Cyclosporine Injection

IMPORTANT WARNING:

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 medicine prescribed?

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.

Are there OTHER USES for this medicine?

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.

HOW should this medicine be used?

Cyclosporine injection comes as a solution (liquid) to be injected over 2 to 6 hours into a vein, usually by a doctor or nurse in a hospital or medical facility. It is usually given 4 to 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.

What SPECIAL PRECAUTIONS should I follow?

Before receiving cyclosporine injection,

• tell your doctor and pharmacist if you are allergic to cyclosporine (Gengraf, Neoral, Sandimmune), any other medications, or Cremophor EL.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking, or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acyclovir (Zovirax); allopurinol (Zyloprim); amiodarone (Cordarone); amphotericin B (Amphotec, Fungizone); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan); certain antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); azithromycin (Zithromax); bromocriptine (Parlodel); calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), nifedipine (Adalat, Procardia),and verapamil (Calan); carbamazepine (Carbitrol, Epitol, Tegretol); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); cimetidine (Tagamet);ciprofloxacin (Cipro); clarithromycin (Biaxin); colchicine; dalfopristin and quinupristin combination (Synercid); danazol; digoxin (Lanoxicaps, Lanoxin); certain diuretics ('water pills') including amiloride (in Hydro-ride), spironolactone (Aldactone), and triamterene (Dyazide, Dyrenium, in Maxzide); erythromycin (E.E.S., E-Mycin, Erythrocin); fenofibrate (Antara, Lipophen, Tricor); gentamicin; HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase); imatinib (Gleevec); metoclopramide (Reglan); methylprednisolone (Medrol); nafcillin; nonsteroidal anti-inflammatory medications such as diclofenac (Cataflam, Voltaren), naproxen (Aleve, Naprosyn), and sulindac (Clinoril); octreotide (Sandostatin); hormonal contraceptives (birth control pills, patches, implants, and injections);orlistat (alli, Xenical); potassium supplements; prednisolone (Pediapred); phenobarbital; phenytoin (Dilantin); ranitidine (Zantac); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sulfinpyrazone (Anturane); terbinafine (Lamisil); ticlopidine (Ticlid); tobramycin (Tobi); trimethoprim with sulfamethoxazole (Bactrim, Septra); and vancomycin (Vancocin). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

• tell your doctor what herbal products you are taking or plan to take, especially St. John's wort.

• tell your doctor if you are being treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light) and if you have or have ever had low levels of cholesterol or magnesium in your blood or high blood pressure.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while receiving cyclosporine injection, call your doctor. Cyclosporine injection may increase the risk that your baby will be born too early.

• tell your doctor if you are breast-feeding or planning to breastfeed.

• do not have vaccinations without talking to your doctor.

• you should know that cyclosporine may cause extra tissue to grow in your gums. Be sure to brush your teeth carefully and see a dentist regularly during your treatment to decrease the risk that you will develop this side effect.

What SPECIAL DIETARY instructions should I follow?

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 medicine cause?

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

• headache
• diarrhea
• nausea
• vomiting
• increased hair growth on the face, arms, and back
• swelling of gum tissue, or growth of extra tissue on the gums
• acne
• uncontrollable shaking of a part of your body
• pain, burning, numbness, or tingling in the hands, arms, feet, or legs
• cramps
• breast enlargement in men

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:

• flushing of the face or chest
• shortness of breath
• wheezing
• fast heartbeat
• rash
• hives
• itching
• difficulty swallowing
• loss of consciousness
• seizures
• changes in mood or behavior
• difficulty moving
• vision problems or sudden blackouts
• swelling of the hands, arms, feet, ankles, or lower legs

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.