Drug Notebook

FDA Alerts

Special Alerts:

[Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and mycophenolate (CellCept) to sirolimus (Rapamune) and mycophenolate at 12 weeks post heart transplantation. The safety and efficacy of mycophenolate in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#CellCept and http://www.fda.gov/medwatch/safety/2007/cellcept_DHCPletter_02-01-2007.pdf.

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cycloSPORINE
(SYE kloe SPOR een)

What is cyclosporine?
Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader. Cyclosporine is used to prevent organ rejection after a kidney, liver, or heart transplant. Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis. Cyclosporine may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

CycloSPORINE 100MG Capsules APOTEX USA60/$299.98 or 180/$869.96
CycloSPORINE 25MG Capsules APOTEX USA60/$84.99 or 180/$241.99
CycloSPORINE Modified 100MG Capsules PLIVA30/$141 or 90/$387
CycloSPORINE Modified 100MG/ML Solution PLIVA50/$239.99 or 150/$697.94
CycloSPORINE Modified 25MG Capsules EON LABS30/$34.3 or 60/$67.99
Gengraf 100MG Capsules ABBOTT60/$319.87 or 180/$949.52
Gengraf 25MG Capsules ABBOTT60/$85.99 or 180/$235.96
Neoral 100MG Capsules NOVARTIS90/$478.18 or 270/$1434.54
Neoral 100MG/ML Solution NOVARTIS50/$301.71 or 150/$868.68
Neoral 25MG Capsules NOVARTIS60/$85.99 or 180/$239.96
Sandimmune 100MG Capsules NOVARTIS60/$452.28 or 180/$1356.84
Sandimmune 100MG/ML Solution NOVARTIS50/$384.97 or 150/$1154.91
Sandimmune 25MG Capsules NOVARTIS60/$121.24 or 180/$357.46
Sandimmune 50MG/ML Solution NOVARTIS5/$38.99 or 15/$99.97

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What are the possible side effects of cyclosporine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using cyclosporine and call your doctor at once if you have any of these serious side effects:

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;

  • drowsiness, confusion, mood changes, increased thirst;

  • swelling, weight gain, feeling short of breath;

  • blurred vision, headache or pain behind your eyes, sometimes with vomiting;

  • seizure (convulsions);

  • muscle pain or weakness, fast heart rate, feeling light-headed;

  • pale skin, easy bruising or bleeding, unusual weakness; or

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • tremors or shaking;

  • increased hair growth;

  • headache or body pain;

  • diarrhea, constipation;

  • nausea, vomiting, stomach pain; or

  • numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take cyclosporine?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day. If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

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What is the most important information I should know about cyclosporine?
You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), or any type of cancer. If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine. You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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What other drugs will affect cyclosporine?
Many other drugs can damage the kidneys, and this risk increases when you use them together with cyclosporine. If you use any of the following medications, you may need a dose adjustment or special tests. Your doctor will tell you if any of your medication doses need to be changed. lithium (Eskalith, Lithobid); methotrexate (Rheumatrex, Trexall); pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Cyclosporine has been assigned to pregnancy category C by the FDA. Human data have revealed evidence of premature birth and low birth weight for gestational age. There are no controlled data in human pregnancy. Cyclosporine should be given during pregnancy only when benefit outweighs risk.

One meta-analysis of fifteen studies (n=410) found that the overall prevalence of major malformations in the study population did not vary substantially from that reported in the general population. The meta-analysis concluded that cyclosporine does not appear to be a major human teratogen. However, it may be associated with increased rates of prematurity. The manufacturer has reported an analysis of 116 pregnancy outcomes (90% of which were in post-transplant patients) revealed a pattern of premature birth and low birth weight for gestational age. In addition, seven malformations in five live births and in 2 cases of fetal loss occurred. The majority of these cases were complicated by preeclampsia, eclampsia, oligohydramnios, and other disorders. A limited number of observations in children exposed to cyclosporine in utero is available up to approximately seven years of age. Renal function and blood pressure in these children were normal.

Cyclosporine is excreted into human milk. Due to potential effects in the nursing infant, such as immunosuppression, neutropenia, growth retardation, and possible carcinogenesis, cyclosporine is not recommended during lactation. Cyclosporine use during lactation is considered contraindicated by the American Academy of Pediatrics.

Some investigators have suggested that women on cyclosporine may breast-feed, challenging the conventional view that cyclosporine is contraindicated during breast-feeding. One study of five mother-infant pairs reported a wide range of infant exposures to the drug in milk, noting that one of the infants had therapeutic blood concentrations of cyclosporine despite relatively low concentrations of the drug in the milk. It was not known if this was a transient phenomenon caused by immaturity of the enzyme system in the neonate. No clinically evident adverse events were noted in any of the infants. Another case has been reported of a woman who exclusively breast-fed her infant during the first 10.5 months of life while she was being treated with cyclosporine. Cyclosporine measurements in infant and maternal blood and breast milk have been reported to have revealed a mean breast milk/maternal blood level ratio of 84%, but undetectable levels in the infant. The infant was reported to have grown and developed normally.

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Who should NOT use this medication?

  • Known hypersensitivity to cyclosporine or to any ingredient in the formulation.
  • Rheumatoid arthritis or psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies.
  • Concurrent therapy with methotrexate or other immunosuppressive agents, coal tar, PUVA, UVB, or other radiation in the management of psoriasis.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), or urinating less than usual or not at all.

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What should I discuss with my health care provider before taking cyclosporine?
You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have: kidney disease; untreated or uncontrolled high blood pressure; or any type of cancer. Before taking cyclosporine, tell your doctor if you are allergic to any drugs, or if you have: psoriasis that has been treated with treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar; or if you are also taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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