A new drug for multiple sclerosis (MS) has been approved in Germany since 2011: For the first time, the active ingredient fingolimod allows it to be taken as a capsule to be swallowed – until then, MS preparations had to be injected. Fingolimod also offers an innovative mode of action. By influencing the distribution of white blood cells, fingolimod prevents destruction of the myelin disks in the brain and thus the inflammation of the nervous system typical of multiple sclerosis.
Use and effect of fingolimod
Fingolimod was originally developed as an artificially produced form of the active ingredient myriocin. This is a metabolite from Isaria sinclairii, a fungus used in traditional Chinese medicine (TCM). Since myriocin has immunosuppressive effects, fingolimod was intended to be used to suppress the immune system after kidney transplants. Here, however, its mode of action was no better than that of conventional products.
As an MS drug, the active ingredient is now used as a second-line therapy in patients who do not respond to treatment with interferon beta. Fingolimod may also be taken by multiple sclerosis patients with a rapidly progressive or very aggressive form of the disease.
The active ingredient starts in the blood: Here, the lymphocytes are prevented from passing from the lymph nodes into the blood. If misdirected T lymphocytes reach the myelin layer of the nerve cells, they can destroy them and thus trigger the symptoms typical of MS, such as motor disorders, paresthesia, psychological problems and visual disturbances.
In Germany, fingolimod has so far been marketed exclusively under the trade name Gilenya
distributed. The manufacturer recommends taking one capsule of the drug daily, regardless of meals. One capsule contains 0.5 milligrams of fingolimod.
Side effects of fingolimod
In the course of the studies, some side effects of fingolimod were detected. Namely, the active substance also suppresses desired reactions of the immune defense, which is why infections can occur more frequently. Side effects of fingolimod may therefore be:
- Influenza
- Fungal diseases
- Diarrhea
- Headache
- Back pain
- Elevated liver enzymes
- Lymphocyte deficiency
There were also two deaths during the trials – one patient died from a herpes infection, the other from chickenpox. However, these patients had taken a higher dose of fingolimod than is available today. Nevertheless, fingolimod is approved in the EU only for second-line treatment of multiple sclerosis because of the potential for severe side effects.
Pregnancy and fingolimod
Fingolimod poses a very high risk of malformations in the unborn child. Therefore, it must not be used in:
- Women during pregnancy
- Women of childbearing age who are not using a safe method of contraception
Due to the increased rate of miscarriage with fingolimod, women with multiple sclerosis must provide a negative pregnancy test before starting therapy. Safe contraception must be used during and at least two months after treatment. If there is a desire to have children, therapy with fingolimod must be discontinued at least two months before an intended pregnancy.
If pregnancy occurs during treatment with fingolimod, treatment must be stopped immediately and the pregnant woman must be closely monitored and counseled.
