mycophenolate sodium

mye-koe-FEN-oh-late SOE-dee-um

Oral route(Tablet, Enteric Coated)

Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe mycophenolate sodium, and they should have complete information requisite for the follow-up of the patient. Female contraception must be used due to increased risk of congenital malformations and pregnancy loss .

Commonly used brand name(s)

In the U.S.

• Myfortic

Available Dosage Forms:

• Tablet, Enteric Coated

Therapeutic Class: Immune Suppressant

Uses For mycophenolate sodium

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

mycophenolate sodium is available only with your doctor's prescription.

Before Using mycophenolate sodium

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 mycophenolate sodium, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mycophenolate sodium 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children. However, safety and efficacy have not been established in children younger than 5 years of age.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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 taking mycophenolate sodium, 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 mycophenolate sodium 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.

• Activated Charcoal


• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Azathioprine


• Bacillus of Calmette and Guerin Vaccine, Live


• Cholestyramine


• Colesevelam


• Colestipol


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Influenza Virus Vaccine, Live


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using mycophenolate sodium 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.

• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Iron


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Valacyclovir

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 mycophenolate sodium. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., neutropenia) or


• Stomach ulcers or bleeding—Use with caution. May make these conditions worse.

• Infection—May decrease your ability to fight an infection.

• Kelley-Seegmiller syndrome (rare genetic disease) or


• Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of mycophenolate sodium

Take mycophenolate sodium exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

mycophenolate sodium should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take mycophenolate sodium on an empty stomach, either one hour before or 2 hours after meals, unless your doctor tells you otherwise.

Swallow the delayed-release tablet whole. Do not break, crush, or chew them.

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

If you are also using antacids that contain aluminum or magnesium (such as Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 1 hour before or 2 hours after your dose of mycophenolate. If you have questions, talk with your doctor about the best times to use your medicines.

Dosing

The dose of mycophenolate sodium 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 mycophenolate sodium. 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 form (delayed-release tablets):
  
  • For kidney transplants:
    
    • Adults—720 milligrams (mg) two times a day.
    
    
    • Older adults—720 milligrams (mg) two times a day.
    
    
    • Teenagers and children 5 years of age and older—Dose is based on body size as determined by the doctor. The dose is 400 milligrams (mg) per square meter [m(2)] two times a day, up to a maximum dose of 720 mg two times a day.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of mycophenolate sodium, 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.

Storage

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.

Precautions While Using mycophenolate sodium

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using mycophenolate sodium while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using mycophenolate sodium to make sure you are not pregnant. Your birth control pills may not work as well while you are using mycophenolate sodium. You must use two forms of birth control together for 1 month before starting mycophenolate sodium, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of mycophenolate sodium. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using mycophenolate sodium 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.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

mycophenolate sodium may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

mycophenolate sodium may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). 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 with breathing; unusual tiredness or weakness; vomiting; or weight gain.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

While you are using mycophenolate sodium, and after you stop, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Do not stop taking mycophenolate sodium without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take mycophenolate sodium.

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 or vitamin supplements.

mycophenolate sodium 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 immediately if any of the following side effects occur:

More common

• Abdominal pain or cramps


• black, tarry stools


• bladder pain


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• bloody or cloudy urine


• blurred vision


• body aches or pain


• bone pain


• burning or stinging of the skin


• burning while urinating


• chest pain


• confusion


• constipation


• convulsions


• cough


• decrease in the amount of urine


• decrease in frequency of urination


• decreased frequency or amount of urine


• decreased urine


• depression


• difficult, burning, or painful urination


• difficulty with breathing


• difficulty in passing urine (dribbling)


• dizziness


• drowsiness


• dry mouth


• ear congestion


• fainting


• fast, pounding, or irregular heartbeat or pulse


• fever or chills


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• headache


• incoherent speech


• increase in heart rate


• increased blood pressure


• increased hunger


• increased thirst


• increased urination


• joint pain, stiffness, or swelling


• lightheadedness


• loss of appetite


• loss of consciousness


• loss of voice


• lower back, side, or stomach pain


• metallic taste


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle spasms (tetany) or twitching


• muscle weakness


• nasal congestion


• nausea or vomiting


• nervousness


• noisy, rattling breathing


• numbness and tingling around the mouth, fingertips, hands, or feet


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pale skin


• pinpoint red spots on the skin


• rapid breathing


• rapid weight gain


• red, tender, or oozing skin at incision


• runny nose


• shortness of breath


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sudden decrease in the amount of urine


• sunken eyes


• sweating


• swelling


• swelling of the face, fingers, hands, or lower legs


• swollen glands


• thirst


• tightness in the chest


• tremor


• troubled breathing


• troubled breathing at rest


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness or heaviness of the legs


• weight gain


• weight loss


• wheezing


• wrinkled skin

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

• Acid or sour stomach


• anxiety


• back pain


• belching


• bleeding gums


• blemishes on the skin


• bloated


• bruise


• diarrhea


• difficulty with moving


• excess air or gas in the stomach or intestines


• facial hair growth in females


• fractures


• full feeling


• full or round face, neck, or trunk


• heartburn


• increased hair growth, especially on the face


• increased thirst or urination


• indigestion


• irritability


• irritation in the mouth


• itching skin


• loose stools


• loss of sexual desire or ability


• menstrual irregularities


• muscle pains or stiffness


• muscle wasting


• pain


• pain or tenderness around the eyes and cheekbones


• passing gas


• pimples


• redness and swelling of the gums


• shakiness in the legs, arms, hands, or feet


• shortness of breath or troubled breathing


• sleeplessness


• sore mouth or tongue


• stomach discomfort, upset, or pain


• stuffy or runny nose


• trouble sleeping


• unable to sleep


• upper abdominal or stomach pain


• white patches in the mouth or on the tongue

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: mycophenolate sodium side effects (in more detail)

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