Myfortic

DRUG DESCRIPTION

Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic (mycophenolic acid) is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.

Its empirical formula is C17H19O6Na. The molecular weight is 342.32 and the structural formula is

Myfortic® (mycophenolic acid) Structural Formula Illustration

Myfortic (mycophenolic acid) , as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1 N hydrochloric acid.

Myfortic (mycophenolic acid) is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K-30), and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, iron oxide yellow, and indigotine (180 mg) or iron oxide red (360 mg).

What are the possible side effects of mycophenolic acid (Myfortic)?

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.

Call your doctor at once if you have any a serious side effect such as:

  • fever, chills, body aches, flu symptoms, mouth sores, white patches in your mouth or throat;
  • pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate;
  • coughing up blood or vomit that looks like coffee grounds;
  • bloody,...

Read All Potential Side Effects and See Pictures of Myfortic »

What are the precautions when taking mycophenolic acid (Myfortic)?

Before taking mycophenolate sodium, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate mofetil; 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, liver disease, stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).

If your transplanted 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...

Read All Potential Precautions of Myfortic »


Myfortic Consumer (continued)

SIDE EFFECTS: See also Warnings section.

Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, 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 sodium, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid, or mycophenolate mofetil; 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, liver disease, stomach/intestinal problems (e.g., ulcers), rare genetic disorders (e.g., Lesch-Nyhan or Kelley-Seegmiller syndromes).

If your transplanted 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 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.


Myfortic Patient Information Including Side Effects

Brand Names: Myfortic

Generic Name: mycophenolic acid (Pronunciation: MYE koe phe NOLE ik AS id)

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

What is mycophenolic acid (Myfortic)?

Mycophenolic acid 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.

Mycophenolic acid is used to prevent your body from rejecting a kidney transplant. This medication is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.

Mycophenolic acid may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mycophenolic acid (Myfortic)?

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.

Call your doctor at once if you have any a serious side effect such as:

  • fever, chills, body aches, flu symptoms, mouth sores, white patches in your mouth or throat;
  • 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;
  • thirst, increased urination, hot and dry skin;
  • chest pain;
  • feeling like you might pass out;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • 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, constipation, upset stomach;
  • headache, dizziness, blurred vision;
  • swelling in your hands or feet;
  • joint or muscle pain, back pain;
  • runny or stuffy nose, cough;
  • anxiety, sleep problems (insomnia); or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mycophenolic acid (Myfortic)?

This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy. Do not use mycophenolic acid 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 mycophenolic acid, 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 mycophenolic acid.

Although mycophenolic acid can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Mycophenolic acid 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 mycophenolic acid 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 certain forms 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 crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.

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