Brand names: CellCept, Myfortic, Myhibbin
Drug class: Antimetabolites, Immunosuppressive Therapy, Miscellaneous

Medically reviewed by Drugs.com on May 10, 2025. Written by ASHP.

Introduction

Immunosuppressive agent.^{1 27 600} Mycophenolate mofetil hydrolyzed in vivo to mycophenolic acid, the pharmacologically active metabolite.^{1 600} Mycophenolate sodium delayed-release tablets release the active moiety, mycophenolic acid, in the small intestine.²⁷

Uses for Mycophenolate

Mycophenolate mofetil (CellCept, Myhibbin) used in conjunction with other immunosuppressants for the prevention of rejection of kidney, heart, or liver allografts in adult and pediatric patients ≥3 months of age.^{1 600}

Mycophenolate sodium (Myfortic) used in conjunction with cyclosporine and corticosteroid therapy for the prevention of rejection of kidney allografts in adults and in pediatric patients ≥5 years of age who are ≥6 months post kidney transplant.²⁷

Renal Allotransplantation

Mycophenolate mofetil: Prevention of rejection of renal allografts in adults and pediatric patients ≥3 months of age.^{1 3 4 5 600}

Mycophenolate sodium: Prevention of rejection of renal allographs in adults and pediatric patients ≥5 years of age who are ≥6 months post kidney transplant.^{27 28 30 31}

The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) guideline on renal transplantation generally recommends first-line use of tacrolimus with mycophenolate for maintenance immunosuppression following induction.⁹⁰⁰ The 2022 consensus guideline on maintenance immunosuppression in solid organ transplant recipients by the American College of Clinical Pharmacy (ACCP), American Society of Transplantation (AST), and International Society for Heart and Lung Transplantation (ISHLT) generally recommends mycophenolic acid over azathioprine for the prevention of acute rejection in kidney transplant.¹⁰⁰⁰ Mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in this population, particularly in those with GI side effects.¹⁰⁰⁰

Cardiac Allotransplantation

Mycophenolate mofetil: Prevention of rejection of cardiac allografts in adults and pediatric patients ≥3 months of age.^{1 7 600}

Mycophenolate sodium: Prevention of rejection of cardiac allografts^{† [off-label]} .^{650 651}

The ACCP/AST/ISHLT consensus recommendations for maintenance immunosuppression in solid organ transplant recipients generally recommends mycophenolic acid over azathioprine for the prevention of acute rejection in cardiac transplant.¹⁰⁰⁰ Mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in this population, particularly in those with GI side effects.¹⁰⁰⁰

Hepatic Allotransplantation

Mycophenolate mofetil: Prevention of rejection of liver allografts in adults and pediatric patients ≥3 months of age.^{1 9 600}

Mycophenolate sodium: Prevention of rejection of hepatic allografts^{† [off-label]} .^{652 653 654 655 656}

The ACCP/AST/ISHLT consensus recommendations for maintenance immunosuppression in solid organ transplant recipients generally recommend mycophenolic acid over azathioprine for the prevention of acute rejection in hepatic transplant.¹⁰⁰⁰ Mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in this population, particularly in those with GI side effects.¹⁰⁰⁰

Autoimmune Hepatitis

Mycophenolate mofetil used in combination with corticosteroids in the treatment of autoimmune hepatitis^{† [off-label]} .^{657 658}

The American Association for the Study of Liver Diseases practice guidelines for the diagnosis and management of autoimmune hepatitis recommends mycophenolate mofetil as a second-line treatment option in adults and children with autoimmune hepatitis who did not respond to first-line therapy.⁹⁹⁶

Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

Mycophenolate mofetil used in management of antineutrophil cytoplasmic antibody-associated vasculitis,^{† [off-label]} including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA)^{† [off-label]} .^{659 660 997}

Based on the American College of Rheumatology (ACR)/Vasculitis Foundation guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis, mycophenolate mofetil may be used as an alternative therapy for remission induction in active, nonsevere GPA.⁹⁹⁷ Mycophenolate mofetil may be used as alternative therapy for maintenance of remission in patients with GPA/MPA unable to take other preferred therapies.⁹⁹⁷ In the management of EGPA, mycophenolate mofetil may be used in remission induction therapy in patients with active nonsevere disease, and also as an alternative agent for remission maintenance in patients with severe EGPA.⁹⁹⁷

Graft-versus-Host Disease

Mycophenolate mofetil used in prevention of graft-vs-host disease (GVHD)^† and treatment of chronic GVHD^†.^{661 662 663 998 999}

Consensus recommendations from the European Society for Blood and Marrow Transplantation recommend mycophenolate mofetil for GVHD prophylaxis for allogeneic hematopoietic cell transplant recipients receiving nonmyeloablative conditioning and dose-reduced conditioning; mycophenolate mofetil is also recommended as an alternative antimetabolite to methotrexate for patients receiving myeloablative conditioning.⁹⁹⁸ According to the American Society for Blood and Marrow Transplant consensus conference on clinical practice in chronic GVHD, mycophenolate mofetil is a second-line treatment option for chronic GVHD.⁹⁹⁹

Immune Checkpoint Inhibitor Therapy-Associated Toxicities

Mycophenolate mofetil used in management of toxicities associated with immune checkpoint inhibitor therapy^† .^{1001 1002}

Guidelines by the American Society of Clinical Oncology and the Society for Immunotherapy of Cancer recommend mycophenolate mofetil for the management of immune checkpoint inhibitor-related adverse events (e.g., steroid-refractory hepatitis, nephritis, pneumonitis, myocarditis, myositis, and hematologic immune-related toxicities).^{1001 1002}

