Enbrel - Instructions For Use, Price, Reviews, Drug Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Enbrel

Enbrel: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Enbrel

ATX code: L04AB01

Active ingredient: etanercept (Etanercept)

Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG (Boehringer Ingelheim Pharma GmbH & Co. KG) (Germany); Vetter Pharma-Fertigung GmbH (Germany); Pfizer Ireland Pharmaceuticals (Ireland); Wyeth Pharmaceuticals (UK); Pfizer MFG. Belgium N. V. (Pfizer MFG. Belgium, NV) (Belgium)

Description and photo update: 2018-27-11

Prices in pharmacies: from 11323 rubles.

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Enbrel is an immunosuppressive agent with anti-inflammatory action.

Release form and composition

• lyophilisate for the preparation of a solution for subcutaneous (s / c) administration: white porous mass or lyophilized powder (10/25 mg each in a colorless glass vial, sealed with a rubber stopper and rolled up with an aluminum cap equipped with a plastic tear-off disk of the FLIP OFF type). The kit with the lyophilisate includes: solvent - a transparent colorless liquid (1 ml in a disposable syringe made of colorless glass), an injection needle - 1 pc., Alcohol wipes - 2 pcs., An adapter for a bottle - 1 pc. The kit is placed in a plastic bag and sealed with adhesive paper; in a cardboard box 4 packages;
• solution for subcutaneous administration: slightly opalescent or transparent, pale yellow or colorless liquid, with the possible presence of small amorphous protein inclusions, transparent colorless or white [1 ml (50 mg) or 0.5 ml (25 mg) in a disposable syringe made of colorless glass, equipped with a stainless steel needle, closed with a double-layer cap; a set of 4 syringes and 4 alcohol wipes in a plastic wrap sealed with paper; in a cardboard box 1, 2 or 6 packs (for 25 mg) or 1, 2 or 3 packs (for 50 mg); 1 ml (50 mg) in a disposable syringe pen with a white plastic needle cap and a purple protective shield, inside the pen is a colorless glass syringe equipped with a stainless steel needle; a set of 4 syringe pens and 4 alcohol wipes in a plastic bag, sealed with paper;in a cardboard box 1 package].

Each pack also contains instructions for the use of Enbrel.

1 bottle with lyophilisate contains:

• active substance: etanercept - 10 or 25 mg;
• additional components: sucrose, mannitol, trometamol (in the form of a mixture of trometamol hydrochloride and trometamol until a pH value of 7.4 is reached).

Solvent: water for injection - 1 ml.

1 ml of solution contains:

• active substance: etanercept - 50 mg;
• additional components: sodium dihydrogen phosphate dihydrate, sodium chloride, arginine hydrochloride, sodium hydrogen phosphate dihydrate, sucrose, water for injection.

Pharmacological properties

Pharmacodynamics

Etanercept is a tumor necrosis factor [TNF; TNF-α (tumor necrosis factor-α)], which is the main cytokine that supports the inflammatory process in rheumatoid arthritis. An increased level of TNF was also detected in psoriatic plaques and synovial membranes against the background of psoriatic arthritis, as well as in synovial tissues and blood plasma with ankylosing spondylitis.

As a competitive inhibitor of the binding of TNF to its cellular receptors, etanercept, as a result, inhibits the biological activity of TNF. Lymphotoxin and TNF are pro-inflammatory cytokines that form a bond with two clearly distinguishable TNF receptors (TNF) located on the cell surface: 75-kilodalton (p75) and 55-kilodalton (p55). Both of these FNORs are found in the body in free and membrane-bound forms. The biological activity of TNF is controlled by soluble TNF.

Lymphotoxin and TNF exist mainly in the form of homotrimers, their biological activity depends on the cross-linking of TNFs localized on the cell surface. Etanercept and other dimeric soluble receptors have a higher affinity for TNF than monomeric receptors and, as a result, are significantly more potent competitive inhibitors of TNF binding to their cellular receptors. In addition, the use of the Fc-fragment of immunoglobulin as a binding element in the structure of the dimeric receptor prolongs the half-life (T _1/2) from blood serum.

Most of the joint disorders associated with rheumatoid arthritis and ankylosing spondylitis, as well as skin changes such as psoriatic plaques, are formed as a result of exposure to pro-inflammatory molecules that are part of the TNF-regulated system.

