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Pharmacological action Enbrel Injection
Enbrel Injection Tumor necrosis factor (TNF-α, TNF) is a key cytokine that supports the inflammatory process in rheumatoid arthritis. Increased TNF has also been found in the synovium and psoriatic plaques in patients with psoriatic arthritis, as well as in plasma and synovial tissue of patients with ankylosing spondylitis. Etanercept is a competitive inhibitor of TNF binding to its receptors on the cell surface and thus inhibits the biological activity of TNF.
TNF and lymphotoxin are proinflammatory cytokines that are associated with two clearly distinguishable receptors on tumor necrosis factor (FNOR) on the cell surface: 55 kilodaltons (p55) and 75 kilodaltons (P75). Both FNOR present in the body in the membrane-bound and free forms. Soluble FNOR regulate the biological activity of TNF.
TNF and lymphotoxin exist predominantly as gomotrimery their biological activity depends on cross-stitching FNOR located on the cell surface. Dimeric soluble receptors such as etanercept, have a greater affinity for TNF than monomeric receptors and, therefore, are much stronger competitive inhibitors of TNF binding to its cellular receptors. Furthermore, the use of immunoglobulin Fc, as an element in the structure of the dimeric binding receptor, prolongs the half-life of serum.
A significant portion of pathological changes in the joints of rheumatoid arthritis and ankylosing spondylitis, as well as changes in the skin in the form of psoriatic lesions arise due to the impact of pro-inflammatory molecules involved in the system, controlled by the FLN. Mechanism of action of etanercept, apparently, is the competitive inhibition of TNF binding to TNF receptors on the cell surface. Thus, etanercept prevents cellular responses mediated by TNF, tumor necrosis factor contributing to the biological inactivation. Etanercept may also modulate biologic responses controlled by additional molecules that transmit signals to downstream (eg, cytokines, adhesion molecules, or proteinases). These responses can either stimulate or control of TNF.
In patients with psoriatic arthritis Enbrel improves physical activity reduces the risk of destruction of peripheral joints.
Pharmacokinetics Enbrel Injection
Absorption
Etanercept is slowly absorbed from the site s / c injection, reaching a Cmax of approximately 48 hours after a single dose of Enbrel. The absolute bioavailability of 76%. With the introduction of Enbrel dose 2 times a week achieved a 2-fold higher equilibrium concentrations than after a single dose. After a single s / c injection 25 mg Enbrel average Cmax in plasma was 1.65 ± 0.66 mg / ml, AUC – 235 ± 96.6 mg × h / ml. Apparent saturation of clearance at the borders of the dose was observed.
Distribution
Concentration of etanercept on time is described by biexponential curve. The average value of Vd is 7.6 l, while the Vd at steady state of 10.4 liters.
Breeding
Etanercept is derived from the body slowly. T1 / 2 is about 80 hours in patients with rheumatoid arthritis clearance is approximately 0.066 l / h, which is slightly below the values of 0.11 L / h in healthy volunteers. Pharmacokinetic properties of etanercept in patients with rheumatoid arthritis, ankylosing spondylitis and psoriasis are similar.
The dose of Enbrel 50 mg 1 time per week bioequivalent dose of 25 mg, administered 2 times a week.
Pharmacokinetics in special clinical situations
In patients with acute renal or hepatic impairment increases the concentration of etanercept is not observed.
Apparent differences in the pharmacokinetics of etanercept in males and females.
Clearance and apparent Vd etanercept in patients 65 to 87 years are similar to those in patients younger than 65 years.
In children with juvenile idiopathic arthritis profile in serum concentrations similar to that in adult patients with rheumatoid arthritis. Modeling suggests that in older children (10-17 years) and adult patients, the level of etanercept in serum is approximately the same, but younger children will be significantly lower.
