Description
Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines (eg, cyclosporine, steroid medicine) to lower the body's natural immunity in patients who receive organ transplants (eg, kidney, heart, or liver).
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Suspension
- Powder for Suspension
- Tablet
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate capsules, suspension, or tablets in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.
Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate capsules, suspension, or tabletsin children receiving heart or liver transplants. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate delayed-release tablets in children receiving kidney transplants. However, safety and efficacy have not been established in children younger than 5 years of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate suspension in children receiving kidney, heart, or liver transplants. However, safety and efficacy have not been established in infants younger than 3 months 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.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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 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.
- Acyclovir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amoxicillin
- Azathioprine
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Cholestyramine
- Ciprofloxacin
- Clavulanic Acid
- Colesevelam
- Colestilan
- Colestipol
- Cyclosporine
- Dengue Tetravalent Vaccine, Live
- Desogestrel
- Dexlansoprazole
- Dienogest
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Drospirenone
- Ebola Zaire Vaccine, Live
- Esomeprazole
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Ferric Citrate
- Ganciclovir
- Gestodene
- Influenza Virus Vaccine, Live
- Isavuconazonium Sulfate
- Lansoprazole
- Lanthanum Carbonate
- Levonorgestrel
- Magaldrate
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.
- Iron
Other Interactions
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:
- Bone marrow problems (eg, neutropenia) or
- Hepatitis B or C infection or
- Stomach or bowel problems (eg, ulcers, bleeding)—Use with caution. May make these conditions worse.
- Infection (eg, bacteria, fungus, or virus), active—May decrease your body's 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.
- Phenylketonuria (PKU)—The oral suspension contains aspartame (phenylalanine), which can make this condition worse.
Proper Use
Take this medicine 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.
This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
It is best to take this medicine on an empty stomach, either 1 hour before or 2 hours after meals, unless your doctor tells you otherwise.
Mycophenolate capsules, delayed-release tablets, and tablets should be swallowed whole. Do not break, crush, cut, open, or chew them.
It is important that you handle this medicine with care. Avoid inhaling the powder from the capsule or allowing the powder or the oral liquid to touch your skin or eyes. If the medicine gets on your skin, wash it thoroughly with soap and water. If the medicine gets in your eyes, wash them with plain water. Should a spill occur, wipe it up using paper towels wetted with water to remove the powder or liquid.
Measure the oral liquid medicine with the oral dispenser. Do not mix with any other medicine. Ask your doctor or pharmacist if you have any questions about this.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
If you are also using antacids that contain aluminum or magnesium (eg, Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 2 hours after your dose. If you have questions, talk with your doctor about the best times to use your medicines.
Dosing
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 (Cellcept® capsules, suspension, or tablets):
- To prevent heart transplant rejection:
- Adults—1.5 grams (g) 2 times a day.
- Children—Use and dose must be determined by your doctor.
- To prevent kidney transplant rejection:
- Adults—1 gram (g) 2 times a day.
- Children 3 months of age and older—Dose is based on body surface area (BSA) and must be determined by the doctor. The suspension dose is 600 milligrams (mg) per square meter [m(2)] 2 times a day. The capsules and tablets are given as 750 mg to 1 gram two times a day.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- To prevent liver transplant rejection:
- Adults—1.5 grams (g) 2 times a day.
- Children—Use and dose must be determined by your doctor.
- To prevent heart transplant rejection:
- For oral dosage forms (Myfortic® delayed-release tablets):
- To prevent kidney transplant rejection:
- Adults—720 milligrams (mg) 2 times a day.
- Children 5 years of age and older (at least 6 months after the transplant)—Dose is based on body surface area (BSA) and must be determined by the doctor. The dose is 400 mg per square meter [m(2)] 2 times a day. Dose is usually not more than 720 mg 2 times a day.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- To prevent kidney transplant rejection:
- For oral dosage forms (Myhibbin™ suspension):
- To prevent heart or liver transplant rejection:
- Adults—1.5 grams (g) 2 times a day.
- Children 3 months of age and older—Dose is based on body surface area (BSA) and must be determined by the doctor. The dose is 600 milligrams (mg) per square meter [m(2)] 2 times a day. Dose is usually not more than 900 mg/m2 (3 g or 15 mL) 2 times a day.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- To prevent kidney transplant rejection:
- Adults—1 gram (g) 2 times a day.
- Children 3 months of age and older—Dose is based on body surface area (BSA) and must be determined by the doctor. The dose is 600 milligrams (mg) per square meter [m(2)] 2 times a day.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- To prevent heart or liver transplant rejection:
Missed Dose
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.
If you miss a dose and it is less than 2 hours from your next scheduled dose, skip the missed dose and return to your regular schedule.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
The oral suspension can also be kept in the refrigerator. Throw away any unused suspension after 60 days.
Precautions
It is very important that your doctor check your or your child's 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 this medicine while you are pregnant can harm your unborn baby or cause a miscarriage during the first 3 months. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine, and 8 to 10 days after you start, to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, including a condom, diaphragm, or contraceptive foam or jelly. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not donate sperm during treatment and for at least 90 days after the last dose.
Do not donate blood during treatment and for at least 6 weeks after the last dose.
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.
Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 30 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 am. and 3 pm. 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 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.
This medicine 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 have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
This medicine may increase your risk of developing rare and serious virus infections, including shingles, herpes, cytomegalovirus (CMV) infection, polyomavirus associated nephropathy (PVAN), BK virus-associated nephropathy (BKVAN), or SARS-CoV-2 (COVID-19) infection. The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have 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.
This medicine may cause reactivation of hepatitis B or C infection. Check with your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
Check with your doctor right away if you have difficulty in moving, fever, muscle pain or stiffness, or pain, swelling, or redness in the joints. These may be symptoms of acute inflammatory (swelling) syndrome.
While you are using mycophenolate, 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.
This medicine may cause serious stomach or bowel problems (eg, ulcers, bleeding). Check with your doctor right away if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, or burning, trouble breathing, or vomiting of blood or material that looks like coffee grounds.
This medicine may inhibit the ability to drive and use machines. Avoid driving or using machines if confusion, dizziness, fainting, lightheadedness, sleepiness, or trembling or shaking of the hands or feet occur during treatment.
Do not stop taking this medicine without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take 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 or vitamin supplements.
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
- 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
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- confusion
- cough or hoarseness
- decreased urine
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty in moving
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- fainting
- fast, slow, pounding, or irregular heartbeat or pulse
- fever or chills
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- heartburn
- increased hunger
- increased thirst
- increased urination
- irregular heartbeats
- irregular pulse
- irritability
- lightheadedness
- loss of appetite
- loss of strength or energy
- lower back or side pain
- muscle cramps in the hands, arms, feet, legs, or face
- muscle pain, stiffness, cramps, or weakness
- muscle spasms (tetany) or twitching
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pain in the joints
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- rapid weight gain
- rapid, shallow breathing
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach cramps, pain, and bloating
- sweating
- swollen glands
- tingling of the hands or feet
- trembling
- tremor
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness or heaviness of the legs
Incidence not known
- Back pain
- bloating
- bloody, black, tarry stools
- constipation
- coughing or spitting up blood
- darkened urine
- general feeling of illness
- indigestion
- night sweats
- pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- severe headache
- sudden high fever or low-grade fever for months
- tenderness
- watery or bloody diarrhea
- yellow eyes or 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
- belching
- fear
- heartburn
- lack or loss of strength
- rash
- trouble sleeping
- 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.
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