Enbrel®

definition

Enbrel® contains the active ingredient Etanercept and is a prescription drug. It is available as an injection vial with the substance in the form of dry powder, which is used to prepare a solution, or as an injection solution in pre-filled syringes and pens.

Mode of action

Etanercept is a genetically engineered one Fusion protein (it consists of two proteins), which is another human protein called tumor necrosis factor alpha / tumor necrosis factor alpha (TNF-a) binds and thus inactivates. This is an important initiator and Mediator of inflammatory reactions in the body and is present in increased amounts with the corresponding disease. It is thus a anti-inflammatory drug.

application areas

Due to its mode of action, it is used in diseases in which there is an excessive inflammatory reaction. It is used for:

  • moderate to severe rheumatoid arthritis in adults (aged 18 years and over). The main cause here is pathological inflammation in the joints. It is used together with methotrexate (MXT), a standard medication for rheumatoid-inflammatory diseases, if the administration of MXT alone has not produced the desired treatment success. It can also be prescribed on its own if there is an oversensitivity to MXT.

  • Psoriatic arthritis that other treatments have not responded to.

  • Severe ankylosing spondyloarthritis, also known as Bechterew's disease, if other therapies have not worked. This is a disease in which there is an inflammatory stiffening of the spine.

  • certain types of juvenile idiopathic arthritis (in children and adolescents) where the cause of the joint inflammation is unclear. E.g. is it for enthesitis-associated arthritis (joints and visual attachments are both affected at the same time), when other treatment approaches do not produce the desired treatment success or other therapy options are not suitable.

Read more on the topic: Rheumatoid arthritis

Enbrel® for psoriasis

Enbrel® can be used to treat moderate and severe forms of psoriasis (psoriasis). Usually, however, therapy with the drug is only considered if other conventional treatment attempts have not achieved sufficient success. However, it has been shown that Enbrel® with its active ingredient Etanercept has a comparatively poor effect on the skin symptoms of psoriasis.
Under certain circumstances, however, the use of Enbrel® for psoriasis can still be recommended: Enbrel® has been shown to have a good effect on the inflammatory joint disease psoriatic arthritis.

Read more on the topic: Treatment of psoriasis

type of application

The finished drug is administered in its usual dose (25 mg) twice a week or in double the dose (50 mg) once a week subcutaneously (under the skin). For children and adolescents, an individual dosage is usually determined by the doctor.

It can be given with or without meals.

dosage

Enbrel® is available in different dosages, with 25mg or 50mg being prescribed in most cases. The syringes usually have to be placed under the skin once or twice a week. The doctor will order the appropriate dosage depending on the patient's illness and circumstances.

For children, the doctor will determine the appropriate dosage and dosage intervals according to body weight, age and illness. It is important to always use Enbrel® exactly as directed by the doctor and to consult with you if you are unsure. Even if the effect of the drug is perceived as too strong or too weak, you should definitely contact the doctor in charge.

Contraindications and Precautions

If there is an allergy to the active ingredient etanercept or to other components of the drug, in the case of blood poisoning (sepsis) and it must not be used for current infections.

In the case of the following diseases, increased caution and prior information and education by the doctor is indicated:

  • Tuberculosis: reactivation or re-infection with tuberculosis bacteria can occur here. A previous medical history, a chest X-ray and a tuberculin test can be performed before taking Enbrel® in order to minimize the risk. If typical symptoms of tuberculosis such as prolonged cough, significant weight loss, slightly increased fever and listlessness occur during treatment, the doctor should be informed immediately.

  • Granulomatous polyangiitis (also Wegener's granulomatosis): This rare immune disease is not treated with Enbrel®, although the body also reacts incorrectly to itself.

  • Chickenpox, hepatitis B and hepatitis C: These virus-caused diseases, like tuberculosis, which is bacterial, can recur or worsen an infection. Therefore, a benefit and risk should also be carefully weighed here.

  • Operations: Even during major surgery, the use of Enbrel® should be monitored and changed if necessary, as operations represent a serious interference with the physical balance and sometimes unforeseen changes can occur.

  • Neurological diseases such as multiple sclerosis (pathological demyelinating in the central nervous system), optic nerve inflammation (Optic neuritis) or transverse myelitis (inflammation that is localized in the spinal cord) require careful consideration by the doctor.

What should be considered when stopping?

When stopping Enbrel® there is nothing special to consider. Unlike some other medications, tapering is not required. However, it is often possible that symptoms that were alleviated by taking Enbrel® reappear after discontinuation, as the drug usually does not lead to a cure but only to contain the disease and its symptoms

What are the alternatives to Enbrel®?

Enbrel® is approved for the treatment of a wide variety of diseases and the alternatives to the drug are therefore primarily based on the disease to be treated.

For the treatment of psoriasis (psoriasis), medication in the form of ointments is usually used first, and additional medication such as Enbrel® or similar products are often not necessary.

In rheumatic diseases, cortisone preparations and the drug methotrexate are not just alternatives but first-choice. Accordingly, there are usually a large number of alternative therapy options for all other diseases for which Enbrel® can be used for treatment.

What are biologics?

Biologics are protein substances that are produced using biotechnology and that inhibit inflammatory reactions in the body. The mechanism of action of biologicals is based on a blockade of inflammatory messenger substances in the body.
This is used in the treatment of chronic inflammatory diseases. Enbrel® or its active ingredient Etanercept. is directed against the particularly important messenger substance "tumor necrosis factor alpha".

