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.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a full glass of water. Do not take with grapefruit juice. Swallow the capsules whole. Do not chew or break the capsule. Follow the directions on the prescription label. Take your medicine at regular intervals. Take the capsules at the same time each day and at the same time in relation to meals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months for selected conditions, precautions do apply.
Patients over 65 years old may have a stronger reaction and need a smaller dose.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you miss more than one dose or if you miss doses on a regular basis.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You will have regular blood checks. Do not change the brand of medicine unless directed by your doctor or health care professional.
If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
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.
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:
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
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store this medicine between 15 and 30 degrees C (59 and 86 degrees F). Keep the medicine in the original packaging. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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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