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|Sandimmune

CYCLOSPORINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Neoral
• Sandimmune
• SangCya

In Canada—

• Neoral
• Sandimmune

Some other commonly used names are ciclosporin and cyclosporin A .

Category

• Immunosuppressant
• antipsoriatic
• antirheumatic

Description

Cyclosporine (SYE-kloe-spor-een) belongs to the group of medicines known as immunosuppressive agents. It is used to reduce the body"s natural immunity in patients who receive organ (for example, kidney, liver, and heart) transplants.

When a patient receives an organ transplant, the body"s white blood cells will try to get rid of (reject) the transplanted organ. Cyclosporine works by preventing the white blood cells from doing this.

Cyclosporine also is used to treat severe cases of psoriasis and rheumatoid arthritis.

Cyclosporine may also be used for other conditions, as determined by your doctor.

Cyclosporine is a very strong medicine. It may cause side effects that could be very serious, such as high blood pressure and kidney and liver problems. It may also reduce the body"s ability to fight infections. You and your doctor should talk about the good this medicine will do as well as the risks of using it.

Cyclosporine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)
• Oral solution (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cyclosporine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cyclosporine.

Pregnancy—Studies have not been done in humans. However, some women who received cyclosporine during pregnancy delivered their babies prematurely, and some babies were smaller than average when they were born. Additionally, some babies had birth defects. It is not certain that these birth defects occurred because of the use of cyclosporine by the mothers. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Cyclosporine passes into breast milk. There is a chance that it could cause the same side effects in the baby that it does in people taking it. It may be necessary for you to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—This medicine has been tested in children receiving organ transplants and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Studies of this medicine have been done only in adult patients with rheumatoid arthritis and psoriasis, and there is no specific information comparing use of cyclosporine for rheumatoid arthritis or psoriasis in children with use in other age groups.

Older adults—Older people are more likely to experience some side effects (e.g., high blood pressure and kidney problems) than are younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cyclosporine, it is especially important that your health care professional knows if you are taking any of the following:

• Amiloride (e.g., Midamor) or
• Spironolactone (e.g., Aldactone) or
• Triamterene (e.g., Dyrenium)—Since both cyclosporine and these medicines increase the amount of potassium in the body, potassium levels could become too high

• Allopurinol (e.g., Zyloprim) or
• Amiodarone (e.g., Cordarone) or
• Androgens (male hormones) or
• Azithromycin (e.g., Zithromax) or
• Bromocriptine (e.g., Parlodel) or
• Cimetidine (e.g., Tagamet) or
• Clarithromycin (e.g., Biaxin) or
• Contraceptives (birth control pills) or
• Danazol (e.g., Danocrine) or
• Diltiazem (e.g., Cardizem) or
• Erythromycins (medicine for infection) or
• Estrogens (female hormones) or
• Fluconazole (e.g., Diflucan) or
• Human immunodeficiency virus (HIV) protease inhibitors (e.g., Crixivan, Fortovase, Invirase, Norvir, Viracept) or
• Imatinib (e.g., Gleevec) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Nefazodone (e.g., Serzone) or
• Nicardipine (e.g., Cardene) or
• Quinupristin/dalfopristin (e.g., Synercid) or
• Verapamil (e.g., Calan, Covera-HS, Isoptin, Verelan)—May increase effects of cyclosporine by increasing the amount of cyclosporine in the body

• Anti-inflammatory drugs, nonsteroidal (NSAIDs) (diclofenac [e.g., Voltaren], Naproxen [e.g., Aleve], Sulindac [e.g., Clinoril])—May increase the effect of kidney problems

• Atorvastatin (e.g., Lipitor) or
• Fluvastatin (e.g., Lescol) or
• Lovastatin (e.g., Altocor, Mevacor) or
• Pravastatin (e.g., Pravachol) or
• Simvastatin (e.g., Zocor)—May cause muscle pain and weakness; doctor may need to lower dose of this medicine when taken together with cyclosporine.

• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Corticosteroids (cortisone-like medicine) or
• Cyclophosphamide (e.g., Cytoxan) or
• Mercaptopurine (e.g., Purinethol) or
• Muromonab-CD3 (monoclonal antibody) (e.g., Orthoclone OKT3)—There may be an increased risk of infection and cancer because both cyclosporine and these medicines decrease the body"s ability to fight them

• Carbamazepine (e.g., Tegretol) or
• Nafcillin or
• Octreotide (e.g., Sandostatin) or
• Orlistat (e.g., Xenical) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin, Phenytek) or
• Rifampin (e.g., Rifadin) or
• St. John"s Wort (e.g., herbal supplement to treat depression) or
• Sulfinpyrazone or
• Terbinafine (e.g., Lamisil) or
• Ticlopidine (e.g., Ticlid)—May decrease effects of cyclosporine by decreasing the amount of cyclosporine in the body

• Coal tar (e.g., Balnetar, Zetar) or
• Methoxsalen (e.g., Oxsoralen) or
• Radiation therapy or
• Trioxsalen (e.g., Trisoralen)—There may be increased risk of some skin cancers

• Colchicine (medicine to treat or prevent attacks of gout) or
• Digoxin (e.g., Lanoxin)—May increase effects of colchicine or digoxin by increasing the amount in the body which may cause serious unwanted effects

• Methylprednisolone (e.g., Medrol)—May increase the amount of cyclosporine in the body

• Sirolimus (e.g., Rapamune)—May increase the amount of sirolimus in the body; it is recommended that sirolimus be given 4 hours after cyclosporine is administered.