The average concentrations of etanercept in serum of children aged 4 to 17 years with psoriasis and children with juvenile idiopathic arthritis who received Enbrel, respectively, at a dose of 0.8 mg / kg, 1 time per week (maximum dose of 50 mg per week) and 0.4 mg / kg 2 times per week (maximum dose of 50 mg per week) for 12-48 weeks, were similar (1.6-2.1 mg / ml). The value of this index coincides with that of adult patients with psoriasis, which Enbrel was administered at a dose of 25 mg 2 times a week.
Indications for use of the drug Enbrel Injection
Rheumatoid arthritis
In combination with methotrexate, Enbrel is prescribed for adults for the treatment of active rheumatoid arthritis medium and high severity, where the answer to the basic anti-inflammatory drugs (DMARDs) including MTX has been inadequate.
Enbrel can be given as monotherapy in case of failure or intolerance to methotrexate.
Enbrel is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate therapy.
Juvenile idiopathic arthritis
Treatment of active juvenile idiopathic arthritis in children and adolescents aged 4-17 years who have had a lack of efficacy or intolerance to methotrexate.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to therapy was inadequate DMARD.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have traditional therapy has not led to significant improvement.
Psoriasis
Treatment of adults with moderate to severe psoriasis severity who have contraindications or intolerance to other systemic therapy including cyclosporine, methotrexate or PUVA-therapy.
Treatment of children 8 years and older with severe chronic psoriasis severity who have had inadequate response or intolerance to other systemic or phototherapy.
Dosage regimen Enbrel Injection
The drug is injected n / k. Enbrel treatment should be initiated and monitored by a physician experienced in diagnosing and treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis or psoriasis.
Enbrel in dosage form, lyophilized preparation of the solution in a dosage of 25 mg recommended for patients weighing less than 62.5 kg, including children.
Before preparing the recovered solution, the initial and subsequent drug administration is necessary to study the instructions for its use, which is located at the end of this section.
Adults
In rheumatoid arthritis the recommended dose is 25 mg two times a week with an interval of 3-4 days. Alternative dose – 50 mg 1 time per week.
If ankylosing spondylitis the recommended dose – 25 mg 2 times a week or 50 mg 1 time per week.
In psoriatic arthritis the recommended dose – 25 mg 2 times a week with an interval of 3-4 days or 50 mg 1 time per week.
In psoriasis, the recommended dose – 25 mg 2 times a week or 50 mg 1 time per week. Alternatively, you can assign Enbrel 50 mg 2 times a week for no more than 12 weeks. If necessary, further treatment Enbrel can be assigned a dose of 25 mg 2 times a week or 50 mg 1 time per week. Enbrel therapy should be carried out until until remission is usually less than 24 weeks. The introduction of the drug should be discontinued if after 12 weeks of treatment is observed positive dynamics of symptoms.
If necessary, re-appointment of Enbrel should be implemented, the duration of treatment mentioned above. It is recommended to appoint a dose of 25 mg 2 times a week or 50 mg 1 time per week.
The duration of therapy in some patients can exceed 24 weeks.
In elderly patients (aged 65 and over) there is no need to adjust either the dose or method of application.
Children
In juvenile idiopathic arthritis in children 4 years and older is determined by calculating the dose of 0.4 mg / kg body weight (maximum single dose 25 mg). The drug is injected two times a week at intervals of 3-4 days between doses.
In psoriasis in children 8 years and older is determined by calculating the dose 0.8 mg / kg body weight (maximum single dose 50 mg). The drug is injected 1 time per week as long as there is no remission, usually no more than 24 weeks. Treatment of drug should be discontinued if, after 12 weeks of therapy is observed positive dynamics of symptoms.
If necessary, re-appointment of Enbrel should be implemented, the duration of treatment mentioned above. Dose – 0.8 mg / kg body weight (maximum single dose 50 mg), 1 per week. In some cases, the duration of treatment may be more than 24 weeks.
If the kidney function and liver there is no need to adjust the dose.
How to use the drug Enbrel Injection
Preparation for injection
This drug should not be mixed in the same syringe or vial with any other drugs!
Instructions for storage of the drug Enbrel, including the recovered solution, are in the section “Storage”.
