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
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(SYE kloe SPOR een)

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.

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.

There are many other medicines that can cause serious medical problems if you take them together with cyclosporine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about cyclosporine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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