Intestinal Allotransplantation

Mycophenolate used for prevention of rejection of intestinal allografts^† .^{669 1000}

According to the ACCP/AST/ISHLT consensus guideline, mycophenolic acid has been adopted as a standard component of early maintenance immunosuppression in intestinal transplant in lieu of azathioprine.¹⁰⁰⁰

Lung Allotransplantation

Mycophenolate mofetil and mycophenolate sodium used for the prevention of rejection of lung allografts^† .^{500 501 502 503 504 505 506 507 508 509}

According to the ACCP/AST/ISHLT consensus guideline, some observational and cohort data have demonstrated less acute rejection with mycophenolic acid as compared to azathioprine and a potential benefit from switching to mycophenolic acid in the setting of bronchiolitis obliterans syndrome.¹⁰⁰⁰ Available data for mycophenolate sodium indicate that it can be utilized in combination with corticosteroids and a calcineurin inhibitor in lung transplant; however, there are no data directly comparing mycophenolate sodium and mycophenolate mofetil.¹⁰⁰⁰

Lupus Nephritis

Mycophenolate mofetil and mycophenolate sodium used in the treatment of lupus nephritis^† .^{667 668 1003 1004}

Guidelines by the ACR and KDIGO recommend the use of a mycophenolic acid analog (mycophenolate mofetil or mycophenolate sodium) in combination with glucocorticoids and other immunosuppressive agents for patients with class III (focal) or class IV (diffuse) lupus nephritis with or without class V (membranous) disease.^{1003 1004}

Pancreatic Allotransplantation

Mycophenolate mofetil and mycophenolate sodium used for the prevention of rejection in pancreas transplant recipients^† .^{664 665 666 667 668 1000}

The ACCP/AST/ISHLT consensus recommendations for maintenance immunosuppression in solid organ transplant recipients generally recommend mycophenolic acid over azathioprine for the prevention of acute rejection in pancreatic transplant.¹⁰⁰⁰ Mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in this population, particularly in those with GI side effects.¹⁰⁰⁰

Systemic Sclerosis

Mycophenolate mofetil and mycophenolate sodium used in the management of systemic sclerosis (often called scleroderma)^† and systemic sclerosis-associated interstitial lung disease^† .^{300 301 302 303 304 305 306 307 308 310 311 312 313 314 315 316 317 318 319 320}

According to the European Alliance of Associations for Rheumatology (EULAR) guideline for the treatment of systemic sclerosis, mycophenolate mofetil should be considered for the treatment of systemic sclerosis skin fibrosis as well as for the treatment of systemic sclerosis-associated interstitial lung disease.³¹⁸ The American Thoracic Society guideline for the treatment of systemic sclerosis-associated interstitial lung disease also recommends mycophenolate for the treatment of this condition.³¹⁹

Takayasu Arteritis

Mycophenolate mofetil used in the treatment of Takayasu arteritis^† .^{679 680 1005}

Based on the EULAR guideline for the management of large vessel vasculitis, mycophenolate mofetil is suggested as an alternative treatment option for Takayasu arteritis.¹⁰⁰⁵ According to the ACR/Vasculitis Foundation guideline for the management of giant cell arteritis and Takayasu arteritis, a nonglucocorticoid immunosuppressive agent (e.g., mycophenolate mofetil) in combination with glucocorticoids is recommended over glucocorticoid monotherapy or tocilizumab for the treatment of active Takayasu arteritis.¹⁰⁰⁶

Vascularized Composite Allotransplantation

Mycophenolate mofetil and mycophenolate sodium used in the prevention of vascular composite allograft rejection^† .^{670 671 672 673 674 675 676}

Regimens for prevention of rejection in vascularized composite allotransplantation largely derived from solid organ transplantation.⁶⁷⁰ Mycophenolate is used as part of maintenance immunosuppression regimens in patients after various transplants (e.g., face, hand).^{674 675 676}

Mycophenolate Dosage and Administration

General

Pretreatment Screening

• Verify pregnancy status of females of reproductive potential prior to initiation.^{1 27 600} Perform a blood or urine pregnancy test (i.e., having a sensitivity of at least 25 mIU/mL for human chorionic gonadotropin [HCG]) immediately prior to beginning mycophenolate therapy.^{1 27 600}

Patient Monitoring

• Monitor for blood dyscrasias including neutropenia and anemia.^{1 27 600} Monitor CBCs weekly for the first month of therapy, twice monthly for the second and third months, and monthly for the remainder of the first year of therapy.^{1 27 600}

• Perform monitoring to detect patients at risk of polyomavirus-associated nephropathy and cytomegalovirus infections.^{1 27 600}

• Monitor for clinical and laboratory signs of active hepatitis B or C infection in infected patients.^{1 27 600}

• Monitor for complications such as bleeding, ulceration, and perforations, especially in patients with underlying GI disorders.^{1 27 600}

• Monitor for symptoms and laboratory parameters of acute inflammatory syndrome associated with mycophenolate products, especially when starting treatment or when increasing the dosage.^{1 27 600}

• Closely monitor kidney transplant patients with severe chronic impairment of the graft.^{1 600}

• Perform a blood or urine pregnancy test (i.e., having a sensitivity of at least 25 mIU/mL for HCG) 8—10 days after treatment initiation.^{1 27 600} Perform repeat pregnancy tests during routine follow-up visits.^{1 27 600}

• Monitor pediatric patients receiving mycophenolate mofetil oral suspension (Myhibbin) for signs and symptoms of GI intolerance.⁶⁰⁰

