Eticovo
- Generic Name: etanercept injection
- Brand Name: Eticovo
Eticovo (Etanercept Injection) side effects drug center
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- infections (such as upper respiratory infections, nasopharyngitis, sinusitis, and influenza),
- injection site reactions,
- diarrhea,
- rash,
- itching,
- fever, and
- hives
- Serious Infections [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Neurologic Reactions [see WARNINGS AND PRECAUTIONS]
- Malignancies [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Patients with Heart Failure [see WARNINGS AND PRECAUTIONS]
- Hematologic Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatitis B Reactivation [see WARNINGS AND PRECAUTIONS]
- Allergic Reactions [see WARNINGS AND PRECAUTIONS]
- Autoimmunity [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
Eticovo (etanercept-ykro) is a tumor necrosis factor (TNF) blocker indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and plaque psoriasis (PsO) in patients 4 years or older. Eticovo is biosimilar to Enbrel (etanercept). Common side effects of Eticovo include:
The dose of Eticovo to treat adult rheumatoid arthritis and psoriatic arthritis is 50 mg once weekly with or without methotrexate (MTX). The dose of Eticovo to treat ankylosing spondylitis is 50 mg once weekly. The dose of Eticovo to treat adult plaque psoriasis is 50 mg twice weekly for 3 months, followed by 50 mg once weekly. The dose of Eticovo to treat pediatric plaque psoriasis or plaque psoriasis (patients who weigh 63 kg or more) is 50 mg once weekly. Eticovo may interact with “live vaccines,” anakinra, abatacept, and cyclophosphamide, and sulfasalazine. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant or plan to become pregnant before using Eticovo; it is unknown how it would affect a fetus. Eticovo passes into breast milk in low levels. Consult your doctor before breastfeeding.
Our Eticovo (etanercept-ykro) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Eticovo Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Clinical Trials Experience
Across clinical studies and postmarketing experience, the most serious adverse reactions with etanercept were infections, neurologic events, CHF, and hematologic events [see WARNINGS AND PRECAUTIONS]. The most common adverse reactions with etanercept were infections and injection site reactions.
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice.
Adverse Reactions In Adult Patients With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Or Plaque Psoriasis
The data described below reflect exposure to etanercept in 2219 adult patients with RA followed for up to 80 months, in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patients with PsO for up to 18 months.
In controlled trials, the proportion of etanercept-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied.
Adverse Reactions In Pediatric Patients
In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients [see WARNINGS AND PRECAUTIONS , Use In Specific Populations , and Clinical Studies].
In a 48-week clinical study in 211 children aged 4 to 17 years with pediatric PsO, the adverse reactions reported were similar to those seen in previous studies in adults with PsO. Long-term safety profile for up to 264 additional weeks was assessed in an open-label extension study and no new safety signals were identified.
In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children.
Infections
Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric patients. Infections have been noted in all body systems and have been reported in patients receiving etanercept alone or in combination with other immunosuppressive agents.
In controlled portions of trials, the types and severity of infection were similar between etanercept and the respective control group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RA and adult PsO patients are provided in Table 3 and Table 4, respectively. Infections consisted primarily of upper respiratory tract infection, sinusitis and influenza.
In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in etanercept/etanercept + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in adult PsO patients, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extension trials and was similar to that observed in etanercept-and placebo-treated patients from controlled trials.
In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed in approximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohort studies in the U.S. and Canada, tuberculosis was observed in approximately 0.006% of patients. These studies include reports of pulmonary and extrapulmonary tuberculosis [see WARNINGS AND PRECAUTIONS].
The types of infections reported in pediatric patients with PsO and JIA were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.
Injection Site Reactions
In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with etanercept developed injection site reactions. In controlled trials in patients with PsO, 15% of adult patients and 7% of pediatric patients treated with etanercept developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given.
Other Adverse Reactions
Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patients with PsA or AS were similar to the types of adverse reactions seen in patients with RA.
Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials
| Reaction | Placebo Controlleda (Studies I, II, and a Phase 2 Study) |
Active Controlledb (Study III) |
||
| Placebo (N=152) |
Etanerceptc (N=349) |
MTX (N=217) |
Etanerceptc (N=415) |
|
| Percent of Patients | Percent of Patients | |||
| Infectiond (total) | 39 | 50 | 86 | 81 |
| Upper Respiratory Infectionse | 30 | 38 | 70 | 65 |
| Non-upper Respiratory Infections | 15 | 21 | 59 | 54 |
| Injection Site Reactions | 11 | 37 | 18 | 43 |
| Diarrhea | 9 | 8 | 16 | 16 |
| Rash | 2 | 3 | 19 | 13 |
| Pruritus | 1 | 2 | 5 | 5 |
| Pyrexia | - | 3 | 4 | 2 |
| Urticaria | 1 | - | 4 | 2 |
| Hypersensitivity | - | - | 1 | 1 |
| a Includes data from the 6-month study in which patients received concurrent MTX therapy in both arms. b Study duration of 2 years. c Any dose. d Includes bacterial, viral and fungal infections. e Most frequent Upper Respiratory Infections were upper respiratory tract infection, sinusitis and influenza. |
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In placebo-controlled adult PsO trials, the percentages of patients reporting adverse reactions in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group.
Table 4 summarizes adverse reactions reported in adult PsO patients from Studies I and II.
Table 4. Percent of Adult PsO Patients Experiencing Adverse Reactions in Placebo-Controlled Portions of Clinical Trials (Studies I & II)
| Reaction | Placebo (N=359) |
Etanercepta (N=876) |
| Percent Patients | ||
| Infectionb (total) | 28 | 27 |
| Non-upper Respiratory Infections | 14 | 12 |
| Upper Respiratory Infectionsc | 17 | 17 |
| Injection Site Reactions | 6 | 15 |
| Diarrhea | 2 | 3 |
| Rash | 1 | 1 |
| Pruritus | 2 | 1 |
| Urticaria | - | 1 |
| Hypersensitivity | - | 1 |
| Pyrexia | 1 | - |
| a Includes 25 mg subcutaneous (SC) once weekly (QW), 25 mg SC twice weekly (BIW), 50 mg SC QW, and 50 mg SC BIW doses. b Includes bacterial, viral and fungal infections. c Most frequent Upper Respiratory Infections were upper respiratory tract infection, nasopharyngitis and sinusitis. |
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Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other etanercept products may be misleading.
Immunogenicity
Patients with RA, PsA, AS or PsO were tested at multiple time points for antibodies to etanercept. Antibodies to the TNF receptor portion or other protein components of the etanercept drug product were detected at least once in sera of approximately 6% of adult patients with RA, PsA, AS or PsO. These antibodies were all non-neutralizing. Results from JIA patients were similar to those seen in adult RA patients treated with etanercept.
In adult PsO studies that evaluated the exposure of etanercept for up to 120 weeks, the percentage of patients testing positive at the assessed time points of 24, 48, 72 and 96 weeks ranged from 3.6%-8.7% and were all non-neutralizing. The percentage of patients testing positive increased with an increase in the duration of study; however, the clinical significance of this finding is unknown. No apparent correlation of antibody development to clinical response or adverse events was observed. The immunogenicity data of etanercept beyond 120 weeks of exposure are unknown.
In pediatric PsO studies, approximately 10% of subjects developed antibodies to etanercept by Week 48 and approximately 16% of subjects developed antibodies to etanercept by Week 264. All of these antibodies were non-neutralizing. However, because of the limitations of the immunogenicity assays, the incidence of binding and neutralizing antibodies may not have been reliably determined.
The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay.
Autoantibodies
Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40) was higher in patients treated with etanercept (11%) than in placebo-treated patients (5%). The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients). The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. In RA Study III, no pattern of increased autoantibody development was seen in etanercept patients compared to MTX patients [see WARNINGS AND PRECAUTIONS].
Postmarketing Experience
Adverse reactions have been reported during post approval use of etanercept products in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to etanercept exposure.
Adverse reactions are listed by body system below:
Blood and lymphatic system disorders: pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia [see WARNINGS AND PRECAUTIONS]
Cardiac disorders: congestive heart failure [see WARNINGS AND PRECAUTIONS]
Gastrointestinal disorders: inflammatory bowel disease (IBD)
General disorders: angioedema, chest pain
Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation
Immune disorders: macrophage activation syndrome, systemic vasculitis, sarcoidosis
Musculoskeletal and connective tissue disorders: lupus-like syndrome
Neoplasms benign, malignant, and unspecified: melanoma and non-melanoma skin cancers, Merkel cell carcinoma [see WARNINGS AND PRECAUTIONS]
Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias [see WARNINGS AND PRECAUTIONS]
Ocular disorders: uveitis, scleritis
Respiratory, thoracic and mediastinal disorders: interstitial lung disease
Skin and subcutaneous tissue disorders: cutaneous lupus erythematosus, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all subtypes including pustular and palmoplantar)
Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use.
Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving etanercept, which is not effective for the treatment of IBD.
Read the entire FDA prescribing information for Eticovo (Etanercept Injection)
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