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U.S. Department of Health and Human Services

Safety

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Myfortic (mycophenolic acid) delayed-release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

September 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.5 Serious Infections
  • Patients receiving immunosuppressants, including Myfortic, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections [see Warnings and Precautions (5.6)]. These infections may lead to serious, including fatal outcomes. Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution.
5.6 New or Reactivated Viral Infections
  • Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives Myfortic and MMF. Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft.
  • The risk of CMV viremia and CMV disease is highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor. Therapeutic approaches to limiting CMV disease exist and should be routinely provided. Patient monitoring may help detect patients at risk for CMV disease.
  • Viral reactivation has been reported in patients infected with HBV or HCV. Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended.

 

 

September 2012

Summary View

MEDICATION GUIDE (NEW)

 

June 2012

Summary View

 

BOXED WARNING

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
  • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
 

WARNINGS

Embryofetal Toxicity
  • Myfortic can cause fetal harm when administered to a pregnant female. Use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.
Pregnancy Exposure Prevention and Planning
  • Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. For recommended pregnancy testing and contraception methods
 
PRECAUTIONS
Pregnancy Exposure Prevention and Planning
  • Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
  • Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause. Menopause is the permanent end of menstruation and fertility. Menopause should be clinically confirmed by a patient’s healthcare practitioner. Some commonly used diagnostic criteria include 1) 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or 2) postsurgical from a bilateral oophorectomy.
Pregnancy Testing
  • To prevent unplanned exposure during pregnancy, females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL immediately before starting Myfortic. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient. In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations.
Contraception
  • Females of reproductive potential taking Myfortic must receive contraceptive counseling and use acceptable contraception (see Table 4 for acceptable contraception methods). Patients must use acceptable birth control during entire Myfortic therapy, and for 6 weeks after stopping Myfortic, unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely).
  • Patients should be aware that Myfortic reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
  • Table 4 (new table)...
Pregnancy Planning
  • For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of Myfortic should be discussed with the patient.
Information for Patients
  • Inform females of reproductive potential that use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, and advise them as to the appropriate steps to manage these risks, including that they must use acceptable contraception.
  • Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential. In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations.
  • Females of reproductive potential must use acceptable birth control during entire Myfortic therapy and for 6 weeks after stopping Myfortic, unless the patient chooses to avoid heterosexual intercourse completely (abstinence).
  • For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of Myfortic should be discussed with the patient.
Oral Contraceptives
  • Although Myfortic may not have any influence on the ovulation-suppressing action of oral contraceptives it is recommended to coadminister Myfortic with hormonal contraceptives, (e.g. birth control pill, transdermal patch, vaginal ring, injection, and implant) with caution and additional barrier contraceptive methods must be used.
Pregnancy
  • Following oral or IV administration, MMF is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic and the active form of the drug. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. In animal studies, congenital malformations and pregnancy loss occurred when pregnant rats and rabbits received mycophenolic acid at dose multiples similar to and less than clinical doses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
  • Risks and benefits of Myfortic should be discussed with the patient. When appropriate, consider alternative immunosuppressants with less potential for embryofetal toxicity. In certain situations, the patient and her healthcare practitioner may decide that the maternal benefits outweigh the risks to the fetus. For those females using Myfortic at any time during…
Postmarketing Experience
Congenital disorder: Embryofetal toxicity:
  • Congenital malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate mofetil (MMF) during pregnancy.
 

MEDICATION GUIDE

  • You should have one pregnancy test immediately before starting Myfortic and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.
  • You must use acceptable birth control during your entire Myfortic therapy and for 6 weeks after stopping Myfortic, unless at anytime you choose to avoid sexual intercourse (abstinence) with a man completely. Myfortic decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take Myfortic and you could become pregnant. If you decide to take birth control pills while using Myfortic you must also use another form of birth control. Talk to your doctor about other birth control methods that can be used while taking Myfortic.
  • If you plan to become pregnant, talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you.
  • If you become pregnant while taking Myfortic do not stop taking Myfortic. Call your doctor right away. In certain situations, you and your doctor may decide that taking Myfortic is more important to your health than the possible risks to your unborn baby.
  • You and your doctor should report your pregnancy to...
 

 

October 2009 

Summary View

 

WARNINGS

Progressive Multifocal Leukoencephalopathy/Latent Viral Infections
  • Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) which have been observed in patients receiving immunosuppressants, including Myfortic. 
  • BKVAN is associated with serious outcomes, including deteriorating renal function and renal
    graft loss. Patient monitoring may help detect patients at risk for BK virus-associated nephropathy. Reduction in immunosuppression should be considered for patients who develop evidence of BK virus associated nephropathy.

ADVERSE REACTIONS

Postmarketing Experience
  • BK virus-associated nephropathy has been observed in patients receiving immunosuppressants, including Myfortic. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss

MEDICATION GUIDE

"What is the most important information I should know about Myfortic?”
  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak

Viral infections that can happen with Myfortic include:

    • shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.
    • BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.