Cyclosporine Solution

What is this medication?

CYCLOSPORINE (SYE kloe spor een) prevents the body from rejecting an organ transplant. It works by lowering the body's immune system response. This helps the body accept the donor organ. It belongs to a group of medications called immunosuppressants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sandimmune, SangCya

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• High blood pressure
• Immune system problems
• Infection
• Kidney disease
• Liver disease
• Previous coal tar, PUVA, ultraviolet, or radiation therapy
• An unusual or allergic reaction to cyclosporine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day and at the same time in relation to meals. Use the specially marked oral syringe to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. For the Sandimmune brand, mix your dose in milk, chocolate milk, or orange juice (at room temperature). If you are taking any other brand of cyclosporine, mix the measured dose in a glass of orange or apple juice that is at room temperature. Do not use grapefruit juice or milk. Mix in a glass container (not plastic) and stir well just before taking. Rinse the glass with more liquid and swallow to make sure you get all the dose. Try to mix with the same diluent for each dose. This will help you keep a constant amount of cyclosporine in your body. After use, dry the outside of the dosing syringe with a clean towel. Do not rinse with water or any other cleaning agent. The dosing syringe must be dry before use.

Keep taking this medication unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 year of age for selected conditions (Neoral) and for children as young as 6 months for selected conditions (Sandimmune), precautions do apply.

People over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team if you miss more than one dose or if you miss doses on a regular basis.

What may interact with this medication?

Do not take this medication with any of the following:

• Bosentan
• Cidofovir
• Mibefradil
• Ranolazine
• Red yeast rice, monascus purpureus
• St. John's Wort
• Tacrolimus

This medication may also interact with the following:

• Acyclovir
• Allopurinol
• Amiloride
• Amiodarone
• Antibiotics, such as ciprofloxacin, gentamicin, tobramycin, vancomycin, trimethoprim; sulfamethoxazole, nafcillin, rifampin, rifabutin, azithromycin, clarithromycin, erythromycin, and uinupristin; dalfopristin
• Bromocriptine
• Carbamazepine
• Cimetidine
• Colchicine
• Danazol
• Digoxin
• Estrogen and progestin hormones
• Imatinib
• Medications for fungal infections, such as amphotericin B, fluconazole, itraconazole, terbinafine, and ketoconazole
• Medications for blood pressure, such as diltiazem, nicardipine, verapamil, enalapril, ramipril, and losartan
• Medications for cholesterol, such as lovastatin, simvastatin, atorvastatin, and fenofibrate
• Medications for HIV infection, such as indinavir, nelfinavir, ritonavir, and saquinavir
• Medications that suppress the immune system
• Melphalan
• Methotrexate
• Metoclopramide
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Octreotide
• Orlistat
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Ranitidine
• Sirolimus
• Spironolactone
• Steroid medications, such as prednisone or cortisone
• Sulfinpyrazone
• Ticlopidine
• Triamterene
• Vaccines
• Voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Do not change the brand of medication unless directed by your care team. You may need blood work while you are taking this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Tenderness, swelling, or minor bleeding of the gums may occur. Talk to your dentist if this happens. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any medications you are taking.

Some products may contain alcohol. Ask your pharmacist or care team if this medication contains alcohol. Be sure to tell all care teams you are taking this medication. Certain medications, such as metronidazole and disulfiram, can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
• High potassium level—muscle weakness, fast or irregular heartbeat
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Nausea
• Sensitive or irritated gums or teeth
• Tremors or shaking
• Unexpected hair growth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store Neoral at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store Sandimmune between 15 and 30 degrees C (59 and 86 degrees F). Do not refrigerate. Do not freeze. Keep this medication in the original packaging. Get rid of any unused medication after two months of opening the bottle or after the expiration date, whichever comes first.

At a temperature below 20 degrees C (68 degrees F), some brands of cyclosporine oral solution (e.g., Neoral and its generic forms) may form a gel or sediment. If this happens, let the medication warm to room temperature (about 77 degrees F) before use.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.