• Vaccines, live virus—During cyclosporine use, vaccines may not work as well. The use of live vaccines should be avoided.

Other medical problems—The presence of other medical problems may affect the use of cyclosporine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer or
• Precancerous skin changes—Cyclosporine can make these conditions worse

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• High blood pressure—Cyclosporine can cause high blood pressure. Patients with high blood pressure who have psoriasis or rheumatoid arthritis should not receive cyclosporine.

• Hyperkalemia (too much potassium in the blood)—Cyclosporine can make this condition worse

• Infection—Cyclosporine decreases the body"s ability to fight infection

• Intestine problems—Effects may be decreased because cyclosporine cannot be absorbed into the body

• Kidney disease—Cyclosporine can have harmful effects on the kidney when it is taken for long periods of time. Patients with psoriasis or rheumatoid arthritis who have kidney disease should not receive cyclosporine.

• Liver disease—Effects of cyclosporine may be increased because of slower removal of the medicine from the body

Proper Use of This Medicine

Take this medicine only as directed by your doctor . Do not take more or less of it and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. This will also help cyclosporine work better by keeping a constant amount in the blood.

Absorption of this medicine may be changed if you change your diet. This medicine should be taken consistently with respect to meals. You should not change the type or amount of food you eat unless you discuss it with your health care professional. If this medicine upsets your stomach, your doctor may recommend that you take it with meals. However, check with your doctor before you decide to do this on your own.

Grapefruit and grapefruit juice may increase the effects of cyclosporine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine .

This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured only with the specially marked dropper provided with your prescription. The dropper should be wiped with a clean towel after it is used, and stored in its container.

To make Sandimmune[reg ] taste better, mix it in a glass container with milk, chocolate milk, or orange juice (preferably at room temperature). To make Neoral[reg ] taste better, mix it in a glass container with apple juice or orange juice (preferably at room temperature). Do not use a wax-lined or plastic disposable container. Stir it well, then drink it immediately. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine. Dry the dropper used to measure the cyclosporine, but do not rinse it with water.

Do not stop taking this medicine without first checking with your doctor . You may have to take medicine for the rest of your life to prevent your body from rejecting the transplant.

Dosing—The dose of cyclosporine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of cyclosporine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or teaspoonfuls of oral solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking cyclosporine .

• For oral dosage forms (capsules, oral solution):
  • For transplant rejection:
    • Adults, teenagers, or children: Dose is based on body weight. The usual dose in the beginning is 12 to 15 milligrams (mg) per kilogram (kg) (5.5 to 6.8 mg per pound) of body weight a day. After a period of time, the dose may be decreased to 5 to 10 mg per kg (2.3 to 4.5 mg per pound) of body weight a day.
  • For rheumatoid arthritis:
    • Adults or teenagers: Dose is based on body weight. The usual dose is 2.5 to 4 mg per kg (1.1 to 1.8 mg per pound) of body weight a day.
    • Children—Use and dose must be determined by your doctor.
  • For psoriasis:
    • Adults or teenagers: Dose is based on body weight. The usual dose is 2.5 to 4 mg per kg (1.1 to 1.8 mg per pound) of body weight a day.
    • Children—Use and dose must be determined by your doctor.
• For injection dosage form:
  • For transplant rejection:
    • Adults, teenagers, or children: Dose is based on body weight. The usual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight a day.

Missed dose—If you miss a dose of cyclosporine and remember it within 12 hours, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose, go back to your regular dosing schedule, and check with your doctor. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not store the oral solution in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits . Your doctor will want to do laboratory tests to make sure that cyclosporine is working properly and to check for unwanted effects.

While you are being treated with cyclosporine, and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not have any immunizations without your doctor"s approval . Cyclosporine lowers your body"s resistance and there is a chance you might get the infection the immunization is meant to prevent. However, it may be especially important to receive certain immunizations to prevent a disease. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums may appear soon after treatment with cyclosporine is started. Brushing and flossing your teeth, carefully and regularly, and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor will watch for others by doing certain tests.

Also, because of the way that cyclosporine acts on the body, there is a chance that it may cause effects that may not occur until years after the medicine is used. These delayed effects may include certain types of cancer, such as lymphomas or skin cancers. You and your doctor should discuss the good this medicine will do as well as the risks of using it.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, cyclosporine is used in certain patients with the following medical conditions:

• Bone marrow transplantation
• Nephrotic syndrome

For patients receiving bone marrow transplantation, cyclosporine may work by preventing the cells from the transplanted bone marrow from attacking the cells of the patient"s own body.

The doses of cyclosporine for patients receiving bone marrow transplantation and for patients with nephrotic syndrome are based on the patients" body weight. The usual starting dose for patients receiving bone marrow transplantation is 12.5 milligrams (mg) per kilogram (kg) (5.7 mg per pound) of body weight a day. The dose of cyclosporine for patients with nephrotic syndrome is 3.5 to 5 mg per kg (1.6 to 2.3 mg per pound) of body weight a day.

The side effects that patients experience when they receive cyclosporine for bone marrow transplantation or nephrotic syndrome are similar to those side effects experienced by patients receiving cyclosporine for organ transplantation.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 10/06/2005

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