Specific Safety Info for Gengraf

Specific Precautions and Warnings With Gengraf

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Gengraf must be taken under the supervision of a healthcare provider who has experience prescribing medications that suppress the immune system and, if you are taking it for transplant rejection, in treating people who have had an organ transplantation.
  • This medication increases your risk for developing cancer, especially skin cancer and lymphoma (cancer of the lymph nodes). Your risk may be even higher if you take other medicines that weaken the immune system or have psoriasis and have received certain other treatments before Gengraf. 
To help lower your risk of skin cancer, limit your time in the sun and wear sun protective factor (SPF) of at least 30 with protective clothing, such as hats and long-sleeved shirts, while you are outside. Contact your healthcare provider if you notice any skin changes or develop lumps in your neck, underarms, or groin area, as these could be signs of a serious problem. 
  • Gengraf contains a modified form of cyclosporine, which has been slightly changed from original cyclosporine and is more easily absorbed into the body. Because they are absorbed differently, Gengraf and original cyclosporine are not interchangeable.

If you receive a prescription for cyclosporine that looks unfamiliar to you, talk to your pharmacist or healthcare provider to make sure you have received the correct type. You should only switch types under the direction of a healthcare provider, as you may need a dosage adjustment after the switch. 

  • This medicine can damage your kidneys and liver, especially when used in high doses or for long periods. It can also cause high blood pressure. Your healthcare provider will monitor you for these side effects during treatment.
  • Gengraf can cause hyperkalemia, which is a high level of potassium in the blood. Your healthcare provider will monitor your potassium levels during treatment with a simple blood test. If your levels start to increase, you may need to limit the amount of potassium in your diet.
  • This medicine may increase the amount of uric acid in your blood, which could cause gout (a type of arthritis that affects the joints, especially of the toe) or kidney stones.
  • You will need regular blood pressure monitoring and certain lab tests while taking this medicine to make sure you are not developing potentially serious Gengraf side effects. Your healthcare provider may also want to monitor your blood levels, especially if you use the medicine to prevent transplant rejection or for rheumatoid arthritis. Make sure to keep all your healthcare provider and lab appointments.
  • Gengraf suppresses the immune system and may increase your risk for developing an infection, including potentially serious bacterial, viral, or fungal infections. You could also become infected with the BK virus, which can damage your kidneys and, if you have received a kidney transplant, cause your new kidney to fail. Contact your healthcare provider right away if you think you may have an infection, or experience symptoms of an infection, such as fever, body aches, or chills.
  • There have reports of seizures in people taking Gengraf, especially when used in combination with methylprednisolone (A-Methapred®, Depo-Medrol®, Medrol®, Solu-Medrol®). There have also been reports of encephalopathy, a disease of the brain that causes altered brain function. Seek immediate medical care if you experience possible signs of encephalopathy, such as:
    • Confusion
    • Vision changes
    • Muscle weakness
    • Problems with movement
    • Seizures.
  • Check with your healthcare provider before getting any type of vaccination or immunization during treatment with Gengraf. This medicine may make vaccines less effective. Also, people taking it should not receive "live" vaccinations (see Gengraf Drug Interactions).
  • This product can react with a number of other medications (see Gengraf Drug Interactions).
  • Gengraf is considered a pregnancy Category C medication. This means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits (see Gengraf and Pregnancy).
  • This medication is known to pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Gengraf and Breastfeeding).
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