What is Neoral?

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Sandimmune (R) (cycloSPORINE) and Neoral (R) (cycloSPORINE, modified). 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. CycloSPORINE and cycloSPORINE, modified are not bioequivalent and cannot be used interchangeably without physician supervision. CycloSPORINE absorption is erratic during chronic administration of Sandimmune (R) capsules and oral solution. Monitor cycloSPORINE blood levels to avoid toxicity due to high concentrations and possible organ rejection due to low levels .

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cycloSPORINE, modified. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Hypertension and nephrotoxicity can occur at recommended dosages, and the risk increases with increasing dose and duration of cycloSPORINE therapy. Monitor blood levels and renal function to avoid toxicity. CycloSPORINE, modified (Neoral (R) or Gengraf (R)) and cycloSPORINE (Sandimmune (R)) are not bioequivalent and cannot be used interchangeably without physician supervision. Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UV-B, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cycloSPORINE .

Cyclosporine is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). It belongs to a group of medicines known as immunosuppressive agents.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Cyclosporine works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Cyclosporine is also used to treat severe rheumatoid arthritis in patients who have failed treatment with methotrexate. This medicine is also used to treat adults with severe plaque psoriasis after other treatments (eg, PUVA, retinoids, methotrexate) failed.

Cyclosporine is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. Using too much will increase the chance for side effects, while using too little may cause you to reject your transplanted organ.

This medicine is always used together with other medicines. Make sure you understand when to take all of your medicines. Your doctor will give you a daily plan for taking your medicines.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Take this medicine the same way every day. Take it at the same time and take it consistently, either with or without food.

Measure the oral liquid only with the dosing syringe that comes with the package. The dosing syringe should be wiped with a clean towel after it is used and stored in its container. Do not rinse the dosing syringe with water or other cleaning agents before or after use.

To make Neoral® oral liquid taste better, mix it in a glass container with apple juice or orange juice (preferably at room temperature). Use a glass container, not plastic. Stir it well and drink it immediately. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine.

To make Sandimmune® oral liquid taste better, mix it in a glass container with milk, chocolate milk, or orange juice (preferably at room temperature).

You should not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice will increase the amount of medicine in the body.

Do not stop taking this medicine without first checking with your doctor. You might have to take medicine for the rest of your life to prevent your body from rejecting the transplant.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or oral solution):
  • For prevention of transplant rejection:
    • Adults and children—
      • Neoral®: Your dose will be determined by your doctor (depends on the transplanted organ). This is taken 4 to 12 hours before organ transplantation or after transplantation. Your doctor may adjust your dose as needed.
      • Sandimmune®: Dose is based on body weight and must be determined by your doctor. The starting dose is usually 15 mg per kg of body weight per day. This is taken as a single dose 4 to 12 hours before organ transplantation and continued after transplantation as directed by your doctor. Your doctor may adjust your dose as needed.
  • For treatment of psoriasis:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2.5 milligrams (mg) per kilogram (kg) of body weight per day, divided into two doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of rheumatoid arthritis:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2.5 milligrams (mg) per kilogram (kg) of body weight per day, divided into two doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not keep the oral liquid in the refrigerator. Throw away any unused medicine 60 days after the bottle is opened for the first time.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies on the relationship of age to the effects of cyclosporine have not been performed in children receiving organ transplants. However, no pediatric-specific problems have been documented to date.

Appropriate studies have not been performed on the relationship of age to the effects of cyclosporine in children with rheumatoid arthritis or psoriasis. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine in the elderly. However, elderly patients are more likely to have high blood pressure or age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving cyclosporine.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Bosentan
• Colchicine
• Dronedarone
• Elagolix
• Eliglustat
• Grazoprevir
• Lercanidipine
• Mifepristone
• Pitavastatin
• Simvastatin
• Sitaxsentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Aceclofenac
• Acemetacin
• Afatinib
• Alefacept
• Alfalfa
• Alfentanil
• Aliskiren
• Amlodipine
• Amtolmetin Guacil
• Aspirin
• Atorvastatin
• Bacillus of Calmette and Guerin Vaccine, Live
• Benzhydrocodone
• Betrixaban
• Black Cohosh
• Bosutinib
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Carbamazepine
• Caspofungin
• Celecoxib
• Ceritinib
• Cerivastatin
• Cholic Acid
• Choline Salicylate
• Clonixin
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclophosphamide
• Dabigatran Etexilate
• Dasabuvir
• Deflazacort
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dihydrocodeine
• Diltiazem
• Diphtheria Toxoid, Adsorbed
• Dipyrone
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droxicam
• Efavirenz
• Eluxadoline
• Encorafenib
• Enzalutamide
• Etodolac
• Etofenamate
• Etoposide
• Etoricoxib
• Etravirine
• Felbinac
• Felodipine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Foscarnet
• Fosnetupitant
• Glecaprevir
• Haemophilus B Vaccine
• Hepatitis A Vaccine, Inactivated
• Hydrocodone
• Ibrutinib
• Ibuprofen
• Ibuprofen Lysine
• Indomethacin
• Infliximab
• Influenza Virus Vaccine
• Isavuconazonium Sulfate
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoprofen
• Ketorolac
• Lanreotide
• Letermovir
• Lornoxicam
• Lovastatin
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Lyme Disease Vaccine (Recombinant OspA)
• Measles Virus Vaccine, Live
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Meningococcal Vaccine
• Meperidine
• Methadone
• Metoclopramide
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Mumps Virus Vaccine, Live
• Mycophenolic Acid
• Nabumetone
• Nafcillin
• Naproxen
• Nepafenac
• Neratinib
• Netupitant
• Nicardipine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Obeticholic Acid
• Octreotide
• Olaparib
• Ombitasvir
• Orlistat
• Oxaprozin
• Oxycodone
• Oxyphenbutazone
• Parecoxib
• Paritaprevir
• Pazopanib
• Pentazocine
• Perindopril
• Pertussis Vaccine
• Phenylbutazone
• Pibrentasvir
• Piketoprofen
• Piperaquine
• Piroxicam
• Pitolisant
• Pixantrone
• Plague Vaccine
• Pneumococcal Vaccine, Diphtheria Conjugate
• Pneumococcal Vaccine Polyvalent
• Poliovirus Vaccine, Live
• Posaconazole
• Pravastatin
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Pyrazinamide
• Rabies Vaccine
• Ranolazine
• Red Yeast Rice
• Ribociclib
• Rifabutin
• Rifampin
• Ritonavir
• Rofecoxib
• Rosuvastatin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Salicylic Acid
• Salsalate
• Silodosin
• Simeprevir
• Smallpox Vaccine
• Sodium Salicylate
• Sonidegib
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Tacrolimus
• Telaprevir
• Telithromycin
• Tenoxicam
• Tetanus Toxoid
• Tezacaftor
• Tiaprofenic Acid
• Tofacitinib
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Topotecan
• Tramadol
• Typhoid Vaccine, Live
• Valdecoxib
• Varicella Virus Vaccine, Live
• Venetoclax
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Voriconazole
• Voxilaprevir
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetazolamide
• Allopurinol
• Ambrisentan
• Amiodarone
• Amphotericin B
• Amphotericin B Cholesteryl Sulfate Complex
• Amphotericin B Lipid Complex
• Amphotericin B Liposome
• Amprenavir
• Azathioprine
• Boceprevir
• Bromocriptine
• Chloramphenicol
• Chloroquine
• Cimetidine
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Clindamycin
• Clonidine
• Colesevelam
• Dalfopristin
• Danazol
• Desogestrel
• Dienogest
• Digoxin
• Dirithromycin
• Drospirenone
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Ezetimibe
• Famotidine
• Fenofibrate
• Fluvoxamine
• Fosamprenavir
• Fosphenytoin
• Furosemide
• Glipizide
• Glyburide
• Imipenem
• Indinavir
• Josamycin
• Ketoconazole
• Levonorgestrel
• Medroxyprogesterone Acetate
• Melphalan
• Mercaptopurine
• Mestranol
• Methotrexate
• Methylprednisolone
• Metronidazole
• Mibefradil
• Midazolam
• Miokamycin
• Modafinil
• Mycophenolate Mofetil
• Nefazodone
• Nelfinavir
• Nevirapine
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Oxypurinol
• Phenytoin
• Probucol
• Propafenone
• Quinine
• Quinupristin
• Repaglinide
• Rifapentine
• Saquinavir
• Sirolimus
• Sulfadiazine
• Sulfasalazine
• Terbinafine
• Tobramycin
• Tolterodine
• Troglitazone
• Verapamil
• Warfarin

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Pomelo Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal kidney function or
• Cancer or
• Hypertension (high blood pressure), uncontrolled—Rheumatoid arthritis patients who also have these conditions should not receive Neoral®.

• Alcohol abuse, or history of or
• Epilepsy (seizures) or
• Liver disease—This medicine contains alcohol, which can make these conditions worse.

• Anemia or
• Bleeding problems or
• Brain disease (eg, encephalopathy) or
• Cancer or
• Eye or visual problems (eg, papilloedema) or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Hyperuricemia (too much uric acid in the blood) or
• Kidney disease or
• Precancerous skin changes or
• Seizures, history of or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Infection—May decrease body's ability to fight an infection.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not take Neoral® if you are receiving treatment for psoriasis, such as PUVA or UVB therapy, methotrexate (Rheumatrex®), coal tar, or radiation therapy.

Check with your doctor right away if you have any of the following symptoms: blood in the urine, change in the frequency of urination or amount of urine, difficulty breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, or swelling of the feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

This medicine may increase your risk of developing rare and serious virus infections, such as progressive multifocal leukoencephalopathy (PML) and polyoma virus-associated nephropathy (PVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

While you are being treated with cyclosporine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Cyclosporine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums may appear soon after treatment with cyclosporine is started. Brushing and flossing your teeth, carefully and regularly, and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. If you are being treated for psoriasis, check with your doctor first before having an ultraviolet (UV) light treatment. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds.

This medicine may cause a serious nervous system problem. Tell your doctor right away if you have the following symptoms: confusion, loss of consciousness, mental changes, muscle weakness, seizures, or vision changes.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.