What is Neoral (cyclosporine)

Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader. Cyclosporine is used to prevent organ rejection after a kidney, liver, or heart transplant. Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis.

What is the most important information I should know about Neoral (cyclosporine)?

You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), or any type of cancer.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Call your doctor at once if you have any signs of kidney failure, such as urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting, swelling, weight gain, or feeling short of breath. Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease. There are many other medicines that can cause serious medical problems if you take them together with cyclosporine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before taking Neoral (cyclosporine)?

You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have:

• kidney disease;

• untreated or uncontrolled high blood pressure; or

• any type of cancer.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take cyclosporine:

• psoriasis that has been treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar; or

• if you are also taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

FDA pregnancy category C. It is not known whether cyclosporine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cyclosporine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Neoral (cyclosporine)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice at room temperature to make the medicine taste better. Neoral "modified" (microemulsion) oral solution should be mixed with orange juice or apple juice that is at room temperature.

Cyclosporine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your blood pressure and kidney function may also need to be checked. Do not miss any scheduled appointments.

Your condition may need to be treated with a combination of different drugs. For best treatment results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person taking cyclosporine should remain under the care of a doctor.

Store cyclosporine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), and urinating less than usual or not at all.

What should I avoid while taking Neoral (cyclosporine)?

Avoid exposure to sunlight, sunlamps, or tanning beds. Cyclosporine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Avoid eating grapefruit or drinking grapefruit juice. Grapefruit may interact with cyclosporine and increase your blood levels of this medication.

Neoral (cyclosporine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst;

• swelling, weight gain, feeling short of breath;

• blurred vision, headache or pain behind your eyes, sometimes with vomiting;

• seizure (convulsions);

• muscle pain or weakness, fast heart rate, feeling light-headed;

• signs of infection such as fever, chills, sore throat, flu symptoms;

• pale skin, easy bruising or bleeding, unusual weakness; or

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• tremors or shaking;

• increased hair growth;

• headache or body pain;

• diarrhea, constipation, vomiting; or

• numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Neoral (cyclosporine)?

Many drugs can interact with cyclosporine. Below is just a partial list. Tell your doctor about all other medications you are using, especially:

• etoposide (VePesid, Etopophos);

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• nefazodone;

• repaglinide (Prandin);

• St. John's wort;

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

• a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar);

• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

• other medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;