CellCept

DRUG DESCRIPTION

CellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.

The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula:

CellCept®
  (mycophenolate mofetil ) Structural Formula Illustration

Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 ?µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group.

Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.

CellCept (mycophenolate mofetil) is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, tablets containing 500 mg of mycophenolate mofetil, and as a powder for oral suspension, which when constituted contains 200 mg/mL mycophenolate mofetil.

Inactive ingredients in CellCept (mycophenolate mofetil) 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

Inactive ingredients in CellCept (mycophenolate mofetil) 500 mg tablets include black iron oxide, croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol, n-butyl alcohol, propylene glycol, and shellac.

Inactive ingredients in CellCept (mycophenolate mofetil) Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum.

CellCept Intravenous is the hydrochloride salt of mycophenolate mofetil. The chemical name for the hydrochloride salt of mycophenolate mofetil is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96.

CellCept (mycophenolate mofetil) Intravenous is available as a sterile white to off-white lyophilized powder in vials containing mycophenolate mofetil hydrochloride for administration by intravenous infusion only. Each vial of CellCept Intravenous contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide may have been used in the manufacture of CellCept (mycophenolate mofetil) Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of mycophenolate mofetil, 6 mg/mL. (For detailed method of preparation, see DOSAGE AND ADMINISTRATION).

What are the possible side effects of mycophenolate mofetil (CellCept)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mycophenolate mofetil and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate;
  • coughing up blood or vomit that looks like coffee grounds;
  • bloody, black, or tarry...

Read All Potential Side Effects and See Pictures of CellCept »

What are the precautions when taking mycophenolate mofetil (CellCept)?

Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any type of cancer, kidney disease, liver disease, stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).

If you had a kidney transplant and the new kidney does not work properly even though you are taking this medication, the amount of mycophenolate in your body may increase, which can result in...

Read All Potential Precautions of CellCept »


CellCept Consumer (continued)

SIDE EFFECTS: See also Warnings section.

Constipation, nausea, headache, diarrhea, vomiting, stomach upset, loss of appetite, gas, tremor, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this medication weakens your immune system, you are more likely to develop infections which may be serious. Tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat/fever, night sweats, flu-like symptoms, painful urination, vision changes, a sore or wound on the skin that feels warm/tender/painful and appears reddened.

This drug increases the risk of a rare and possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, fast/irregular heartbeat, muscle weakness, easy bleeding/bruising, swelling of the feet or ankles, mental/mood changes, weakness on one side of the body, unusual change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, shortness of breath/rapid breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any type of cancer, kidney disease, liver disease, stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).

If you had a kidney transplant and the new kidney does not work properly even though you are taking this medication, the amount of mycophenolate in your body may increase, which can result in increased side effects.

Mycophenolate may cause swelling and growth of the gums (gingival hyperplasia). Brush and floss your teeth daily, and see your dentist regularly.

Because this medication may increase your risk of developing skin cancers, it is best to avoid prolonged sun exposure, tanning booths and sunlamps while you are using this medication. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Avoid contact with people who have the flu or any other infection.

Notify your doctor if you are scheduled for any kind of test or surgery involving your colon (e.g., colonoscopy, abdominal surgery) that requires cleaning out your colon before the procedure. Removing the bacteria in your digestive tract can decrease the amount of mycophenolate in your body.

Caution is advised when using this drug in the elderly because they are less able to remove this drug from their bodies, and therefore may be more sensitive to its effects.

This medication is not recommended for use during pregnancy because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Women of childbearing age should have a negative pregnancy test within 1 week of starting this medication. Also, use two reliable forms of birth control starting 4 weeks before beginning therapy, and continue for at least 6 weeks after mycophenolate is stopped. Consult your doctor for more details.

It is not known whether this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug and for 6 weeks after stopping mycophenolate. If you must take the drug while you are producing milk, but wish to resume breast-feeding six weeks after treatment is finished, pump your breast milk and discard. Consult your doctor for more details.


CellCept Patient Information Including Side Effects

Brand Names: CellCept

Generic Name: mycophenolate mofetil (Pronunciation: MYE koe FEN oh late MOE fe til)

  • What is mycophenolate mofetil (CellCept)?
  • What are the possible side effects of mycophenolate mofetil (CellCept)?
  • What is the most important information I should know about mycophenolate mofetil (CellCept)?
  • What should I discuss with my healthcare provider before using mycophenolate mofetil (CellCept)?
  • How should I use mycophenolate mofetil (CellCept)?
  • What happens if I miss a dose (CellCept)?
  • What happens if I overdose (CellCept)?
  • What should I avoid while using mycophenolate mofetil (CellCept)?
  • What other drugs will affect mycophenolate mofetil (CellCept)?
  • Where can I get more information?

What is mycophenolate mofetil (CellCept)?

Mycophenolate mofetil lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Mycophenolate mofetil is used to prevent your body from rejecting a kidney, liver, or heart transplant. This medication is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.

Mycophenolate mofetil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mycophenolate mofetil (CellCept)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mycophenolate mofetil and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate;
  • coughing up blood or vomit that looks like coffee grounds;
  • bloody, black, or tarry stools;
  • painful or difficult urination;
  • chest pain;
  • feeling like you might pass out;
  • problems with vision, speech, balance, or memory; or
  • weakness in your legs, lack of coordination.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, diarrhea, or constipation;
  • headache, mild weakness;
  • swelling in your hands or feet;
  • numbness or tingly feeling; or
  • anxiety, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mycophenolate mofetil (CellCept)?

This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use mycophenolate mofetil without telling your doctor if you are pregnant or if you plan to become pregnant during treatment.

If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy before and during your treatment with mycophenolate mofetil, and for at least 6 weeks after your treatment ends. You will also need to have a negative pregnancy test within 1 week before you start using this medication.

Tell your doctor right away if you become pregnant while using mycophenolate mofetil.

Although mycophenolate mofetil can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Mycophenolate mofetil is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.

Using mycophenolate mofetil can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of cancer. Your blood will need to be tested on a weekly or monthly basis while using this medication. Do not miss any scheduled appointments.

Do not open the mycophenolate mofetil capsule or crush or chew a tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin.

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