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Transplant Digest Spring/Summer 2012, Issue No. 12 TRANSPLANT DIGEST SPRING/SUMMER 2012, Issue No.12 St. Michael’s Transplant Program Living Kidney Donor Celebration and Recognition Event By: Maureen Connelly RN BScN Living Kidney Donor Coordinator Sharon Lee, MSW, RSW Living Donor Social Worker The St. Michael’s Transplant Program held a recognition event on April 26, 2012 to honour individuals who donated a kidney to a friend, relative or stranger in the past five years. It was wonderful to see the many donors who have given so selflessly to improve the life of another individual. Our previous event was held in 2007 and honoured our donors since the start of living kidney donation at St. Michael’s. The event this past April, recognized and honoured the 221 living kidney donors from April 2007-April 2012. The event coincided with the National Organ and Tissue Donation Awareness Week. Our external stakeholders from the Kidney Foundation and Trillium Gift of Life Network were able to provide information about organ donation at their respective booths. The research coordinator Lindita Rapi was also on hand to promote the national post donation living donor study. Also on hand at the celebration was the Honourable Deb Matthews, Minister of Health, Trillium Gift of Life Network CEO, Ronnie Gavsie and Susan McKenzie, Senior Director of Development at the Kidney Foundation of Canada and recipient of a living donor kidney transplant. It was a very moving and joyous event that provided an opportunity for donors to meet each other and share their experiences with fellow donors and the St. Michael’s staff. The following is a speech by Stephen Zaluski, kidney donor in 2010 that eloquently sums up the experience of being a kidney donor: “I am genuinely honoured to be here tonight and to say a few words as a donor. I don’t claim to speak for all donors since I suspect our experiences are about as varied as those of our recipients. But I’ll just offer a couple of thoughts from my own experience which will hopefully have some resonance for others. There are two prevailing reactions that one encounters as a donor: First and most obvious is – why? “What made you decide to do it?” Life may have many mysteries, but to me, this isn’t one of them. In my books, nothing could be more basic than the human desire to help. Often, though, we feel helpless to do anything. The world’s problems are too vast, or the pain or need of others – whether loved ones or strangers is beyond our ability to reach. And then suddenly, there’s a way we can help, in a real tangible way and without much jeopardy to ourselves. So the real question is why wouldn’t you donate, if your life circumstances allow it? What better way is there to respond to the call of our common humanity? The second common reaction is to express some version of wonder at the donor’s courage. To me this is also misplaced. The real courage is that of individuals and their families who live with chronic debilitating kidney disease, and who face each day with fortitude, hope, determination and grace. Those are the people who inspire and reinforce belief in the human spirit. And nobility lies not in the act of the donor, but in the lived life of the recipient. Donating my kidney was a wonderful experience. I was tremendously supported by family, friends and by the fabulous care team here at St. Mike’s who were so terrific throughout the entire process. I came away feeling recharged about life and about living it fully. My only regret is that I don’t have another kidney to give, for the time being. But I’ll always be grateful for having been given the chance to donate once. While it may have made a difference to someone else’s life, it most surely made a difference to my own. How nice to share that bond with you.” In this issue ... St. Michael’s Transplant Program Living Kidney Donor Celebration and Recognition Event From the Editor’s Desk Your Transplant Admission St. Michael’s Hospital Renal Transplant Program Milestones Being Admitted to the Hospital Kidney Transplant Biopsy Can we grow organs in the lab? Generic Anti-Rejection Medications and the Kidney Transplant Patient: What You Need to Know Post Transplant Chat

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Page 1: Transplant Digest - Spring 2012, issue 12 · Digest Spring/Summer 2012, Issue No. 12 TRANSPLANT DIGEST SPRING/SUMMER 2012, I ssue No.12 St. Michael’s Transplant Program Living Kidney

Transplant Digest

Spring/Summer 2012, Issue No. 12

TRANSPLANT DIGESTSPRING/SUMMER 2012, Issue No.12

St. Michael’s Transplant Program Living Kidney Donor Celebration and Recognition EventBy: Maureen Connelly RN BScN Living Kidney Donor Coordinator Sharon Lee, MSW, RSW Living Donor Social Worker

The St. Michael’s Transplant Program held a recognition event on April 26, 2012 to honour individuals who donated a kidney to a friend, relative or stranger in the past five years. It was wonderful to see the many donors who have given so selflessly to improve the life of another individual. Our previous event was held in 2007 and honoured our donors since the start of living kidney donation at St. Michael’s. The event this past April, recognized and honoured the 221 living kidney donors from April 2007-April 2012.

The event coincided with the National Organ and Tissue Donation Awareness Week. Our external stakeholders from the Kidney Foundation and Trillium Gift of Life Network were able to provide information about organ donation at their respective booths. The research coordinator Lindita Rapi was also on hand

to promote the  national post donation living donor study.

Also on hand at the celebration was the Honourable Deb Matthews, Minister of Health, Trillium Gift of Life Network CEO, Ronnie Gavsie and Susan McKenzie, Senior Director of Development at the Kidney Foundation of Canada and recipient of a living donor kidney transplant.

It was a very moving and joyous event that provided an opportunity for donors to meet each other and share their experiences with fellow donors and the St. Michael’s staff.

The following is a speech by Stephen Zaluski, kidney donor in 2010 that eloquently sums up the experience of being a kidney donor:

“I am genuinely honoured to be here tonight and to say a few words as a donor.

I don’t claim to speak for all donors since I suspect our experiences are about as varied as those of our recipients. But I’ll just offer a couple of thoughts from my own experience which will hopefully have some resonance for others.

There are two prevailing reactions that one encounters as a donor:

First and most obvious is – why? “What made you decide to do it?” Life may have many mysteries, but to me, this isn’t one of them. In  my books, nothing could be more basic than the human desire to help. Often, though, we feel helpless to do anything. The world’s problems are too vast, or the pain or need of others – whether loved ones or strangers is beyond our ability to reach.

And then suddenly, there’s a way we can help, in a real tangible way and without much jeopardy to ourselves. So the real question is why wouldn’t you donate, if your

life circumstances allow it? What better way is there to respond to the call of our common humanity?

The second common reaction is to express some version of wonder at the donor’s courage. To me this is also misplaced. The real courage is that of individuals and their families who live with chronic debilitating kidney disease, and who face each day with fortitude, hope, determination and grace. Those are the people who inspire and reinforce belief in the human spirit. And nobility lies not in the act of the donor, but in the lived life of the recipient.

Donating my kidney was a wonderful experience. I was tremendously supported by family, friends and by the fabulous care team here at St. Mike’s who were so terrific throughout the entire process. I came away feeling recharged about life and about living it fully. My only regret is that I don’t have another kidney to give, for the time being. But I’ll always be grateful for having been given the chance to donate once. While it may have made a  difference to someone else’s life, it most surely made a difference to my own.

How nice to share that bond with you.”

In this issue ...St. Michael’s Transplant Program Living Kidney Donor Celebration and Recognition Event

From the Editor’s Desk

Your Transplant Admission

St. Michael’s Hospital Renal Transplant Program Milestones

Being Admitted to the Hospital

Kidney Transplant Biopsy

Can we grow organs in the lab?

Generic Anti-Rejection Medications and the Kidney Transplant Patient: What You Need to Know

Post Transplant Chat

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St. Michael’s HospitalRenal Transplant Program(across the hospital)61 Queen Street 9th Floor Toronto, Ontario, M5C 2T2 Phone: (416) 867-3665

Please send your comments or suggestions of topics for future publication to:[email protected]

Disclaimer Note:Views presented in this newsletter are those of the writers and do not necessarily reflect those of St. Michael’s Hospital or the University of Toronto. Subject matter should not be construed as specific medical advice and may not be relevant to individual patient circumstances. For all questions related to your  own health please contact your health care provider.

Contact InformationDr. Ramesh Prasad – EditorMeriam Jayoma-Austria, RN, CNeph(C) – Newsletter Coordinator

Another successful year for the Transplant Program has gone by, and as we march from one accomplishment to the next, we constantly are reminded that the real reason we all do what we do is to serve our many patients with kidney disease and their donors. This could be through improved clinic service, expanding the recipient and donor pool, improving immunosuppressive techniques, and performing cutting edge research, to name a few. Transplant Digest is a readily visible, but by no means singular method of providing such service. As we complete our sixth year of publication (twelve issues!) we hope that you will continue to find Transplant Digest informative, enjoyable and a useful, perhaps permanent addition to your reading library. It  is especially gratifying to see other transplant

centres start up their own, similar publications. It is said that imitation is the sincerest form of flattery.

