Tecfidera® is a drug that is mainly used to treat multiple sclerosis. Multiple sclerosis is a chronic inflammatory type of nerve disease. In the course of this disease, the myelin sheaths of the nerves in the central nervous system (CNS) are gradually destroyed. The myelin sheath is the layer of lipids (fats or fat-like compounds) that spirally envelops the individual nerves of the CNS and thus significantly increases the speed of signal transmission.
However, if you get multiple sclerosis, the body attacks the myelin sheaths with inflammation. The myelin sheaths are damaged more and more until it comes to relapsing symptoms of paralysis and pain. Such symptoms are caused by the malfunctioning signal transmission in the CNS.
Multiple sclerosis is not curable, one can only try to give the patient a little quality of life back through intensive therapy and thereby the Slow down the course of the disease through various drugs. Tecfidera® is one such drug. The chemical substance behind the name Tecfidera® is dimethyl fumarate, a chemical compound made from fumaric acid and methanol, an alcohol. As a medicinal substance are the fumaric acid dimethyl ester among others immunological regulating effects said.
Mode of action
The exact mechanism behind the effects of Tecfidera® is at this point in time still unclear. It is assumed that Tecfidera®, or its active ingredient, dimethyl fumarate, immunomodulatory and antioxidant effects to have.In this context, immunomodulatory means that the immune system is kept in check and thus the inflammatory “attacks” on the myelin sheaths are reduced at least to a certain extent.
Antioxidants are substances that intercept free radicals in the body and thus Prevent cell damage. Both properties are presumably favored by an intracellular (inside the cell) signaling pathway. This signaling pathway normally causes the formation of proteins that are involved in anti-inflammatory and antioxidant reactions and protect cells from oxidative stress. Through the weakened immune response and the Development of cellular protection systems, Tecfidera® has a positive effect on the progression of multiple sclerosis.
Areas of application
Tecfidera® has two main areas of application. For one, it will in multiple sclerosis, on the other hand, a chemically very similar fumaric acid is used under the name Fumaderm® in the psoriasis (psoriasis) applied.
In the treatment of multiple sclerosis, the main focus when using Tecfidera® is to reduce the number of relapses that occur.
Like multiple sclerosis, psoriasis is one of them chronic inflammatory diseases. In the course of this disease there is an abnormally rapid growth of the epidermis (epidermis), which manifests itself in large, scaly skin areas. These areas of the skin are very dry and cause the affected person a lot of suffering due to persistent itching.
Fumaderm® can also be here through his throttling effect on the immune system. However, the exact mechanism by which the drug develops its effect is also not yet sufficiently known. To treat psoriasis is Fumaderm® Already approved for years, approval for therapy with a fumaric acid for multiple sclerosis was only obtained years later.
- Therapy of psoriasis
Dosage forms and dosages
If you treat multiple sclerosis with Tecfidera®, the dosage form is the oral (oral) intake to disposal. Tecfidera® is called Hard capsule sold in two different dosages. The hard capsule protects the active ingredient from gastric juice, so that the dimethyl fumarate is only released in the intestine and can be absorbed into the blood via the cells of the intestinal wall.
At the start of treatment, two tablets of the lower dose are taken daily for the first few days, then the dose is increased. The number of daily intake is also in the higher dosage two tablets a day. Tecfidera® is so far Approved only for adults from the age of eighteen, There are no studies available for the effects of Tecfidera® in older people and children under ten years of age. The use of the drug is therefore not permitted here.
If patients take a drug, it can in principle always happen that hypersensitivity reactions, allergies or, in the worst case, an allergic shock occur. These side effects are also possible with Tecfidera®, as everyone reacts differently to different active ingredients in drugs.
Other common side effects while taking Tecfidera® are hot flashes and the so-called flush. The term flush describes a sudden reddening of the face that is accompanied by a strong sensation of heat. Symptoms that affect the digestive tract are also common during therapy with Tecfidera®. Nausea, stomach cramps or diarrhea are examples of such complaints.
Side effects such as kidney damage are described less frequently.
Another side effect that also occurs is the drop in various blood cell counts. For example, leukopenia and lymphopenia have been found several times. Both terms denote a reduced number of cells. Leukopenia refers to the leukocytes (white blood cells), which are responsible for the immune system. Patients with leukopenia are therefore more susceptible to infectious diseases than healthy people. For example, they are more likely to get colds or more severe illnesses such as pneumonia. The white blood cells also include lymphocytes as a subgroup, which are responsible for the production of antibodies and the destruction of invading pathogens. If a patient has lymphopenia, the effects are similar to those of leukopenia, the immune system is extremely weakened and infectious diseases have an easy time of it. For the reasons mentioned, patients who are being treated with Tecfidera® must be regularly monitored by laboratory tests of their blood values.
With Tecfidera®, interactions mainly occur when the other drug being taken has a nephrotoxic (toxic for the kidneys) effect. Since Tecfidera® sometimes also causes side effects on the kidneys, it could be with Combination of two nephrotoxic drugs to severe kidney damage and in the worst case, kidney failure.
Medicines that put strain on the kidneys are, for example, the NSAIDS, which also include Aspirin® and ibuprofen. Caution is also advised when using Tecfidera® at the same time as substances that suppress the immune system, such as cortisol. The fact that Tecfidera® probably has a throttling effect on the immune system can lead to an increase in effectiveness. There are no studies on the use of the contraceptive pill with Tecfidera®, but there are still recommendations that non-hormonal contraceptive methods such as condoms should be considered when taking Tecfidera®.
Tecfidera in pregnancy
For taking Tecfidera® during pregnancy and breastfeeding there is no clinical studies, however, based on various experiments, it is believed that the drug could have a negative impact on the health of the unborn child.
Treatment with Tecfidera® is due to the limited current state of knowledge not recommendable. Whether the active ingredient of Tecfidera® passes into breast milk has also not been proven, breastfeeding mothers should therefore carefully weigh up the benefits and possible risks of taking Tecfidera®.
Although the active ingredient dimethyl fumarate is relatively cheap, the drug Tecfidera® costs a lot.
The annual cost of a daily treatment with Tecfidera® is around 15,000 euros.
If two tablets are taken daily, this results in a price of around 46 euros per day, which corresponds to a price of 23 euros per tablet.
Fumarderm®, on the other hand, costs only a fraction, but is not approved for MS therapy.