Generic Immunosuppression: Deciphering the Message Our Patients are Receiving

Hulbert, Amanda; Pilch, Nicole A.; Taber, David J.; Chavin, K.; Baliga, Prabhakar K.

doi:10.1345/aph.1r028

Cited by 16 publications

(9 citation statements)

References 15 publications

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“…A survey in the UK showed that 84% of renal transplant patients felt that generics are not equivalent or only equivalent sometimes and that they were uncertain that generics had the same quality as branded medicines . In the US, a survey among 255 transplant recipients showed that 81 patients (32%) had been converted to a generic immunosuppressant, but 25% of converted patients did not believe that there was equivalence between generic and brand products . When patients are not allowed to choose freely, this may affect their adherence to medication, intentional, or unintentional, potentially influencing clinical outcome.…”

Section: The Perspective Of the Patientmentioning

confidence: 99%

Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs

Gelder

Gabardi

2013

Transpl Int

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Summary Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US.

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Section: The Perspective Of the Patientmentioning

confidence: 99%

Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs

Gelder

Gabardi

2013

Transpl Int

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“…Medications: Exposing the lung transplant recipient to different generic formulations of a particular immunosuppressant medication could result in adverse outcomes because of the potential variation in their pharmacokinetic effects and drug-drug interactions. 114,115 The International Society for Heart and Lung Transplantation recommends that 114 (1) patients inform their care coordinators of any potential generic drug substitution of their immunosuppressant medications, (2) generic immunosuppressants should be used with a high degree of caution, and (3) surveillance strategies and frequent TDM should be implemented until stable immunosuppression is achieved.…”

Section: Caution With Generic Substitution Of Immunosuppressantmentioning

confidence: 99%

Comprehensive Care of the Lung Transplant Patient

Adegunsoye

Strek

Garrity

et al. 2017

Chest

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Lung transplantation has evolved into a life-saving treatment with improved quality of life for patients with end-stage respiratory failure unresponsive to other medical or surgical interventions. With improving survival rates, the number of lung transplant recipients with preexisting and posttransplant comorbidities that require attention continues to increase. A partnership between transplant and nontransplant care providers is necessary to deliver comprehensive and optimal care for transplant candidates and recipients. The goals of this partnership include timely referral and assistance with transplant evaluation, optimization of comorbidities and preparation for transplantation, management of common posttransplant medical comorbidities, immunization, screening for malignancy, and counseling for a healthy lifestyle to maximize the likelihood of a good outcome. We aim to provide an outline of the main aspects of the care of candidates for and recipients of lung transplants for nontransplant physicians and other care providers.

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“…[12][13][14][15][16][17] The same increased intrapatient variability was associated with poorer patient outcomes and greater treatment costs. A subsequent large retrospective study from the Collaborative Transplant Group showed that a group of 397 patients receiving generic cyclosporine had a trend toward overall poorer graft survival compared to the 17,198 patients receiving branded cyclosporine.…”

Section: Article In Pressmentioning

confidence: 99%