Cyclosporine is a drug that reduces the body's ability to fight illness/disease (an immunosuppressant), leaving patients vulnerable to infection or other problems (including cancers such as lymphoma). Using other drugs that treat organ transplant rejection along with this drug may increase these tendencies.
Cyclosporine can also cause high blood pressure and kidney problems. The risk of both problems increases with higher doses and longer treatment with this drug. Psoriasis patients who have had certain previous treatments (e.g., PUVA, UVB, coal tar, radiation therapy, methotrexate) are at increased risk to develop skin cancer. Therefore, cyclosporine must be given only under close medical supervision.
Because different brands deliver different amounts of medication, do not switch brands of cyclosporine without your doctor's permission and directions.Who should not take Sandimmune intravenous?
This medication is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually used along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting a transplanted organ.
Because of the risk of severe allergic reactions from intravenous cyclosporine, it should be used only in patients who are unable to take cyclosporine by mouth. (See also How to Use section.) Once you are able to take medications by mouth, you should be switched from this form of cyclosporine to either the capsules or oral solution.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to prevent rejection in other types of organ transplants (e.g., cornea, pancreas) or bone marrow transplant. It may also be used to treat other conditions that may be helped by affecting the immune system (e.g., Crohn's disease, ulcerative colitis).
This medication is given into a vein as directed by your doctor, usually once daily over 2 to 6 hours. Dosage is based on your medical condition, cyclosporine blood level, kidney function, and response to therapy. Follow the dosing schedule for this medication carefully.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
When cyclosporine is given into a vein, one of the other ingredients in this product, polyoxyethylated castor oil, may rarely cause a serious allergic reaction. If you are using this medication at home, be prepared to self-treat as directed by your doctor if symptoms of an allergic reaction occur. (See Side Effects section).
Use this medication regularly in order to get the most benefit from it. This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.
See also the Warning section.
Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Your risk of infection may be higher while you are using this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination.
Tell your doctor right away if you have any serious side effects, including: muscle spasms/weakness, fast/irregular heartbeat, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes (such as confusion, difficulty concentrating), vision changes, swollen glands, unusual lumps, night sweats, problems with speech, clumsiness, loss of coordination, weakness on one side of the body, severe leg pain.
Get medical help right away if you have any very serious side effects, including: chest pain, seizures.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), flushing, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using cyclosporine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: chicken pox/shingles, high blood pressure, cancer, skin lesions of unknown cause, current use of radiation therapy (including phototherapy with PUVA or UVB), kidney disease, liver disease, any recent/current infections, seizures, untreated mineral imbalance (e.g., low magnesium or high potassium), blood disorders, diabetes, a certain gut problem (malabsorption), high blood fats (cholesterol or triglycerides).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This drug may reduce the magnesium levels in your blood. Ask your doctor about adding magnesium to your diet. Your doctor may prescribe a magnesium supplement.
Cyclosporine can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
This drug may increase your risk for developing skin cancer. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication may cause swelling and growth of the gums (gingival hyperplasia). Brush your teeth and floss daily to minimize this problem. See your dentist regularly.
This medication may contain alcohol. Caution is advised if you have liver disease, alcohol dependence, seizures, or any other condition that require you to limit/avoid alcohol in your diet. Caution is also advised if you are pregnant or breast-feeding. Carefully watch children while they use this medication. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
The elderly may be at greater risk for the effects on blood pressure and kidneys while using this drug.
This medication should be used only when clearly needed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other more serious problems have also been reported, including death of the unborn baby. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
See also the How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: birth control pills, caspofungin, coal tar, ezetimibe, sulfinpyrazone, tacrolimus, temsirolimus, terbinafine, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, tofacitinib), drugs that worsen kidney problems (e.g., acyclovir, aminoglycoside antibiotics including tobramycin; amphotericin B; colchicine; melphalan; sulfa drugs including sulfamethoxazole; vancomycin), drugs that may increase potassium levels (e.g., potassium supplements, "water pills" including amiloride, spironolactone).
Other medications can affect the removal of cyclosporine from your body, which may affect how cyclosporine works. Examples include allopurinol, amiodarone, barbiturates including phenobarbital, boceprevir, bosentan, calcium channel blockers including diltiazem/nifedipine/verapamil, cimetidine, HIV protease inhibitors including indinavir, imatinib, certain man-made male hormones such as danazol/methyltestosterone, methylprednisolone, metoclopramide, metronidazole, mifepristone, nafcillin, nefazodone, octreotide, orlistat, quinupristin/dalfopristin, rifamycins including rifampin/rifabutin, certain anti-seizure drugs including carbamazepine/phenytoin, St. John's wort, telaprevir, ticlopidine, among others.
This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aliskiren, ambrisentan, digoxin, dronedarone, repaglinide, tolterodine, statins (such as atorvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin), other immunosuppressants (such as azathioprine, methotrexate, sirolimus), among others.
Do not use potassium-containing salt substitutes while taking this medication. Consult your doctor or pharmacist for more information.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all laboratory and medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function, blood pressure, blood mineral levels, uric acid, cyclosporine blood levels) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
Have your blood pressure checked regularly while using this medication. Discuss with your doctor how to monitor your own blood pressure. Inform your doctor of your blood pressure readings.
If you have had an organ transplant, it is recommended that you attend a transplant education class or support group. Learn the symptoms of organ rejection such as a feeling of being ill, fever, pain around the transplanted organ, and signs of a failing transplanted organ (a decrease in the amount of urine with kidney transplant, yellowing of the skin/eyes with liver transplant, shortness of breath/inability to exercise with heart transplant). Seek immediate medical attention if these symptoms of rejection occur.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.
Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2015. Copyright(c) 2015 First Databank, Inc.
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