advised to inject their dose as soon as they remember, then take the next dose at the regular(ly) scheduled time.
RYMTI Page 18 of 87 Among RA patients in placebo-controlled, active-controlled, and open-label trials of etanercept, infections and malignancies were the most common serious adverse events observed. Other infrequent serious adverse events observed in RA, PsA, AS or PsO clinical trials are listed below by body system: Cardiovascular: cardiomyopathy, fainting, heart failure, hypertension, hypotension, myocardial infarction, myocardial ischemia, deep vein thrombosis, thrombophlebitis Digestive: cholecystitis, diarrhea, esophageal ulcer, gastrointestinal hemorrhage, pancreatitis, appendicitis General: impaired healing, asthenia Hematologic/Lymphatic: lymphadenopathy, myelodysplastic syndrome, necrotizing granulomatous lymphadenitis Hepatic: hepatic disorder, hepatic steatosis Musculoskeletal: bursitis, fistula, fracture nonunion, polymyositis Nervous: anxiety, cerebral ischemia, convulsion, depression, multiple sclerosis Respiratory: asthma, dyspnea, pulmonary embolism, sarcoidosis Skin: worsening psoriasis Urogenital: membranous glomerulonephropathy, kidney calculus In a randomized controlled trial in which 51 patients with RA received etanercept 50 mg twice weekly and 25 patients received etanercept 25 mg twice weekly, the following serious adverse events were observed in the 50 mg twice weekly arm: gastrointestinal bleeding, normal pressure hydrocephalus, seizure, and stroke.
No serious adverse events were observed i n the 25 mg arm. In controlled trials, the proportion of patients who discontinued treatment due to adverse events was approximately 4% in both the etanercept and placebo treatment groups. The vast majority of these patients were treated with the recommended dose of 25 mg SC twice weekly.
In adult PsO studies, etanercept doses studied were 25 mg SC once or twice a week and 50 mg SC once or twice a week. In three randomized, placebo-controlled studies of adult patients with PsO, the safety profile for patients receiving 50 mg twice a week was similar to those receiving 25 mg once or twice weekly, and all were similar to placebo.
No cumulative toxicities were observed in long term studies in adult patients with PsO up to 144 weeks and AS up to 192 weeks. 26%) placebo-treated patients. 49). In the long-term open-label RA studies, the rate of death did not increase over time with increasing exposure to etanercept.
08%) etanercept-treated patients compared to 0 of 720 placebo-treated patients. 25). No deaths were reported in PsA, AS, or JIA studies. 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. Adverse reactions reported in at least 1% of all patients who received etanercept in placebo- controlled RA trials (including the combination methotrexate […]
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, RYMTI therapy should not be initiated. If inactive (‘latent’) tuberculosis is diagnosed, treatment should be started with anti-tuberculosis therapy before the initiation of RYMTI.
In this situation, the benefit/risk balance of RYMTI therapy should be very carefully considered. Anti-tuberculosis therapy should also be considered prior to initiation of RYMTI 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.
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 RYMTI, 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 RYMTI. Tuberculosis should be strongly considered in patients who develop a new infection during RYMTI 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 th ese 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.
RYMTI should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with RYMTI should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an RYMTI Page 10 of 87 immunocompromised patient, and antimicrobial therapy should be initiated, as appropriate.
In post-marketing studies of patients with JIA, 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 RYMTI should be discontinued immediately and appropriate therapy initiated.
Concurrent RYMTI 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 […]