We recently conducted an appreciation event for our living donors of the past 5  years, and continue to hold a biannual transplant educational day for our allied health colleagues from other hospitals. Look inside for details of our donor event. Topics covered in this issue include some less comfortable topics for patients-hospital readmissions, infections, and kidney biopsies. We would after all be left incompletely served if such topics were avoided. There is an update on our current immunosuppressive drug conversion programs. We do have an encouraging article though about your transplant admission, the only type of happy admission

other than for delivering a baby. On popular demand we also have a follow-up article about growing kidneys in the laboratory. As always patient suggestions and contributions (not just promises!) are welcome.

Dr. Ramesh Prasad Editor

From the Editor’s Desk

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Your Transplant AdmissionBy Dr. Ramesh Prasad

Congratulations! You have been called for a kidney transplant. So what happens now? The purpose of this article is to give a general guideline about what to expect when you are admitted for a kidney transplant. Patients scheduled to get their transplant at a later date can be better prepared as a result, while those who have already received their kidney may find it interesting to compare what’s here to their actual experiences.

Feel free to call your loved ones when called to share the news. You may require their help as well. Once you get the call, you are expected to come to the hospital as soon as you can. Don’t speed on the highway though, and follow all the relevant rules. You have no special traffic privileges. If you are on dialysis when you get the call, you are allowed to finish your treatment and then come. If that is the case, try to come off about a kilogram above your usual post-dialysis weight. If you are on home dialysis, disconnect yourself as you normally would, slowly and safely. Your doctor will advise you about when to come off if you are on nocturnal dialysis. Bring some essential items, but leave valuables at  home and do not bring too much luggage. If yours is  a  living donor transplant, you will be asked to come in the previous evening. You can eat your dinner, but will not be allowed to have anything else after that except ice chips.

When you arrive, you will come to the Transplant Ward. Your vital signs (blood pressure, heart rate, temperature) will be checked and you will have some blood tests done (such as the potassium and hemoglobin). An ECG and chest x-ray are typically done. You will be interviewed by  the nephrology resident, surgery resident, and anaesthesia resident. Please give them your entire history, even though most of the time there will already be a detailed note in the hospital database. We try to preserve confidentiality as much as possible. You may be asked about participating in research. There will be consent forms to be signed. Most importantly, do not withhold anything! The staff are here to help you. Let them know of any hospital admissions since your last assessment at St. Michael’s, whether you have had any blood transfusions or surgeries, infections, a heart attack, are on blood thinners, and so on. Bring all your medications with you. Sometimes you will require a short run of dialysis before the transplant, especially if you have missed your dialysis session in the process of coming to St. Michael’s. If you are on peritoneal dialysis, a nurse is available to help you with any connections/ disconnections.

Sometimes a “stat” cross match is sent to make sure that the donor organ is the right one for you. If this has been sent, expect a delay of four or five hours before you go for surgery. You may be sent home at any time, if the cross match is positive, someone ahead of you has been given the kidney instead, or if the donor organ itself has been found unsuitable. But don’t be too disappointed because you could be called back again soon!

After the surgery, you will be evaluated in the Recovery Room where you will be before being transferred up to the Transplant Ward. The first night is very busy. You  are under continuous cardiac monitoring, and fluids will be given in large amounts through a vein in your neck, hopefully because you are making lots of urine! You will have a  Foley catheter in your urine bladder for five days. Visitors are allowed with permission. The next day you should be sitting up in a chair, and walking around in the hallways shortly thereafter. You   can control your pain with a PCA pump, to  be used on an as-needed basis. You must use your incentive spirometer (a breathing device) to prevent pneumonia. After two days you will be transferred to a regular ward bed, where you can stay with your living donor if applicable and if you wish. Some of your pre-transplant medications will stay, others discontinued, and you will be on some brand new, unfamiliar drugs for your transplant. You might feel a little swollen from all the extra fluid, but as long as the kidney is working you should be able to gradually get rid of it all. Sometimes dialysis is required if the kidney doesn’t work right away, but the odds are in your favour that it eventually will. You will get one; possibly two or more transplant ultrasounds during your stay, and sometimes may require a kidney biopsy. If all goes well you will be discharged six or seven days after the transplant, after your IV lines and Foley catheter have been removed. A pharmacist and nurse from the Transplant Clinic will go over your medications and important Transplant Clinic procedures for after your discharge. Of course, the doctors on the Ward will visit you at least once daily during your hospital stay. Do  not hesitate to ask them questions. Remember there is constant communication between the Transplant Ward and Transplant Clinic. It is a “closed loop” so you will not be forgotten!

