Buy Enbrel solution 50 mg/ml 1 ml syringes + wipes 4 pcs

Etanercept

Brand Pfizer

In stock 1951 Items

Available since: 2019-09-19

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Clinical Pharmacology

ENBREL - a drug with anti-inflammatory action. Tumor necrosis factor alpha inhibitor (TNF-α).

Indications

Treatment of moderate or severe active rheumatoid arthritis (in combination with methotrexate or as monotherapy).
Treatment of moderate and severe active polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.
To reduce symptoms and slow the progression of structural damage in active arthritis and improve function in patients with psoriatic arthritis.
To reduce symptoms in patients with active ankylosing spondylitis.
For the treatment of adult patients (aged 18 years and older) with chronic moderate or severe psoriasis (with plaques), which are shown systemic therapy or phototherapy.

Composition

Etanercept 50 mg;

Excipients: arginine hydrochloride, sodium chloride, sucrose, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water d / and.

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Dosage and Administration

Enbrel injected s / c. A single dose for adults is 50 mg, for children aged 8 to 17 years - 800 mg / kg (but not more than 50 mg per week). For children 4 years and older, the dose is determined on the basis of 400 mcg / kg of body weight (maximum single dose of 25 mg). The drug is administered 2 times a week at intervals of 3-4 days between doses.

Frequency of administration and duration of use depend on the indications and tolerability of treatment.

Treatment must be administered and monitored by a physician experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic polyarthritis, psoriatic arthritis, ankylosing spondylitis, or psoriasis.

Adverse reactions

Adverse reactions, depending on the frequency of occurrence, were grouped as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, 1/10 000, <1/1000 ), very rarely (Infections and invasions: very often - infections (including upper respiratory tract infections, cystitis, skin infections); infrequently - serious infections (including pneumonia, cellulitis, septic arthritis, sepsis); rarely - tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial and atypical mycobacterial infections).
From the hemopoietic system: infrequently - thrombocytopenia; rarely - anemia, leukopenia, neutropenia, pancytopenia; very rarely - aplastic anemia.
On the part of the immune system: often - the formation of autoantibodies; rarely, allergic / anaphylactic reactions (including angioedema, bronchospasm); in isolated cases - macrophage activation syndrome.
On the part of the central nervous system: rarely - seizures, demyelination symptoms in the central nervous system, similar to those observed in multiple sclerosis or a state of local demyelination, such as optic neuritis and transverse myelitis.
On the part of the respiratory system: Infrequently - interstitial lung diseases (including pneumonitis and pulmonary fibrosis).
On the part of the digestive system: rarely - increased activity of liver enzymes, autoimmune hepatitis.
Since the cardiovascular system: rarely - the deterioration of congestive heart failure.
On the part of the skin: often - itching; infrequently, skin cancer not related to melanoma, urticaria, rash, psoriasis (including debut of the disease and pustular lesions, mainly of the soles and palms); rarely, skin forms of vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme; very rarely, toxic epidermal necrolysis.
On the part of the musculoskeletal system and connective tissue: skin manifestations of subacute lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome.
General disorders and reactions at the injection site: very often - local reactions after injections (including bleeding, subcutaneous hematoma, erythema, itching, pain, swelling); often - fever.
Additional Information
Adverse reactions in adults
The frequency of drug withdrawal due to the development of adverse reactions in controlled clinical trials in patients with rheumatoid arthritis was comparable in patients receiving Enbrel and placebo. Against the background of treatment with Enbrel, the most common reactions were at the injection site.
Adverse reactions in children
The frequency and types of adverse reactions in children with juvenile idiopathic polyarthritis were similar to those seen in adult patients with rheumatoid arthritis. Differences from adults and additional data are given below.
Infections that were observed in clinical studies in patients with juvenile idiopathic arthritis were mild and moderate in severity, and their types did not contradict those that are usually found among outpatients. Reports of severe adverse events included varicella with symptoms of aseptic meningitis that resolved without complications, appendicitis, gastroenteritis, depression / personality disorders, skin ulcers, esophagitis / gastritis, aseptic shock caused by group A streptococci, diabetes mellitus type 1 and soft tissue infections and postoperative wounds. Four reports of macrophage activation syndrome were recorded in these patients.
The frequency and types of adverse reactions in children with psoriasis were similar to those observed in adult patients.

Contraindications

Sepsis or conditions with an increased risk of its development; severe active infections, including chronic or localized infections; simultaneous use with inhibitors of interleukin 1 (including anakinry); pregnancy and lactation; children up to 3 years; hypersensitivity to etanercept.

