Sandimmune

Sandimmune is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants. Sandimmune belongs to a group of drugs called immunosuppressants. They work by decreasing the activity of the immune system.

Sandimmune comes as a capsule, an oral liquid solution, and an intravenous (IV) injection. It is usually taken once a day. This medication is available in the original form of cyclosporine. 

Common side effects of Sandimmune oral and injectable include high blood pressure, gum overgrowth, and tremors. 

Sandimmune is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Common side effects of Sandimmune include:

• headache
• diarrhea
• nausea
• vomiting
• kidney dysfunction
• tremor
• hirsutism (excessive growth of hair in women in a male-like pattern)
• high blood pressure
• gum tissue overgrowth

Tell your doctor if any side effect is bothersome or does not go away. Sandimmune may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf)
• other medicines that can cause high blood pressure or kidney damage such as amphotericin B (Amphotec, Fungizone); cimetidine (Tagamet); ciprofloxacin (Cipro); colchicine; fenofibrate (Antara, Lipophen, Tricor); gemfibrozil (Lopid); gentamicin; ketoconazole (Nizoral); melphalan (Alkeran); nonsteroidal anti-inflammatory drugs such as diclofenac (Cataflam, Voltaren), naproxen (Aleve, Naprosyn), and sulindac (Clinoril); ranitidine (Zantac); tobramycin (Tobi); trimethoprim with sulfamethoxazole (Bactrim, Septra); and vancomycin (Vancocin)
• acyclovir (Zovirax)
• allopurinol (Zyloprim)
• amiodarone (Cordarone)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• certain antifungal medications such as fluconazole (Diflucan), and itraconazole (Sporanox); azithromycin (Zithromax)
• bromocriptine (Parlodel)
• calcium channel blockers such as diltiazem (Cardizem), nicardipine (Cardene), and verapamil (Calan); carbamazepine (Tegretol)
• cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)
• clarithromycin (Biaxin)
• dalfopristin and quinupristin combination (Synercid)
• danazol
• digoxin (Lanoxin)
• certain diuretics ('water pills') including amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyazide)
• erythromycin
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase)
• imatinib (Gleevec)
• metoclopramide (Reglan)
• methylprednisolone (Medrol)
• nafcillin; octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• orlistat (Xenical)
• phenobarbital
• phenytoin (Dilantin)
• potassium supplements
• prednisolone (Pediapred)
• repaglinide (Prandin)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• St. John's wort
• sulfinpyrazone (Anturane)
• terbinafine (Lamisil)
• ticlopidine (Ticlid)

This is not a complete list of Sandimmune drug interactions. Ask your doctor or pharmacist for more information.

Grapefruit and grapefruit juice may interact with Sandimmune and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Your doctor may tell you to limit the amount of potassium in your diet. Follow these instructions carefully. Talk to your doctor about the amount of potassium-rich foods such as bananas, prunes, raisins, and orange juice you may have in your diet. Many salt substitutes contain potassium, so talk to your doctor about using them during your treatment.

Before using Sandimmune, tell your doctor about all of your medical conditions including:

• if you are allergic to Sandimmune any other medications, or any of the inactive ingredients in Sandimmune. Ask your pharmacist for a list of the inactive ingredients
• tell your doctor if you have or have ever had any of the conditions mentioned in the "Sandimmune Precautions" section
• tell your doctor if you have low cholesterol, low levels of magnesium in your blood, any condition that makes it difficult for your body to absorb nutrients, or liver disease
• tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye
• if you are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not have vaccinations without talking to your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sandimmune falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Sandimmune is excreted in human breast milk or if it will harm your nursing baby.

Sandimmune comes as a capsule and a solution (liquid) to take by mouth and is usually taken once a day. It is important to take Sandimmune on a regular schedule. Take Sandimmune at the same time(s) each day, and allow the same amount of time between doses and meals every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Sandimmune exactly as directed. Do not take more or less of the medication or take it more often than prescribed by your doctor.

You may notice an unusual smell when you open a blister card of Sandimmune capsules. This is normal and does not mean that the medication is damaged or unsafe to use.

Sandimmune oral solution must be mixed with a liquid before use. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice. You should choose one drink from the appropriate list and always mix your medication with that drink.

To take either type of oral solution, follow these steps:

• Fill a glass (not plastic) cup with the drink you have chosen.
• Remove the protective cover from the top of the dosing syringe that came with your medication.
• Place the tip of the syringe into the bottle of solution and pull back on the plunger to fill the syringe with the amount of solution your doctor has prescribed.
• Hold the syringe over the liquid in your glass and press down on the plunger to place the medication in the glass.
• Stir the mixture well.
• Drink all of the liquid in the glass right away.
• Pour a little more of the drink you have chosen into the glass, swirl the glass around to rinse, and drink the liquid.
• Dry the outside of the syringe with a clean towel and replace the protective cover. Do not wash the syringe with water. If you do need to wash the syringe, be sure that it is completely dry before you use it to measure another dose.

Injectable:

• This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
• Sandimmune injection comes as a solution (liquid) to be injected over 2 to 6 hours into a vein, usually by a health care professional in a hospital or medical facility. It is usually given 4 to 12 hours before transplant surgery and once a day after the surgery until medication can be taken by mouth.
• A health care professional will watch you closely while you are receiving Sandimmune injection so that you can be treated quickly if you have a serious allergic reaction.

If you take too much Sandimmune, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Sandimmune is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed and out of reach of children.
• Store this medication at room temperature and away from excess heat and moisture (not in the bathroom).
• Do not store this medicine in the refrigerator and do not freeze it.
• Oral Sandimmune: throw away any medication that is outdated or no longer needed.
• Throw away any remaining oral solution 2 months after you first open the bottle. Talk to your pharmacist about the proper disposal of your medication.

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune® (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Sandimmune (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED.

Sandimmune and Neoral are not bioequivalent and cannot be used interchangeably without physician supervision.

The absorption of cyclosporine during chronic administration of Sandimmune Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed.