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Generic Name: cyclosporine (Oral route, Intravenous route)
sye-kloe-SPOR-een
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune(R) (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Sandimmune(R) (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution (cyclosporine oral solution, USP) MODIFIED.
Sandimmune(R) and Neoral(R) are not bioequivalent and cannot be used interchangeably without physician supervision.
The absorption of cyclosporine during chronic administration of Sandimmune(R) Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed .
Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. SANDIMMUNE(R) and NEORAL(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Monitor cyclosporine blood levels to avoid toxicity due to high levels and possible organ rejection due to low levels as a result of the erratic absorption of cyclosporine during chronic administration of SANDIMMUNE(R) .
Intravenous routeSolutionOnly physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune(R) (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Sandimmune(R) (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral(R) oral solution (cyclosporine oral solution, USP) MODIFIED.
Sandimmune(R) and Neoral(R) are not bioequivalent and cannot be used interchangeably without physician supervision.
The absorption of cyclosporine during chronic administration of Sandimmune(R) Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed .
Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. SANDIMMUNE(R) and NEORAL(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Monitor cyclosporine blood levels to avoid toxicity due to high levels and possible organ rejection due to low levels as a result of the erratic absorption of cyclosporine during chronic administration of SANDIMMUNE(R) .
Oral routeCapsule, Liquid FilledSolutionOnly physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral(R). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral(R). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite of the follow-up of the patient.
Neoral(R), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral(R) may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.
Neoral(R) soft gelatin capsules (cyclosporine capsules, USP) modified and Neoral(R) oral solution (cyclosporine oral solution, USP) modified have increased bioavailability in comparison to Sandimmune(R) soft gelatin capsules (cyclosporine capsules, USP) and Sandimmune(R) oral solution (cyclosporine oral solution, USP). Neoral(R) and Sandimmune(R) are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral(R) than with Sandimmune(R). If a patient who is receiving exceptionally high doses of Sandimmune(R) is converted to Neoral(R), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral(R) to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.
For psoriasis patients: Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral(R).
Cyclosporine, the active ingredient in Neoral(R), in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy .
Cyclosporine, a systemic immunosuppressant, may increase the susceptibility to infection and development of neoplasia. Hypertension and nephrotoxicity can occur at recommended dosages, and the risk increases with increasing dose and duration of cyclosporine therapy. Monitor blood levels and renal function to avoid toxicity. Neoral(R) and Sandimmune(R) are not bioequivalent and cannot be used interchangeably without physician supervision. Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cyclosporine .
Commonly used brand name(s):
In the U.S.
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Therapeutic Class: Immune Suppressant
Cyclosporine 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.
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:
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.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies on the relationship of age to the effects of cyclosporine have not been performed in children receiving organ transplants. However, no pediatric-specific problems have been documented to date .
Appropriate studies have not been performed on the relationship of age to the effects of cyclosporine in children with rheumatoid arthritis or psoriasis. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine in the elderly. However, elderly patients are more likely to have high blood pressure or age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving cyclosporine .
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain cyclosporine. It may not be specific to Apo-Cyclosporine. Please read with care.
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® taste better, mix it in a glass container with milk, chocolate milk, or orange juice (preferably at room temperature). To make Neoral® 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.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine 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 using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Call your doctor or pharmacist for instructions.
If you miss a dose of cyclosporine and remember it within 12 hours, take the missed dose as soon as you remember.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Do not store the oral solution in the refrigerator.
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.
This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. If you are being treated for psoriasis, check with your doctor first before having an ultraviolet (UV) light treatment. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds .
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.
Check with your doctor immediately if any of the following side effects occur:
RareCheck with your doctor as soon as possible if any of the following side effects occur:
More commonThis medicine may also cause the following side effects that your doctor will watch for:
More commonSome 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More commonOther side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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