Presumably, the mechanism of action of etanercept consists in competitive suppression of the binding of TNF to TNF on the cell surface, which prevents the cellular response mediated by TNF and promotes the biological inactivation of the latter. Enbrel also has the ability to modulate biological responses controlled by additional molecules such as cytokines, adhesion molecules or proteinases (downstream). And these responses are capable of either controlling or stimulating TNF.

Enbrel helps to improve physical activity, reduce the risk of peripheral joint damage and reduce the growth of structural damage in patients with psoriatic arthritis.

After completion of drug therapy, an exacerbation of the disease may occur for a month. The effect of repeated treatment within 24 months after the cessation of previous therapy is comparable to that for patients using Enbrel without interruption.

Pharmacokinetics

Etanercept is slowly absorbed from the site of subcutaneous injection and reaches its maximum concentration (C _max) approximately 48 hours after the administration of a single dose. The absolute bioavailability is 76%, in the case of administration of Enbrel twice a week, it is possible to achieve equilibrium concentrations 2 times higher than those achieved after using a single dose.

After a single injection of s / c etanercept at a dose of 25 mg, the average C _max in the plasma of healthy volunteers was 1.65 ± 0.66 μg / ml, and the area under the concentration-time curve (AUC) reached 235 ± 96.6 μg × h / ml. There was no apparent saturation of clearance within the dose range. The time dependence of etanercept concentration is described by a biexponential curve. The average value of the volume of distribution (V _d) is 7.6 liters, and when an equilibrium state is reached, this indicator is 10.4 liters.

Etanercept is slowly eliminated from the body, T _1/2 is approximately 70 hours. In the presence of rheumatoid arthritis in patients, the clearance of the substance is approximately 0.066 l / h, which is slightly less than that in healthy volunteers, which is 0.11 l / h. The pharmacokinetic parameters of etanercept in patients with ankylosing spondylitis, rheumatoid arthritis, and psoriasis are similar.

The administered single dose of Enbrel 50 mg, bioequivalent to the dose, which is obtained by two injections of 25 mg, produced almost simultaneously.

Although in patients and healthy volunteers after injection of labeled etanercept, the radioactive label is excreted through the kidneys, in the presence of acute renal or hepatic failure, no increase in its plasma concentration in the blood was noted. No dose adjustment is required in patients with hepatic / renal impairment.

No clear differences in the pharmacokinetics of etanercept in men and women have been identified.

In children with juvenile idiopathic polyarthritis, the serum concentration profile of the substance is similar to that in adults with rheumatoid arthritis. Based on the modeling of pharmacokinetic processes, it can be assumed that in children aged 10-17 years, the level of etanercept in serum will approximately correspond to that of adult patients, and in young children, the concentration of the substance will be significantly lower.

Stationary concentrations of etanercept in blood plasma in patients aged 4-17 years with psoriasis and in patients of the same age group with juvenile idiopathic polyarthritis who received Enbrel, respectively, 0.8 mg / kg once a week, and 0.4 mg / kg 2 times a week (the maximum weekly dose in both cases - no more than 50 mg) for 48 and 12 weeks, were similar and amounted to 1.6-2.1 μg / ml. These values were similar to those in adult psoriasis patients who used Enbrel twice a week at a dose of 25 mg.

Indications for use

All forms of Enbrel's release are recommended for the treatment of the following diseases / conditions:

• active juvenile idiopathic polyarthritis (seropositive and seronegative for lyophilisate 25 mg and solution for subcutaneous administration) in children and adolescents aged 2-17 years (for solution for subcutaneous administration - over 12 years old and weighing more than 62.5 kg), with insufficient effectiveness or intolerance to methotrexate;
• chronic psoriasis of severe severity in children from 6 years of age and older (for a solution for subcutaneous administration - over 12 years old and weighing more than 62.5 kg) with intolerance to other systemic therapy or phototherapy, as well as in case of insufficient response to their conduct.

