Cyclosporine (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have ever been treated for psoriasis. Tell your doctor if you have kidney disease, liver disease, anemia, bleeding problems, brain disease, cancer, high blood pressure, eye or visual problems (such as papilloedema), or a history of seizures. Tell your doctor if you have heart problems, high or low cholesterol, or any other medical problems.
• This medicine may increase your risk of developing skin cancer or blood cancer. Talk to your doctor if you have concerns about this risk.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Also, avoid excessive exposure to ultraviolet (UV) light, such as staying out in the sun for long periods of time.
• This medicine may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in your urine, or a change in how much or how often you urinate.
• Chest pain, fast or uneven heartbeat, high blood pressure, or new or worsening swelling.
• Confusion, weakness, uneven heartbeat, shortness of breath, or numbness or tingling in your hands, feet, or lips.
• Dark-colored urine, pale stools, nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Fever, chills, cough, sore throat, and body aches.
• Hearing loss or ringing in your ears.
• New or worsening numbness, tingling, or loss of movement anywhere in your body.
• Seizures, confusion, or severe changes in mood or behavior.
• Tremors (shaking).
• Unusual bleeding, bruising, or weakness.
• Vision changes.
• Warmth or redness in your face, neck, arms, or upper chest.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Acne, or excess growth of hair around your lips, over your chin, chest, hands, or legs.
• Headache, joint pain, or muscle aches.
• Runny or stuffy nose.
• Stomach upset, diarrhea, constipation, nausea, vomiting, or loss of appetite.
• Swelling and bleeding of your gums.

Introduction

Cyclosporine (sye-kloe-SPOR-een)

Used with other medicines to help prevent organ rejection after a kidney, liver, or heart transplant. Also treats rheumatoid arthritis and psoriasis.

Brand Name(s)

Neoral, Sandimmune, Gengraf

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to. Take this medicine at the same time every day.
• You may take this medicine with or without food.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
• This medicine may be used with other medicines that prevent organ rejection. Take all other medicines your doctor prescribed as part of your combination treatment.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Mix the oral liquid in a drinking glass, not a plastic cup. You can mix it with milk, chocolate milk, apple or orange juice to make it taste better, but do not mix Neoral® oral liquid with milk. Do not mix it with very cold or hot drinks. Stir well, and drink your medicine right away. Rinse the glass with more juice or water and drink that too, so you get all of the medicine.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Keep the medicine in the original container. Store at room temperature, away from heat and direct light. Do not keep this medicine in the refrigerator or freezer. Throw away any unused oral liquid after 60 days.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other drugs that can interact with cyclosporine. Make sure your doctor knows about all other medicines you are using. Tell your doctor if you are using medicine that weakens the immune system such as methylprednisolone (Decadron®) or other steroids, chemotherapy, or radiation therapy.
• Make sure your doctor knows if you are using pain or arthritis medicine (such as azapropazon, colchicine, diclofenac, naproxen, sulindac, Clinoril®, Naprosyn®, or Voltaren®), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Depakote®, Dilantin®, Tegretol®, or Trileptal®), or medicine to treat HIV or AIDS (such as indinavir, nelfinavir, ritonavir, saquinavir, Fortovase®, Invirase®, or Norvir®). Tell your doctor if you are also using melphalan (Alkeran®), tacrolimus (Protopic®), or medicine that can be hard on your kidneys.
• Make sure your doctor knows if you are using medicine to treat an infection (such as azithromycin, ciprofloxacin, clarithromycin, erythromycin, gentamicin, nafcillin, quinupristin/dalfopristin, rifabutin, rifampin, trimethoprim/sulfamethoxazole, tobramycin, vancomycin, Bactrim®, Biaxin®, Cipro®, Cotrim®, E-mycin®, Ery-tab®, Garamycin®, Mycobutin®, Nebcin®, Rifadin®, Septra®, Synercid®, Unipen®, or Vancocin®) or for fungal infections (such as amphotericin B, fluconazole, itraconazole, ketoconazole, terbinafine, voriconazole, Diflucan®, Fungizone®, Lamisil®, Nizoral®, Sporanox®, or Vfend®). Tell your doctor if you are using a stomach medicine (such as cimetidine, ranitidine, Pepcid®, Tagamet®, or Zantac®) or blood pressure medicine (such as diltiazem, nicardipine, nifedipine, verapamil, Calan®, Cardene®, Cardizem®, Isoptin®, Lotrel®, Procardia®, or Verelan®).
• Make sure your doctor knows if you are also using birth control pills, medicine to lower cholesterol (such as atorvastatin, bezafibrate, fenofibrate, fluvastatin, lovastatin, pravastatin, simvastatin, Bezalip®, Lescol®, Lipitor®, Pravachol®, Tricor®, or Zocor®), allopurinol (Zyloprim®), amiodarone (Cordarone®, Pacerone®), bosentan (Tracleer®), bromocriptine (Parlodel®), danazol (Danocrine®), digoxin (Lanoxin®), etoposide (VePesid®), imatinib (Gleevec®), metoclopramide (Reglan®), octreotide (Sandostatin®), orlistat (Xenical®), repaglinide (Prandin®), sulfinpyrazone (Anturane®), ticlopidine (Ticlid®), or St. John's wort.
• Do not take diuretics or "water pills" (such as spironolactone, triamterene, or Aldactone®) while you are using this medicine. Tell your doctor if you are using certain blood pressure medicines (such as enalapril, lisinopril, losartan, olmesartan, valsartan, Accupril®, Atacand®, Cozaar®, Diovan®, Hyzaar®, or Zestril®) or any potassium supplements.
• If you are using sirolimus (Rapamune®) together with this medicine, it is recommended to use sirolimus 4 hours after using cyclosporine.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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