Mycophenolate (Oral)

Mycophenolate is part of a group of medicines called immunosuppressive agents. It is used together with other medicines (like cyclosporine or steroid medicine) to reduce the body's natural immunity in patients who have kidney transplants.

When a patient gets an organ transplant, the body's white blood cells may attack the transplanted organ and try to reject it. Mycophenolate helps stop the white blood cells from rejecting the transplanted organ.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to monitor your progress closely during regular visits to see if the medicine is working properly and to adjust the dose if needed. You may need blood tests to check for any unwanted effects.

Using this medicine while pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may perform a pregnancy test before you start this medicine and again 8 to 10 days after starting it to ensure you are not pregnant. Your birth control pills may not be as effective while using this medicine. You must use two forms of birth control together for the entire time you are being treated and for 6 weeks after your last dose of this medicine. Use birth control pills along with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. Male patients with female partners should use an effective form of birth control and avoid donating sperm during treatment and for at least 90 days after the last dose. If you think you might be pregnant while using this medicine, inform your doctor immediately.

Do not donate sperm during treatment and for at least 90 days after the last dose.

Using this medicine may increase your risk of developing skin cancer or lymphoma (cancer of the lymph system). 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 regularly when you are outside. Wear protective clothing and hats and avoid direct sunlight, especially between 10 a.m. and 3 p.m. Stay away from sunlamps and tanning beds.

Mycophenolate can temporarily reduce the number of white blood cells in your blood, increasing your risk of getting an infection. If possible, avoid contact with people who have infections. Contact your doctor immediately if you think you are developing an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risk of a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Contact your doctor right away if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding others, or weakness in your legs.

This medicine may raise your risk of developing rare and serious viral infections, such as shingles, herpes, cytomegalovirus (CMV) infection, BK virus-associated nephropathy (BKVAN), polyoma virus-associated nephropathy (PVAN), or SARS-CoV-2 (COVID-19) infection. CMV can lead to serious tissue and blood infections. The BK virus may affect your kidney function and cause a transplanted kidney to fail. Contact your doctor right away if you notice bloody urine, a decrease in urine frequency or amount, fever, increased thirst, loss of appetite, lower back or side pain, nausea, painful cold sores or blisters, sore throat, swelling of your face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may reactivate hepatitis B or C infections. Contact your doctor immediately if you have dark-colored urine, pale stools, nausea, vomiting, loss of appetite, upper stomach pain, or yellowing of your skin or eyes.

Mycophenolate may cause pure red cell aplasia (PRCA), a very rare condition where the body stops making red blood cells, leading to severe anemia. Contact your doctor right away if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

Contact your doctor immediately if you have bloody or black, tarry stools, vomiting blood or material that looks like coffee grounds, severe stomach pain, or constipation. These could be signs of a serious stomach or bowel issue (e.g., ulcers, bleeding).

Contact your doctor right away if you have difficulty moving, fever, muscle pain or stiffness, or pain, swelling, or redness in your joints. These may indicate acute inflammatory (swelling) syndrome.

While you are using this medicine and after you stop, do not get any immunizations (vaccinations) without your doctor's approval. Mycophenolate lowers your body's resistance, and you may get the infection that the immunization is meant to prevent.

Do not donate blood during treatment and for at least 6 weeks after your last dose.

Do not stop taking this medicine without first consulting your doctor. Stopping suddenly may lead to rejection of your transplanted organ. Your doctor will determine how long you should take this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it is important to consider the risks of taking it against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your health care provider if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems that would limit the usefulness of mycophenolate in children 5 years of age and older who had a kidney transplant at least 6 months ago. However, safety and effectiveness have not been established in children younger than 5 years of age.

Geriatric

Studies conducted so far have not shown any specific problems that would limit the usefulness of mycophenolate in older adults. However, older patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and a dose adjustment for patients taking mycophenolate.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could occur. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are selected based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• 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
• Cholestyramine
• Ciprofloxacin
• Clavulanic Acid
• Colesevelam
• Colestipol
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Desogestrel
• Dexlansoprazole
• Dienogest
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Drospirenone
• Esomeprazole
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Influenza Virus Vaccine, Live
• Isavuconazonium Sulfate
• Lansoprazole
• Levonorgestrel
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Measles Virus Vaccine, Live
• Medroxyprogesterone
• Mercaptopurine
• Mestranol
• Metronidazole
• Mumps Virus Vaccine, Live
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Omeprazole
• Pantoprazole
• Poliovirus Vaccine, Live
• Rabeprazole
• Rifampin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Segesterone
• Smallpox Vaccine
• Tacrolimus
• Telmisartan
• Typhoid Vaccine, Live
• Ulipristal
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may increase the 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 take one or both of the medicines.

• Iron
• Lanthanum Carbonate
• Sevelamer

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare provider the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Bone marrow problems (e.g., neutropenia) or
• Hepatitis B or C infection, history of or
• Stomach or bowel problems—Use with caution. May worsen these conditions.

• Infection—May reduce 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.

• Severe kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from your body.

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
• blurred vision
• body aches or pain
• bone pain
• burning or stinging of the skin
• chest pain or tightness
• cloudy urine
• confusion
• constipation
• 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, twitching, or 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
• seizures
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain or cramps
• sunken eyes
• sweating
• swelling
• swollen glands
• thirst
• tremor
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

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
• 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 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

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.

In the U.S.

• Cellcept
• Myfortic

Available Dosage Forms:

• Capsule
• Powder for Suspension
• Tablet
• Tablet, Enteric Coated

Therapeutic Class: Immune Suppressant

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. 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.

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

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. If you have questions, talk with your doctor about the best times to use your medicines.

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

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 form (delayed-release tablets):For kidney transplants: Adults—720 milligrams (mg) 2 times a day. 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 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.

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.