Dispensing and Administration Precautions

Handling and Disposal

• Mycophenolate mofetil and mycophenolic acid are classified as hazardous drugs by the Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH).⁶⁰² Because of the teratogenic potential of the drug, handle and prepare mycophenolate oral and parenteral preparations with care.¹

REMS

• Because of the risk of fetal/neonatal morbidity and mortality, mycophenolate products are available only through a Risk Evaluation and Mitigation Strategy (REMS) program; see the REMS website for additional information and requirements.⁶⁰¹

Administration

Mycophenolate mofetil available as oral capsules, film-coated tablets, or powder for oral suspension, and as mycophenolate mofetil hydrochloride lyophilized powder for injection for IV infusion (CellCept).¹ Mycophenolate mofetil is also available as a ready-to-use oral suspension (Myhibbin).⁶⁰⁰

Mycophenolate sodium available as oral delayed-release (enteric-coated) tablets (Myfortic).²⁷

Do not use mycophenolate mofetil or mycophenolate sodium without supervision of a clinician with experience in immunosuppressive therapy.^{1 27 600}

Do not use mycophenolate mofetil capsules, tablets, or oral suspension interchangeably with mycophenolate sodium delayed-release tablets without supervision of a clinician with experience in immunosuppressive therapy.^{1 600}

Handle and prepare mycophenolate oral and parenteral preparations with care.¹

If a dose of mycophenolate mofetil is missed, take the dose as soon as it is remembered unless it is closer than 2 hours to the next scheduled dose; in this case, continue to take mycophenolate mofetil at the usual times.^{1 600}

Oral Administration

Mycophenolate mofetil: Administer orally as soon as possible following renal, cardiac, or hepatic transplantation.^{1 600}

Mycophenolate mofetil: Administer on an empty stomach.^{1 600} May be given with food, if necessary, in stable renal transplant recipients.^{1 600}

Mycophenolate mofetil: Do not crush film-coated tablets; do not open or crush capsules.^{1 600}

Avoid inhalation of powder in capsules or oral suspension and contact with skin or mucous membranes.^{1 600} In case of skin or mucous membrane contact, wash affected area with soap and water.^{1 600} If contact with eyes occurs, wash with water.^{1 600}

Mycophenolate sodium: Administer as soon as possible following renal transplantation in adults.²⁷

Mycophenolate sodium: Administer on an empty stomach, 1 hour before or 2 hours after food.²⁷

Mycophenolate sodium: Do not crush, chew, or cut tablets.²⁷ Tablets should be swallowed whole to maintain integrity of enteric coating.²⁷

Mycophenolate sodium: Administer in stable pediatric renal transplant recipients; safety and efficacy in de novo pediatric renal transplant recipients not established.²⁷

Reconstitution

Mycophenolate mofetil for oral suspension (CellCept, not Myhibbin): Reconstitute at time of dispensing by adding 94 mL of water (about 47 mL initially followed by another 47 mL after vigorous shaking for 1 minute) to provide a suspension containing 200 mg/mL.¹ Shake bottle well again for 1 minute.¹

Mycophenolate mofetil for oral suspension: Do not admix with other drugs.^{1 600}

NG Tube

Mycophenolate mofetil for oral suspension: Can administer by nasogastric tube (minimum 1.7 mm in interior diameter; minimum French size number 8).¹ r600

IV Administration

Mycophenolate mofetil hydrochloride injection: Initiate within 24 hours following transplantation.¹

Reserve IV administration for patients who cannot tolerate or are unable to take an oral dosage form.¹

Administer IV for up to 14 days.¹

Switch from parenteral to oral therapy as soon as possible.¹

Incompatible with IV infusion solutions other than 5% dextrose; do not mix or administer concurrently via the same infusion catheter with any other IV drugs or infusion admixtures.¹

Reconstitution

Mycophenolate mofetil hydrochloride injection: Add 14 mL of 5% dextrose injection to a vial containing 500 mg of mycophenolate mofetil; shake vial gently.¹ Reconstituted solution is slightly yellow.¹

Use strict aseptic technique; drug contains no preservative.¹

Dilution

For a 1-g IV infusion dose, add contents of 2 reconstituted vials into 140 mL of 5% dextrose injection to provide a solution containing 6 mg/mL.¹

For a 1.5-g IV infusion dose, add the contents of 3 reconstituted vials into 210 mL of 5% dextrose injection to provide a solution containing 6 mg/mL.¹

Start IV administration within 4 hours of reconstitution and dilution.¹

Rate of Administration

Infuse over a period of no less than 2 hours by either a peripheral or central vein; do not administer by rapid IV (“bolus”) injection or rapid IV infusion.¹

Dosage

Available as mycophenolate mofetil (oral capsules, tablets, for oral suspension, ready-to-use oral suspension) and mycophenolate mofetil hydrochloride (injection); dosage expressed in terms of mycophenolate mofetil.^{1 600} Mycophenolate mofetil tablets, capsules, and oral suspension (CellCept) reportedly are bioequivalent.¹

Available as mycophenolate sodium (delayed-release tablets); dosage expressed in terms of mycophenolic acid.²⁷

Mycophenolate sodium delayed-release tablets should not be used interchangeably with mycophenolate mofetil tablets, capsules, or oral suspension without clinician supervision.²⁷

Pediatric Patients

Pediatric dosing of mycophenolate mofetil based on body surface area.^{1 600}

Mycophenolate sodium should be administered as maintenance therapy only in stable pediatric renal transplant recipients; safety and efficacy in de novo pediatric renal transplant recipients have not been established.²⁷

Renal Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

Children ≥3 months of age: 600 mg/m² as the oral suspension twice daily (maximum 2 g daily or 10 mL of the oral suspension).¹

Children with a body surface area of 1.25 to <1.5 m²: 750 mg as capsules twice daily (total daily dose of 1.5 g).¹

Children with a body surface area ≥1.5 m²: 1 g as capsules or tablets twice daily (total daily dosage of 2 g).¹

Mycophenolate sodium delayed-release tablets

Oral

Children ≥5 years of age who are at least 6 months post kidney transplant: 400 mg/m² twice daily (maximum 720 mg twice daily).²⁷

Children ≥5 years of age (who are at least 6 months post kidney transplant) with a body surface area <1.19 m²: accurate dosage cannot be administered using commercially available tablets.²⁷

Children ≥5 years of age (who are at least 6 months post kidney transplant) with a body surface area of 1.19–1.58 m²: 1080 mg daily (given as three 180-mg tablets twice daily or as one 180-mg tablet and one 360-mg tablet twice daily).²⁷

Children ≥5 years of age (who are at least 6 months post kidney transplant) with a body surface >1.58 m²: 1440 mg daily (given as four 180-mg tablets twice daily or two 360-mg tablets twice daily).²⁷

Cardiac Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

Children ≥3 months of age: 600 mg/m² as the oral suspension twice daily.^{1 600} If well tolerated, dosage can be increased to a maintenance dosage of 900 mg/m² twice daily, up to a maximum total daily dosage of 3 g or 15 mL of oral suspension.^{1 600} Dosage may be individualized based on clinical assessment.^{1 600}

Children with a body surface area of 1.25 to <1.5 m²: 750 mg as capsules twice daily as starting dosage (total daily dosage of 1.5 g).¹ Maximum maintenance dosage is 3 g total daily.¹

Children with a body surface area ≥1.5 m²: 1 g as capsules or tablets twice daily as starting dosage (total daily dosage of 2 g).¹ Maximum maintenance dosage is 3 g total daily.¹

Hepatic Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

Children ≥3 months of age: 600 mg/m² as the oral suspension twice daily.^{1 600} If well tolerated, dosage can be increased to a maintenance dosage of 900 mg/m² twice daily, up to a maximum total daily dosage of 3 g or 15 mL of oral suspension.^{1 600} Dosage may be individualized based on clinical assessment.^{1 600}

Children with a body surface area of 1.25 to <1.5 m²: 750 mg as capsules twice daily as starting dosage (total daily dosage of 1.5 g).¹ Maximum maintenance dosage is 3 g total daily.¹

Children with a body surface area ≥1.5 m²: 1 g as capsules or tablets twice daily as starting dosage (total daily dosage of 2 g).¹ Maximum maintenance dosage is 3 g total daily.¹

Adults

Renal Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

1 g twice daily (2 g total daily dosage).^{1 600}

Mycophenolate sodium delayed-release tablets

Oral

720 mg twice daily (1440 mg total daily dosage).²⁷

Mycophenolate mofetil hydrochloride for injection

IV

1 g twice daily (2 g total daily dosage).¹

Cardiac Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

1.5 g twice daily (3 g total daily dosage).^{1 600}

Mycophenolate mofetil hydrochloride for injection

IV

1.5 g twice daily (3 g total daily dosage).¹

Hepatic Allotransplantation

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

1.5 g twice daily (3 g total daily dosage).^{1 600}

Mycophenolate mofetil hydrochloride for injection

IV

1 g twice daily (2 g total daily dosage).¹

Lupus Nephritis†

Mycophenolate mofetil capsules, tablets, and oral suspension

Oral

Initial therapy for active class III or IV lupus nephritis: 1–1.5 g twice daily for at least 6 months.¹⁰⁰⁴

Maintenance therapy for active class III or IV lupus nephritis: 1–2 g per day.¹⁰⁰⁴

Early maintenance phase for active class III or IV lupus nephritis: 750—1000 mg twice daily.¹⁰⁰⁴

Mycophenolate sodium delayed-release tablets

Oral

Initial therapy for active class III or IV lupus nephritis: 0.72—1.08 g twice daily for at least 6 months.¹⁰⁰⁴

Maintenance therapy for active class III or IV lupus nephritis (mycophenolic acid): 720—1440 mg per day.¹⁰⁰⁴

Early maintenance phase for active class III or IV lupus nephritis (mycophenolic acid): 540—720 mg twice daily.¹⁰⁰⁴

Dosage Modification for Neutropenia

If neutropenia (ANC <1300/mm³) develops, temporarily discontinue or reduce dosage, perform suitable diagnostic tests, and institute appropriate patient management.^{1 27 600}

Special Populations

Hepatic Impairment

No dosage adjustment necessary in renal transplant recipients with severe hepatic parenchymal disease; not known whether dosage adjustment is needed for other hepatic diseases.^{1 600} No data available for cardiac transplant recipients with severe hepatic parenchymal disease.^{1 600}

Manufacturer makes no specific dosage recommendations for mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) in patients with hepatic impairment.²⁷

Renal Impairment

Dosage adjustment not necessary in renal transplant recipients experiencing postoperative delayed graft function.^{1 600}

Mycophenolate mofetil capsules, tablets, or oral suspension or mycophenolate mofetil hydrochloride for injection: Avoid dosages >1 g twice daily in renal transplant recipients with severe chronic impairment of the graft (GFR <25 mL/minute per 1.73 m²); closely monitor these patients.^{1 600}

Manufacturer makes no specific dosage recommendations for mycophenolic acid (administered as mycophenolate sodium delayed-release tablets) in patients with renal impairment.²⁷

Geriatric Patients

No specific dosage recommendations at this time.^{1 27 600}

Select dosage carefully, taking into consideration the presence of decreased hepatic, renal, or cardiac function and of concomitant drug therapies.^{1 27 600}

Cautions for Mycophenolate

Contraindications

• Known hypersensitivity to mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, or any ingredient in the formulation.^{1 27 600}

• Mycophenolate mofetil hydrochloride for IV injection; mycophenolate mofetil oral suspension (Myhibbin): known hypersensitivity to polysorbate (Tween) 80.^{1 600}

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm (see Boxed Warning).^{1 27 600} Congenital malformations and increased risk of first-trimester pregnancy loss reported.^{1 27 600} Congenital malformations and pregnancy loss demonstrated in animals.^{1 27 600}

Avoid use during pregnancy if safer treatment options available.^{1 27 600} Advise females of reproductive potential of potential risk; counsel them regarding pregnancy prevention and planning.^{1 27 600}

Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for human chorionic gonadotropin [HCG]) immediately prior to starting mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits.^{1 27 600} If pregnancy test positive, consider alternative immunosuppressants with less potential for embryofetal toxicity.^{1 27 600}

Counsel patients of reproductive potential regarding acceptable contraception methods.^{1 27 600} Advise patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after discontinuance, unless committed to continuous abstinence.^{1 27 600}

Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation.^{1 27 600} Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after cessation of treatment.^{1 27 600}

Because of risk of fetal/neonatal morbidity and mortality, mycophenolate products available only through a REMS program.⁶⁰¹

Management of Immunosuppression

Only clinicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolate sodium (see Boxed Warning).²⁷

Patients should be managed in facilities equipped and staffed with appropriate laboratory and supportive resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.²⁷

Lymphoma and Other Malignancies

Risk of lymphoma and other malignancies in patients receiving immunosuppressive regimens (see Boxed Warning).^{1 27 600} Risk appears to be related to intensity and duration of immunosuppression rather than to any specific immunosuppressive agent.^{1 600}

Posttransplant lymphoproliferative disorder reported in patients receiving mycophenolate mofetil in conjunction with other immunosuppressive agents.^{1 600} Most cases appear to be related to Epstein Barr Virus (EBV) infection.^{1 27 600} Risk appears greatest in individuals who are EBV seronegative, a population which includes many small children.^{1 27 600}

Advise patients with increased risk of skin cancer to limit exposure to sunlight or other ultraviolet light by wearing protective clothing and using broad-spectrum sunscreen with a high protection factor.^{1 27 600}

Serious Infections, Including New or Reactivated Viral Infections

Increased susceptibility to infections (bacterial, fungal, and protozoal infections; new or reactivated viral infections), including opportunistic infections.^{1 27 600} May lead to hospitalizations and death (see Boxed Warning).^{1 27 600} Risk increases with the total immunosuppressive load;^{1 27 600} use combination immunosuppressant therapy with caution.²⁷

Serious viral infections reported include polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection; JC virus-associated progressive multifocal leukoencephalopathy (PML); cytomegalovirus (CMV) infections; reactivation of HBV or HCV; and COVID-19.^{1 27 600} PVAN is associated with serious outcomes (e.g., deteriorating kidney function, renal graft loss).^{1 27 600} PML (sometimes fatal) commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia.^{1 27 600} Risk of CMV viremia and CMV disease highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor.^{1 27 600}

Consider dosage reduction or discontinuation of mycophenolate therapy in patients with new infections or reactivated viral infections, considering the risk that reduced immunosuppression represents to the functioning allograft.^{1 27 600} Monitoring may help identify patients at risk for PVAN.^{1 27 600}

Consider PML in the differential diagnosis in immunosuppressed patients reporting neurologic symptoms;^{1 27 600} consider consultation with a neurologist as clinically indicated.²⁷

Routinely provide therapeutic approaches to limiting CMV disease; monitoring may help identify patients at risk.^{1 27 600}

Monitor infected patients for clinical and laboratory signs of active HBV or HCV infection.^{1 27}

Other Warnings and Precautions

Blood Dyscrasias

Severe neutropenia (ANC <500/mm³) reported; observed most frequently between 31–180 days posttransplant.^{1 600} Neutropenia may be related to mycophenolate, concomitant therapies, viral infection, or a combination of these causes.^{1 27 600}

Monitor for blood dyscrasias including neutropenia during therapy.^{1 27 600} Perform CBCs weekly during the first month of therapy, twice monthly during the second and third months, and then monthly thereafter during the first year.^{1 27 600}

If neutropenia (ANC <1300/mm³) develops (or anemia with mycophenolate sodium therapy), discontinue or adjust dosage, perform suitable diagnostic tests, and initiate appropriate patient management.^{1 27 600}

Instruct patients to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow depression.^{1 600}

Pure red cell aplasia (PRCA) reported in patients receiving immunosuppressive regimens containing mycophenolate.^{1 27 600} Mechanism for mycophenolate-induced PRCA not been determined.²⁷ Consider possibility of graft rejection if immunosuppression is reduced in transplant patients; implement any changes to immunosuppressive therapy under appropriate medical supervision.²⁷

GI Effects

GI bleeding (requiring hospitalization), ulceration, and perforation reported.^{1 27 600} Clinicians should be aware of serious adverse GI effects when administering mycophenolate mofetil to patients with GI disease.^{1 600}

Use caution in patients with serious active GI disease.²⁷

Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency

Mycophenolic acid inhibits inosine monophosphate dehydrogenase; avoid in patients with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.^{1 27 600} In such patients, the drug may cause an exacerbation of disease symptoms characterized by overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease, including renal failure.^{1 27 600}

Acute Inflammatory Syndrome

Cases of acute inflammatory syndrome (AIS), some resulting in hospitalization, reported.^{1 27 600} AIS characterized by fever, arthralgias, arthritis, muscle pain, and elevated inflammatory markers (e.g., C-reactive protein, erythrocyte sedimentation rate) without evidence of infection or underlying disease recurrence.^{1 27 600} Symptoms occur within weeks to months of drug initiation or a dosage increase; improvement of symptoms and inflammatory markers usually observed within 24—48 hours following treatment discontinuation.^{1 27 600}

Monitor patients for symptoms and laboratory parameters of AIS when initiating treatment with mycophenolate products or when increasing the dosage.^{1 27 600} Discontinue treatment and consider treatment alternatives based on risks and benefits for the patient.^{1 27 600}

Immunizations

Avoid use of live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines) during treatment with mycophenolate mofetil.^{1 27 600} Advise patients that vaccinations may be less effective.^{1 27 600} Advise patients to discuss with the clinician before seeking any immunizations.^{1 27 600}

Local Adverse Reactions with Rapid IV Administration

Do not administer mycophenolate mofetil IV solution by rapid or bolus IV injection; rapid infusion increases risk of local adverse reactions (e.g., phlebitis, thrombosis).¹

Phenylketonuria

Mycophenolate mofetil oral suspension (CellCept, not Myhibbin) contains aspartame, a source of phenylalanine (0.56 mg of phenylalanine/mL of the suspension).¹ Phenylalanine can be harmful to patients with phenylketonuria.¹

Before prescribing mycophenolate mofetil oral suspension to a patient with phenylketonuria, consider combined daily amount of phenylalanine from all sources, including mycophenolate mofetil.¹

Blood Donation

Do not donate blood during therapy and for ≥6 weeks following treatment discontinuation.^{1 27 600}

Semen Donation

Men should not donate semen during therapy and for at least 90 days following treatment discontinuation.^{1 27 600}

Effect on Mycophenolic Acid Concentrations of Concomitant Drugs

Several drugs, when used concomitantly with mycophenolate mofetil, have potential to alter systemic mycophenolic acid exposure.^{1 600}

May be appropriate to measure plasma mycophenolic acid concentrations before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant drugs.^{1 600}

Potential Impairment of Ability to Drive or Operate Machinery

Mycophenolate mofetil may impact the ability to drive or operate machinery.^{1 600} Advise patients to avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with mycophenolate mofetil.^{1 600}

Specific Populations

Pregnancy

Pregnancy exposure registry available that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing the drug.^{1 27 600} Visit [Web] or call 1-800-617-8191 for more information.^{1 27 600}

May cause fetal toxicity when administered to pregnant women.^{1 27 600} Increased risk of first-trimester pregnancy loss and serious congenital malformations in multiple organ systems reported.^{1 27 600} Documented malformations include external ear and other facial abnormalities (e.g., cleft lip and palate) and anomalies of the distal limbs, heart, esophagus, kidney and nervous system.^{1 27 600}

Congenital malformations and pregnancy loss also observed in animals.^{1 27 600}

Apprise females of reproductive potential and pregnant women of the potential hazard.^{1 27 600} Consider alternative immunosuppressants with less potential for embryofetal toxicity.^{1 27 600}

Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later.^{1 27 600} Perform repeat pregnancy tests during routine follow-up visits.^{1 27 600}

Lactation

No data on presence of mycophenolate in human milk or effects of the drug on milk production.^{1 27 600} Distributed into milk in rats.^{1 27 600}

Consider developmental and health benefits of breast-feeding along with mother's clinical need for mycophenolate and any potential adverse effects on breast-fed infant from the drug or underlying maternal condition.^{1 27 600}

Females and Males of Reproductive Potential

Advise females of reproductive potential of the potential risks of fetal toxicity; counsel them regarding pregnancy prevention and planning.^{1 27 600}

If pregnancy being considered, discuss risks and benefits of mycophenolate therapy and consider alternative immunosuppressants with less potential for embryofetal toxicity.^{1 27 600}

In females of reproductive potential, perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits.^{1 27 600} If pregnancy test is positive, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.^{1 27 600}

Counsel patients of reproductive potential regarding use of acceptable contraception; refer to the prescribing information for specific, acceptable contraceptive methods.^{1 27 600} Advise female patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after treatment discontinuance, unless committed to complete abstinence from heterosexual contact.^{1 27 600} Advise patients that concomitant use of mycophenolate and certain oral hormonal contraceptives may result in decreased concentrations of the oral hormonal contraceptive.^{1 27 600}

Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation.^{1 27 600} Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after discontinuation of treatment.^{1 27 600}

Pediatric Use

Mycophenolate mofetil: Safety and effectiveness established in pediatric patients ≥3 months of age for the prophylaxis of organ rejection of allogenic renal, cardiac, or hepatic transplants.^{1 600} Combination of inactive ingredients (e.g., simethicone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, glycerin) in oral suspension (Myhibbin) may impact GI tolerability; monitor pediatric patients receiving the drug for signs and symptoms of GI intolerance.⁶⁰⁰

Mycophenolate sodium: Safety and efficacy established in stable renal transplant recipients 5–16 years of age who were initiated on the drug ≥6 months posttransplant.²⁷ Safety and efficacy not established in children <5 years of age; a mycophenolate sodium dosage form appropriate for pediatric patients with body surface area <1.19 m² currently not available.²⁷ Safety and efficacy not established in de novo renal transplant patients.²⁷

