Myfortic

• Use during pregnancy is associated with increased risks of 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 Specific Populations (8.1, 8.3)]
  .
• 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 (5.2)]
  .
• Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression
   
  [see Warnings and Precautions (5.3)]
  .
• Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections
   
  [see Warnings and Precautions (5.4, 5.5)]
  .

• Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (
  1.1     Prophylaxis of Organ Rejection in Kidney Transplant

  Myfortic^®(mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

  Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

  Myfortic is to be used in combination with cyclosporine and corticosteroids.
  )
• Use in combination with cyclosporine and corticosteroids. (
  1.1     Prophylaxis of Organ Rejection in Kidney Transplant

  Myfortic^®(mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

  Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

  Myfortic is to be used in combination with cyclosporine and corticosteroids.
  )

• Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (
  1.2     Limitations of Use

  Myfortic delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
  )
  

• In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. (
  2.1     Dosage in Adult Kidney Transplant Patients

  The recommended dose of Myfortic is 720 mg administered twice daily (1,440 mg total daily dose).
  )
• In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m² by mouth, twice daily (up to a maximum of 720 mg twice daily). (
  2.2     Dosage in Pediatric Kidney Transplant Patients

  The recommended dose of Myfortic in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m²body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily).
  )
• Do not crush, chew, or cut tablet prior to ingestion. (
  2.3     Administration

  Myfortic tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake

  [see Clinical Pharmacology (12.3)]

  .

  Myfortic tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

  Pediatric patients with a BSA of 1.19 m²to 1.58 m²may be dosed either with three Myfortic 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1,080 mg daily dose). Patients with a BSA of > 1.58 m²may be dosed either with four Myfortic 180 mg tablets, or two Myfortic 360 mg tablets twice daily (1,440 mg daily dose). Pediatric doses for patients with BSA < 1.19 m²cannot be accurately administered using currently available formulations of Myfortic tablets.
  )

Myfortic is available as 180 mg and 360 mg tablets.

• 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 female patients taking Myfortic who are considering pregnancy, consider alternative immunosuppressants with less potential for embryo-fetal toxicity. Risks and benefits of Myfortic should be discussed with the patient.

  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, consider alternative immunosuppressants with less potential for embryo-fetal toxicity whenever possible.

  Contraception

  Female Patients

  Females of reproductive potential taking Myfortic must receive contraceptive counseling and use acceptable contraception (see Table 5 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

  [see Patient Counseling Information (17), Drug Interactions (7.8)]

  .

  Table 5: 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 had a 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 2.5 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 Myfortic and for at least 90 days after cessation of treatment

  [see Use in Specific Populations (8.1), Nonclinical Toxicology (13.1), Patient Counseling Information (17)]

  .
  )