[Special considerations in generic substitution of immunosuppressive drugs in transplantation].
Long-term success in solid organ transplantation strongly depends on the optimal use of maintenance immunosuppressive treatment. Cyclosporin and tacrolimus are the most frequently administered immunosuppressants and they are designed to narrow therapeutic index drugs. The substitution of the branded formulation by their generic counterparts may lead to economic benefit only if equivalent clinical outcomes can be achieved. There is no published evidence to date on the guarantee of their long-term therapeutic equivalence and cases of therapeutic failures have been reported due to inadvertent drug conversion. The disadvantageous clinical consequences of a non medical, mechanistic forced switch from the original to generic formulation of tacrolimus and the estimated loss of the payer's presumed savings are presented in a kidney transplant recipient population. Special problems related to pediatric patients, drug interactions with concurrent medications and the burden of additional therapeutic drug monitoring and follow up visits are also discussed. The authors are convinced that the implementation of the European Society of Organ Transplantation guidelines on generic substitution may provide a safe way for patients and healthcare payers.
Szent Imre Kórház Nefrológia-Hypertonia Profil Budapest Tétényi. remportadam@hotmail.com
Adám
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Remport
Dávid
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Dankó
Zsuzsa
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Gerlei
Krisztina
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Czebe
István
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Kiss
D003362:Cost-Benefit Analysis; D016572:Cyclosporine / Q000008:administration & dosage / Q000191:economics; D003692:Delayed-Action Preparations; D016527:Drug Costs; D004347:Drug Interactions; D016903:Drug Monitoring; D057915:Drug Substitution / Q000009:adverse effects / Q000191:economics; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics*; D006801:Humans; D006814:Hungary; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics*; D016030:Kidney Transplantation; D016377:Organ Transplantation; D016559:Tacrolimus / Q000008:administration & dosage / Q000191:economics; D013810:Therapeutic Equivalency
D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus