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Check Drug InteractionsMycophenolate Mofetil Prescribing Information
• 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
• Increased risk of development of lymphoma and other malignancies, particularly of the skin
• 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
,
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit
Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems
Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman.
The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.
Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure.
In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.,
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.
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. 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.
Females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see
Patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness
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 and for at least 90 days after cessation of treatment)].
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, kidney and nervous system. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available
[see Use in Specific Populations (8.1, 8.3)].
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit
www.mycophenolateREMS.com
or call 1-800-617-8191.Risk Summary
Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems
[see Human Data]
. Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients)[see Animal Data]
.Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman.
The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Human Data
A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.
Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure.
Animal Data
In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.
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. 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 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 |
|
OR
Option 2 | Hormone Methods choose 1 | Barrie r Methods choose 1 | |
Choose One Hormone Metho d AND On e Barrier Method | Estrogen and Progesterone
Progesteron e - only
| AND |
|
OR
Option 3 | Barrie r Methods choose 1 | Barrie r Methods choose 1 | |
Choose One Barrier Method from each column (mus t choose two methods) |
| AND |
|
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 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)].
• Increased risk of development of lymphoma and other malignancies, particularly of the skin
[see
Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving mycophenolate mofetil (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients].
Patients receiving immunosuppressants, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin
[see Adverse Reactions (6.1)]
. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. For patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving mycophenolate mofetil (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients
[see Adverse Reactions (6.1)].
The majority of PTLD cases appear to be related to Epstein Barr Virus (EBV) infection. The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children. In pediatric patients, no other malignancies besides PTLD were observed in clinical trials[see Adverse Reactions (6.1)].
• 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
Serious viral infections reported include:
• Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection
• JC virus-associated progressive multifocal leukoencephalopathy (PML), and
• Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.
• Viral reactivation in patients infected with Hepatitis B and C
• COVID-19
Consider dose reduction or discontinuation of mycophenolate mofetil in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.
PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss
PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia
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.].
Patients receiving immunosuppressants, including mycophenolate mofetil, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. The risk increases with the total immunosuppressive load. These infections may lead to serious outcomes, including hospitalizations and death
[see Adverse Reactions (6.1, 6.2)].
Serious viral infections reported include:
• Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection
• JC virus-associated progressive multifocal leukoencephalopathy (PML), and
• Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.
• Viral reactivation in patients infected with Hepatitis B and C
• COVID-19
Consider dose reduction or discontinuation of mycophenolate mofetil in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.
PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss
[see Adverse Reactions (6.2)]
. Patient monitoring may help detect patients at risk for PVAN.PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia
[see Adverse Reactions (6.2)].
In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms.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.
Warnings and Precautions (5.8) 05/2025
Mycophenolate mofetil capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
[see
The three
In all three
Mycophenolate mofetil, in combination with corticosteroids and cyclosporine, reduced (statistically significant at 0.05 level) the incidence of treatment failure within the first 6 months following transplantation (
One open-label, safety and pharmacokinetic study of mycophenolate mofetil oral suspension 600 mg/m2twice daily (up to 1 g twice daily) in combination with cyclosporine and corticosteroids was performed at centers in the United States (9), Europe (5) and Australia (1) in 100 pediatric patients (3 months to 18 years of age) for the prevention of renal allograft rejection. Mycophenolate mofetil was well tolerated in pediatric patients],
heartAdults
The three
de novo
kidney transplantation studies compared two dose levels of oral mycophenolate mofetil (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) to prevent acute rejection episodes. One of the two studies with azathioprine (AZA) control arm also included anti-thymocyte globulin (ATGAM®) induction therapy. The geographic location of the investigational sites of these studies are included inTable 13
.In all three
de novo
kidney transplantation studies, the primary efficacy endpoint was the proportion of patients in each treatment group who experienced treatment failure within the first 6 months after transplantation. Treatment failure was defined as biopsy-proven acute rejection on treatment or the occurrence of death, graft loss or early termination from the study for any reason without prior biopsy-proven rejection.Mycophenolate mofetil, in combination with corticosteroids and cyclosporine, reduced (statistically significant at 0.05 level) the incidence of treatment failure within the first 6 months following transplantation (
Table 13
). Patients who prematurely discontinued treatment were followed for the occurrence of death or graft loss, and the cumulative incidence of graft loss and patient death combined are summarized inTable 14
. Patients who prematurely discontinued treatment were not followed for the occurrence of acute rejection after termination.Table 13 Treatment Failure in De Novo Kidney Transplantation Studies
USA Study (N=49 9 patients) | Mycophenolate mofetil 2 g/day (n=167 patients) | Mycophenolate mofetil 3 g/day (n=166 patients) | AZA 1 to 2 mg/kg/day (n=166 patients) |
| All 3 groups received anti-thymocyte globulin induction, cyclosporine and corticosteroids | |||
| All treatment failures | 31.1% | 31.3% | 47.6% |
| Early termination without prior acute rejection | 9.6% | 12.7% | 6.0% |
| Biopsy-proven rejection episode on treatment | 19.8% | 17.5% | 38.0% |
Europe/Canada/ Australia Study (N=503 patients) | Mycophenolate mofetil 2 g/day (n=173 patients) | Mycophenolate mofetil 3 g/day (n=164 patients) | AZA 100 to 150 mg/day (n=166 patients) |
| No induction treatment administered; all 3 groups received cyclosporine and corticosteroids. | |||
| All treatment failures | 38.2% | 34.8% | 50.0% |
| Early termination without prior acute rejection | 13.9% | 15.2% | 10.2% |
| Biopsy-proven rejection episode on treatment | 19.7% | 15.9% | 35.5% |
Europe Study (N=491 patients) | Mycophenolate mofetil 2 g/day (n=165 patients) | Mycophenolate mofetil 3 g/day (n=160 patients) | Placebo (n=166 patients) |
| No induction treatment administered; all 3 groups received cyclosporine and corticosteroids. | |||
| All treatment failures | 30.3% | 38.8% | 56.0% |
| Early termination without prior acute rejection | 11.5% | 22.5% | 7.2% |
| Biopsy-proven rejection episode on treatment | 17.0% | 13.8% | 46.4% |
*Does not include death and graft loss as reason for early termination.
No advantage of mycophenolate mofetil at 12 months with respect to graft loss or patient death (combined) was established (
Table 14
). Numerically, patients receiving mycophenolate mofetil 2 g/day and 3 g/day experienced a better outcome than controls in all three studies; patients receiving mycophenolate mofetil 2 g/day experienced a better outcome than mycophenolate mofetil 3 g/day in two of the three studies. Patients in all treatment groups who terminated treatment early were found to have a poor outcome with respect to graft loss or patient death at 1 year.Table 14 De Novo Kidney Transplantation Studies Cumulative Incidence of Combined Graft Loss or Patient Death at 12 Months
Study | Mycophenolate mofetil 2 g/day | Mycophenolate mofetil 3 g/day | Control (A Z A or Placebo) |
| USA | 8.5% | 11.5% | 12.2% |
| Europe/Canada/Australia | 11.7% | 11.0% | 13.6% |
| Europe | 8.5% | 10.0% | 11.5% |
Pediatrics- De Novo Kidney transplantation PK Study with Long Term Follow-Up
One open-label, safety and pharmacokinetic study of mycophenolate mofetil oral suspension 600 mg/m2twice daily (up to 1 g twice daily) in combination with cyclosporine and corticosteroids was performed at centers in the United States (9), Europe (5) and Australia (1) in 100 pediatric patients (3 months to 18 years of age) for the prevention of renal allograft rejection. Mycophenolate mofetil was well tolerated in pediatric patients
[see Adverse Reactions (6.1)],
and the pharmacokinetics profile was similar to that seen in adult patients dosed with 1 g twice daily mycophenolate mofetil capsules[see Clinical Pharmacology (12.3)].
The rate of biopsy-proven rejection was similar across the age groups (3 months to <6 years, 6 years to <12 years, 12 years to 18 years). The overall biopsy-proven rejection rate at 6 months was comparable to adults. The combined incidence of graft loss (5%) and patient death (2%) at 12 months post-transplant was similar to that observed in adult kidney transplant patients.[see
The analyses of the endpoints showed:
• Rejection: No difference was established between mycophenolate mofetil and AZA with respect to biopsy-proven rejection with hemodynamic compromise.
