Mycophenolate Mofetil

• Use 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

  [see Warnings and Precautions (5.1), Use in Special Populations (8.1, 8.3)]

  .
• Increased risk of development of lymphoma and other malignancies, particularly of the skin

  [see Warnings and Precautions (5.2)]

  .
•  
  Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes

  [see Warnings and Precautions (5.3)]

  .

Indications and Usage, Pediatric Heart or

Liver Transplants                                                                                                                                            06/2022

Dosage and Administration, Dosage Recommendations for Heart Transplant Patients (2.3)                        06/2022

Dosage and Administration, Dosage Recommendations for Liver Transplant Patients (2.4)                         06/2022

Warnings and Precautions, Serious Infections (5.3)                                                                                       10/2021

Warnings and Precautions, Acute Inflammatory Syndrome Associated with Mycophenolate Products (5.7) 10/2021

Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney

• Reduce or interrupt dosing in the event of neutropenia. (
  2.5 Dosage
  Modifications: Patients with Renal Impairment, Neutropenia

  Renal Impairment

  No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively

  [see Clinical Pharmacology (12.3)]

  . In

  kidney transplant patients with severe chronic impairment of the graft

  (GFR < 25 mL/min/1.73 m²), do not administer doses of mycophenolate mofetil tablets greater than 1 g twice a day. These patients should be carefully monitored

  [see Clinical Pharmacology (12.3)]

  .

  Neutropenia

  If neutropenia develops (ANC < 1.3 x 10³/µL), dosing with mycophenolate mofetil tablets should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately

  [see Warnings and Precautions (5.4)

  and

  Adverse Reactions (6.1)]

  .
  )
• See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia. (
  2.5 Dosage
  Modifications: Patients with Renal Impairment, Neutropenia

  Renal Impairment

  No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively

  [see Clinical Pharmacology (12.3)]

  . In

  kidney transplant patients with severe chronic impairment of the graft

  (GFR < 25 mL/min/1.73 m²), do not administer doses of mycophenolate mofetil tablets greater than 1 g twice a day. These patients should be carefully monitored

  [see Clinical Pharmacology (12.3)]

  .

  Neutropenia

  If neutropenia develops (ANC < 1.3 x 10³/µL), dosing with mycophenolate mofetil tablets should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately

  [see Warnings and Precautions (5.4)

  and

  Adverse Reactions (6.1)]

  .
  )

Mycophenolate mofetil tablets USP, 500 mg are available as peach to purple-colored, oblong, film-coated tablets debossed with “E735” on one side and plain on the other.

• Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. (
  8.3 Females and Males of Reproductive Potential

  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.

  Pregnancy Planning

  For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Risks and benefits of mycophenolate mofetil should be discussed with the patient.

  Pregnancy Testing

  To prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL immediately before starting mycophenolate mofetil tablets. 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, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.

  Contraception

  Female Patients

  Females of reproductive potential taking mycophenolate mofetil tablets must receive contraceptive counseling and use acceptable contraception (see

  Table 9

  for acceptable contraception methods). Patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence.

  Patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness

  [see Drug Interactions (7.2)]

  .

  Table 9: Acceptable Contraception Methods for Females of Reproductive Potential

  Pick from the following birth control options:
  Option 1
  Methods to Use Alone	Intrauterine devices (IUDs) Tubal sterilization Patient’s partner vasectomy
  OR
  Option 2	Hormone Methods choose 1		Barrier Methods choose 1
  Choose One Hormone Method AND One Barrier Method	Estrogen and Progesterone Oral Contraceptive Pill Transdermal patch Vaginal ring Progesterone-only Injection Implant	AND	Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge Male condom Female condom
  OR
  Option 3	Barrier Methods choose 1		Barrier Methods choose 1
  Choose One Barrier Method from each column (must choose two methods)	Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge	AND	Male condom Female condom

  Male Patients

  Genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. Thus, the risk of genotoxic effects on sperm cells cannot be excluded. Based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. Also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil tablets and for at least 90 days after cessation of treatment

  [see Use in Special Populations (8.1), Nonclinical Toxicology (13.1), Patient Counseling Information (17.9)]

  .
  )