Since we are always trying to do things better, we welcome feedback from patients both positive and negative about your hospital stay.

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St. Michael’s Hospital Renal Transplant Program Milestones:

1969 SMH Transplant Program Inaugurated

1972 First Live Donor Transplant performed

1999 1000th Transplant performed

2000 First Laparoscopic Surgery in Ontario

2005 First Paired Exchange Living Donor Transplant

in Canada, with University Health Network

2006 Hosted first province-wide Renal Transplant Symposium

2006 Recipient of Values in Action Award for Team Excellence

2007 First Transplant from a Donation after Cardiac Death

(DCD) Donor

2007 First Live Donor Recognition Event

2007 First Living Anonymous Donor Transplant

2008 2000th Transplant performed

2009 First List Exchange Living Donor Transplant

2011 First in North America to transplant incompatible

donor/recipient pairs using immunoabsorbtion columns

2012 Over 60 peer reviewed publications since 2000

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Being Admitted to the HospitalBy Dr. Ramesh Prasad

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A hospital admission can be quite a traumatic experience for anyone, and this would certainly be true for transplant recipients. Since there really only two “happy” reasons to be admitted to the hospital, namely to give birth and to receive a transplant, anything else would have to count as being undesirable. However, if hospital admission is advised, you can be quite confident that it is necessary. Due to high volumes of patients in Ontario hospitals and the competitiveness to get hospital beds both within and between hospitals, you can be assured that if you have been asked to be admitted, there is a good reason for doing so.

We will leave aside the original hospital admission for the transplant to a sister article. Common reasons for a hospital admission after the transplant include those related to the transplant itself, and non-transplant related causes.

Admissions that have to do with the transplant include an infection of the kidney (pyelonephritis), acute rejection of the kidney, or less commonly, recurrence of the original disease in the kidney, serious infections, or failure of the kidney and transitioning to dialysis. Sometimes patients have to be admitted for fluid collections around the kidney or urine leaks, or admitted to the Medical Day Unit for procedures such as blood transfusions. Generally speaking, in these situations patients will be admitted to the Nephrology service at our hospital. Visits to the hospital that typically do not require overnight stays include transplant kidney biopsies, urinary stent removals, and administering some anti-rejection medications.

Reasons for hospital admission not related to the transplant include things like heart attacks and strokes, pneumonia, blood clots in the legs, removal of the native kidney(s) and surgeries of various other kinds such as hip replacements, cancer surgeries, and so on. There may be problems related to the transplant itself in those situations, in which case it would be addressed accordingly. Generally speaking, patients are admitted to non-nephrology services at our hospital for these indications.

Sometimes patients are admitted to hospitals other than ours because the ambulance transported them to the nearest hospital, or they live so far away from Toronto that it is simply more convenient to be admitted to a hospital closer to home. In that situation, remember that access to Transplant expertise is always available. Your staff physician can always call the Transplant Clinic for advice, and they sometimes do, but in fact Nephrologists in the community all have some experience with transplants. Remember that an inter-hospital transfer to St. Michael’s is not always in your best interest because expertise for your particular condition

may be excellent at the other site, and the hazards involved in transporting sick patients can make them worse, delaying their recovery overall, or could actually be dangerous. We do welcome calls from patients or their relatives as well when patients are admitted to other hospitals. However, if you strongly feel that advice from the Transplant Clinic would be valuable, please request the doctor taking care of you to call us.

Once you are discharged from the hospital, whether it is St. Michael’s or elsewhere, please give us a call. Often times we can see you in the Transplant Clinic shortly thereafter. A follow-up visit becomes particularly important if your transplant function was affected during the admission. And remember, please bring your hospital discharge slip with you. This is extremely important. We need to know the medical diagnosis of what you had, and your medications may have been changed so our database needs to be updated. Bring your medications. We may need to follow-up on certain tests and procedures as well. Although a hospital admission is not the end of the world, it is a major life event. As  your partner in health, keeping us informed will help us to help you.

Of course if we could manage everything in the Transplant Clinic itself we would do so, but this is not possible. The Transplant Clinic staff will be pleased to  guide you as to what procedures can be done where. Sometimes certain procedures can be managed through a Home Care Service. We will try to do whatever it takes to keep you out of the hospital.