• Survival: mycophenolate mofetil was shown to be at least as effective as AZA in preventing death or re-transplantation at 1 year (see
]
or liver transplantsA double-blind, randomized, comparative, parallel-group, multicenter study in primary
de novo
heart transplant recipients was performed at centers in the United States (20), in Canada (1), in Europe (5) and in Australia (2). The total number of patients enrolled (ITT population) was 650; 72 never received study drug and 578 received study drug (Safety Population). Patients received mycophenolate mofetil 1.5 g twice daily (n=289) or AZA 1.5 to 3 mg/kg/day (n=289), in combination with cyclosporine (Sandimmune®or Neoral®) and corticosteroids as maintenance immunosuppressive therapy. The two primary efficacy endpoints were: (1) the proportion of patients who, after transplantation, had at least one endomyocardial biopsy-proven rejection with hemodynamic compromise, or were re-transplanted or died, within the first 6 months, and (2) the proportion of patients who died or were re-transplanted during the first 12 months following transplantation. Patients who prematurely discontinued treatment were followed for the occurrence of allograft rejection for up to 6 months and for the occurrence of death for 1 year.The analyses of the endpoints showed:
• Rejection: No difference was established between mycophenolate mofetil and AZA with respect to biopsy-proven rejection with hemodynamic compromise.
• Survival: mycophenolate mofetil was shown to be at least as effective as AZA in preventing death or re-transplantation at 1 year (see
Table 15
).Table 15 De Novo Heart Transplantation Study Rejection at 6 Months/Death or Re-transplantation at 1 Year
Al l Patients (ITT) | Treate d Patients | |||
AZA N = 323 | Mycophenolate mofetil N = 327 | AZA N = 289 | Mycophenolate mofetil N = 289 | |
| Biopsy-proven rejection with hemodynamic compromise at 6 monthsa | 121 (38%) | 120 (37%) | 100 (35%) | 92 (32%) |
| Death or re-transplantation at 1 year | 49 (15.2%) | 42 (12.8%) | 33 (11.4%) | 18 (6.2%) |
aHemodynamic compromise occurred if any of the following criteria were met: pulmonary capillary wedge pressure ≥20 mm or a 25% increase; cardiac index <2.0 L/min/m2or a 25% decrease; ejection fraction ≤30%; pulmonary artery oxygen saturation ≤60% or a 25% decrease; presence of new S3gallop; fractional shortening was ≤20% or a 25% decrease; inotropic support required to manage the clinical condition.
[see
],
in combination with other immunosuppressants.A double-blind, randomized, comparative, parallel-group, multicenter study in primary hepatic transplant recipients was performed at centers in the United States (16), in Canada (2), in Europe (4) and in Australia (1). The total number of patients enrolled was 565. Per protocol, patients received mycophenolate mofetil 1 g twice daily intravenously for up to 14 days followed by mycophenolate mofetil 1.5 g twice daily orally or AZA 1 to 2 mg/kg/day intravenously followed by AZA 1 to 2 mg/kg/day orally, in combination with cyclosporine (Neoral®) and corticosteroids as maintenance immunosuppressive therapy. The actual median oral dose of AZA on study was 1.5 mg/kg/day (range of 0.3 to 3.8 mg/kg/day) initially and 1.26 mg/kg/day (range of 0.3 to 3.8 mg/kg/day) at 12 months. The two primary endpoints were: (1) the proportion of patients who experienced, in the first 6 months post-transplantation, one or more episodes of biopsy-proven and treated rejection or death or re-transplantation, and (2) the proportion of patients who experienced graft loss (death or re-transplantation) during the first 12 months post-transplantation. Patients who prematurely discontinued treatment were followed for the occurrence of allograft rejection and for the occurrence of graft loss (death or re-transplantation) for 1 year.
