Neoral

Neoral Medication Information:

Price Break On Neoral
Generic is available for less money: Generic Cyclosporine

Neoral medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Neoral 10 mg
Neoral 25 mg
Neoral 50 mg
Neoral 100 mg
Neoral oral suspension 100 mg/mL

About Neoral

What Neoral is used for

Your doctor has prescribed the drug NEORAL or SANDIMMUNE I.V. It is used after organ transplantations to help prevent organ rejection, or to treat autoimmune conditions such as severe psoriasis, severe rheumatoid arthritis and nephrotic syndrome.

NEORAL or SANDIMMUNE I.V. are the brand name for a drug called “cyclosporine”. It belongs to a family of drugs known as “immunosuppressants”. These drugs work to “suppress” or reduce the body's immune response.

What Neoral does

Your body's immune system normally works to protect you from infections and other foreign material. When you receive a transplant, this system does not recognize the new organ, and will try to reject it.

NEORAL and SANDIMMUNE I.V. work to reduce this response, so your body is more likely to accept the new organ.

NEORAL and SANDIMMUNE I.V. do not completely suppress the immune system, so your body will still have some infection-fighting ability.

NEORAL and SANDIMMUNE I.V. may be given alone, but are often given with other drugs which also suppress your immune system. Together these help prolong the life of an organ transplant, or to suppress certain function of your immune system to treat your psoriasis, rheumatoid arthritis or nephrotic syndrome.

When Neoral should not be used

Do not use NEORAL or SANDIMMUNE I.V if you have ever had a bad, unusual or allergic reaction to cyclosporine or any of the non-medicinal ingredients of NEORAL or SANDIMMUNE I.V.

For the treatment of psoriasis and rheumatoid arthritis, do not take NEORAL or SANDIMMUNE I.V. if you have one of the following conditions:

  • abnormal kidney function;

  • uncontrolled blood pressure;

  • any type of cancer (except a skin cancer which is not a melanoma);

  • uncontrolled infection (not treated or cured);

  • inherited or acquired immune deficiency.

What the medicinal ingredient is

NEORAL contains cyclosporine for microemulsion.

NEORAL is the microemulsion formulation of cyclosporine which can be taken orally, while SANDIMMUNE is the intravenous form of cyclosporine which you may need to receive during your stay in hospital.

The “microemulsion” formulation allows more reliable absorption of cyclosporine from your stomach compared to conventional types of oral dosage forms. This means almost the same amount will go into your body each time you take the drug, and that food will have less of an effect on the amount of cyclosporine that gets absorbed.

SANDIMMUNE I.V. contains cyclosporine for injection.

What the important nonmedicinal ingredients for Neoral are

Nonmedicinal ingredients for NEORAL capsules are the following: DL-α-Tocopherol, ethanol, propylene glycol, maize oil, hydrogrenated castor oil. Capsule shell: glycerol, propylene glycol, gelatin, iron oxide black, titanium dioxide. Imprint: caminic acid, aluminum chloride, sodium hydroxide, hydroxypropyl methylcellulose.

Nonmedicinal ingredients for NEORAL oral solution are the following: DL-α-Tocopherol, propylene glycol, ethanol, maize oil, hydrogrenated castor oil.

Nonmedicinal ingredients for SANDIMMUNE I.V. are the following: ethanol and castor oil.

What dosage forms Neoral comes in

NEORAL comes in two forms: a soft gelatin capsule and an oral solution. The following points tell you how to take the form you have been given.

Capsules

NEORAL capsules come with 10 mg, 25 mg, 50 mg or 100 mg of cyclosporine. Each capsule is contained in a foil strip.

Solution

NEORAL solution comes in 50 millilitre bottles.

SANDIMMUNE I.V. (concentrate for solution for infusion), is supplied in l mL and 5 mL sterile ampoules containing 50 mg of cyclosporine per mL in a polyoxyethylated castor oil and ethanol.


Warnings and Precautions

Medicines which suppress the immune system, such as NEORAL or SANDIMMUNE I.V. may influence your body's ability to fight against infection and may increase the risk of developing cancers, particularly of the skin and lymphoid system. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying a sunscreen with a high protection factor.

Tell all health professionals you see (doctor, dentists, nurses, pharmacists) that you are taking NEORAL or SANDIMMUNE I.V. It is also a good idea to wear a Medic-Alert bracelet.

Before you use NEORAL or SANDIMMUNE I.V. talk to your doctor or pharmacist if:

  • You have any current or have had past health conditions.

  • You are taking other drugs: Do not take any other drugs without asking your doctor or pharmacist first-including over-the-counter medicines and herbal or home remedies. NEORAL or SANDIMMUNE I.V. is often given with other medicines. Make sure you know if you are to stop, or to continue, other immunosuppressant drugs you had been taking.

  • You are to receive vaccinations: NEORAL or SANDIMMUNE I.V. may make vaccinations less effective or increase your risk of getting an illness from a live vaccine. Always discuss this possibility with your doctor before you get any vaccinations or immunizations.

  • You receive NEORAL or SANDIMMUNE I.V. for psoriasis, rheumatoid arthritis, or nephrotic syndrome, your renal function and blood pressure should be checked before initiation of therapy and regularly thereafter. If high blood pressure develops during therapy and cannot be controlled, treatment should be stopped.

  • You are or become pregnant: There is an increased risk of difficult pregnancies (up to 25% of pregnancies) in patients who have taken cyclosporine during pregnancy. These difficult pregnancies have resulted in an increased risk to the babies during and immediately after birth. As well, some babies have been born with abnormalities.

    For these reasons it is recommended that you do not take NEORAL or SANDIMMUNE I.V. if you are, or become, pregnant. During your treatment with NEORAL and for 2 months after stopping your NEORAL or SANDIMMUNE I.V. treatment, you must use a reliable method of birth control. Should you become pregnant during the time you are taking your NEORAL or SANDIMMUNE I.V. you should inform your doctor at once. You will want to discuss the possible benefits and risks of continuing with this drug.

  • You are breast-feeding: Do not breast feed your baby if you are taking NEORAL or SANDIMMUNE I.V. as it passes into breast milk and may harm your baby.

Do not stop taking NEORAL or SANDIMMUNE I.V. on your own even if you have been taking it for several years. Transplant patients: Although you may not notice any symptoms of rejection for several weeks, missing even a few doses of NEORAL or SANDIMMUNE I.V. may lead to rejection of your transplanted organ.


Interactions with Neoral

Make sure your doctor knows if you are taking, or begin to take, any other medicines, including drugs, or herbal (natural) products that you can buy without a prescription while you take NEORAL or SANDIMMUNE I.V. Some medicines may interact with NEORAL or SANDIMMUNE I.V. such as:

  • weak analgesic drugs (non-steroid anti-inflammatory drugs),

  • digoxin,

  • caspofungin,

  • colchicines,

  • HMG-CoA reductase inhibitors (statins),

  • prednisolone,

  • etoposide

  • repaglinide

  • fibric acid derivatives (e.g. bezafibrate, fenofibrate).

  • methotrexate,

  • lercanidipine,

  • potassium sparing drugs (e.g. potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists),

  • potassium containing drugs,

  • bosentan,

  • oxcarbazepine,

  • voriconazole

  • oral contraceptives

  • protease inhibitors

  • imatinib

  • nefazodone

Never take NEORAL or SANDIMMUNE I.V. with grapefruit juice.

NEORAL or SANDIMMUNE I.V. is also used in combination with other immunosuppressive agents. However, do not use it together with other calcineurin inhibitors such as tacrolimus.


Proper Use of Neoral

Usual dose

  • Always take NEORAL or SANDIMMUNE I.V. exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Do not change the dose on your own, no matter how you are feeling. Blood tests are one of the ways your doctor tells how much NEORAL or SANDIMMUNE I.V. you need. Based on these tests, and on your response to this drug, your doctor may change your dose from time to time.

  • Space your doses of NEORAL as evenly as you can throughout the day. For example, if you take the drug 2 times a day, leave about 12 hours between each dose.

  • Try to take your dose(s) at the same time(s) each day. This will help keep a constant amount of drug in your body and will also help you remember each dose. NEORAL may be taken with or without food. But it is best to be consistent: once you decide when you are going to take it in relation to food, do it the same way each time.

  • Never take NEORAL or SANDIMMUNE I.V with grapefruit juice.

  • Leave the capsules in the foil until you need a dose. When you are ready to take a dose, remove the number of capsules you need to make up the dose your doctor prescribed.

  • Swallow the capsules whole. You may use any kind of drink except grapefruit juice.

NEORAL Oral Solution

To open the bottle for the first time:

(See package insert for illustrations.)

  1. Raise the plastic cap.

  2. Tear off the sealing ring completely.

  3. Remove the black stopper and throw it away.

  4. Push the tube unit with the white stopper firmly into the neck of the bottle.

  5. Insert the syringe into the white stopper.

  6. Draw up prescribed volume of solution.

  7. Expel any large bubbles by depressing and withdrawing plunger a few times before removing syringe containing prescribed dose from bottle. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.

  8. Push the medicine out of the syringe into a small glass with some liquid, but no grapefruit juice. Do not let the syringe touch the liquid in the cup. Most drinks other than grapefruit juice can be used, for example, apple juice, orange juice, or a soft drink. Once you have chosen a drink, use the same one each time. The medicine can be mixed just before you take it. Stir and drink the entire mixture right away. Please take the medicine immediately after preparation.

  9. After use, wipe syringe on outside only with a dry tissue and replace in its case. Do not rinse the syringe with water, alcohol, or any other liquid. White stopper and tube should remain in bottle. Close bottle with cap provided.

Once the bottle is opened the first time, you can start at point number 5 above for your next dose.

  • Each dose of NEORAL solution must be measured accurately. Be sure to ask your doctor, nurse or pharmacist if you have any question about how to measure the solution.

  • If you accidentally take too much of your medicine (i.e. more than twice the prescribed dose), tell your doctor right away, or call your nearest emergency room or poison control centre.

Missed dose

  • For transplant patients, missing even a few doses of NEORAL or SANDIMMUNE I.V. may lead to rejection of your transplanted organ. That is why it is so important to take each of the doses your doctor prescribes.

  • Talk to your doctor, nurse or pharmacist if you have trouble remembering doses, or if you are uncertain about how to take them. Also be sure to discuss any concerns you have about taking this drug as prescribed. These people can often suggest ways to overcome problems you have taking your medication.

  • Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time—that way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.

  • If you ever do miss a dose of NEORAL, do not try to catch up on your own. Instead, call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.

  • Be sure to keep all appointments at your clinic. Some of these visits will be used to check the level of cyclosporine in your blood. For transplant patients, levels that are too low can cause transplant rejection, while levels that are too high may cause damage to other organs. It is therefore very important not to miss any tests or check-ups your doctor orders.


Side Effects for Neoral and What to Do About Them

Like all medicines, NEORAL or SANDIMMUNE I.V. causes side effects in some people. Be sure to talk to your doctor if you have any concerns about this.

The most common side effects noted were:

  • high blood pressure;

  • kidney or liver problems;

  • headache;

  • increased levels of lipids (e.g. cholesterol) in the blood;

  • loss of appetite, nausea, vomiting or diarrhea;

  • acne or oily skin;

  • slight trembling of the hands;

  • increased growth of fine hairs on the body;

  • muscle or joint pains or cramping;

  • weakness, anxiety;

  • tingling in the fingers, toes or mouth;

  • night sweats; hearing loss; swelling of the face;

  • increased potassium in the body (your doctor may instruct you to avoid high dietary potassium intake);

  • tender or swollen gums

  • decreased ability to fight infection

  • Because NEORAL or SANDIMMUNE I.V. reduces the function of your immune system, you are more likely to get bacterial, fungal or viral infections. To help reduce complications from these infections, tell your doctor right away about any cold or flu-like symptoms (such as a fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).

  • The decreased function of your immune system may also increase your chances of developing cancer. Although very rare, cancers of the white blood cells (lymphomas) and other types of cancer have occurred in people taking cyclosporine. The following are some possible warning signs of cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away: a change in your bowel or bladder habits; any sore that doesn't heal; unusual bleeding or discharge; the appearance of a lump or thickened areas in your breast or anywhere else on your body; unexplained stomach upset or any trouble with swallowing; an obvious change in a wart or a mole; a nagging cough or hoarseness; night sweats.

  • Vomiting or diarrhea may stop NEORAL from being absorbed (going) into your body.

Be sure to tell your doctor right away if you notice any of these symptoms listed above, and especially if they continue, bother you in any way, or seem to increase in intensity. Remember, only a doctor can tell if these symptoms might be from NEORAL or SANDIMMUNE I.V. If you think you are having side effects, talk to your doctor right away. Do not stop taking this drug on your own.

Serious Side Effects, How Often They Happen and What to Do About Them
Symptom/Effect Talk with your doctor or pharmacist Stop taking drug and call your doctor or pharmacist
Only if severe In all cases
Common Tremor   a
High blood pressure  
Tingling  
Bacterial, fungal or viral infection  
Vomiting or diarrhea  
Muscle or joint pains or cramping  
Weakness  
Anxiety  
Blurred vision  
High level of potassium in the blood  
Uncommon Ulcers   a
Convulsions  
Allergic reactions  
Very rarely Tumours/malignancies   a
a. Do not stop your medicines unless you have discussed this with your doctor first.

This is not a complete list of side effects. For any unexpected effects while taking NEORAL or SANDIMMUNE I.V., contact your doctor or pharmacist.


 

Technical Information