Optimmune

Cyclosporine is a prescription medication used to prevent transplant rejection in those who have received kidney, liver, and heart transplants. Cyclosporine may also be used to treat psoriasis and symptoms of rheumatoid arthritis. Cyclosporine eye drops are prescribed to increase tear production in people with chronic dry eye disease caused by inflammation.

Cyclosporine belongs to a group of drugs called immunosuppressants. They work by decreasing the activity of the immune system.

Cyclosporine comes as a capsule, an oral liquid solution, an intravenous (IV) injection and an eye drop. It is usually taken once or twice a day, depending on the particular product you are using. This medication is available in its original form and in a modified form that has been slightly changed to be more easily absorbed by the body.

Common side effects of cyclosporine oral and injectable include high blood pressure, gum overgrowth, and tremors. Cyclosporine eye drops commonly cause eye burning, itching, stinging or redness.

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

Cyclosporine (modified) may also be used to treat psoriasis  symptoms of rheumatoid arthritis.

Cyclosporine ophthalmic emulsion is used to increase tear production in patients with chronic dry eye disease caused by inflammation.

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

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.

Oral/Injectable:

• Cyclosporine is available in its original form and as another product that has been modified (changed) so that the medication can be better absorbed in the body. Original cyclosporine and cyclosporine (modified) are absorbed by the body in different amounts, so they cannot be substituted for one another. Take only the type of cyclosporine that was prescribed by your doctor. When your doctor gives you a written prescription, check to be sure that he or she has specified the type of cyclosporine you should receive. Each time you have your prescription filled, look at the brand name printed on your prescription label to be sure that you have received the same type of cyclosporine. Talk to your pharmacist if the brand name is unfamiliar or you are not sure you have received the right type of cyclosporine.
• Taking cyclosporine or cyclosporine (modified) may increase the risk that you will develop an infection or cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. This risk may be higher if you take cyclosporine or cyclosporine (modified) with other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Tell your doctor if you are taking any of these medications, and if you have or have ever had any type of cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately:
  • sore throat
  • fever
  • chills and other signs of infection
  • flu-like symptoms
  • coughing
  • difficulty urinating
  • pain when urinating
  • a red, raised, or swollen area on the skin
  • new sores or discoloration on the skin
  • lumps or masses anywhere in your body
  • night sweats
  • swollen glands in the neck, armpits, or groin
  • trouble breathing
  • chest pain
  • weakness or tiredness that does not go away
  • pain, swelling, or fullness in the stomach
• Cyclosporine and cyclosporine (modified) may cause high blood pressure and kidney damage. Tell your doctor if you have or have ever had high blood pressure or kidney disease. If you experience any of the following symptoms, call your doctor immediately:
  • dizziness
  • swelling of the arms, hands, feet, ankles, or lower legs
  • fast, shallow breathing
  • nausea
  • irregular heartbeat
• If you have psoriasis, tell your doctor about all the psoriasis treatments and medications you are using or have used in the past. The risk that you will develop skin cancer is greater if you have ever been treated with PUVA (psoralen and UVA; treatment for psoriasis that combines an oral or topical medication with exposure to ultraviolet A light); methotrexate (Rheumatrex) or other medications that suppress the immune system; UVB (exposure to ultraviolet B light to treat psoriasis); coal tar; or radiation therapy. You should not be treated with PUVA, UVB, or medications that suppress the immune system while you are taking cyclosporine (modified) to treat psoriasis.
• Cyclosporine may cause growth of extra tissue in your gums. Be sure to brush your teeth carefully and see a dentist regularly during your treatment to decrease the risk that you will develop this side effect.
• Tell your doctor if you are being treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light) and if you have or have ever had low levels of cholesterol or magnesium.
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cyclosporine or cyclosporine (modified).

Ophthalmic:

• Cyclosporine eye drops is for ophthalmic (eye) use only.
• Do not use cyclosporine eye drops if you:
  • have a current eye infection
  • are allergic to cyclosporine (brand name Restasis)
  • are wearing contact lenses. Remove contact lenses before instilling Restasis eye drops and wait at least 15 minutes before putting contacts back in. Talk to your doctor about wearing contact lenses if you have dry eye disease.

Oral/Injectable:

Common side effects of cyclosporine 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

Ophthalmic:

Common side effects of cyclosporine eye drops include:

• burning, itching, stinging, redness
• eye pain
• overflow of tears
• red eyes
• watery eyes or eye discharge
• blurred vision or other vision changes
• feeling that something is in the eye

Tell your doctor if any side effect is bothersome or does not go away. Cyclosporine 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 cyclosporin drug interactions. Ask your doctor or pharmacist for more information.

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.

Cyclosporine 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 cyclosporine  is excreted in human breast milk or if it will harm your nursing baby.

Cyclosporine comes in variety of different formulations, so be sure to follow the directions on how to properly take or use this medication.

Grapefruit and grapefruit juice may interact with cyclosporine 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. 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 as well.

Cyclosporine may cause growth of extra tissue in your gums. Be sure to brush your teeth carefully and see a dentist regularly during your treatment to decrease the risk that you will develop this side effect.