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WHAT IS
IMMUNOSUPPRESSION?

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WHAT IS MODIFIED
CYCLOSPORINE?

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More than

35,000

Americans received kidney, liver, and heart transplants in 20197

More than

108,000

candidates were on kidney, liver, and heart transplant waiting lists as of July 20208

More than

735,000

Americans have undergone kidney, liver, or heart transplant surgery7

What to expect with kidney, liver, and heart transplant

Familiarize yourself with the process

If a patient’s kidney, liver, or heart is failing, the patient and their doctor will need to discuss if a transplant may be an option.

Transplantation surgery is performed to replace the failing organ with a healthy one.1 Sometimes a new kidney may come from a living donor. Other times, a kidney, liver, or heart will come from a person who has recently died.2

As the patient will learn from discussions with their healthcare team, it’s important to understand that organ transplantation is major surgery. It has many risks and downsides, like organ rejection. The healthcare team will discuss all the options with the patient before they make a decision about transplantation surgery.1

The kidney, liver, and heart transplant process: Patient perspective3,4

Each transplant center may operate differently. However, several steps are common to the patient journey for kidney, liver, and heart transplant patients.

  • Become familiar with the transplant process
  • Know what transplantation success and failure look like
  • Discuss the pros and cons of each center with your doctor
  • Consider the center’s reviews, location, whether it will honor your insurance, whether there is a waiting list, areas of concentration, and reputation
  • Work with your doctor to choose a transplant center
  • Schedule an evaluation
  • Follow your center’s recommendations for how to prepare for your evaluation
  • Know what documents you must bring to your evaluation
  • Work with your healthcare team to prepare a list of questions to ask
  • Evaluations may include:
    • Blood and tissue typing
    • Chest x-rays
    • Heart and lung work-ups
    • Cancer and infectious disease screening
    • Psychological assessment
  • Consult your doctor if you have any questions or are unsure what to do
  • The transplant team decides whether you are an appropriate candidate for a transplant
  • Make sure you understand the rules for being on the waiting list
  • Be aware that violating waiting list rules could cause delays or result in cancellation of transplant surgery
  • Work with your healthcare team to address questions
  • Talk to friends and family about your feelings and next steps
  • Understand the costs involved
  • Talk to insurance companies to determine coverage
  • Work with your transplant center’s financial coordinator
  • Work with your transplant team to adjust your expectations for the wait
  • Ask your transplant team to help you plan for when you get the call that a donor organ has been found

Your doctor knows you and your medical history. Make sure you know what they expect of you and follow their direction each step of the way.

How a donor kidney, liver, or heart is matched

Many factors are considered when determining a match between a transplant candidate and a donated kidney, liver, or heart:2,5

  • Blood type
  • Organ size
  • Waiting list time
  • Recipient’s health
  • Immune systems of donor and recipient
  • Location

Available organs are offered locally first. If no match is found, they are offered regionally, then nationally.2

Talk to your doctor if you have questions about the factors that are considered when making a donor match. Your doctor is most familiar with you and your medical history.

What is transplant rejection?

The immune system is designed to protect the body from things that could hurt it, like germs and viruses. Left to its own devices, the immune system is likely to treat a newly transplanted kidney, liver, or heart as a foreign substance and attack it. If this happens, it will destroy the new organ. This is what is meant when you hear the word rejection related to kidney, liver, or heart transplants.

To help prevent rejection, your doctor may prescribe a medicine called an immunosuppressant to keep the body from rejecting the transplanted kidney, liver, or heart.6

USE9,10

GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) and GENGRAF® Oral Solution (cyclosporine oral solution, USP [MODIFIED]) are prescription medicines used to help prevent organ rejection in people who have received a kidney, liver, or heart transplant. Cyclosporine (MODIFIED) has been used with other immunosuppressants, such as azathioprine and corticosteroids.

IMPORTANT SAFETY INFORMATION9,10

WARNING

While you are on this treatment, it is important to be under the care of a doctor who has experience treating and monitoring organ transplant patients who are taking medicines like GENGRAF.