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^{1 27 600} Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant diseases and drug therapy.^{1 27 600}

Possible increased risk of developing GI hemorrhage, pulmonary edema, or certain infections (e.g., invasive CMV infection).^{1 600}

Hepatic Impairment

Mycophenolate mofetil: No dosage adjustment necessary for renal transplant recipients with severe hepatic parenchymal disease; not known whether dosage adjustment is needed for other hepatic diseases.^{1 600} No data available for cardiac transplant recipients with severe hepatic parenchymal disease.^{1 600}

Mycophenolate sodium: Specific studies evaluating pharmacokinetics of mycophenolate sodium have not been conducted in patients with hepatic impairment.²⁷

Renal Impairment

Mycophenolate mofetil: Dosage adjustment not necessary in renal transplant recipients experiencing postoperative delayed graft function; however, closely monitor these patients.^{1 600} Do not use mycophenolate mofetil dosages exceeding 1 g twice daily in renal transplant recipients with severe chronic impairment of the graft (GFR <25 mL/minute per 1.73 m²).^{1 600} No data available in cardiac or hepatic transplant recipients with severe chronic renal impairment; may use if potential benefits outweigh potential risks.^{1 600}

Mycophenolate sodium: Specific studies evaluating pharmacokinetics not conducted in patients with renal impairment.²⁷ Mycophenolic acid AUC in patients with renal impairment receiving mycophenolate sodium not expected to increase appreciably relative to values in patients with normal renal function; however, AUC values for the phenolic glucuronide metabolite of mycophenolic acid are expected to increase substantially.²⁷

Common Adverse Effects

The most common adverse effects (≥20%) with mycophenolate mofetil are diarrhea, leukopenia, infection, and vomiting; there is evidence of a higher frequency of certain types of infections (e.g., opportunistic infection).^{1 600}

The most common adverse effects (≥20%) with mycophenolate sodium are anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, cytomegalovirus infection, insomnia, and postoperative pain.²⁷

Drug Interactions

Anti-infective Agents

Anti-infective agents that eliminate beta-glucuronidase-producing bacteria in the intestine (e.g., aminoglycosides, cephalosporins, fluoroquinolones, penicillins) may interfere with enterohepatic recirculation of mycophenolic acid and the phenolic glucuronide metabolite of mycophenolic acid (MPAG, the predominant inactive metabolite), thus leading to reduced systemic mycophenolic acid exposure.^{1 600}

Drugs Modulating Glucuronidation

Concomitant use of mycophenolate mofetil with drugs inducing glucuronidation (e.g., telmisartan) decreases systemic exposure of mycophenolic acid.^{1 600} Concomitant use of telmisartan and mycophenolate mofetil resulted in approximately 30% decrease in mycophenolic acid concentrations.^{1 600}

Concomitant use of mycophenolate mofetil with drugs inhibiting glucuronidation (e.g., isavuconazole) increases systemic exposure of mycophenolic acid.^{1 600} Increase of 35% in mycophenolic acid AUC observed with concomitant use of isavuconazole.^{1 600}

Monitor patients for alterations in efficacy or mycophenolate mofetil related-adverse reactions when used concomitantly with such drugs.^{1 27 600}

Drugs That Interfere with Enterohepatic Recirculation

Decreased systemic exposure of mycophenolic acid may occur with concomitant use of drugs that directly interfere with enterohepatic recirculation or indirectly interfere with enterohepatic recirculation by altering the GI flora.^{1 27 600} Examples of such drugs include cyclosporine, trimethoprim/sulfamethoxazole (co-trimoxazole), bile acid sequestrants (cholestyramine), rifampin, aminoglycosides, cephalosporins, fluoroquinolone, and penicillins.^{1 600}

Concomitant use with mycophenolate mofetil with cholestyramine decreased AUC of mycophenolic acid by approximately 40%.^{1 27 600}

Monitor patients for alterations in efficacy or mycophenolate mofetil related-adverse reactions when used concomitantly with such drugs.^{1 600}

Do not administer mycophenolate sodium with drugs that may interfere with enterohepatic recirculation or drugs that may bind bile acids (e.g., bile acid sequestrants such as cholestyramine, oral activated charcoal).²⁷

Drugs That Undergo Renal Tubular Secretion

MPAG may compete with drugs eliminated by renal tubular secretion (e.g., acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir); possible increased plasma concentrations of MPAG or other drugs that undergo renal tubular secretion.^{1 27 600}

Concomitant use of acyclovir with mycophenolate mofetil increased plasma concentrations of acyclovir and MPAG.^{1 27 600}

Following single-dose administration to stable kidney transplant patients, no pharmacokinetic interaction observed between mycophenolate mofetil and IV ganciclovir.^{1 600}

Monitor for drug-related adverse reactions in patients with renal impairment.^{1 600} Monitor blood cell counts if used concomitantly with mycophenolate sodium.²⁷

Oral Contraceptives

Concomitant use of ethinyl estradiol and levonorgestrel with mycophenolate mofetil resulted in decreased plasma concentrations of levonorgestrel;^{1 27 600} systemic exposure to ethynyl estradiol not affected.^{1 600} Possibility of decreased effectiveness of combined oral contraceptive.^{1 600}

Mean AUCs for ethinyl estradiol and norethindrone similar when coadministered with mycophenolate mofetil as compared to administration of oral contraceptives alone.²⁷