Select a clean well-lighted flat work surface. Eject the tray with a set of Enbrel injections for the refrigerator. Move back to other trays in the refrigerator. In the remaining tray should contain all items required for one injection. A list of these items is shown below. Use only the listed items. Do not use any other syringes.
- 1 vial containing the lyophilized drug Enbrel;
- 1 syringe filled with clear, colorless solvent;
- 2 empty syringe;
- 5 needles;
- 6 alcohol wipes.
If the tray does not have any of these items, do not use this tray.
Make sure that prepared for the use of a cotton swab after the injection. Check the expiry date on the vial and syringe. They should not be used after month and year specified in the “shelf life”.
Preparation dose injections of Enbrel for
Get a bottle of the drug Enbrel from the tray. Remove the plastic cap from the bottle Enbrel. Do not remove the aluminum ring around the neck of the bottle or stopper. Wipe the rubber stopper on the vial of a new alcohol wipe. After treatment with alcohol did not touch the tube with his hands and avoid contact her with any surface.
Put the bottle in a vertical position on a clean flat surface.
Unscrew the cap from the syringe with solvent, without touching the tip of a syringe and preventing its contact with any surface.
Putting a needle on a syringe
To maintain its sterility, the needle was placed in a plastic bag. Take one of the needles from the tray. Break the seal on the package with a needle, bending her over the long end up and down until it breaks. Remove the short, wide end of the plastic packaging. Hold the needle and container in one hand, insert the tip of the syringe needle into the hole and attach it to the needle, turning the syringe clockwise until they lock completely needle.
Carefully remove the plastic cap from the needle. To avoid damaging the needle does not bend or twist the cap is not at his disposal.
Adding solvent to the powder
In the bottle standing upright on a flat surface, to introduce the needle straight down through the center ring of a rubber stopper on the vial. If the needle is inserted correctly, it feels a slight resistance and then a “failure” at a time when the needle passes through the center tube. Do not inject the needle into the vial at an angle, as it can lead to bending of the needle and / or adding a solvent to the wrong vial.
Very slowly push the plunger until all the solvent will not appear in the vial. This will help prevent the formation of foam (many bubbles). After the solvent is added to the drug Enbrel, the piston can move up spontaneously.
Remove the syringe containing the solvent from the vial and needle and dispose of them.
Gently shake the bottle in a circular motion to dissolve the powder. Do not shake vial. Wait until complete dissolution of powder (usually less than 10 min.) The solution should be clear or slightly opalestsirovat, it can be colorless or pale yellow, with no lumps, flakes or particles. A certain amount of foam may remain in the vial – this is allowed.
Do not inject Enbrel if all the powder in the vial is not dissolved within 10 minutes. Start all over again with another tray.
A set of solution of the drug Enbrel from the vial
Amount of solution that should be recruited from the vial, determined by the attending doctor.
Get one of the empty syringe from the tray and remove his plastic bag.
Fasten a new needle from the tray on an empty syringe in the same way as for a syringe with the solvent (see Putting a needle on a syringe).
In the Enbrel vial standing on a flat surface, to introduce the needle straight down through the center circle rubber stopper on the vial. Do not inject the needle into the vial at an angle, as this could lead to inflection needles and / or to the wrong set of solution from the vial.
Not removing the needle, turn the bottle upside down and hold it at eye level. Slowly pull the plunger of the syringe and collect the necessary amount of liquid in the syringe.
As soon as the level of liquid in the syringe is reduced, you may have partially removed the needle from the vial, so that the needle tip was in the liquid.
Not removing the needle, check whether the syringe of air bubbles. Gently tap the syringe to move the air bubbles up the syringe closer to the tip. Slowly pushing the plunger to release air bubbles from the syringe into the vial. If at this time accidentally squeezed the liquid into the vial, slowly pull the plunger on the dial and a liquid back into the syringe. Dial into the syringe contents of the bottle, unless otherwise has been prescribed. For children to collect only a portion of the contents of the vial as directed by physician. After dialing the drug Enbrel from the vial, the syringe may contain some air.