GENGRAF is an immunosuppressant, a drug that reduces the body’s ability to fight illness and disease. Immunosuppressant drugs may increase your chances of getting an infection and certain types of cancers. In organ transplant patients, using GENGRAF with other immunosuppressants may increase this effect.

Different formulations of cyclosporine deliver different amounts of medicine. Do not switch formulations of cyclosporine without your doctor’s permission and direction, as switching formulations may require a dosage change.

GENGRAF can cause high blood pressure and kidney problems. This risk increases the longer you take GENGRAF and with higher doses. Ongoing laboratory tests must be performed to monitor your kidney function while you are being treated with GENGRAF.

  • Do not take GENGRAF if you are allergic to cyclosporine or any of the ingredients in GENGRAF.
  • Occasionally patients have developed a condition that causes damage to the small blood vessels, which may result in graft failure.
  • Occasionally some patients have experienced abnormally high levels of potassium in their blood.
  • Cases of liver damage, including liver failure, have been reported in patients treated with cyclosporine. In some cases, fatal outcomes have been reported. Most reports included patients who also had other medical conditions. Ongoing laboratory tests must be performed to monitor your liver function while you are being treated with GENGRAF.
  • Patients receiving immunosuppressants, including cyclosporine, are at an increased risk of developing lymphomas and other types of cancers, especially skin cancers. Some of these cancers may be fatal. You should avoid excess sun exposure, including tanning booths.
  • Transplant patients taking cyclosporine are at an increased risk for serious infections, some of which may have fatal outcomes. Infections may include the polyoma virus, which may have a serious and sometimes fatal outcome.
  • There have been reports of convulsions (uncontrolled shaking of the body) in patients taking cyclosporine and, in particular, in patients also taking high doses of corticosteroids.
  • High blood pressure is a common side effect of taking cyclosporine.
  • During treatment with cyclosporine, vaccination may be less effective, and the use of vaccines containing live viruses should be avoided.
  • You should take GENGRAF exactly as prescribed by your physician. This includes taking your medication on the same schedule every day. You should avoid grapefruit and grapefruit juice while taking GENGRAF.
  • Tell your doctor about any other medications, vitamins, nutritional supplements, or herbal products you are taking. GENGRAF and other medicines may affect each other, causing side effects. GENGRAF may affect the way other medicines work, and other medicines may affect how GENGRAF works.
  • If you are or are planning to become pregnant, tell your doctor right away and follow the instructions you receive about taking GENGRAF.
  • The most common side effects include kidney problems, high blood pressure, abnormal hair growth on your body or face, tremor, headache, nausea, vomiting, swollen or painful gums, low number of white blood cells, urinary tract infections, and other infections.

References:

1. WebMD. What you need to know about organ transplants. https://www.webmd.com/a-to-z-guides/organ-transplant-overview#1. Reviewed June 5, 2017. Accessed July 22, 2020.

2. UNOS. Transplantation. Frequently asked questions. https://unos.org/transplantation/faqs/. Accessed July 22, 2020.

3. US Department of Health & Human Services. US Government Information on Organ Donation and Transplantation. The organ transplant process. https://www.organdonor.gov/about/process/transplant-process.html. Accessed July 22, 2020.

4. UNOS. Talking about transplantation: what every patient needs to know [brochure]. https://www.unos.org/wp-content/uploads/unos/WEPNTK.pdf. Accessed July 22, 2020.

5. US Department of Health & Human Services. US Government Information on Organ Donation and Transplantation. Matching donors and recipients. https://www.organdonor.gov/about/process/matching.html. Accessed July 22, 2020.

6. Medline Plus. US National Library of Medicine. Transplant rejection. https://medlineplus.gov/ency/article/000815.htm. Updated April 5, 2018. Accessed July 22, 2020.

7. US Department of Health and Human Services. Organ Procurement and Transplantation Network: National data. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/#. Accessed July 22, 2020.

