Simulect

Simulect is a prescription medication used along with other drugs to help prevent organ rejection after a kidney transplant.

Simulect belongs to a group of drugs called immunosuppressants. These work by decreasing the activity of the body's immune system so it will not attack the transplanted organ.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

The most common side effect of Simulect is gastrointestinal upset.

Simulect can also cause dizziness. Do not drive or operate heavy machinery until you know how Simulect affects you.

Simulect is a prescription medication that is used with cyclosporine and corticosteroids to prevent immediate transplant rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in people who are receiving kidney transplants.

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

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Simulect. See the “Simulect Precautions” section.

Common side effects of Simulect include the following:

• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• heartburn
• swelling of the hands, feet, ankles, or lower legs
• runny nose
• headache
• shaking of a part of the body that you cannot control
• difficulty falling asleep or staying asleep
• pain in the place where you received the injection

This is not a complete list of Simulect side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No Simulect drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Simulect, including an increased risk of infection. Tell your healthcare provider right away if you have signs or symptoms of an infection such as a fever.

Also tell your healthcare provider if you experience any of the following symptoms, which may indicate a serious reaction to Simulect:

• hives
• rash
• itching
• sneezing
• cough
• wheezing
• difficulty breathing or swallowing
• fast heartbeat
• muscle aches
• fatigue
• lightheadedness, dizziness, or fainting
• weight gain and swelling all over the body
• sore throat, fever, chills, or other signs of infection
• difficult or painful urination
• decreased urination

Simulect can cause dizziness. Do not drive or operate heavy machinery until you know how Simulect affects you.

Do not take Simulect if you are allergic to Simulect or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Simulect, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Simulect, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Simulect or to any of its ingredients
• have ever been treated with Simulect
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simulect falls into category B. There are no well-done studies that have been done in humans with Simulect. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Simulect crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Simulect.

Take Simulect exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

In adult patients, the recommended Simulect regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation.

If you take too much Simulect, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Simulect is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Talk to your doctor about the risks associated with this medication.
• This medication should only be administered by a healthcare provider in a clinical setting.

WARNING

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.