Mycophenolate mofetil (Oral)

Mycophenolate belongs to a group of medicines called immunosuppressive agents. It is used along with other medicines (for example, cyclosporine, steroid medicine) to reduce the body's natural immunity in patients who have organ transplants (such as kidney, heart, or liver).

When a patient has an organ transplant, the body's white blood cells may try to reject the transplanted organ. Mycophenolate stops the white blood cells from rejecting the transplanted organ.

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

It is very important for your doctor to monitor your progress at regular visits. Your doctor will perform blood tests to ensure that mycophenolate is working correctly and to check for any 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 become pregnant, your doctor may give you a pregnancy test before you start using this medicine to confirm that you are not pregnant. Your birth control pills may not work as effectively while you are taking 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 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 during treatment and for at least 90 days after the last dose. If you suspect that you have become 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 getting skin cancer or cancer of the lymph system (lymphoma). Discuss any concerns about this risk with your doctor.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 30 regularly when you are outdoors. Wear protective clothing and hats, and avoid direct sunlight, especially between 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 possible, avoid close contact with people who have infections. Contact your doctor immediately if you believe 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.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body stops producing red blood cells, leading to severe anemia. Contact your doctor immediately 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). Contact your doctor immediately if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding others, and weakness in the legs.

This medicine may increase your risk of developing rare and serious viral 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 impact how your kidneys function and could cause a transplanted kidney to fail. Contact your doctor immediately if you notice 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. Contact your doctor immediately if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, upper stomach pain, or yellowing of the skin or eyes.

Contact your doctor right away if you experience difficulty moving, fever, muscle pain or stiffness, or pain, swelling, or redness in the joints. These may be symptoms of acute inflammatory (swelling) syndrome.

While using mycophenolate, and after you stop, do not receive any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's ability to fight infections, and there is a risk you might contract the infection that the immunization is intended to prevent.

This medicine may cause serious stomach or bowel issues (e.g., ulcers, bleeding). Contact your doctor immediately if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, or burning, difficulty breathing, or vomiting blood or material that looks like coffee grounds.

This medicine may impair your ability to drive and operate machinery. Avoid driving or using machines if you experience confusion, dizziness, fainting, lightheadedness, sleepiness, or trembling or shaking of the hands or feet during treatment.

Do not stop taking this medicine without first consulting your doctor. Stopping it 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, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any others. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any pediatric-specific issues that would limit the use of mycophenolate capsules, suspension, or tablets in children receiving kidney transplants. However, safety and effectiveness have not been established in infants younger than 3 months.

Studies have not been conducted on how age affects the use of mycophenolate capsules, suspension, or tablets in children receiving heart or liver transplants. Safety and effectiveness have not been established.

Studies have not shown any pediatric-specific issues that would limit the use of mycophenolate delayed-release tablets in children receiving kidney transplants. However, safety and effectiveness have not been established in children younger than 5 years.

Geriatric

Studies have not shown any geriatric-specific issues that would limit the use of mycophenolate in older adults. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and dose adjustments for those using mycophenolate.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should be prescribed an alternative to this medication or stop breastfeeding while taking this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if interactions might occur. In these cases, your doctor may need to adjust doses or take other precautions. It's important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may change the dose or frequency of one or both 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 may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Iron
• Lanthanum Carbonate
• Sevelamer

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

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

• Active infection (e.g., bacteria, fungus, or virus)—May reduce 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.

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

• Phenylketonuria (PKU)—The oral suspension contains aspartame (phenylalanine), which may worsen this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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
• 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 happen 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.

In the U.S.

• Cellcept

Available Dosage Forms:

• Capsule
• Powder for Suspension
• Tablet

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 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 (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.
• For oral dosage forms (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.

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.