In combination with corticosteroids and cyclosporine, mycophenolate mofetil demonstrated a lower rate of acute rejection at 6 months and a similar rate of death or re-transplantation at 1 year compared to AZA (
Table 16
).Table 16 De Novo Liver Transplantation Study Rejection at 6 Months/Death or Retransplantation at 1 Year
AZA N = 287 | Mycophenolate mofetil N = 278 | |
| Biopsy-proven, treated rejection at 6 months (includes death or re- transplantation) | 137 (47.7%) | 107 (38.5%) |
| Death or re-transplantation at 1 year | 42 (14.6%) | 41 (14.7%) |
ADULTS | DOSAGE | ||||||
Kidne y Transplant | 1 g twice daily orally (Adults The recommended dosage for adult kidney transplant patients is 1 g orally, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) Pediatric dosing is based on body surface area (BSA). Pediatric patients with BSA ≥ 1.25 m2may be dosed with capsules as follows: Table 1 Pediatric Kidney Transplant: Dosage Using Capsules
| ||||||
Heart Transplant | 1.5 g twice daily orally (Adults The recommended dosage of mycophenolate mofetil capsules for adult heart transplant patients is 1.5 g orally administered twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA ≥1.25 m2may be started on therapy with capsules as follows: Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules
*Maximum maintenance dose: 3 g total daily. | ||||||
L i ve r Transplant | 1.5 g twice daily orally (Adults The recommended dosage of mycophenolate mofetil capsules for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA ≥1.25 m2may be started on therapy with capsules as follows: Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules
*Maximum maintenance dose: 3 g total daily. | ||||||
PEDIATRICS | | ||||||
Kidne y Transplant | 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( Adults The recommended dosage for adult kidney transplant patients is 1 g orally, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) Pediatric dosing is based on body surface area (BSA). Pediatric patients with BSA ≥ 1.25 m2may be dosed with capsules as follows: Table 1 Pediatric Kidney Transplant: Dosage Using Capsules
| ||||||
Heart Transplant | 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) ( Adults The recommended dosage of mycophenolate mofetil capsules for adult heart transplant patients is 1.5 g orally administered twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA ≥1.25 m2may be started on therapy with capsules as follows: Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules
*Maximum maintenance dose: 3 g total daily. | ||||||
Liver Transplant | 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2twice daily (3 g) ( Adults The recommended dosage of mycophenolate mofetil capsules for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g). Pediatrics (3 months and older) Pediatric patients with BSA ≥1.25 m2may be started on therapy with capsules as follows: Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules
*Maximum maintenance dose: 3 g total daily. |
• Mycophenolate mofetil Intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. (
Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.
Mycophenolate Mofetil Capsules
Mycophenolate mofetil capsules
should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy
because the rates of absorption following the administration of mycophenolate mofetil capsule and mycophenolic acid delayed-release tablets are not equivalent.Mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in Mycophenolate mofetil capsules. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water.
The initial oral dose of mycophenolate mofetil capsules should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil capsules be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil capsules may be administered with food if necessary
[see Clinical Pharmacology (12.3)].
Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil capsules at the usual times.
• Reduce or interrupt dosing in the event of neutropenia. (
Renal Impairment
No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively
[see Clinical Pharmacology (12.3)].
Inkidney transplant patients with severe chronic impairment of the graft
(GFR <25 mL/min/1.73 m2), do not administer doses of mycophenolate mofetil capsules 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 capsules 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. (
Renal Impairment
No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively
[see Clinical Pharmacology (12.3)].
Inkidney transplant patients with severe chronic impairment of the graft
(GFR <25 mL/min/1.73 m2), do not administer doses of mycophenolate mofetil capsules 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 capsules 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 is available in the following dosage form and strength:
| Capsules | 250 mg mycophenolate mofetil, two-piece hard gelatin capsules, blue/brown colored size ‘1’, hard gelatin capsules, imprinted with “H” on cap and “M1” on body, filled with white to off white powder. |
• 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 (
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. 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 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 |
|
OR
Option 2 | Hormone Methods choose 1 | Barrie r Methods choose 1 | |
Choose One Hormone Metho d AND On e Barrier Method | Estrogen and Progesterone
Progesteron e - only
| AND |
|
OR
Option 3 | Barrie r Methods choose 1 | Barrie r Methods choose 1 | |
Choose One Barrier Method from each column (mus t choose two methods) |
| AND |
|
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 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)].
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available