8. US Department of Health and Human Services. Organ Procurement and Transplantation Network: Data. https://optn.transplant.hrsa.gov/data/. Accessed July 22, 2020.

9. GENGRAF Capsules [package insert]. North Chicago, IL: AbbVie Inc.

10. GENGRAF Oral Solution [package insert]. North Chicago, IL: AbbVie Inc.

Please see full Prescribing Information for additional information about GENGRAF Capsules.

Please see full Prescribing Information for additional information about GENGRAF Oral Solution.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

If you have any questions about AbbVie's Gengraf.com website that have not been answered, click here. This website and the information contained herein is intended for use by U.S. residents only and is provided for informational purposes only.

+

USE9,10

GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) and GENGRAF® Oral Solution (cyclosporine oral solution, USP [MODIFIED]) are prescription medicines used to help prevent organ rejection in people who have received a kidney, liver, or heart transplant. Cyclosporine (MODIFIED) has been used with other immunosuppressants, such as azathioprine and corticosteroids.

IMPORTANT SAFETY INFORMATION9,10

WARNING

While you are on this treatment, it is important to be under the care of a doctor who has experience treating and monitoring organ transplant patients who are taking medicines like GENGRAF.

GENGRAF is an immunosuppressant, a drug that reduces the body’s ability to fight illness and disease. Immunosuppressant drugs may increase your chances of getting an infection and certain types of cancers. In organ transplant patients, using GENGRAF with other immunosuppressants may increase this effect.

Different formulations of cyclosporine deliver different amounts of medicine. Do not switch formulations of cyclosporine without your doctor’s permission and direction, as switching formulations may require a dosage change.

GENGRAF can cause high blood pressure and kidney problems. This risk increases the longer you take GENGRAF and with higher doses. Ongoing laboratory tests must be performed to monitor your kidney function while you are being treated with GENGRAF.

  • Do not take GENGRAF if you are allergic to cyclosporine or any of the ingredients in GENGRAF.
  • Occasionally patients have developed a condition that causes damage to the small blood vessels, which may result in graft failure.
  • Occasionally some patients have experienced abnormally high levels of potassium in their blood.
  • Cases of liver damage, including liver failure, have been reported in patients treated with cyclosporine. In some cases, fatal outcomes have been reported. Most reports included patients who also had other medical conditions. Ongoing laboratory tests must be performed to monitor your liver function while you are being treated with GENGRAF.
  • Patients receiving immunosuppressants, including cyclosporine, are at an increased risk of developing lymphomas and other types of cancers, especially skin cancers. Some of these cancers may be fatal. You should avoid excess sun exposure, including tanning booths.
  • Transplant patients taking cyclosporine are at an increased risk for serious infections, some of which may have fatal outcomes. Infections may include the polyoma virus, which may have a serious and sometimes fatal outcome.
  • There have been reports of convulsions (uncontrolled shaking of the body) in patients taking cyclosporine and, in particular, in patients also taking high doses of corticosteroids.
  • High blood pressure is a common side effect of taking cyclosporine.
  • During treatment with cyclosporine, vaccination may be less effective, and the use of vaccines containing live viruses should be avoided.
  • You should take GENGRAF exactly as prescribed by your physician. This includes taking your medication on the same schedule every day. You should avoid grapefruit and grapefruit juice while taking GENGRAF.
  • Tell your doctor about any other medications, vitamins, nutritional supplements, or herbal products you are taking. GENGRAF and other medicines may affect each other, causing side effects. GENGRAF may affect the way other medicines work, and other medicines may affect how GENGRAF works.
  • If you are or are planning to become pregnant, tell your doctor right away and follow the instructions you receive about taking GENGRAF.
  • The most common side effects include kidney problems, high blood pressure, abnormal hair growth on your body or face, tremor, headache, nausea, vomiting, swollen or painful gums, low number of white blood cells, urinary tract infections, and other infections.