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Cyclosporine Solution for injection

It is used to decrease the immune system's response to a transplanted organ.

Generic Name: cyclosporine

Brand Names: Restasis, Sandimmune, Gengraf, Sangcya, Neoral

There is an FDA Alert for this drug. Click here to view it.

    Supervising Clinician and Medical Resources
  • Only clinicians experienced in management of systemic immunosuppressive therapy for the indicated disease and/or management of organ transplant patients should prescribe cyclosporine.
  • Patients should be managed in facilities with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.
    Effects of Immunosuppression
  • Immunosuppression may result in increased susceptibility to infection and possible development of lymphoma or other neoplasms. (See Lymphomas and Other Malignancies under Cautions.)
  • Manufacturer cautions that conventional (nonmodified) oral formulations and the concentrate for injection should be administered with corticosteroids but not with other immunosuppressive agents in organ transplant recipients. Manufacturers state that modified oral formulations of cyclosporine (Neoral® and Gengraf®) may be administered with oral immunosuppressive agents in transplant patients, although the degree of immunosuppression produced may result in increased susceptibility to infection and possible development of lymphoma and other neoplasms.
    Bioequivalency of Formulations
  • Conventional (nonmodified) oral formulations (Sandimmune® liquid-filled capsules and solution) have decreased bioavailability compared with modified oral formulations (Neoral® and Gengraf® liquid-filled capsules and solution). Conventional (nonmodified) and modified formulations are not bioequivalent and cannot be used interchangeably without physician supervision. (See Conversion from Conventional Oral Formulations [Sandimmune®] to Modified Oral Formulations [Gengraf®, Neoral®] under Dosage and Administration.)
  • Absorption of cyclosporine during chronic administration of Sandimmune® capsules and oral solution may be erratic. Patients, especially liver transplant recipients, receiving these formulations over a period of time should be monitored at repeated intervals for blood cyclosporine concentrations and possible organ rejection due to low absorption of cyclosporine.
  • For a given trough concentration, cyclosporine exposure will be greater with Neoral® or Gengraf® preparations than with Sandimmune® preparations. Exercise particular caution if a patient is receiving exceptionally high doses of Sandimmune® and is converted to Gengraf® or Neoral®. (See Conversion from Conventional Oral Formulations [Sandimmune®] to Modified Oral Formulations [Gengraf®, Neoral®] under Dosage and Administration.)
  • Patients receiving Gengraf® or Neoral® liquid-filled capsules or oral solution for organ transplant or in the management of rheumatoid arthritis should also have blood cyclosporine concentrations monitored to avoid toxicity due to high concentrations. (See Monitoring of Cyclosporine Concentrations under Cautions.)
    Psoriasis Patients
  • Previous therapy with psoralen and UVA light (PUVA) and, to a lesser extent, methotrexate, other immunosuppressive agents, UVB, coal tar, or radiation therapy may increase risk of skin malignancies in patients receiving cyclosporine.
  • Recommended dosages can cause hypertension and nephrotoxicity; risk increases with dose and duration of therapy. Monitor renal function (see General: Psoriasis, under Dosage and Administration).

What is this medicine?

CYCLOSPORINE (SYE kloe spor een) is used to decrease the immune system's response to a transplanted organ.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • gout
  • high blood pressure
  • infection
  • kidney disease
  • liver disease
  • recent vaccinations
  • an unusual or allergic reaction to cyclosporine, alcohol, castor oil, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • bosentan
  • cidofovir
  • cisapride
  • mibefradil
  • ranolazine
  • red yeast rice, monascus purpureus
  • St. John's wort
  • tacrolimus

This medicine may also interact with the following medications:

  • acyclovir
  • allopurinol
  • amiloride
  • amiodarone
  • bromocriptine
  • carbamazepine
  • certain antibiotics
  • cimetidine
  • colchicine
  • danazol
  • digoxin
  • female hormones, including contraceptive or birth control pills
  • imatinib
  • medicines for fungal infections like amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole
  • medicines for blood pressure like diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan
  • medicines for cholesterol like lovastatin, simvastatin, atorvastatin, and fenofibrate
  • medicines for HIV infection like indinavir, nelfinavir, ritonavir, and saquinavir
  • medicines that suppress the immune system
  • melphalan
  • methotrexate
  • metoclopramide
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • octreotide
  • orlistat
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • ranitidine
  • sirolimus
  • spironolactone
  • steroid medicines like prednisone or cortisone
  • sulfinpyrazone
  • ticlopidine
  • triamterene
  • vaccines
  • voriconazole

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work while you are taking this medicine.

If you get a cold or other infection while taking this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

The medicine can cause unusual growth of gum tissue and can make your gums bleed. Practice good oral hygiene, and be careful when brushing and flossing your teeth. See your dentist regularly.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

This medicine may increase your risk for certain types of skin cancer, especially if you have psoriasis. To decrease your risk, were protective clothing, including hats, and use sunscreen with a high protection factor when exposed to the sun. Avoid using tanning beds.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • changes in vision
  • high blood pressure
  • increased urge to urinate or frequent urination
  • numbness or tingling in the hands and feet
  • seizures
  • severe stomach pain
  • vomiting
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • bleeding or tender gums, overgrowth of gum tissue
  • diarrhea
  • excessive hair growth on the face or body
  • nausea
  • tremors

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

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.

Last Updated: March 02, 2009
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