Additional indications for Enbrel lyophilisate at a dosage of 25 mg and a solution for subcutaneous administration:

• rheumatoid arthritis: active rheumatoid arthritis of moderate to high severity in adults, in the case when the response to basic anti-inflammatory drugs (DMARDs), including methotrexate, was inadequate, or as a monotherapy drug for methotrexate intolerance; severe, active and progressive rheumatoid arthritis in adults who have not previously received methotrexate therapy;
• juvenile idiopathic polyarthritis: common oligoarthritis in children and adolescents over the age of 2 years (for the solution - over 12 years old and weighing more than 62.5 kg), with insufficient effectiveness or intolerance to methotrexate; psoriatic arthritis in adolescents over 12 years old (for solution - also weighing more than 62.5 kg), with insufficient effectiveness or intolerance to methotrexate; enthesitis-associated arthritis in adolescents over 12 years of age (for solution - also weighing more than 62.5 kg), with insufficient effect or intolerance to standard treatment;
• psoriatic arthritis (active and progressive) in adults, in the case when the response to DMARD treatment was inadequate;
• axial spondyloarthritis: severe active ankylosing spondylitis in adults, with no significant improvement after conventional therapy; pre-X-ray stage of severe axial spondyloarthritis in adult patients who had an inadequate response or resistance to standard treatment, as well as objective signs of lesion activity, confirmed by an increase in the concentration of C-reactive protein (CRP) and / or by MRI scan data;
• psoriasis (moderate to severe) in adults, with contraindications or intolerance to other systemic treatment, which includes methotrexate, cyclosporine or PUVA therapy.

Contraindications

Absolute:

• active infection, including chronic or localized infections;
• sepsis or risk of sepsis;
• pregnancy and the period of breastfeeding;
• age under 12 years old and body weight less than 62.5 kg - for a solution for subcutaneous administration;
• hypersensitivity to any of Enbrel's constituents.

Relative (use an immunosuppressive agent with extreme caution):

• chronic heart failure (CHF);
• demyelinating diseases;
• state of immunodeficiency;
• lesions predisposing to the development / activation of infections (hepatitis, diabetes mellitus);
• hepatitis C;
• moderate / severe alcoholic hepatitis;
• nervous diseases (optic neuritis, multiple sclerosis, transverse myelitis);
• dyscrasia of blood.

Enbrel, instructions for use: method and dosage

Enbrel should be injected into the subcutaneous fatty tissue in the skin fold.

Drug therapy should be prescribed and monitored by a physician experienced in the diagnosis and treatment of juvenile idiopathic polyarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

Enbrel in the form of a ready-made solution of 25/50 mg in a disposable syringe containing, respectively, 0.5 / 1 ml of solution, or 50 mg in a syringe pen containing 1 ml of solution, should be used in patients weighing more than 62.5 kg. With a body weight of less than 62.5 kg (including children), it is required to use a lyophilisate to prepare a solution that allows you to enter a dose below 25 mg.

Before administering the drug, you must carefully study the instructions.

It is forbidden to mix Enbrel with other drugs in the same syringe or bottle!

Recommended dosing regimen for adults:

• psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, pre-radiological stage of the axial form of spondyloarthritis: it is recommended to use Enbrel 2 times a week, 25 mg at intervals of 3-4 days; alternatively, the agent is allowed to be used once a week at a dose of 50 mg, which can be administered by means of 1 s / c injection of 50 mg or 2 injections of 25 mg, made almost simultaneously;
• psoriasis: it is recommended to use the drug 2 times a week at 25 mg with an interval of 3-4 days, it is also allowed to use the drug once a week at a dose of 50 mg, which can be administered by 1 s / c injection of 50 mg or 2 injections of 25 mg produced almost simultaneously; alternatively, it is possible to inject 50 mg 2 times a week for no more than 12 weeks; if it is necessary to continue therapy, then the agent should be used 2 times a week at a dose of 25 mg or 1 time per week at 50 mg; Enbrel is used until remission is achieved and, as a rule, no longer than 24 weeks; if, 12 weeks after the start of the course, there is no positive response to treatment, therapy should be discontinued.

In some cases, the duration of Enbrel therapy can be more than 24 weeks.

In adult patients, depending on the state of health and as prescribed by the doctor, drug treatment can be carried out continuously or intermittently. If re-appointment is required, the duration of therapy indicated above should be observed. It is recommended to use the product 2 times a week at 25 mg or 1 time per week at 50 mg.

In children, the dose of etanercept is set based on body weight. Patients over 12 years old and with a body weight of 62.5 kg or more can use Enbrel in the form of a solution for subcutaneous administration in syringes or syringe pens for single use.

