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 1 hour before or 2 hours after meals, unless your doctor tells you otherwise.

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

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. 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.
    • 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Do not keep outdated medicine or medicine no longer needed.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.

Applies to mycophenolic acid: oral tablet enteric coated

Along with its needed effects, mycophenolic acid 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 while taking mycophenolic acid:

• Abdominal or stomach 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
• blurred vision
• body aches or pain
• bone pain
• burning or stinging of the skin
• chest pain
• cloudy urine
• confusion
• constipation
• convulsions
• cough
• decrease in the amount of urine
• decreased frequency or amount of urine
• depression
• difficult, burning, or painful urination
• dizziness or lightheadedness
• 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
• loss of appetite
• loss of consciousness
• loss of voice
• lower back, side, or stomach pain
• metallic taste
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms or twitching
• muscle weakness
• 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
• red, tender, or oozing skin at incision
• runny nose
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sunken eyes
• sweating
• swelling
• swollen glands
• thirst
• tightness in the chest
• tremor
• trouble breathing at rest or with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

Some side effects of mycophenolic acid 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:

• Acid or sour stomach
• anxiety
• back pain
• belching
• bleeding gums
• blemishes on the skin
• bruising
• diarrhea
• difficulty moving
• excess air or gas in the stomach or intestines
• facial hair growth in females
• 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
• 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
• sleeplessness
• sore mouth or tongue
• stomach discomfort or upset
• trouble sleeping
• upper abdominal or stomach pain
• white patches in the mouth or on the tongue

No dosage adjustments are needed in patients experiencing delayed renal graft function postoperatively.

Patients with severe chronic renal impairment (GFR less than 25 mL/min) should be carefully followed for potential adverse reactions due to increased mycophenolic acid and total mycophenolic acid glucuronide concentrations.

Although dialysis may be used to remove the inactive metabolite mycophenolic acid glucuronide, it would not be expected to remove clinically significant amounts of the active moiety mycophenolic acid. This is in large part due to the high plasma protein binding of mycophenolic acid.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate. It includes a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

The drug is to be administered in combination with cyclosporine and corticosteroids.

Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because of the rate of absorption following administration of the two products is not equivalent.

There are no data on the excretion of mycophenolic acid into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to mycophenolic acid in nursing infants, a decision should be made to discontinue the drug or discontinue nursing while on treatment or within 6 weeks after stopping therapy, taking into account the importance of the drug to the mother.