Generic Name: cyclosporine (SYE-kloe-SPOR-in)
Brand Name: Sandimmune
Sandimmune should be used with adrenal corticosteroids (eg, hydrocortisone). It should not be used with other medicines that suppress the immune system. Suppressing the immune system may increase the risk of developing an infection or a certain type of cancer (lymphoma).
Sandimmune cannot be switched with other forms of cyclosporine (eg, Neoral) without your doctor's approval.
If you are taking Sandimmune for a long period of time, lab tests should be performed to monitor your progress or to check for side effects. This is especially important for liver transplant patients.
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. It works by suppressing the immune system. This prevents the body from rejecting transplanted organs.
Do NOT use Sandimmune if:
- you are allergic to any ingredient in Sandimmune or to Cremophor EL
- you are taking aliskiren, bosentan, disulfiram, dronedarone, enzalutamide, lovastatin, metronidazole, mifepristone, orlistat, pitavastatin, a potassium-sparing diuretic (eg, spironolactone), or simvastatin
- you are taking another medicine to suppress the immune system (eg, azathioprine, sirolimus)
- you have taken or will be taking tacrolimus within 24 hours before or after using Sandimmune
- you are having radiation therapy, including psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy, for psoriasis
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; gout or high blood uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; a weakened immune system; or problems absorbing food or medicine
- if you have high blood potassium levels or your diet contains a lot of potassium
- if you have a history of seizures
- if you are having phototherapy for psoriasis or are having radiation treatment
- if you have recently had or will be having a vaccine
- if you are taking medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
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 aches and pains, allergic reactions, arthritis, asthma, birth control, blood thinning, cancer, diabetes, endometriosis, fibrocystic breast disease, gout, heartburn or reflux, hepatitis C, high blood pressure, high blood prolactin levels, HIV, infection, immune system suppression, inflammation, high cholesterol, irregular heartbeat or other heart problems, mental or mood problems, Parkinson disease, psoriasis, pulmonary arterial hypertension [PAH], sleep, stomach or bowel problems, seizures, weight loss), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with Sandimmune. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Sandimmune
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 dosing instructions.
- Sandimmune is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Sandimmune at home, a health care provider will teach you how to use it. Be sure you understand how to use Sandimmune. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not eat grapefruit or drink grapefruit juice while you use Sandimmune.
- Continue to use Sandimmune even if you feel well. Do not miss any doses.
- If you miss a dose of Sandimmune, use 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 use 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. This effect 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. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.
- Sandimmune may lower the ability of your body to fight infection. This may increase the risk of serious and sometimes fatal infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.
- Some patients treated with Sandimmune have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; you do not care about things that you usually care about; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine).
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune. Talk with your doctor before you receive any vaccine.
- Sandimmune may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- 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; 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; mild diarrhea; 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 stools; burning, numbness, or tingling; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased coordination; fast or irregular heartbeat; gum disease or overgrowth; mental or mood changes (eg, depression); mouth sores or swelling; muscle aches, cramps, pain, or weakness; ringing in the ears or hearing loss; seizures; severe or persistent diarrhea; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden unusual sweating; symptoms of infection (eg, chills, fever, increased or painful urination, sore throat, severe or persistent cough, warm or painful skin); symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite); tremor; unusual bleeding or bruising; unusual lumps; unusual swelling; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes (eg, blindness); vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include drowsiness; fast or irregular heartbeat; headache; symptoms of kidney problems (eg, change in the amount of urine produced); vomiting.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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Sandimmune or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sandimmune. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sandimmune. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Sandimmune.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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