Recommended dosing regimen for children:

• juvenile idiopathic polyarthritis, common oligoarthritis (lyophilisate - for children over 2 years old, solution - for adolescents over 12 years old with a weight over 62.5 kg); psoriatic arthritis or arthritis associated with enthesitis (for adolescents over 12 years old, additionally for a solution - weighing more than 62.5 kg): it is recommended to use Enbrel 2 times a week with an interval of 3-4 days, a single dose for a lyophilisate is 0.4 mg / kg, for solution - 25 mg; the maximum single dose should not be higher than 25 mg; therapy should be completed if, 4 months after its start, it is not possible to achieve positive dynamics of symptoms; it is allowed to administer a dose once a week, which is 0.8 mg / kg for a lyophilisate, and 50 mg for a solution; the maximum single dose is 50 mg;
• psoriasis (lyophilisate - for children from 6 years old; solution - for adolescents over 12 years old with a weight of more than 62.5 kg): it is recommended to inject once a week, a single dose for a lyophilisate - 0.8 mg / kg, for a solution - 50 mg; the maximum single dose is not higher than 50 mg, the duration of therapy should not exceed 24 weeks; if, 12 weeks after the start of the course, no therapeutic effect is observed, treatment with the drug should be discontinued; if it is necessary to repeat the course, it is required to observe the duration of therapy indicated above, introducing Enbrel 1 time per week at a dose of 0.8 mg / kg, with a maximum single dose of 50 mg.

If a dose has been missed, Enbrel should be used as soon as possible, provided that the next injection should be carried out no earlier than every other day. Otherwise, you should skip the forgotten dose and give the next injection as usual.

It is recommended to inject the drug into the following areas of the body: the anterior surface of the middle third of the thigh, abdomen (except for the 5 cm area around the navel), the outer surface of the shoulder. Each introduction should be made in a new place, at a distance of at least 3 cm from the previous one. Do not inject into areas where there is soreness, redness, bruising, induration, or scars / stretch marks. If Enbrel is administered to a child with psoriasis, it is necessary to avoid injections into areas raised above the surface of the skin, reddened, thickened, or into lesions with scaling.

In preparation for the procedure, you should thoroughly wash your hands and select a well-lit, clean, flat work surface. The plastic packaging for the administration of one dose of the lyophilisate should contain: 1 vial of powder, 1 syringe with water for injection (solvent), 1 injection needle, 1 adapter for the vial and 2 alcohol wipes. When introducing Enbrel, only the items included in this set should be used. On the labeling of the syringe and vial, you must check the expiration date (month and year).

Before the injection, you should take out the contents of the package and remove the plastic cap from the vial with lyophilisate, without removing the aluminum ring and the rubber stopper around its neck. Having treated the cork with an alcohol wipe, do not allow it to come into contact with any surface, and also do not touch it with your hands. Place the vial upright on a clean surface and remove the paper covering from the vial adapter packaging. After that, without removing the adapter from the plastic packaging, it must be placed on the vial with the drug so that the tip of the adapter is located in the center of the raised circle on the bottle cap. Firmly holding the bottle on the working surface with one hand, with the other, press straight down on the package with the adapter until its tip completely passes through the bottle cap and the rim falls into place.

After removing the plastic wrap from the adapter, break off the protective cap of the solvent syringe along the perforated line without removing the remainder of the white cap on the syringe. Holding the adapter in one hand and the glass barrel of the syringe in the other, connect the adapter to the syringe by inserting its tip into the hole and turning clockwise until it is fully connected. To add solvent, push the plunger very slowly (to prevent foaming) until all of the solvent is in the vial. After that, without disconnecting the syringe, it is necessary to carefully rotate the vial without shaking until the lyophilisate dissolves completely (about 10 minutes). The prepared solution should be colorless, transparent and free of lumps, flakes or any other visible particles. A small amount of white foam is allowed in the bottle.

In order to draw the solution from the vial without disconnecting the syringe from the adapter, raise the vial upside down to eye level and press the plunger so that it completely enters the syringe. Slowly pulling the plunger and absorbing the required dose of solution, holding the bottle upside down, unscrew the syringe from the adapter by turning it counterclockwise.

Next, put the needle on the syringe, breaking the seal on the plastic package and removing its short, wide part. Holding the needle and container in one hand, it is required to insert the tip of the syringe into the hole of the needle and turn the latter clockwise until it is fully connected. Carefully removing the cap from the needle, without bending or twisting it, it is necessary to slowly push the plunger to remove air bubbles from the syringe.

When preparing for an injection of Enbrel in the form of a solution for subcutaneous administration in a syringe or pen, it is recommended to remove one pre-filled syringe / pen from the box in the refrigerator without shaking. Leave it on the working surface, without removing the needle cap, at room temperature for 15-30 minutes. It is forbidden to heat the solution in any other way! After assessing the state of the solution visually and making sure of its suitability, you can prepare the injection site and proceed with the injection.

The area of the skin into which Enbrel will be injected must be wiped with a circular motion with a clean alcohol wipe and then do not touch this area until the procedure. After the skin on the site has dried, collect it in a fold with the thumb and forefinger of one hand, and hold it until the drug is injected. The other hand is required, after removing the cap from the needle, hold the syringe like a pencil, and then with a quick short movement, direct the needle into the skin at an angle of 45–90 °. When it completely enters the skin, you need to release the fold, push the plunger and inject the solution at a slow constant rate.

When using a solution from a pen, after removing the needle cap, a purple protective screen will be visible at the end of the pen, while the needle itself will remain protected, being inside the pen until the moment of activation. During the procedure, the syringe pen should be firmly pressed against the prepared injection site with its open end so that the protective screen is completely hidden inside the syringe. In order to inject the solution, it is required to press and immediately release the green activation button located at the top of the syringe pen. After releasing the button, a click will be heard, then the syringe pen must be pressed tightly against the skin for about 10 seconds until the second click, which will indicate the completion of the injection, after which the protective screen will automatically extend and close the needle. For the complete introduction of the solution, do not hold down the button.

After the introduction of Enbrel, the injection site should be pressed with a cotton swab (without rubbing) for 10 seconds. There may be a slight bleeding, which is allowed to apply a bandage.

The syringe / pen and needles are for single use only. They cannot be reused.

Side effects

• infectious and parasitic diseases: very often - infections (including bronchitis, upper respiratory tract infections, cystitis,); infrequently - severe infections (including pneumonia, sepsis, phlegmon, septic arthritis, parasitic invasions); rarely - mycobacterial infections (including tuberculosis), opportunistic infections (including bacterial, invasive fungal, atypical mycobacterial, protozoal, atypical viral infections and diseases caused by Legionella); isolated cases - activation of hepatitis B, infections due to Listeria;
• immune system: often - the formation of autoimmune antibodies, allergic reactions; infrequently - systemic vasculitis (including ANCA-associated vasculitis); rarely - sarcoidosis, severe allergic / anaphylactic reactions (including angioedema, bronchospasm), some cases - macrophage activation syndrome; increased severity of symptoms of dermatomyositis (for lyophilisate 10 mg);
• hematopoietic organs and lymphatic system: infrequently - thrombocytopenia; rarely - leukopenia, anemia, pancytopenia, neutropenia; extremely rare - aplastic anemia;
• unspecified, benign, malignant neoplasms (including cysts and polyps): infrequently - skin cancer not related to melanoma (PKHM); rarely - melanoma, lymphoma; isolated cases - Merkel's carcinoma, leukemia;
• nervous system: rarely - seizures, demyelination phenomena in the central nervous system (CNS), similar to those observed in states of local demyelination or multiple sclerosis (including transverse myelitis, optic neuritis); extremely rare - peripheral demyelinating diseases, including chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome; multifocal motor neuropathy (MMN) demyelinating polyneuropathy (for solution);
• skin and subcutaneous tissue: often - itchy skin; infrequently - rash, psoriasis-like rash, urticaria, psoriasis (including the onset or worsening of the disease and pustular lesions, mainly of the palms and soles), angioedema; rarely - erythema multiforme, Stevens-Johnson syndrome, cutaneous forms of vasculitis; extremely rare - toxic epidermal necrolysis;
• cardiovascular system: rarely - worsening of the course of CHF;
• respiratory system, chest and mediastinal organs: infrequently - interstitial lung disease (including pulmonary fibrosis, pneumonitis);
• organ of vision: infrequently - scleritis, uveitis;
• hepatobiliary system: rarely - increased activity of liver enzymes, autoimmune hepatitis;
• musculoskeletal system and connective tissue: rarely - discoid lupus erythematosus, cutaneous manifestations of subacute lupus erythematosus, lupus-like syndrome;
• general disorders and reactions at the injection site: very often - at the injection site, swelling, pain, itching, the formation of subcutaneous hematoma, bleeding, erythema; often fever.

