Generic Name: cyclosporine (Intravenous route)
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 oral Sandimmune(R). Monitor cycloSPORINE blood levels to avoid toxicity due to high concentrations and possible organ rejection due to low levels .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Suppressant
Pharmacologic Class: Calcineurin Inhibitor
Uses For Neoral
Cyclosporine injection is given together with a steroid medicine to prevent the body from rejecting a transplanted organ (e.g., 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 a very strong medicine. It can cause side effects that can be very serious, such as high blood pressure, kidney problems, or liver problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits this medicine will do as well as the risks of using it.
This medicine is to be given only by or under the direct supervision of a doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, cyclosporine is used in certain patients with the following medical conditions:
- Bone marrow transplantation.
- Nephrotic syndrome.
Before Using Neoral
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 injection have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cyclosporine injection 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 injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
Interactions with Medicines
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 receiving 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.
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.
- Amtolmetin Guacil
- Bacillus of Calmette and Guerin Vaccine, Live
- Black Cohosh
- Cholic Acid
- Choline Salicylate
- Dabigatran Etexilate
- Diphtheria Toxoid, Adsorbed
- Doxorubicin Hydrochloride Liposome
- Eslicarbazepine Acetate
- Flufenamic Acid
- Haemophilus B Vaccine
- Hepatitis A Vaccine, Inactivated
- Ibuprofen Lysine
- Influenza Virus Vaccine
- Isavuconazonium Sulfate
- Lyme Disease Vaccine (Recombinant OspA)
- Measles Virus Vaccine, Live
- Mefenamic Acid
- Meningococcal Vaccine
- Morphine Sulfate Liposome
- Mumps Virus Vaccine, Live
- Mycophenolic Acid
- Niflumic Acid
- Pertussis Vaccine
- Plague Vaccine
- Pneumococcal Vaccine, Diphtheria Conjugate
- Pneumococcal Vaccine Polyvalent
- Poliovirus Vaccine, Live
- Propionic Acid
- Rabies Vaccine
- Red Yeast Rice
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Salicylic Acid
- Smallpox Vaccine
- Sodium Salicylate
- St John's Wort
- Tetanus Toxoid
- Tiaprofenic Acid
- Tolfenamic Acid
- Typhoid Vaccine, Live
- Varicella Virus Vaccine
- Vincristine Sulfate Liposome
- Yellow Fever Vaccine
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.
- Amphotericin B
- Amphotericin B Cholesteryl Sulfate Complex
- Amphotericin B Lipid Complex
- Amphotericin B Liposome
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
- Mycophenolate Mofetil
Interactions with Food/Tobacco/Alcohol
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
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:
- Allergy to polyoxyethylated castor oil (Cremophor® EL)—Should not be used in patients with this condition.
- Anemia or
- Bleeding problems or
- Brain disease (e.g., encephalopathy) or
- Cancer or
- Eye or visual problems (e.g., 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
- Liver disease or
- Precancerous skin changes or
- Seizures, history of or
- Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse. .
- Hypertension (high blood pressure) or
- Hypocholesterolemia (low cholesterol in the blood) or
- Hypomagnesemia (low magnesium in the blood)—May increase risk for encephalopathy.
- Infection—May decrease body's ability to fight infection.
Proper Use of cyclosporine
This section provides information on the proper use of a number of products that contain cyclosporine. It may not be specific to Neoral. Please read with care.
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
This medicine is usually given 4 to 12 hours before organ transplantation. Then your doctor will switch you to the oral (by mouth) form of Sandimmune®.
Precautions While Using Neoral
It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, flushing of the face, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.
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.
Hyperkalemia (high potassium in the blood) may occur while you are receiving this medicine. Tell your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. 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.
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 receiving 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 lowers your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. However, it may be especially important to receive certain immunizations to prevent a disease. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
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.
Grapefruit and grapefruit juice may increase the effects of cyclosporine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are receiving this medicine.
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 (e.g., St. John's wort) or vitamin supplements.
Neoral Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:More common
- Abdominal or stomach pain or tenderness
- black, tarry stools
- blurred vision
- chest pain
- clay colored stools
- cloudy urine
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- decreased appetite
- loss of appetite
- nausea and vomiting
- painful or difficult urination
- pounding in the ears
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- skin rash
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the feet or lower legs
- swollen glands
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- Bleeding gums
- blood in the urine
- blood in the vomit
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty swallowing
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe or continuing stomach pain
- tightness in the chest
- troubled breathing with exertion
- chest discomfort
- darkened urine
- lower back or side pain
- night sweats
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- vomiting of blood or material that looks like coffee grounds
- Back pain
- headache, severe and throbbing
- muscle spasms (tetany) or twitching
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach discomfort
- bleeding, tender, or enlarged gums
- blemishes on the skin
- increased hair growth, especially on the face
- pain or tenderness around the eyes and cheekbones
- stuffy or runny nose
- Brittle fingernails
- burning feeling in the chest or stomach
- burning, dry, or itching eyes
- continuing ringing or buzzing or other unexplained noise in the ears
- discharge or excessive tearing
- feeling of warmth
- hearing loss
- redness of the face, neck, arms, and occasionally, upper chest
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- swelling of the breasts or breast soreness in both females and males
- weight loss
- Blurred or loss of vision
- disturbed color perception
- double vision
- fear or nervousness
- feeling sad or empty
- halos around lights
- joint pain
- loss of interest or pleasure
- night blindness
- overbright appearance of lights
- trouble concentrating
- trouble sleeping
- tunnel vision
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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