Neoral is the brand name for cyclosporine oral solution, USP MODIFIED, which contains the active ingredient cyclosporine in a cyclic polypeptide form. It is classified as an immunosuppressant agent. The formulation is an oral solution with a concentration of 100 mg/mL, administered orally. Key inactive ingredients include dehydrated alcohol, polyoxyl 40 hydrogenated castor oil, and polyglycerol oleates.

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. You should always take it the same way. Do not take this medication with grapefruit juice. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, 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.

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 Gengraf between 15 and 30 degrees C (59 and 86 degrees F).

Keep this medication in the original packaging. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

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
• Change in your skin, such as a new growth, a sore that doesn't heal, or a change in a mole
• 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 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.

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

What may interact with this medication?

Do not take this medication with any of the following:

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

This medication may also interact with the following:

• Acyclovir
• Allopurinol
• Amiloride
• Amiodarone
• Bromocriptine
• Carbamazepine
• Certain antibiotics
• 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. You may need blood work while taking this medication. Do not change the brand of medication unless directed by your care team.

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.

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 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.

The medication can cause dental (tooth and gum) problems. Brush your teeth every morning and night. Check with your dentist if your gums get red, swollen, or bleed. Make sure you see your dentist for regular cleanings.

Some products may contain alcohol. Ask your pharmacist or care team if this medication contains alcohol. Be sure to tell your care team 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 are the most serious risks of this medication?

If you get this medicine for an organ transplant, it should be started in the hospital, a clinic, or in a healthcare treatment setting.

This medicine should only be given by a healthcare provider who is trained to treat your illness. You will get tests to make sure the right amount of medicine is in your blood. Your healthcare provider will monitor you closely to make sure this medicine is working right.

There is a risk of getting skin cancer when this medicine is used for psoriasis. The highest risk is in those who have had PUVA light therapy. There is also a risk in those who have had the following treatments: methotrexate; immunosuppression medicines; UVB; coal tar; or radiation.

This medicine can cause high blood pressure. Your healthcare provider should monitor your blood pressure regularly while you take this medicine.

This medication may affect how well your kidneys work. Your care team will monitor you closely while you are taking this medication.

This medicine will make your immune system weak. A weak immune system puts you at risk of serious infections and of cancer. Your healthcare provider will monitor you closely.