Carefully the drug should be prescribed for demyelinating diseases, congestive heart failure, immunodeficiency states, blood dyscrasia, diseases predisposing to the development or activation of infections (diabetes, hepatitis).

Drug interactions

In adult patients with combination therapy with Enbrel and Anakra, there was a significant increase in the incidence of serious infections and neutropenia compared with patients who were only administered Enbrel. The joint reception of Enbrel and Anakinra showed no clinical advantage and, therefore, is not recommended.
The simultaneous administration of abatacept and Enbrel was accompanied by an increase in the incidence of serious adverse events. This combination of drugs has not demonstrated clinical benefits and, therefore, is not recommended.
In patients who were given Enbrel during the treatment with Sulfasalazinee, a significant decrease in the average number of leukocytes compared with those patients who took Enbrel or only Sulfasalazine was described.
No undesirable interactions were observed with co-administration of Enbrel with GCS, salicylates (with the exception of Sulfasalazinee), NSAIDs, analgesics.
Methotrexate does not affect the pharmacokinetics of etanercept. The effect of Enbrel on the pharmacokinetics of methotrexate in humans has not been studied.
No clinically significant mutual effect on pharmacokinetics was detected with simultaneous use of digoxin and Enbrel.
No clinically significant mutual effect on pharmacokinetics was detected with simultaneous use of warfarin and Enbrel.
Live vaccines should not be administered during treatment with Enbrel. There is no data on the secondary transmission of infection through live vaccine to patients receiving Enbrel. It is recommended that, before the start of treatment with Enbrel, patients should, if possible, receive all vaccinations in accordance with the current national immunization schedule.

