What is this medication?
Calcineurin Inhibitor; Immunosuppressant Agent
Indicated for transplant rejection treatment/prophylaxis, rheumatoid arthritis, psoriasis.
“ALERT: US Boxed Warning
Only health care providers experienced in the management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine. At doses used in solid organ transplantation, only health care providers experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine. Patients receiving cyclosporine should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The health care provider responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Cyclosporine may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients, Gengraf and Neoral 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.
Sandimmune and cyclosporine injection should be administered with adrenal corticosteroids but not with other immunosuppressive agents.
The absorption of Sandimmune capsules and oral solution during long-term administration was found to be erratic. It is recommended that patients taking Sandimmune capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and that subsequent dose adjustments be made to avoid toxicity from high levels and possible organ rejection from low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine.
Sandimmune capsules and oral solution have decreased bioavailability in comparison with Gengraf and Neoral capsules and Gengraf and Neoral oral solution. Gengraf and Neoral have increased bioavailability compared to Sandimmune capsules and oral solution and are not bioequivalent to Sandimmune and cannot be used interchangeably without the supervision of a health care provider. For a given trough concentration, cyclosporine exposure will be greater with Neoral and Gengraf than with Sandimmune. If a patient who is receiving exceptionally high doses of Sandimmune is converted to Neoral or Gengraf, particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis (RA) patients taking Gengraf and Neoral 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.
Psoriasis (Neoral, Gengraf):
Psoriasis patients previously treated with psoralens plus ultraviolet A (PUVA) and, to a lesser extent, methotrexate or other immunosuppressive agents, ultraviolet B (UVB), coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cyclosporine. Also see boxed warnings above.
Cyclosporine, in recommended doses, 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.”
How does this medication work?
Cyclosporin, Neoral/Gengraff/SandIMMUNE inhibits the interleukin II from being produced and released thereby reducing interleukin II-induced activation of T-lymphocytes.
How should I take this medication?
Neoral/Gengraf (cyclosporine modified) and Sandimmune (cyclosporine non-modified) are not bioequivalent and cannot be used interchangeably. Cyclosporine (modified) is more commonly used clinically in general. Dosing is complex and must be tailored to the patient based on various factors and requires a physician experienced with immunosuppressive therapies.
How to Take: Follow instructions provided by physician/pharmacy label, administer medication consistently with relation to time of day and meals, unless otherwise directed, store at room temperature.
Oral solution: Do not administer liquid from plastic or styrofoam cup. May dilute Neoral oral solution with room temperature orange juice or apple juice. May dilute Sandimmune oral solution with milk, chocolate milk, or orange juice. Avoid changing diluents frequently. Mix thoroughly and drink at once. Use syringe provided to measure dose. Mix in a glass container and rinse container with more diluent to ensure total dose is taken. Do not rinse syringe before or after use (may cause dose variation).
You Need to Avoid: Avoid grapefruit juice with oral cyclosporine use. Potentially significant drug/food/supplement interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult prescriber or pharmacist before starting anything new.
What should I watch for while using this medication?
Before starting Cyclosporin, Neoral/Gengraff/SandIMMUNE make sure your physician is aware of any allergies or medications you currently take, if you have liver disease, psoriasis, abnormal kidney function, are pregnant or breastfeeding. Cyclosporin, Neoral/Gengraff/SandIMMUNE use has been associated with rare but serious adverse events such as gingival hyperplasia, hepatotoxicity, hyperkalemia, hypertension, hyperuricemia, infections, malignancy, nephrotoxicity, skin cancer, thrombotic microangiopathy.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Hypertension, edema, headache, paresthesia, hypertrichosis, hirsutism, increased serum triglycerides, female genital tract disease, nauseam diarrhea, gingival hyperplasia, abdominal distress, dyspepsia, urinary tract infection, increased susceptibility to infection, tremor, leg cramps, increased serum creatinine, renal insufficiency
Note this is not a complete list of side effects, only the most common.
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