TO THE QUESTION OF THE POSSIBILITY AND ACCEPTABILITY OF USING OFF-LABEL DRUGS IN PEDIATRIC RHEUMATOLOGY ACCORDING TO EXPERIENCE WITH RITUXIMAB IN CHILDREN WITH SYSTEMIC CONNECTIVE TISSUE DISEASES THAT ARE RESISTANT TO THERAPY

Oshlianska O.A.¹, Omelchenko L.I.²

• ¹P.L. Shupyk National Medical Academy of Postgraduate Education, Ministry of Health of Ukraine, Kyiv
• ²SI «O.M. Lukyanova Institute of Pediatrics, Obstetrics and Gynecology NAMS of Ukraine», Kyiv

Summary. Off-label prescription of drugs (the use of the drug in cases, age groups and dosages that differ from the official instructions) is quite common in Europe and the USA. For pediatrics in general and pediatric rheumatology in particular, off-label prescriptions are sometimes the only possible solution, especially in life-threatening conditions in children, because of lack of registered dosage forms for patients under 18 years. Objective: to analyze self experience with rituximab in patients with systemic diseases of the connective tissue. Object: pediatric patients with systemic connective tissue diseases resistant to therapy. Methods: analysis of data of medical records. Results: a comparative characteristic of five cases of using rituximab off-label in patients who were treated in the clinic of the SI «O.M. Lukyanova Institute of Pediatrics, Obstetrics and Gynecology NAMS of Ukraine» was provided. Conclusions: the question of the prescription of off-label drugs should be decided very carefully, because each of these drugs, in addition to the potential benefits, carries a risk to the patient’s health. However, in cases where all protocol treatment methods have been exhausted, and the patient’s health and quality of life continue to deteriorate threateningly, it is important to be able to escalate therapy before decomposition of irreversible critical changes in organs and systems.