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At some point in time before or after the kidney transplant most patients have had a biopsy of their transplant kidney. If this doesn’t make sense to you right away, consider when a biopsy is performed:

1. At certain times and based on certain indications, a living donor may have had a kidney biopsy.

2. Many times an implantation biopsy is performed of the donor kidney, at the time of the transplant surgery.

3. Protocol biopsies may be obtained at fixed times post-transplant as part of clinical care or research.

4. A biopsy may be performed by “indication”, which means that the transplant is in some sort of trouble and the physician feels that information obtained from the biopsy will be of significant help in determining the course of action. This last occasion for a biopsy will be the focus of the remainder of our discussion.

What is a Kidney Transplant Biopsy?A biopsy involves taking a very small piece of kidney tissue, about half the size of a matchstick for analysis in the pathology lab. This tissue is obtained through the skin using a specialized needle under the guidance of ultrasound, at our hospital typically by an interventional radiologist. This sample is cut into several parts and is analyzed using several different types of microscopes. Usually two or three “cores” of tissue are obtained, after making sure that the tissue retrieved is indeed kidney and not something else e.g. fat. The kidney tissue that is of value is the “cortex”, or outer part of the kidney because it contains most of the kidney’s urine filters, or glomeruli.

When is a Biopsy Performed?Apart from reasons 1-3 above, when it is performed for indication, it is often because acute rejection is suspected (see our previous issues for a detailed discussion of rejection). Other reasons would include drug toxicity (which can be hard to distinguish from rejection based on blood tests alone), suspected recurrent disease in the transplant, and to determine the amount of viable tissue if the kidney function is extremely poor. The reason for your biopsy will be explained to you sometimes over the phone if it is very urgent, but usually during a Transplant Clinic visit. The number of kidney filters removed is extremely small compared to the total number of urine filters in the kidney. Out of a million or so filters, about 10-20 are usually removed.

What is Involved in the Procedure?It is typically a day surgery, which means that you will go home the same day. It is done in the Radiology Department. You will be asked to come in early in the morning, preferably on an empty stomach. After the admission formalities are complete including signing the informed consent document you will be taken to the interventional suite, asked to lie on your back (not your belly, as with a native kidney biopsy), and the skin over your kidney will be cleaned with an antiseptic solution. The skin and underlying tissues are numbed with local anesthetic (e.g. lidocaine). The doctor or technologist will find the exact location of the kidney and the safest and best part of the kidney to take the samples from with the help of ultrasound. The biopsy needle will be passed through the skin to the correct depth. You may feel a little pressure and sometimes slight pain after the biopsy, which is done when you hear some clicks from the gun connected to the needle. Once the doctor is satisfied that enough tissue has been obtained, or feels that it is unwise to proceed further for some reason, the procedure will end, a dressing may be placed and you will be sent to the recovery area.

After the BiopsyYou should rest in bed for at least 6 hours. Your vital signs (blood pressure, pulse rate) will be regularly monitored. You urine will be looked at for any signs of bleeding. You should be able to eat, and should preferably drink lots of fluids. You may be allowed to go to the bathroom to void or may have to use a bedpan depending on the situation. If you feel well by later in the day you will be allowed to leave with a companion who should drive you home. If there is a complication such as bleeding you may be admitted to the hospital for further observation. Either way, you should not engage in exercise or other strenuous activity including sexual intercourse for a week afterwards. Once discharged if you notice blood in the urine or have pain over the transplant kidney you should come to the Emergency Room for evaluation.

Discussing the ResultsSome results may come back the same or next day depending on the urgency of the situation. However, a full report is not usually obtained for 2 or 3 weeks because some of the tests done on the biopsy sample

Kidney Transplant BiopsyBy Dr. Ramesh Prasad

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are quite sophisticated. You may be called by phone to come in but we strongly encourage you to book your appointment to discuss the results even before the biopsy is actually done.

What are the Risks of a Biopsy?Overall, the risks are small. The main risk is bleeding. It is important to let the clinic know if you have bled from other procedures in the past, or are taking drugs such as aspirin, nonsteroidal agents, clopidogrel (Plavix®), or coumadin (warfarin). The clinic will decide if and when these drugs should be stopped before the biopsy, and when to resume them afterwards. If you are taking any of these a hospital admission may be required ahead of time. It is also important to let everyone know if you are allergic to antiseptics such as iodine or local anesthetics such as lidocaine. The risk of minor bleeding (a noticeable drop in hempglobin, bruising, or blood in the urine) is about 1 in 10. This is common, but fortunately is usually self-limited. About 1 in 100 times the bleeding is sufficient that a blood transfusion is needed. About 1 in 1000 times either surgery or another

interventional procedure (e.g. embolization) is needed to stop the bleeding. Deaths have been described but are extremely rare. The risks of bleeding can be minimized by avoiding blood thinners, keeping your blood pressure well-controlled, and doing exactly as instructed when the biopsy is being done. Complications also tend to be less when the kidney is still working relatively well.

