CYCLOSPORINE (Systemic)
Some commonly used brand names are:
In the U.S.?
In Canada?
Some other commonly used names are ciclosporin and cyclosporin A.
Category
- Immunosuppressant
- antipsoriatic
- antirheumatic
Description
Cyclosporine (SYE-kloe-spor-een) belongs to the groupof medicines known as immunosuppressive agents. It is used to reduce the body'snatural 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 cellswill try to get rid of (reject) the transplanted organ. Cyclosporine worksby preventing the white blood cells from doing this.
Cyclosporine also is used to treat severe cases of psoriasis and rheumatoidarthritis.
Cyclosporine may also be used for other conditions, as determined by yourdoctor.
Cyclosporine is a very strong medicine. It may cause side effects thatcould 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 doctorshould talk about the good this medicine will do as well as the risks of usingit.
Cyclosporine is available only with your doctor's prescription, in thefollowing 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 willdo. This is a decision you and your doctor will make. For cyclosporine, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to cyclosporine.
Pregnancy?Studies have not been done in humans. However, somewomen 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 defectsoccurred because of the use of cyclosporine by the mothers. Before takingthis medicine, make sure your doctor knows if you are pregnant or if you maybecome pregnant.
Breast-feeding?Cyclosporine passes into breast milk. There isa chance that it could cause the same side effects in the baby that it doesin people taking it. It may be necessary for you to stop breast-feeding duringtreatment. Be sure you have discussed the risks and benefits of the medicinewith your doctor.
Children?This medicine has been tested in children receivingorgan transplants and, in effective doses, has not been shown to cause differentside effects or problems than it does in adults.
Studies of this medicine have been done only in adult patients with rheumatoidarthritis and psoriasis, and there is no specific information comparing useof cyclosporine for rheumatoid arthritis or psoriasis in children with usein other age groups.
Older adults?Older people are more likely to experience some sideeffects (e.g., high blood pressure and kidney problems) than are younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingcyclosporine, it is especially important that your health care professionalknows 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 thesemedicines increase the amount of potassium in the body, potassium levels couldbecome 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 increaseeffects 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 increasethe 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)?Theremay be an increased risk of infection and cancer because both cyclosporineand 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 cyclosporineby 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 ofsome skin cancers
- Colchicine (medicine to treat or prevent attacks of gout) or
- Digoxin (e.g., Lanoxin)?May increase effects of colchicineor digoxin by increasing the amount in the body which may cause serious unwantedeffects
- Methylprednisolone (e.g., Medrol)?May increase the amount ofcyclosporine in the body
- Sirolimus (e.g., Rapamune)?May increase the amount of sirolimusin the body; it is recommended that sirolimus be given 4 hours after cyclosporineis administered.
- Vaccines, live virus?During cyclosporine use, vaccines maynot work as well. The use of live vaccines should be avoided.
Other medical problems?The presence of other medicalproblems may affect the use of cyclosporine. Make sure you tell your doctorif you have any other medical problems, especially:
- Cancer or
- Precancerous skin changes?Cyclosporine can make these conditionsworse
- Chickenpox (including recent exposure) or
- Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body
- High blood pressure?Cyclosporine can cause high blood pressure.Patients with high blood pressure who have psoriasis or rheumatoid arthritisshould not receive cyclosporine.
- Hyperkalemia (too much potassium in the blood)?Cyclosporinecan make this condition worse
- Infection?Cyclosporine decreases the body's ability to fightinfection
- Intestine problems?Effects may be decreased because cyclosporinecannot be absorbed into the body
- Kidney disease?Cyclosporine can have harmful effects on thekidney when it is taken for long periods of time. Patients with psoriasisor rheumatoid arthritis who have kidney disease should not receive cyclosporine.
- Liver disease?Effects of cyclosporine may be increased becauseof 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 moreor less of it and do not take it more often than your doctor ordered. Theexact amount of medicine you need has been carefully worked out. Taking toomuch may increase the chance of side effects, while taking too little maynot improve your condition.
