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Cyclosporine Injection

(sye' kloe spor een)

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IMPORTANT WARNING:   Return to top

[Posted 07/14/2009] The FDA is requiring the makers of certain immunosuppressant drugs [Sirolimus (Rapamune), Cyclosporine (Sandimmune and generics), Cyclosporine modified (Neoral and generics), Mycophenolate mofetil (Cellcept and generics), Mycophenolic acid (Myfortic)] to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

IMPORTANT WARNING:   Return to top

Cyclosporine injection must be given under the supervision of a doctor who is experienced in treating transplant patients and prescribing medications that decrease the activity of the immune system.

Receiving cyclosporine injection may increase the risk that you will develop an infection or cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. This risk may be higher if you receive cyclosporine injection with other medications that decrease the activity of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Tell your doctor if you are taking any of these medications, and if you have or have ever had any type of cancer. If you experience any of the following symptoms, call your doctor immediately: sore throat, fever, chills, and other signs of infection; flu-like symptoms; coughing; difficulty urinating; pain when urinating; a red, raised, or swollen area on the skin; new sores or discoloration on the skin; lumps or masses anywhere in your body; night sweats; swollen glands in the neck, armpits, or groin; difficulty breathing; chest pain; weakness or tiredness that does not go away; or pain, swelling, or fullness in the stomach.

Talk to your doctor about the risks of receiving cyclosporine injection.

Why is this medication prescribed?   Return to top

Cyclosporine injection is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who have received kidney, liver, and heart transplants. Cyclosporine injection should only be used to treat people who are unable to take cyclosporine by mouth. Cyclosporine is in a class of medications called immunosuppressants. It works by decreasing the activity of the immune system.

How should this medicine be used?   Return to top

Cyclosporine injection comes as a solution (liquid) to be injected over 2-6 hours into a vein, usually by a doctor or nurse in a hospital or medical facility. It is usually given 4-12 hours before transplant surgery and once a day after the surgery until medication can be taken by mouth.

A doctor or nurse will watch you closely while you are receiving cyclosporine injection so that you can be treated quickly if you have a serious allergic reaction.

Other uses for this medicine   Return to top

Cyclosporine injection is also sometimes used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) and to prevent rejection in patients who have received pancreas or cornea transplants. Talk to your doctor about the risks of receiving this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

Before receiving cyclosporine injection,

What special dietary instructions should I follow?   Return to top

Avoid drinking grapefruit juice or eating grapefruit while receiving cyclosporine injection.

Your doctor may tell you to limit the amount of potassium in your diet. Follow these instructions carefully. Talk to your doctor about the amount of potassium-rich foods such as bananas, prunes, raisins, and orange juice that you may have in your diet. Many salt substitutes contain potassium, so talk to your doctor about using them during your treatment.

What side effects can this medication cause?   Return to top

Cyclosporine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

Cyclosporine injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?   Return to top

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cyclosporine injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Sandimmune®

Last Reviewed - 09/01/2008


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