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.
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;
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.
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.
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;
medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
other medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);
IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).
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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