Special instructions

Infections
Patients should be screened for infections before Enbrel is prescribed, during treatment and after the course of Enbrel therapy is completed, taking into account the average half-life of etanercept for approximately 80 hours (7-300 hours).
When using Enbrel, it was reported about sepsis, tuberculosis and severe infections, including opportunistic, including invasive fungal infections. When examining patients it is necessary to take into account the possibility of developing opportunistic infections in them, for example, endemic mycoses.
Patients in whom new infections develop during treatment with Enbrel should be carefully monitored. Enbrel should be discontinued if the patient develops a severe infection. With care, Enbrel should be prescribed to patients with a history of frequent or chronic infections or with a underlying disease, such as progressive or poorly controlled diabetes, which may contribute to the development of infections.
The safety and efficacy of Enbrel in patients with chronic infections has not been evaluated.
Tuberculosis
Cases of active tuberculosis included miliary tuberculosis and extrapulmonary tuberculosis localization.
Prior to the appointment of Enbrel, all patients should be examined for the presence of active or latent tuberculosis. The examination should include a detailed study of the medical history regarding tuberculosis or the presence of contacts with tuberculosis patients in the past, and data on previous or current immunosuppressive therapy. All patients should have appropriate screening procedures (according to local requirements), namely, a tuberculin skin test and lung radiography.It is necessary to bear in mind the possibility of a false-negative tuberculin test, especially in seriously ill patients or patients with immunocompromised status.
In the case of diagnosis of active tuberculosis Enbrel should not be appointed. The diagnosis of inactive tuberculosis involves the prescription of standard anti-tuberculosis therapy before starting treatment with Enbrel. In this case, the ratio of the benefits and risks of treatment with Enbrel should be carefully analyzed.
All patients should be informed about the appropriateness of going to a doctor when complaints or symptoms characteristic of tuberculosis (for example, persistent cough, weight loss, subfebrileity) appear on the background of treatment with or after Enbrel.
Hepatitis B virus activation
Reported cases of activation of the hepatitis B virus in patients-carriers who received TNF inhibitors, including Enbrel. Before prescribing Enbrel to patients at high risk for hepatitis B, an appropriate diagnostic search should be performed. Special care should be taken when prescribing Enbrel to patients with hepatitis B virus. When symptoms of this disease appear in them, discuss the possibility of specific therapy.
Exacerbation of hepatitis C
Cases of exacerbation of hepatitis C have been reported during treatment with Enbrel, although no clear causal link has been established.
Allergic reactions
Allergic reactions often accompany Enbrel. Allergic reactions, including severe course included angioedema and urticaria. For any severe allergic or anaphylactic reactions, Enbrel should be stopped immediately and appropriate treatment should be initiated.
Immunosuppression
With anti-TNF therapy, incl. and Enbrel, there is the possibility of inhibition of the protective mechanisms of the human body against infections and malignant tumors, since TNF is involved in the processes of inflammation and modulates the cellular immune response. However, in adult patients with rheumatoid arthritis during treatment with Enbrel, no cases of inhibition of delayed hypersensitivity, a drop in the level of immunoglobulin or a change in the number of the effector cell population were detected. Children with juvenile idiopathic arthritis rarely developed chickenpox and symptoms of aseptic meningitis, which were resolved without complications. Patients who have been in contact with chickenpox patients should temporarily stop taking Enbrel and give prophylactic treatment with immunoglobulin against Varicella zoster virus.
Malignant and lymphoproliferative diseases
In the post-marketing period, reports on various malignant neoplasms (including breast and lung carcinoma, and lymphoma) were obtained.
More often, lymphoma was diagnosed in patients taking TNF inhibitors than in patients who did not receive them. On the other hand, these cases were rare, and the observation period for patients from the placebo group was shorter than for patients treated with TNF inhibitors. In addition, there is a high risk of lymphoma in patients with rheumatoid arthritis - a protracted, highly active inflammatory disease that complicates risk assessment. In accordance with current knowledge, the possible risk of developing lymphomas or other malignant neoplasms in patients receiving TNF inhibitors cannot be ruled out.
Skin cancer not related to melanoma (FCNM)
FCNM was registered in patients treated with TNF inhibitors, including Enbrel. Most often, the FCNM is diagnosed in patients with psoriasis. For all patients at risk, periodic examination of the skin is recommended.
The formation of autoimmune antibodies
Enbrel treatment may be accompanied by the formation of autoimmune antibodies.These antibodies do not belong to neutralizing and usually disappear quickly. There was no correlation between antibody formation and the clinical efficacy of the drug, as well as the incidence of adverse reactions. Isolated cases of the formation of additional autoantibodies in combination with lupus-like syndrome or a rash similar to the subacute form of lupus erythematosus or discoid lupus erythematosus (clinical examination and biopsy) were observed in patients, including patients with rheumatoid arthritis with positive rheumatoid factor.
Hematologic reactions
It was reported about rare cases of pancytopenia and very rare cases of aplastic anemia, incl. fatalities in patients receiving Enbrel. Caution should be exercised when prescribing Enbrel to patients with a history of blood dyscrasia. All patients, their relatives / carers should be aware that if a patient develops signs and symptoms during an Enbrel intake that are characteristic of an infection or hematological disorders (for example, prolonged fever, sore throat, bruises, bleeding, pallor), they should seek medical attention immediately. In such patients, it is recommended to conduct an examination, including a complete blood count. When confirming the diagnosis of dyscrasia, Enbrel treatment should be discontinued.
CNS defeat
Several cases of CNS disorders caused by demyelination have been reported in adult patients receiving Enbrel. Although Enbrel has not been studied in patients with multiple sclerosis, studies of other TNF inhibitors with this comorbid disease have shown the possibility of exacerbation.
It is recommended that before prescribing Enbrel, the risk / benefit, including neurological status, be carefully assessed in patients with a previous or recent attack of a demyelinating disease or in those for whom there is an increased risk of developing a demyelinating disease.
Combination therapy
The combination of Enbrel and Methotrexate did not give unexpected results in a safety study. Long-term study of this indicator continues. The safety data of Enbrel, which was administered with methotrexate, was similar to the data from the periodic safety reports of Enbrel and Methotrexate separately. Long-term safety when taking Enbrel with other basic anti-inflammatory drugs has not been investigated.
Congestive heart failure
Caution should be exercised in prescribing Enbrel to patients with congestive heart failure. Data from a number of studies suggest the possibility of worsening the course of congestive heart failure in patients receiving Enbrel.
Alcoholic hepatitis
Special care should be taken when prescribing Enbrel to patients with moderate-to-severe alcoholic hepatitis.
Wegener's granulomatosis
The incidence of malignant tumors of various types of extracutaneous localization was significantly higher in patients receiving Enbrel than in the control group. Therefore Enbrel is not recommended for the treatment of patients with Wegener's granulomatosis.
Use in Pediatrics
There is not enough experience with Enbrel in children under 4 years of age.
The composition of the drug solvent Enbrel includes benzyl alcohol, which can cause toxic and anaphylactic reactions in children under 3 years of age. Therefore Enbrel should not be appointed to this category under any circumstances.
Influence on ability to drive motor transport and control mechanisms
Studies on the ability to drive and complex mechanisms have been conducted.

Overdosage

When treating patients with rheumatoid arthritis, no excess of the marginal toxic dose was recorded.The highest dose, introduced in / in, amounted to 32 mg / m2, followed by sc injection of 16 mg / m2 2 times a week. One patient with rheumatoid arthritis mistakenly self-administered 62 mg Enbrel n / a 2 times a week for 3 weeks without any undesirable effects.
The specific antidote for Enbrel is unknown.