To help you remember to take your medicine, try to get into the habit oftaking it at the same time each day. This will also help cyclosporine workbetter by keeping a constant amount in the blood.
Absorption of this medicine may be changed if you change your diet. Thismedicine should be taken consistently with respect to meals. You should notchange the type or amount of food you eat unless you discuss it with yourhealth care professional. If this medicine upsets your stomach, your doctormay recommend that you take it with meals. However, check with your doctorbefore you decide to do this on your own.
Grapefruit and grapefruit juice may increase the effects of cyclosporineby increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are takingthis 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 markeddropper provided with your prescription. The dropper should be wiped witha clean towel after it is used, and stored in its container.
To make Sandimmune[reg ] taste better, mix itin a glass container with milk, chocolate milk, or orange juice (preferablyat room temperature). To make Neoral[reg ] tastebetter, mix it in a glass container with apple juice or orange juice (preferablyat room temperature). Do not use a wax-lined or plastic disposable container.Stir it well, then drink it immediately. After drinking all the liquid containingthe 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 thecyclosporine, but do not rinse it with water.
Do not stop taking this medicine without first checkingwith your doctor. You may have to take medicine for the rest of yourlife to prevent your body from rejecting the transplant.
Dosing?The dose of cyclosporine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking cyclosporine.
- For oral dosage forms (capsules, oralsolution):
- For transplant rejection:
- Adults, teenagers, or children: Dose is based on body weight. Theusual 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, thedose may be decreased to 5 to 10 mg per kg (2.3 to 4.5 mg per pound) of bodyweight a day.
- For rheumatoid arthritis:
- Adults or teenagers: Dose is based on body weight. The usual doseis 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 doseis 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. Theusual dose is 2 to 6 mg per kg (0.9 to 2.7 mg per pound) of body weight aday.
Missed dose?If you miss a dose of cyclosporine and rememberit 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 yourregular 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 otherdamp 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 surethat 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 atregular visits. Your doctor will want to do laboratory tests to makesure that cyclosporine is working properly and to check for unwanted effects.
While you are being treated with cyclosporine, and after you stop treatmentwith it, it is important to see your doctor about theimmunizations (vaccinations) you should receive. Do not have any immunizationswithout your doctor's approval. Cyclosporine lowers your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. However, it may be especially important to receive certain immunizationsto prevent a disease. In addition, other persons living in your house shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus 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 verylong. If you cannot take these precautions, you should consider wearing aprotective face mask that covers the nose and mouth.
In some patients (usually younger patients), tenderness, swelling, or bleedingof the gums may appear soon after treatment with cyclosporine is started.Brushing and flossing your teeth, carefully and regularly, and massaging yourgums may help prevent this. See your dentist regularlyto have your teeth cleaned. Check with your medical doctor or dentist if youhave any questions about how to take care of your teeth and gums, or if younotice 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. Yourdoctor will watch for others by doing certain tests.
Also, because of the way that cyclosporine acts on the body, there is achance that it may cause effects that may not occur until years after themedicine is used. These delayed effects may include certain types of cancer,such as lymphomas or skin cancers. You and your doctor should discuss thegood this medicine will do as well as the risks of using it.
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although not specifically included in the productlabeling, cyclosporine is used in certain patients with the following medicalconditions:
- Bone marrow transplantation
- Nephrotic syndrome
For patients receiving bone marrow transplantation, cyclosporine may workby preventing the cells from the transplanted bone marrow from attacking thecells of the patient's own body.
The doses of cyclosporine for patients receiving bone marrow transplantationand for patients with nephrotic syndrome are based on the patients' body weight.The usual starting dose for patients receiving bone marrow transplantationis 12.5 milligrams (mg) per kilogram (kg) (5.7 mg per pound) of body weighta day. The dose of cyclosporine for patients with nephrotic syndrome is 3.5to 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 cyclosporinefor bone marrow transplantation or nephrotic syndrome are similar to thoseside effects experienced by patients receiving cyclosporine for organ transplantation.
Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.
Revised: 10/06/2005