According to the results of clinical studies, during treatment in adults, reactions at the site of the Enbrel injection were most common. The maximum frequency of these violations was observed in the first month of using the drug, and then gradually decreased. These undesirable effects were in most cases transient and were observed for about 4 days. In some cases, during their development at the injection site, reactions also occurred at the sites of previous injections.

The frequency and types of side effects of Enbrel in children were predominantly similar to those observed in adult patients. The most common disorders were infections. In clinical studies in children with juvenile idiopathic polyarthritis aged 2–18 years, the appearance of side effects of moderate / mild severity, and the type corresponding to those usually found in children treated on an outpatient basis, was revealed. In rare cases, patients under the age of 18 have had severe reactions such as chickenpox, symptoms of aseptic meningitis (passed without complications), gastroenteritis, esophagitis / gastritis, appendicitis, septic shock (caused by group A streptococci), depression / personality disorders, infections of soft tissues and postoperative wounds, skin ulcers, type 1 diabetes mellitus.

Overdose

In case of an overdose of Enbrel, you should immediately contact your doctor or pharmacist. The carton should be kept from the injected drug, even if it is empty.

The maximum dose of Enbrel has not been determined. In the course of a clinical study, healthy volunteers received the drug once at a dose of 60 mg / m², which did not cause the development of toxic phenomena requiring dose limitation. When treating patients with rheumatoid arthritis, there were no cases of exceeding the maximum toxic dose. The maximum dose administered intravenously was 32 mg / m², with further subcutaneous administration 2 times a week at 16 mg / m².

Enbrel's specific antidote is unknown.

special instructions

Before using the drug Enbrel, during the period of therapy and after its completion, patients should be examined for infections, given that T _{1/2 of} etanercept is approximately 70 hours (7–300 hours). The examination requires taking into account the risk of developing opportunistic infections, such as endemic mycoses. Patients who develop new infections during the period of treatment need careful monitoring. If a severe infection develops, treatment should be discontinued.

The efficacy and safety of Enbrel in patients with chronic infectious lesions and in patients with immunosuppression has not been evaluated.

During therapy, cases of the development of active tuberculosis, including miliary tuberculosis and extrapulmonary tuberculosis, were recorded. The appearance of these lesions may be due to the reactivation of a latent infection or the development of a new infection. Before treatment with the drug, all patients should be examined for both active and latent tuberculosis. It is also required to take into account the likelihood of a false-negative tuberculin test, especially in patients with impaired immunity or in serious condition.

In the presence of active tuberculosis, Enbrel should not be used. In the case of existing inactive tuberculosis, before starting treatment, it is necessary to carry out standard anti-tuberculosis therapy according to local recommendations. In this case, it is required to carefully analyze the ratio of the benefits and risks of using Enbrel. If you experience weight loss, persistent cough, low-grade fever and other symptoms characteristic of tuberculosis during treatment with a drug, you should definitely consult a doctor.

There are reports of the activation of the hepatitis B virus in patients with carriers who received TNF inhibitors. Most of these cases were observed with the combined use of Enbrel with other drugs that suppress the immune system, which can also lead to reactivation of the hepatitis B virus.

During treatment with TNF inhibitors, cases of leukemia have been observed. The risk of leukemia and lymphoma is exacerbated by the presence of rheumatoid arthritis, which is a long-term lesion characterized by active inflammation, which in itself makes risk assessment difficult.

In patients receiving Enbrel, isolated cases of pancytopenia and aplastic anemia, including with a fatal outcome, were recorded. If there is a history of blood disorders, special care should be taken during the period of use of the drug. If, during treatment, the patient develops signs and symptoms typical of infection or hematological disorders (tonsillitis, prolonged fever, bleeding, bruising, pallor), it is necessary to urgently receive medical attention and conduct an examination, including a complete blood count. If a hematological disorder is confirmed, therapy must be discontinued.

The safety of long-term treatment with Enbrel in combination with other DMARDs has not been established. The use of the drug in combination with other systemic therapy or phototherapy for psoriasis has not been studied.

During treatment in patients taking antidiabetic drugs, there were cases of hypoglycemia, which required a change in the dose of these drugs.

Influence on the ability to drive vehicles and complex mechanisms

Since the effect of etanercept on the ability to drive vehicles and complex equipment has not been studied, when performing these types of work against the background of treatment with Enbrel, patients should be careful.

Application during pregnancy and lactation

There is no experience of using Enbrel in pregnant women, and therefore its use during pregnancy, as well as in women planning pregnancy, is contraindicated.

