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CONSENSUS STATEMENT OF THE CROATIAN SOCIETY FOR NEPHROLOGY, DIALYSIS AND TRANSPLANTATION REGARDING THE USE OF GENERIC IMMUNOSUPPRESSIVE DRUGS

NIKOLINA BAŠIĆ-JUKIĆ orcid id orcid.org/0000-0002-0221-2758 ; Klinički bolnički centar Zagreb, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju bubrega, Zagreb, Hrvatska
SANJIN RAČKI ; Klinički bolnički centar Rijeka, Zavod za nefrologiju i dijalizu, Rijeka, Hrvatska
MLADEN KNOTEK ; Klinička bolnica Merkur, Zavod za nefrologiju, Zagreb, Hrvatska
LJUBICA BUBIĆ-FILIPI ; Klinički bolnički centar Zagreb, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju bubrega, Zagreb, Hrvatska
IVAN BUBIĆ ; Klinički bolnički centar Rijeka, Zavod za nefrologiju i dijalizu, Rijeka, Hrvatska
LADA ZIBAR ; Klinički bolnički centar Osijek, Zavod za dijalizu, Osijek, Hrvatska
PETAR KES ; Klinički bolnički centar Zagreb, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju bubrega, Zagreb, Hrvatska


Puni tekst: hrvatski pdf 84 Kb

str. 211-213

preuzimanja: 541

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Sažetak

The use of generic immunosuppressive drugs may decrease the cost of immunosuppressive medication, although total cost savings are still a matter of debate since patients need close monitoring after conversion from original to the generic formulation. A working group of the Croatian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in renal transplant recipients based on a review of the available data. Immunosuppressive drugs belong to the ‘narrow therapeutic index’ drugs, with huge pharmacokinetic variations secondary to the impact of food, other drugs, as well as of kidney and liver function. Failure to maintain an appropriate balance of immunosuppression seriously influences graft and patient survival. Published evidence supporting therapeutic equivalence of generic formulations is scarce or completely lacking. Different generic formulations may expose patients to uncontrolled product switching by pharmacists or general practitioners, which is very dangerous for patients, since generic preparations are not required to demonstrate bioequivalence with each other. The Croatian Society for Nephrology, Dialysis and Transplantation is not against the use of generic immunosuppressive drugs, but it requires close supervision of nephrologists and respecting the strict rules of their use. More efforts should be invested in education of primary care physicians as well as of patients to be aware of differences between the original and generic, as well as between different generic formulations.

Ključne riječi

generic, immunosuppression, monitoring, position statement, Croatia

Hrčak ID:

126817

URI

https://hrcak.srce.hr/126817

Podaci na drugim jezicima: hrvatski

Posjeta: 1.136 *