Extract the needle from the syringe. If you picked up the excess solution, not re-enter the vial from the needle pulled out. If there is a surplus in the syringe solution by holding the syringe upright needle up at eye level, push the plunger and release the excess solution to obtain the necessary volume of his. Remove and discard the needle.
Get a new needle from the tray and secure it to the syringe, as indicated above (see Putting a needle on a syringe). With this needle to enter the drug Enbrel.
Selecting the injection
There are three areas where the drug Enbrel should enter: the front surface of the middle third of the thigh, anterior abdominal wall, with the exception of a diameter of 5 cm from the umbilicus, the outer surface of the shoulder. When self-administration should not be used outside of the shoulder.
Each successive administration of the drug should be carried out in different areas. The distance between the injection site should not be less than 3 cm not administer the drug in areas where the skin is painful, damaged, compacted or red. Exclude areas with scars or stretch marks. (It is convenient to write the place is the injection). Do not inject the drug directly to the sites elevated above the skin surface, thick, red, or spots of desquamation (“psoriatic plaques”).
Preparing the site of injection and infusion of the drug Enbrel
Hold the syringe needle upward, remove it from the air bubbles, slowly pushing the plunger to their expulsion.
Edit place the drug Enbrel alcohol wipe. Do not touch the treated area of skin prior to injection.
After the finished surface of the skin has dried, one hand take the skin in the crease. With your other hand to take the syringe like a pencil.
Rapid movement of short-type needle completely into the skin at an angle of 45 ° to 90 °. Do not inject the needle too slowly or with excessive force.
Once the needle is fully inserted into the skin, release the skin fold. Freed a hand to hold the base of the syringe that he had not moved. Then, by pushing the plunger, slowly introduce the whole uniform solution.
After emptying the syringe, remove the needle from the skin. Remove the needle at the same angle at which the introduction was carried out.
Do not rub the injection site. If necessary, you can put in place the introduction of the patch.
Storage solution of the drug Enbrel in the period between injections
By using two doses of the drug Enbrel one vial, the solution of the drug between the first and second injection should be stored in a refrigerator (2 ° -8 ° C). The bottle should be stored between doses in an upright position.
Each vial of the drug Enbrel after dissolving 25 mg lyophilisate in 1 ml of solvent to be used for a maximum of two injections of the same patient.
Repeated sampling from a vial of the drug Enbrel solution prepared
Get Enbrel solution from the refrigerator. Wait for 15-30 minutes to a solution of Enbrel vial has reached room temperature. Do not heat the drug Enbrel in any other way (for example, do not heat it in the microwave or hot water).
New alcohol wipe, wipe the cork on a bottle of the drug Enbrel. After treatment with alcohol did not touch the tube with his hands and avoid contact her with any surface.
To prepare the second dose of the drug Enbrel in a vial, follow the instructions in “Set Enbrel solution from the bottle” using a new, empty syringe, needle and napkins from the tray.
If enough of the solution in the vial for another dose of medication, dispose of the bottle and start afresh with a new tray.
After dialing the second dose of the drug Enbrel from the vial, the vial disposed (even if it remains a certain amount of solution).
Recycling
Do not reuse syringes and needles! Never put the cap back on the needle. Dispose of needle and syringe in accordance with the instructions.
Side Effect Enbrel Injection
Adverse reactions, depending on the frequency of occurrence were grouped as follows: Very common (> 1 / 10), common (> 1 / 100, <1 / 10), uncommon (> 1 / 1000, <1 / 100), rare (> 1 / 10 000, <1 / 1000), very rare (<1 / 10, 000), isolated cases (frequency can not be determined).
Infections and infestations: very often – infections (including upper respiratory tract infection, cystitis, skin infections); rare – serious infections (including pneumonia, abscess, septic arthritis, sepsis), rarely – tuberculosis, opportunistic infections (including invasive fungal, protozoan, bacterial and atypical mycobacterial infection).
