Risk for medication errors Methotrexate

Safety warnings | messages in brief | 18/04/2013

Methotrexate (MTX) is used to treat severe forms of psoriasis, autoimmune diseases (e.g., rheumatoid arthritis), and various tumor diseases. It is strictly available only on prescription.

As a so-called "antimetabolite", the active ingredient methotrexate inhibits the formation of certain building blocks of the DNA of the cell nucleus and thus actively intervenes in their synthesis and repair as well as in cell division. Cells that divide very strongly, such as tumor cells or epithelial cells of the skin, whose division rate is greatly increased in psoriasis compared to normal skin, react first and foremost to this effect.

Since the hematopoietic system of the human body also has a high cell division rate, therapy with MTX is associated with the risk of a reduced number of white blood cells (resulting in reduced immune defense) or platelets (resulting in reduced blood clotting ability). This can lead to the occurrence or bleeding, which in rare cases can be fatal if not detected and treated in time.

MTX is administered for:

  • oncological indications:

individual depending on indication and general condition

  • dermatological and rheumatological indications:

only once a week

Dosing errors in the use of methotrexate can lead to serious side effects including death.

Situation in Austria

In Austria, the following drug specialties are approved in this context:

For oncological indications:

  • Ebetrexate 100 mg/ml concentrate for infusion preparation.
  • Ebetrexate 10 mg/ml parenteral solution
  • Methotrexate Accord 25 mg/ml solution for injection
  • Methotrexate Lederle 25 mg lancing ampoule

For dermatological / rheumatological indications:

  • Ebetrexate 10 mg/ml solution for injection in a prefilled syringe.
  • Ebetrexate 20 mg/ml solution for injection in a prefilled syringe
  • Ebetrexate 5 mg tablets
  • Ebetrexate 2.5 mg tablets
  • Methotrexate Dermapharm 25 mg/ml solution for injection in a prefilled syringe
  • Methotrexate Ebewe 5 mg ampoules
  • Methotrexate 10 mg/ml solution for injection in a prefilled syringe
  • Metoject 10mg/ml solution for injection in a prefilled syringe
  • Metoject 50 mg/ml solution for injection in a prefilled syringe

For oncological and dermatological / rheumatological indications:

  • Ebetrexate 10 mg tablets

BASG recommendations for physicians/pharmacists:

  • For dermatological/rheumatological indications, MTX must be taken only once a week on the day specified by the physician.
  • Under no circumstances may it be taken continuously on a daily basis! This must be made emphatically clear to the patient and/or his relatives.
  • The day of intake should be specified on the prescription.
  • During therapy, elderly patients in particular should be monitored for early signs of toxicity at short intervals.
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