Other less common complications include creation of a small A-V fistula inside the kidney, damage to nearby bowel, or infection.

Are there Alternatives to a Biopsy?

At best, supplemental information such as blood tests (your creatinine level) and urine tests (such as positive blood or protein) can give only a rough guide to the Transplant Clinic about what is wrong with your kidney. While decisions can be made, they are only as good as the information available. Since there are risks to a biopsy, the decision to pursue one is not taken lightly. It is recommended only when it is felt that the potential benefits outweigh any risks.

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Can we grow organs in the lab?By: Darren Yuen MD PhD

Growing organs in the lab has been

a  goal for doctors and researchers

working in the field of transplantation

for many years. If we could grow kid-

neys artificially, we would eliminate

the need to use kidneys from human

donors, overcoming the  shortage of

kidneys that is a critical limiting factor

for patients with kidney failure who

want a  transplant. Unfortunately, so

far we have been limited by several

key problems: (1) our inability to grow

new kidney cells from patients and

(2)   being able to organize these cells

into the proper arrangement required

for a functioning kidney.

Recent research, however, has made

signifi cant advances that may eventually

allow us to overcome these challenges.

Growing organs from skin cells

One of the major problems that we have

faced in growing organs is our inability

to easily grow new kidney cells from

patients. In people with kidney failure,

it is virtually impossible to get healthy

kidney cells, as not only would this

involve removal of the kidney (a major

surgery), but also many of the kidney

cells are already dysfunctional in such

patients. Recently, however, research-

ers from Japan made a  breakthrough

discovery, demonstrating for the first

time that certain skin cells can be

easily isolated from a skin biopsy and

“re-programmed” to form many dif-

ferent types of cells, including kidney

cells. This finding has revolutionized

the field, opening the door to grow-

ing kidney cells from a patient’s own

skin cells for the purposes of generat-

ing a new artificial kidney. While still

in the early stages of development,

research groups around the world are

actively working to convert this theo-

retical possibility into reality.

Creating the scaffold for an artificial organ

One of the main challenges in growing

any organ has been how to  organize

the many different types of cells that

make up an organ into a  function-

ing system. The kidney is  a complex

network of various cells that interact

with one another in very specific ways.

While researchers have for years been

able to grow certain types of kidney

cells in culture dishes, they have had

difficulty organizing these cells into

function ing kidneys. Recently, how-

ever, researchers in the United States

have created “scaffolds” that help orga-

nize cells into their proper locations by

taking organs from animals or human

organ donors. Using the heart, liver,

and lung as examples, these research-

ers were able to remove all the original

donor cells, and then seed the leftover

protein “scaffold” with new cells from

potential recipients, to create a hybrid

organ that consists of a  scaffold from

the donor, and cells from the recipi-

ent. Importantly, the new organs were

able to perform basic functions. The

importance of this advance is that it

allows doctors to potentially gener-

ate organs that are made up of  cells

from the proposed recipient, meaning

that theoretically we will not need

to use immune suppressing drugs to

prevent organ rejection. Interestingly,

the first such tissue-engineered trans-

plantation occurred in Spain in 2008,

where a woman received a new airway

seeded with her own cells. While this

technique has yet to be applied to the

kidney, the above reports suggest that

bioengineering kidneys is a potential

future option to treat patients with

kidney failure.

Together, these exciting advances

bring the hope of protecting and regen-

erating kidney tissue closer to  reality.

Research into these areas is  intensive

and ongoing, and  hopefully will bear

fruit in the near future.

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Generic Anti-Rejection Medications and the Kidney Transplant Patient: What You Need to KnowBy: Helen Fanous, Pharm.D

Recently, there has been concern regarding generic formulations of anti-rejection medications. This is due to the fact that generic formulations will soon be/are now available at your local pharmacy for two crucial medications you may be taking: Mycophenolate Mofetil (Cellcept®) and Tacrolimus Immediate Release (Prograf®).