From the hemopoietic system: Infrequent – thrombocytopenia, rarely – anemia, leukopenia, neutropenia, pancytopenia, and very rarely – aplastic anemia.
By the immune system: common – the formation of autoantibodies, rare – allergic / anaphylactic reactions (including angioedema, bronchospasm), and in rare cases – a syndrome of macrophage activation.
Central nervous system: rarely – seizures, symptoms of demyelination in the CNS, similar to those observed during multiple sclerosis or a state of local demyelination, such as optic neuritis and transverse myelitis.
The respiratory system: Infrequent – interstitial lung disease (including pneumonitis and pulmonary fibrosis).
From the digestive system: rarely – increased liver enzymes, autoimmune hepatitis.
Cardio-vascular system: rarely – worsening of congestive heart failure.
For the skin: common – itching infrequently – skin cancer, not related to melanoma, urticaria, rash, psoriasis (including the debut of the disease and pustular lesion, mainly soles and palms), rare – form of cutaneous 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 administration site reactions: very common – Local reactions after injection (including bleeding, subcutaneous hematoma, erythema, itching, pain, swelling), and often – a fever.
Additional information
Adverse reactions in adults
The frequency of drug discontinuation because of adverse reactions in controlled clinical trials in patients with rheumatoid arthritis was similar in patients treated with Enbrel and placebo. The treatment Enbrel were the most common reaction in the injection site.
Adverse reactions in children
The frequency and types of adverse reactions in children with juvenile idiopathic arthritis were similar to those observed in adult patients with rheumatoid arthritis. Differences from adults and additional information are listed below.
Infections were observed in clinical trials in patients with juvenile idiopathic arthritis were mild to moderate severity, and their views do not contradict those that are commonly found among outpatients. Reports of serious adverse events included varicella with signs of aseptic meningitis which resolved without complications, appendicitis, gastroenteritis, depression / personality disorders, skin ulcers, esophagitis / gastritis, aseptic shock caused by group A streptococcus, type 1 diabetes and soft tissue infections and postoperative wounds. 4 registered reports of macrophage activation syndrome in these patients.
The frequency and types of adverse reactions in children with psoriasis were similar to those observed in adults.
Contraindications to the use of the drug Enbrel Injection
- Sepsis or risk of sepsis;
- An active infection, including chronic or localized infections (including tuberculosis);
- Pregnancy
- Lactation;
- Children up to age 3 years (the solution contains benzyl alcohol);
- Hypersensitivity to etanercept or any other component of the dosage form.
Precautions should be prescribed the drug for demyelinating diseases, congestive heart failure, conditions of immune deficiency, blood dyscrasia, diseases predisposing to the development or activation of infections (diabetes mellitus, hepatitis).
Use of the drug Enbrel Injection during pregnancy and lactation
Pregnant women are not recommended for treatment Enbrel, as no experience of using this drug in these patients.
Women of childbearing age should not plan pregnancy during treatment with Enbrel.
It is not known whether etanercept is excreted in breast milk. Because immunoglobulins, like many other drugs may be excreted in human milk, either stop breastfeeding or stop taking Enbrel while breast-feeding.
Use in hepatic dysfunction
If abnormal liver function No dose adjustment is necessary.
Use in renal impairment
If the kidney function is not necessary to adjust the dose.
Cautions
Infections
Patients should be screened for infections before the appointment of Enbrel in the course of treatment and after completion of therapy, Enbrel, taking into account the average half-life of etanercept, equal to approximately 80 hours (7-300 hours).
If you are using Enbrel reported sepsis, tuberculosis and severe infections, including opportunistic, including invasive fungal infections. In a study of patients need to take into account the possibility of their opportunistic infections, such as endemic mycosis.
Patients who develop new infections during treatment with Enbrel should be monitored carefully. Receiving Enbrel should be discontinued if a patient develops a severe infection. Precautions should be prescribed Enbrel in patients with frequent or chronic infections or have a history of underlying disease, such as progressive or poorly controlled diabetes, which can promote infection.
