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Generic Name: Cyclosporine Injection (SYE-kloe-spor-een)
Brand Name: Sandimmune
Sandimmune should always be used along with adrenal corticosteroids
(eg, hydrocortisone), but not with other medicines that suppress the immune system. The risk of developing an infection or a certain type of cancer (lymphoma)
may be increased by suppressing the immune system.
Sandimmune cannot be interchanged with other forms of cyclosporine
(eg, Neoral) without your doctor"s approval.
If you are taking Sandimmune for a long period of time, especially for a liver transplant, lab tests should be performed to monitor your progress or to check for side effects such as toxicity or decreased effectiveness.
Sandimmune is used for:
Preventing the rejection of organ transplants (kidney, liver, and heart). It is used in combination
with adrenal corticosteroids. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents. It may also be used for other conditions as determined by your doctor.
Sandimmune is an immunosuppressant. How Sandimmune works is not fully understood, but it may block certain white blood cells (lymphocytes).
Do NOT use Sandimmune if:
- you are allergic to any ingredient in Sandimmune or to Cremophor EL
- you are taking bosentan, disulfiram, fluorouracil, an immunosuppressant
(eg, azathioprine, tacrolimus), metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)
- you are having radiation therapy for psoriasis
- you are going to be vaccinated with a live vaccine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sandimmune :
Some medical conditions may
interact with Sandimmune . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; gout; an infection; or have had a recent vaccination
- if your diet contains high amounts of potassium
- if you have a history of seizures
Some MEDICINES MAY INTERACT with Sandimmune . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements
(eg, St. John"s wort) may interact with Sandimmune . They may increase the risk of side effects or decrease the effectiveness of this or other medicines
- Immunosuppressants (eg, azathioprine, tacrolimus) because risk of developing an infection or cancer may be increased
- Potassium-sparing diuretics (eg, spironolactone)
because the risk of high blood potassium levels may be increased
- Bosentan because the risk of its side effects and toxic effects may be increased by Sandimmune
- Orlistat because it may decrease Sandimmune "s effectiveness
- Disulfiram, fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sandimmune may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sandimmune :
Use Sandimmune as directed by your doctor. Check the label on the medicine for exact
- Take Sandimmune on a regular schedule with regard to food and time of day.
- Do not eat grapefruit or drink grapefruit juice while you use Sandimmune .
- If you miss a dose of Sandimmune , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Sandimmune .
Important safety information:
- Sandimmune may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sandimmune with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not switch to another doseform or change brands of Sandimmune without talking to your doctor. Products made by other companies may not work as well for you.
- Sandimmune may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sandimmune . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Sandimmune may increase risk of developing certain forms of cancer. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune . Talk with your doctor before you receive any vaccine.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Sandimmune may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Tell your doctor or dentist that you take Sandimmune before you receive any medical or dental care, emergency
care, or surgery.
- Diabetes patients - Sandimmune may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- LAB TESTS, including kidney and liver function tests; cyclosporine levels;
and blood pressure, lipids, and electrolytes, may be performed while you use Sandimmune . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Sandimmune with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Sandimmune may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sandimmune while you are pregnant. Sandimmune is found in breast milk. Do not breast-feed while taking Sandimmune .
Possible side effects of Sandimmune :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; dizziness; headache; increased hair growth; nausea; runny nose;
sleeplessness; stomach discomfort; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stool; blood in the urine; chest pain; chills; confusion; dark urine;
diarrhea; fast or irregular heartbeat; fever; flushing of the face, chest, back, or abdomen; gum disease or overgrowth; increased or decreased urination;
infection; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness;
shortness of breath; sore throat; tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or lesion of the skin; unusual
tiredness or weakness;
vision changes; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.
Proper storage of Sandimmune :
Sandimmune is usually handled and stored by a health care provider. If you are using Sandimmune at home, store Sandimmune as directed by your pharmacist or health care
provider. Keep Sandimmune , as well as syringes and needles, out of the reach of children and away from pets.
- If you have any questions about Sandimmune , please talk with your doctor, pharmacist, or other health care provider.
- Sandimmune is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Sandimmune . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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