So what does this mean anyway? Are these generic formulations safe?

Difference between a brand name medication and a generic medication

When a drug becomes available for use on the market, it is produced only by the brand name company, which has a patent on their specific formulation. This manufacturer is protected and retains medication manufacturing rights until their patent date expires. When this occurs, other manufacturers can now produce this drug as long as it contains the same active ingredient as the brand name medication. The new generic manufacturer assigns the actual chemical drug name, referred to as the “generic name” to their drug – i.e. Tacrolimus, or Mycophenolate Mofetil, often without a brand name such as Prograf® or Cellcept®. The provincial government may choose to stop funding payment for the brand name and only cover the generic formulation since generic drugs are substantially less expensive than the brand name. You may or may not be informed of this change at your pharmacy when you are picking up your medication.

Will generic formulations of my anti-rejection medications work the same?

Although the generic formulations may have the same active ingredient, there are still potential risks associated with their use in the transplant population. For example, the amount of research that is done on the generic formulation is not as extensive as the brand name formulation. Since the brand name manufacturer did the research to prove that its ingredients are safe and effective, the generic drug does not need to do the same rigorous studies provided that the active ingredient is the same.

Another important concern is the potential for switching between different generic formulations. Although each generic manufacturer must show their equivalence to the brand name medication within an accepted margin, this does not ensure that generic formulations will be equivalent to each other. It is also important to note that pharmacies may switch between generic formulations without physician consent. This can lead to variability of

drug exposure and possibly increase the chance for rejection or increased side effects.

What your St. Michael’s Hospital Kidney Transplant Program Recommends

At this time, in order to maintain efficacy and safety with critical anti-rejection medications, our program recommends that our patients remain on a brand name medication with no generic substitutions. This will ensure that our transplant patients maintain appropriate drug exposure.

If you are prescribed either Prograf® or Cellcept®, please read below for instructions on how to ensure that you remain on a brand name medication:

Prograf: This medication will be available in generic formulations in 2013. Our transplant clinic has begun converting all patients taking Prograf to the extended release formulation known as Advagraf®. Both Prograf and Advagraf are approved as anti-rejection drugs for kidney transplant patients and contain the same active ingredient, Tacrolimus. However, they are released in the body in different ways. Prograf is an immediate-release formulation to be taken every 12 hours when used for the prevention of organ rejection, whereas Advagraf is an extended release formulation that is to be taken every 24 hours. If you are taking Prograf, you will be contacted in the near future to set up an appointment to our conversion clinic.

Cellcept: This medication is already available in generic formulations as of November 2011. The provincial government no longer covers the brand name, but only generic versions. In order to keep receiving brand name Cellcept®, a coupon card will be given to each patient at his/her next clinic appointment. This coupon card allows you to receive the brand name medication at the generic formulation cost, by charging the difference to the Cellcept® manufacturer. It is important to keep this card with you at all times and show it to your pharmacist whenever you have a prescription for Cellcept®. You should also make your pharmacy aware if you do not wish to receive any generic versions of this medication.

It is important to continuously be vigilant in regards to the shape, color, and size of your anti-rejection pills. Information on the drug manufacturer can be found on the prescription label or on the packaging of the medication. If you notice any changes to the appearance of your medications, please notify your pharmacy and transplant coordinator immediately.

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Post Transplant ChatBy: Fernanda Shamy, RN, Jennie Huckle RN, Thelma Carino, RN, Imelda Lo, RN

INFECTIONS1. Why do transplant recipients get infections?

Transplant recipients require anti rejection medications to suppress their immune system and prevent the kidney from rejecting. Due to the immune system being suppressed by these medications, transplant recipients are more at risk for infections because protection against foreign objects (such as infectious organisms) is one of its major roles.

2. What kind of infections do recipients get?

This is only a brief overview.i) Fungal infections- most common between

one and six months after the transplant. Examples of fungal infections (these are quite rare, by the way) include aspergillosis, histoplasmosis, blastomycosis, and coccidioidomycosis. A common fungal infection is yeast/thrush which looks like white coating on the inside of the mouth and or tongue and can occur even in the first month. Fungus can also cause vaginal infections in women and can be bothersome causing itch and white discharge. Most fungus infections do not get into the blood stream but, if so they can be treated with intravenous anti-fungal medications.