It is known that etanercept passes through the placenta, the clinical significance of this fact has not been established. However, children whose mothers have used the drug during pregnancy may have an increased sensitivity to infections. Newborns should not receive live vaccines for 16 weeks after their mothers received the last dose of Enbrel.

Women of reproductive age are required to use reliable contraceptive methods during the period of treatment with Enbrel, as well as within three weeks after its end.

After subcutaneous injection, etanercept passes into breast milk. If it is necessary to use the drug during lactation, you should stop breastfeeding.

Pediatric use

The safety and efficacy of using Enbrel for the treatment of juvenile idiopathic polyarthritis and advanced oligoarthritis in children under 2 years of age have not been studied.

The safety and efficacy of Enbrel therapy for psoriasis in children under 6 years of age, as well as arthritis associated with enthesitis, and psoriatic arthritis in children under 12 years of age, have not been studied.

With impaired renal function

In patients with impaired renal function, there is no need to change the dose of Enbrel.

For violations of liver function

In patients with impaired liver function, there is no need to change the dose of Enbrel.

Use in the elderly

V _d and etanercept clearance values at age 65–87 years are similar to those in patients under 65 years of age. It is not required to adjust the dosage regimen of Enbrel in old age.

Drug interactions

• abatacept: increased risk of increased frequency of serious adverse reactions; this combination is not recommended;
• anakinra: significantly increased the incidence of neutropenia and serious infections, when compared with the use of these drugs in the form of monotherapy drugs; since this combination has not demonstrated clinical benefit, it is not recommended;
• sulfasalazine: there was a decrease in the number of leukocytes compared with patients receiving only etanercept or only sulfasalazine;
• glucocorticosteroids, non-steroidal anti-inflammatory drugs, salicylates (except for sulfasalazine), methotrexate, analgesics: no unwanted interactions were detected in patients with rheumatoid arthritis;
• methotrexate: there was no effect on the pharmacokinetic processes of etanercept, the effect on the pharmacokinetics of methotrexate was not studied;
• warfarin, digoxin: there was no clinically significant effect on the pharmacokinetics of etanercept.

Live vaccines should not be administered during drug therapy. There is no data confirming the secondary transmission of infection through the live vaccine during the use of Enbrel. Children and adolescents should, if possible, receive all necessary vaccinations according to the current national immunization schedule before starting treatment. In the overwhelming number of patients with psoriatic arthritis, when using the drug, an increase in the B-cell immune response to the pneumococcal polysaccharide vaccine was observed, while the titers were generally somewhat lower. In a significantly smaller number of patients, antibody titers were twice as high when compared with those in patients who did not receive Enbrel.

Analogs

Enbrel's analogs are: Infliximab, Remicade, Simponi, Humira, Actemra, Orencia, Efalizumab, Rituxan.

Terms and conditions of storage

Keep out of the reach of children.

Store the drug at 2–8 ° C without freezing. The solvent is stored at a temperature not exceeding 30 ° C.

The shelf life is 3 years.

The solution prepared from the lyophilisate should be used within 6 hours.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Enbrel

According to many reviews, Enbrel is an effective agent that inactivates tumor necrosis factor and significantly attenuates the inflammatory process against the background of autoimmune diseases. The drug does not lead to addiction, which makes it possible to carry out repeated courses after a break in treatment. Patients indicate a good result of using the drug for the treatment of rheumatoid arthritis in adults and juvenile rheumatoid arthritis in children.

The disadvantages of Enbrel include the development of unwanted reactions and its high cost.

The price of Enbrel in pharmacies

The price for Enbrel can be:

• lyophilisate for preparation of a solution for subcutaneous administration per set containing 4 bottles: 10 mg - 12800-15800 rubles, 25 mg - 22000-28800 rubles;
• solution for subcutaneous administration of 50 mg / ml per set containing 4 syringes: 53,100 rubles.

Enbrel: prices in online pharmacies

Drug name Price Pharmacy

Enbrel 10 mg lyophilisate for preparation of solution for subcutaneous administration 4 pcs. RUB 11323 Buy

Enbrel 25 mg lyophilisate for preparation of solution for subcutaneous administration complete with solvent 4 pcs. RUB 23,000 Buy

Enbrel 50 mg / ml solution for subcutaneous administration 1 ml 4 pcs. RUB 38,000 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!