Read more on the topic: Biologics

Side effects

Since the drug inhibits a central mediator of the immune system, not only pathological, i.e. pathological, but also physiological, i.e. health-promoting and necessary inflammatory reactions that cause a defense against microorganisms (bacteria, viruses, parasites, etc.) and other harmful influences are influenced .

Since everyone reacts differently to drugs, the side effects listed below need not occur, but they are possible.

  • Allergic reactions, which can be expressed as swelling of the face, throat or extremities. It can also lead to severe rashes with itching and hives.

  • Infections such as colds, bronchitis or urinary tract infections occur very frequently, i.e. in more than 10% of users.

  • Reactions at the puncture site that manifest themselves as local redness, bleeding or pain.

  • Frequently, i.e. in 1-10% of users, there is a fever or the formation of autoantibodies (antibodies that are wrongly produced against their own body tissue).

  • Occasionally, up to 1% of users, serious infections such as lung infections, blood infections or joint infections can occur. It can also lead to skin cancer (except melanoma), a reduced number of blood platelets (high risk of bleeding and bruising), inflammation of the eyes, lungs including scarring and blood vessels.

  • Lymphoma or melanoma (both types of cancer) can occur rarely, i.e. in up to 0.1% of users. Furthermore, it can lead to sarcoidosis (inflammatory immune disease affecting the whole body), serious damage to the nervous system including severe muscle weakness and other symptoms similar to those found in diseases of the nervous system such as multiple sclerosis or spinal cord inflammation. In addition, there is an isolated or combined decrease in all types of cellular components of the blood such as red blood cells, neutrophils (a type of white blood cell) and blood platelets (thrombocytes). In addition, lupus or lupus-like symptoms can develop. A tuberculosis infection can flare up again (e.g. there can be an acute outbreak of a silent, latent infection) or inflammation of the liver with increased liver values, which is caused by the body itself, also called autoimmune hepatitis.

  • Very rarely, in less than 0.01% of users, there may be general functional disorders of the bone marrow and the associated severe disruption of blood cell formation, since the bone marrow is the main production site for blood cells in adults.

In individual cases, a certain form of skin cancer (Merkel cell carcinoma), recurrence of a certain form of virus-induced liver inflammation (hepatitis B), worsening of dermatomyositis (inflammatory changes in the muscles and skin), leukemia (a type of blood cancer) or a There may be an excessive inflammatory reaction affecting the whole body, which occurs due to excessive activation of macrophages and is called macrophage activation syndrome.

fatigue

Fatigue is a fairly unspecific symptom that can have a variety of possible causes. Under certain circumstances it can also occur as a side effect when using Enbrel®.
In very rare cases, for example, it is possible that the drug may lead to a decreased production of red blood cells. The resulting anemia (anemia) can initially manifest itself as tiredness.
Likewise, illnesses such as urinary tract infections or a cold can occur more frequently during treatment with Enbrel®, which can also lead to fatigue, among other things. In addition, symptoms such as coughing and runny nose or burning sensation when urinating usually occur.

Serious illnesses caused by the drug can also lead to fatigue, among other things. In case of doubt, it is best to discuss with the doctor who prescribed the drug whether the tiredness may be related to the use of Enbrel®.

cancer

Treatment with Enbrel® can in some cases actually promote or trigger the occurrence of certain cancers. These include on the one hand cancers affecting the blood system, which are known as leukemia. On the other hand, a special form of skin cancer (Merkel cell carcinoma) can occur more frequently.

In contrast to other possible side effects of Enbrel, however, it cannot be said how often cancer is caused by taking the drug. This is due to the fact that the current knowledge from scientifically collected data is not sufficient to assess this.
Patients who are taking Enbrel® must therefore be checked regularly. In the event that a serious illness such as cancer occurs, it can then at best be treated early.

skin rash

A rash is a relatively common possible side effect of Enbrel®. This usually occurs as part of an allergic reaction to the active ingredient of the drug. Other possible symptoms include shortness of breath, fever and itching. The rash can occur without any further signs of an allergic reaction.

The rash can develop immediately after injecting the syringe, but it can also develop after a few hours or days. It is possible that the skin on the entire body is affected or only certain parts of the body are showing the rash. However, since a skin rash can have many other possible causes, the attending physician should be consulted if a side effect is suspected. If necessary, the treatment with Enbrel® must be stopped. Medicines to treat the allergic reaction only need to be administered in severe cases.

Read more on the topic: Medication rash

Weight gain

Weight gain is usually not expected during treatment with Enbrel®. If there is an increase in body weight as part of therapy with the drug, this usually has another cause. Usually a higher calorie intake with food than the calorie consumption (through physical activity) is responsible.

Under certain circumstances, however, Enbrel® can in rare cases actually be responsible for rapid weight gain: If the pumping function of the heart deteriorates as a side effect (heart failure), water retention can form in the legs (edema). In addition to an increase in body weight, there is usually a noticeable and visible swelling of the ankles and lower legs. In such a case, the attending physician should be consulted.

Read more on the topic: Edema in the leg

costs

Enbrel® is a relatively expensive drug. The treatment costs for a single syringe are several hundred euros and the entire treatment usually costs several thousand euros. As a rule, however, the drug is only prescribed if it is covered by the health insurance company.
If the indication is justified, this is usually unproblematic for both private and statutory insurance. However, it is advisable to clarify the assumption of costs in advance. In exceptional cases, the medication can be prescribed in consultation with the doctor even if the costs are not covered. In this case, however, the patient has to pay for the drug himself.