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Myfortic

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Myfortic

MYFORTIC®
(mycophenolic acid) Delayed-release Tablets

Myfortic

WARNING

EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS

  • Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
  • Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see WARNINGS AND PRECAUTIONS].
  • Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see WARNINGS AND PRECAUTIONS].
  • Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. Patients receiving Myfortic 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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4enoic 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, 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 0.1N hydrochloric acid.

Myfortic 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 (K30), 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.

Serious and sometimes fatal infections may occur during treatment with mycophenolic acid. Call your doctor right away if you have signs of infection such as:

  • fever, flu symptoms, runny or stuffy nose, cough, sore throat, swollen glands;
  • stomach pain, vomiting, diarrhea, weight loss;
  • ear pain, headache;
  • white patches or sores in your mouth or throat;
  • pale skin, easy...

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 »

Last reviewed on RxList: 10/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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Myfortic - User Reviews

Myfortic User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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