Safety and efficacy of Enbrel in patients with chronic infections has not been evaluated.
Tuberculosis
Cases of active tuberculosis include miliary tuberculosis and tuberculosis of extrapulmonary localization.
Before his appointment as Enbrel, all patients should be screened for the presence of active or latent tuberculosis. The survey should include a detailed study of medical history regarding the presence of tuberculosis or contact with TB patients in the past, and data on previous or current immunosuppressive therapy. All patients should be made appropriate screening procedures (or local requirements), namely, tuberculin skin test and X-ray of the lungs. To keep in mind the possibility of false-negative tuberculin test, especially in severely ill or immunocompromised patients with status.
In the case of diagnosis of active tuberculosis Enbrel should not be given. Inactive tuberculosis diagnosis involves administering a standard anti-TB therapy before beginning treatment Enbrel. In this case, the ratio of benefits and risks of treatment Enbrel should be carefully analyzed.
All patients should be informed about the advisability of seeking medical attention with the appearance during treatment with Enbrel or after the complaints or symptoms characteristic of tuberculosis (eg persistent cough, weight loss, subfebrile).
Activation of hepatitis B virus
Cases of hepatitis B virus activation in patients carriers who received TNF inhibitors, including Enbrel. Before the appointment of Enbrel patients within the high risk of hepatitis B, it is necessary to undertake a diagnostic search. Particular caution should be exercised when administering Enbrel patients-carriers of the hepatitis B virus when they have symptoms of the disease, to discuss the possibility of specific therapy.
Exacerbation of hepatitis C
Cases of acute hepatitis C treatment Enbrel, although a clear causal link has been established.
Allergic reactions
Allergic reactions are often accompanied by receiving Enbrel. Allergic reactions, including the severity of the included angioedema and urticaria. If any serious allergic or anaphylactic reactions, stop taking Enbrel and start appropriate treatment.
Immunosuppression
When anti-TNF therapy, including and Enbrel, there is the possibility of suppression of defense mechanisms of the human body against infections and malignancies since TNF is involved in inflammation and modulates cellular immune response. However, in adult patients with rheumatoid arthritis during treatment with Enbrel showed no cases of delayed hypersensitivity of oppression, declining levels of immunoglobulin, or changes in the number of effector cell populations. In children with juvenile idiopathic arthritis, in rare cases developed symptoms of chickenpox, and aseptic meningitis which resolved without complications. Patients who were in contact with patients with chickenpox, you should temporarily stop taking Enbrel and appoint a preventative treatment against the virus immune globulin Varicella zoster.
Malignant lymphoproliferative disease and
In post-marketing period, were received reports of various malignancies (including carcinomas of the breast and lung, lymphoma).
Lymphoma was diagnosed more often in patients taking TNF inhibitors than in patients who have not received them. On the other hand, these cases were rare, and the period of observation of 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 inflammatory disease, which complicates the risk assessment. In line with current knowledge we can not exclude the possible risk of developing lymphoma or other malignancies in patients treated with TNF inhibitors.
Skin Cancer, not related to melanoma (FCNM)
FCNM was reported in patients treated with TNF inhibitors, including Enbrel. Most often diagnosed in FCNM patients with psoriasis. For all patients at risk, periodic examinations of the skin.
Education autoimmune antibodies
Enbrel treatment may be accompanied by the formation of autoimmune antibodies. These antibodies are not neutralizing and usually disappear quickly. There was no correlation between antibody response and clinical efficacy of the drug and the frequency of adverse reactions. Isolated cases of the formation of additional antibodies in combination with lupus-like syndrome or a rash, similar to the subacute form of lupus erythematosus or discoid form of lupus erythematosus (clinical examination and biopsy) have been reported in patients, including patients with rheumatoid arthritis with positive rheumatoid factor.
