IMPORTANT INFORMATION – ORAL SOLUTION New Stopper - Same Gengraf Product

WHAT IS MODIFIED
CYCLOSPORINE?

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How to take GENGRAF

Flexible and dependable dosing options

Gengraf 25 mg capsule
Gengraf 100 mg capsule
Gengraf 100 mg/mL Oral Solution

Use GENGRAF as prescribed by your doctor. Read all information given to you. Follow all instructions closely.1,2

Dosage and administration1,2

  • The daily dose of GENGRAF should always be given in two divided doses (BID)
  • It is recommended that GENGRAF be administered on a consistent schedule with regard to time of day and relation to meals
  • Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided
  • Take with or without food. Always take with food or always take on an empty stomach—be consistent
  • If you are taking sirolimus, take it 4 hours after taking this medicine
  • To gain the most benefit, do not miss doses
  • Keep taking GENGRAF as you have been told by your doctor or other healthcare provider
  • Even if you feel well, take this medicine at the same time of day

Dosing for newly transplanted patients1,2

  • The initial oral dose of GENGRAF can be given 4 to 12 hours prior to transplantation or be given postoperatively
  • The initial dose of GENGRAF varies depending on the transplanted organ and the other immunosuppressive agents included in the immunosuppressive protocol

What if you miss a dose?3

  • Take a missed dose as soon as you think about it
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time
  • Do not take 2 doses at the same time or extra doses

Modified cyclosporines, like GENGRAF, are not interchangeable with cyclosporine.

Switching to another modified cyclosporine should be handled with extreme caution.

  • GENGRAF (modified cyclosporine) and cyclosporine are not bioequivalent
  • GENGRAF (modified cyclosporine) and cyclosporine cannot be used interchangeably without physician supervision
  • Blood concentrations should be monitored in transplant patients switching immunosuppression therapy to avoid toxicity due to high concentrations
  • Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations4

Safety Considerations1,2

  • Only physicians experienced in systemic immunosuppressive therapy and management of organ transplant recipients should prescribe GENGRAF. Patients receiving GENGRAF should be managed in facilities with adequate laboratory and supportive medical resources.
  • Patients treated with GENGRAF are at increased risk for developing lymphoma and other malignancies, particularly of the skin. Some malignancies may be fatal.
  • Patients treated with GENGRAF have increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections, which may lead to serious, including fatal, outcomes.
  • GENGRAF and Sandimmune®* (cyclosporine capsules, USP) Soft Gelatin Capsules are not bioequivalent and cannot be used interchangeably without physician supervision.
  • Cyclosporine blood concentrations should be monitored and dose adjustments made in transplant patients taking GENGRAF to avoid toxicity due to high concentrations and to minimize possible organ rejection due to low concentrations.
  • GENGRAF in recommended dosages can cause systemic hypertension and nephrotoxicity.
  • Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine; therefore, renal function must be monitored during therapy.
  • GENGRAF is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.
  • Cases of hepatotoxicity and liver injury, some fatal, have been reported in patients treated with cyclosporine.
  • The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia.

*Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation.

USE1,2

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 INFORMATION1,2

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

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

3. GENGRAF (Capsules, Modified). Drugs.com website. https://www.drugs.com/cdi/gengraf-cyclosporine-capsules-modified.html. Accessed July 24, 2020.

4. 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.

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.

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USE1,2

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 INFORMATION1,2

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.