What is modified cyclosporine?

Preventing transplant rejection

Cyclosporine is one of several maintenance drugs recommended by KDIGO guidelines for immunosuppression.1 Cyclosporine helps prevent rejection of a transplanted organ such as a liver, heart, or kidney.2

Maintenance drugs recommended for immunosuppression1

Drug class Drug names
Calcineurin inhibitors (CNIs)
  • Cyclosporine (Sandimmune®)
  • Modified cyclosporine (GENGRAF®, Neoral®)
  • Tacrolimus (Prograf®, Protopic®, Astagraf XL®, Envarsus XR®)
Antiproliferative agents
  • Azathioprine (Azasan®)
  • Mycophenolate mofetil (CellCept®)
  • Mycophenolate sodium (Myfortic®)
mTORi
  • Everolimus (Zortress®, Afinitor®, Afinitor Disperz®)
  • Sirolimus (Rapamune®)
Steroids
  • Prednisolone (Omnipred™, Pediapred®, Pred Mild®, Veripred® 20, Pred Forte®, Millipred™ DP, Orapred ODT®)
  • Prednisone (Rayos, PredniSONE Intensol™)

Not all cyclosporines are the same

  • Original cyclosporine demonstrated low and inconsistent absorption3
  • Cyclosporine was modified (changed) so that it could be better absorbed in the body; it is now called “modified cyclosporine”
  • Modified cyclosporine provides greater and more consistent absorption than the original version of cyclosporine2
  • GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) is an example of a modified cyclosporine
Cyclosporine ≠ modified cyclosporine

Cyclosporines are not interchangeable

  • Original cyclosporine and modified cyclosporine are absorbed differently by the body; they cannot be substituted for one another2
  • Substitution of original cyclosporine and modified cyclosporine for one another could cause severe side effects3

Take only the type of cyclosporine you were prescribed

  • When your doctor writes your prescription, double-check that they specified the type of cyclosporine you should receive
  • Each time you have your prescription filled, check that the brand name on the label is the same type of cyclosporine
  • Alert your pharmacist if the brand name is unfamiliar or if you are not sure you received the right type of cyclosporine

Blood testing is required if the type of cyclosporine is switched

  • If someone is switched from a cyclosporine to a modified cyclosporine, caution should be exercised3
  • Blood concentration levels should be monitored to avoid toxicity due to high concentrations3
  • Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations3
  • It’s important to reinforce that your doctor protect your prescription from being switched at the pharmacy: They can do this by including “Do Not Substitute,” “Dispense as Written” (DAW), or the state’s regulated language on the prescription

KDIGO=Kidney Disease: Improving Global Outcomes.

USE4

GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) is a prescription medicine 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 INFORMATION4

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. Kasiske BL, Zeier MG, Chapman JR, et al. KDIGO clinical practice guideline for the care of kidney transplant recipients: a summary. Kidney Int. 2010;77(4):299-311.

2. Medline Plus. US National Library of Medicine. Cyclosporine. https://medlineplus.gov/druginfo/meds/a601207.html#why. Updated April 2, 2018. Accessed April 25, 2018.

3. Haug MT III. Cyclosporine products: a potential for inappropriate substitution. Pharmacy Times. July 1, 2004. http://www.pharmacytimes.com/publicationsissue/2004/2004-07/2004-07-8030 . Accessed April 25, 2018.

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

If you have any questions about AbbVie’s Gengraf.com website that have not been answered, click here.

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USE4

GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) is a prescription medicine 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 INFORMATION4

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.