Hematologic reactions
Reported on rare occasions, pancytopenia and very rare cases of aplastic anemia, including fatal, in patients receiving Enbrel. Should exercise care in prescribing Enbrel to patients with a history of blood dyscrasia. All of the patients, their relatives / carers should be aware that if a patient while receiving Enbrel develop signs and symptoms of infection or hematologic disorders (such as prolonged fever, sore throat, bruising, bleeding, pallor), they should seek immediate medical attention. In these patients, it is recommended to conduct a survey, including complete blood count. When the diagnosis is confirmed dyscrasia, treatment with Enbrel should be discontinued.
CNS
Several cases of CNS disorders resulting from demyelination in adult patients receiving Enbrel. Although Enbrel has not been studied in patients with multiple sclerosis, studies of other TNF inhibitors with concomitant disease showed the possibility of relapse.
It is recommended before prescribing Enbrel to carefully assess the risk / benefit, including the neurological status in patients with previous or recent onset demyelinating disease, or those for which there is an increased risk of developing demyelinating disease.
Combination therapy
The combination of Enbrel and methotrexate did not produce unexpected results in the study of security. Long-term study of this indicator continues. Enbrel Safety Data, which is administered together with methotrexate, were similar to data from periodic safety reports Enbrel and methotrexate alone. Long-term safety of Enbrel in the admission basis with other anti-inflammatory drugs has not been investigated.
Congestive heart failure
Caution must be exercised in the appointment of Enbrel in patients with congestive heart failure. Several studies suggest the possibility of worsening of congestive heart failure in patients receiving Enbrel.
Alcoholic hepatitis
It should be particularly careful when assigning Enbrel in patients with alcoholic hepatitis and moderately severe illness.
Wegener’s granuloma
The incidence of malignant tumors of various types vnekozhnoy localization was significantly higher in patients treated with Enbrel than in the control group. Therefore, Enbrel is not recommended for patients with Wegener’s granulomatosis.
Use in Pediatrics
There is enough experience with Enbrel in children younger than 4 years.
In the solvent composition of the drug Enbrel is benzyl alcohol, which can cause toxic and anaphylactic reactions in children under 3 years. Therefore, Enbrel should not be given in this category under any circumstances.
Effects on ability to drive and control mechanisms
Studies of the effect on driving ability and complex mechanisms are not carried out.
Overdose Enbrel Injection
When treating patients with rheumatoid arthritis have been reported exceeding the limit toxic dose. The highest dose, which was introduced in the I / O, was 32 mg/m2, followed by n / a Introduction 16 mg/m2, 2 times a week. One patient with rheumatoid arthritis independently mistakenly injected 62 mg of Enbrel p / 2 times a week for 3 weeks without the appearance of undesirable effects. The specific antidote to Enbrel is unknown.
Drug Interactions Enbrel Injection
In adult patients on combined therapy Enbrel and anakinra showed a significant increase in the incidence of serious infections and neutropenia compared with patients who were administered only Enbrel. Joint reception Enbrel and anakinra has not shown clinical benefit and, therefore, not recommended.
Simultaneous appointment of abatacept and Enbrel was accompanied by an increased frequency of serious adverse events. This combination of drugs has not demonstrated clinical benefit and, therefore, not recommended.
In patients who during treatment with sulfasalazine was administered Enbrel, described a significant reduction in the average number of leukocytes compared with those patients who took Enbrel or just only sulfasalazine.
There were no adverse interactions with a joint appointment with Enbrel GCS, salicylates (except sulfasalazine), NSAIDs, analgesics.
Methotrexate has no effect on the pharmacokinetics of etanercept. Effect of methotrexate on the pharmacokinetics of Enbrel in humans has not been studied.
Not detected clinically significant mutual influence on the pharmacokinetics of digoxin, while the application and Enbrel.
Not detected clinically significant mutual influence on the pharmacokinetics, while the use of warfarin and Enbrel.
Live vaccines should not be administered during treatment with Enbrel. No evidence of secondary transmission of infection by live vaccines in patients receiving Enbrel. It is recommended that prior to treatment Enbrel, patients as possible were fully immunized in accordance with the national immunization schedule.
