Pronunciation:

mye-koe-fe-NOLE-ik AS-id

Brand Names:

• Cellcept
• Myfortic

Dosage Forms:

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

Warnings:

Embryofetal Toxicity, Malignancies and Serious InfectionsUse during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning.Increased risk of development of lymphoma and other malignancies, particularly of the skin.Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes .

Embryo-Fetal Toxicity, Malignancies, and Serious InfectionsUse during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning.Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolate sodium. Patients receiving mycophenolate sodium should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression.Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections .

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

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 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.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-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 before. However, safety and efficacy have not been established in children younger than 5 years of age.

Older adults—

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.

Breast-feeding—

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.

Other 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 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.

• 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 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
• Lanthanum Carbonate
• Sevelamer

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, history of or
• Stomach or bowel problems—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 This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using this medicine 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 this medicine and 8 to 10 days after using this medicine 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 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, 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 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.

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 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.

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, 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 cause serious tissue and blood infections. 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, fever, increased thirst, loss of appetite, lower back or side pain, nausea, painful cold sores or blisters, sore throat, 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, yellow skin or eyes.

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.

Check with your doctor right away if you have bloody or black, tarry stools, vomiting of blood or material that looks like coffee grounds, severe stomach pain, constipation. These could be symptoms of a serious stomach or bowel problem (eg, ulcers, bleeding).

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 this medicine, 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 donate blood during treatment and for at least 6 weeks after the last dose.

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 of This Medicine:

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.