ii) Viral infections – Cytomegalovirus (CMV) a common virus which is community-acquired or re-activated and is usually not serious for healthy people. This virus is however more concerning for people who are taking immunosuppressive medications. Some patients are more at risk of getting CMV and usually will get it between one and six months after transplant. In most cases, the patient has been identified by the Transplant Clinic that he/she is more at risk of getting CMV medication, such as a “CMV positive” donor giving a kidney to a “CMV negative” recipient. Medication such as valganciclovir is given to prevent or treat this infection. Other infections include Epstein-Barr virus,

which sometimes causes lymphomas as well, and BK virus, which can damage the kidney transplant. Herpes virus (zoster, simplex) can also reactivate and cause rashes or more serious sickness, again usually one to six months after the transplant.

iii) Bacterial infections- Patients can get a variety of urine infections and wound infections, or pneumonias early after the transplant. Later on, tuberculosis and recurrent urine infections can become a problem. Sometimes bacteria can more easily get in to the bloodstream (bacteremia) because of the immunosuppression.

iv) Parasitic infections – A good example is Pneumocystis carinii pneumonia (PCP). Rarely we see hookworms, roundworms, and other parasitic infestations depending on the part of the world in which the patient grew up.

3. What can be done to prevent infections?

Practice good hand washing techniques. Please take the time to read the posters in the hospital and public washrooms-they really do apply to you. Encourage any family and friends who are in contact with you to also have good washing practices. Avoid as much as possible contact with persons who have obvious illnesses such as flu or colds. Travel in the subway is permissible. You do not need a mask.

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Do not share razors, toothbrushes or eating utensils since many viral illnesses are spread this way. When gardening make sure gloves are worn and hands are washed frequently. Some soils can carry molds that can cause respiratory infections for patients who are immunosuppressed. Be especially careful if you have long or artificial fingernails. If you have pets make certain that vaccines are up to date as recommended and do not handle animal waste. Avoid pets such as reptiles, turtles, hamsters and guinea pigs for these animals often carry infections that may cause you to be ill. Finally, practice safe sex – use condoms.

4. What can be done to treat infections?

There are many antibiotics that can be used for treating infections but before you take any medication prescribed to you by anyone other than the Transplant Clinic you must call your transplant team. This is important to make certain that there are no interactions with the transplant medications you are taking and that the dose prescribed is suitable for your level of kidney function. Be fully aware of any previously identified medication allergies that you may have and report them.

5. Are all infections serious? Which are more serious than others?

While all infections should be taken seriously, fortunately not all are serious. A medical professional should decide about the seriousness of an infection because this will dictate how quickly and how aggressively it should be treated. Sometimes the help of an Infectious Diseases specialist is required.

6. Do I need antibiotics for dental procedures?

This is a very common question. Generally you do not require antibiotics prior to dental work after transplant. However if you have a birth heart defect, have had rheumatic fever, a heart valve replacement, previous heart infection, or a heart transplant as well, then you need antibiotics. Your dentist will decide on your particular need but a kidney transplant in itself does not increase the need for an antibiotic.

7. Do I need antibiotics for other operations?

Depending on the procedure you are going to have you may need an antibiotic, such as for stent removal or operation on an infected urinary tract. Again, that decision is made by the operating doctor.

8. What are the side effects of antibiotics I should be looking out for?

If you are on any antibiotics always watch out for a possible allergic reaction such as skin rashes, swollen throat or tongue, and stop the antibiotic immediately if this happens and call your doctor. Not all new things that occur after starting an antibiotic are due to allergy, but it is just chance timing. Sometimes an allergy specialist can be consulted to help desensitize your body, if that antibiotic is a very useful one.

9. Does the transplant clinic need to know about all my infections? Who should I call if I have an infection? How can I even tell if I have an infection?

As much as possible, keep your transplant team informed of any health changes including infections. If you think you may be ill, you can call the Transplant Clinic for advice or your family physician or go to a local emergency department to be seen. Usually if you have an infection you may have fever, burning when passing urine or you may feel general malaise and weakness. If you feel unwell and different from your usual self then you may have an infection.

10. Can I share antibiotics with family members and friends?

NO, you cannot share antibiotics with anyone. Antibiotics are prescribed based on the type of infection you may have. If you share antibiotics you may be using the wrong antibiotic which could in turn make the infection worse, delay diagnosis, make your cultures negative and mask the diagnosis, cause resistance, or you may be allergic to that particular antibiotic and get very sick.

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Funding for this publication provided by Hoffmann-La Roche Limited

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