When ethinyl estradiol and desogestrel were administered with mycophenolate mofetil, AUCs for ethinyl estradiol and 3-keto desogestrel were not affected.^{1 600}

Use additional barrier contraceptive methods.^{1 27 600}

Phosphate Binders

Concomitant use with calcium-free phosphate binders (e.g., sevelamer) decreases systemic exposure of mycophenolic acid.^{1 27 600}

Concomitant administration of sevelamer and mycophenolate mofetil decreased mean peak plasma concentration and AUC of mycophenolic acid by 36 and 26%, respectively.^{1 27 600}

Administer non-calcium-containing phosphate binders ≥2 hours after administration of mycophenolate mofetil.^{1 600}

Do not administer non-calcium-containing phosphate binders simultaneously with mycophenolate sodium.²⁷

Proton Pump Inhibitors

Decreased systemic exposure of mycophenolic acid and reduced drug efficacy possible.^{1 600}

Coadministration of PPIs (e.g., lansoprazole, pantoprazole) and mycophenolate mofetil resulted in 30–70% reductions in maximum plasma concentration and 25–35% reductions in AUC of mycophenolic acid, possibly due to decreased mycophenolic acid solubility at an increased gastric pH.^{1 600} Monitor patients for alterations in efficacy when PPIs used concomitantly with mycophenolate mofetil.^{1 600}

Administration of pantoprazole (40 mg twice daily for 4 days) did not alter pharmacokinetics mycophenolate sodium.²⁷

Vaccines

Vaccines may be less effective; avoid use of live virus vaccines.^{1 27 600}

Specific Drugs

Mycophenolate Pharmacokinetics

Absorption

Bioavailability

Mycophenolate mofetil: Rapidly absorbed following oral administration; bioavailability is 94% relative to IV mycophenolate mofetil.^{1 600}

Following oral and IV administration, mycophenolate mofetil undergoes rapid and complete metabolism to mycophenolic acid (active metabolite).^{1 600}

Mycophenolate sodium: Following oral administration of the delayed-release, enteric-coated tablets, mycophenolic acid is released in the small intestine; bioavailability is 72%.²⁷

Mycophenolate mofetil tablets, capsules, and oral suspension (CellCept) are bioequivalent.¹

Mycophenolate sodium delayed-release tablets cannot be used interchangeably with mycophenolate mofetil tablets, capsules, or oral suspension without clinician supervision.²⁷

Food

Food decreases peak plasma concentrations of mycophenolic acid (by 33–40%); no effect on the mycophenolic acid AUC.^{1 27 600}

Special Populations

Increased AUCs of mycophenolic acid and the phenolic glucuronide metabolite of mycophenolic acid (MPAG) in severe chronic renal impairment (GFR <25 mL/minute per 1.73 m²).^{1 600} Plasma mycophenolic acid concentrations in patients with delayed graft function similar to values in patients not experiencing delayed graft function.^{1 600}

Pharmacokinetic parameters, including AUC, in children 1–18 years of age receiving mycophenolate mofetil 600 mg/m² (oral suspension) twice daily following renal transplantation similar to values in adult renal transplant recipients receiving 1 g twice daily.^{1 600}

Peak plasma concentrations and AUC of mycophenolic acid in stable pediatric renal transplant patients 5–16 years of age receiving a single dose of mycophenolate sodium (mycophenolic acid 450 mg/m²) delayed-release tablets increased (33 and 18%, respectively) relative to adults receiving the same dose based on body surface area.²⁷ Clinical importance not determined.²⁷

Distribution

Extent

Distributed into milk in rats; no data on presence in human milk.^{1 27 600}

Plasma Protein Binding

Mycophenolic acid: ≥97–98% (mainly albumin).^{1 27 600}

Elimination

Metabolism

Mycophenolate mofetil undergoes complete metabolism to mycophenolic acid, the pharmacologically active metabolite; metabolism occurs presystemically following oral administration.^{1 27 600} Mycophenolic acid metabolized by glucuronyl transferase to the phenolic glucuronide of mycophenolic acid (MPAG), an inactive metabolite.^{1 27 600} MPAG is converted to mycophenolic acid via enterohepatic recirculation.^{1 27 600}

Elimination Route

Mycophenolate mofetil: Excreted in urine (93%) as MPAG (87%) and in feces (6%).^{1 600}

Mycophenolate sodium: Excreted principally in urine as MPAG (>60%) and as unchanged mycophenolic acid (3%).²⁷

Half-life

Mycophenolic acid: 17.9 hours following oral administration; 16.6 hours following IV administration.^{1 600}

Following administration of mycophenolate sodium, mean elimination half-lives of mycophenolic acid and MPAG ranged between 8—16 hours and 13—17 hours, respectively.²⁷

Special Populations

Dialysis does not remove mycophenolic acid.^{1 27 600}

Pharmacokinetic studies in patients with alcoholic cirrhosis indicate that hepatic mycophenolic acid glucuronidation is not affected by hepatic parenchymal disease;^{1 27 600} hepatic disease with other etiologies (e.g., biliary cirrhosis) may show a different effect.²⁷

Stability

Storage

Oral

Capsules

Mycophenolate mofetil: 25°C (may be exposed to 15–30°C).¹

Suspension

Mycophenolate mofetil (CellCept): Store dry powder at 25°C (may be exposed to 15–30°C).¹ Store reconstituted suspension at 25°C (may be exposed to 15–30°C) for up to 60 days.¹ Reconstituted suspension may be refrigerated at 2—8°C; do not freeze.¹

Mycophenolate mofetil (Myhibbin): 20—25°C (may be exposed to 15–30°C).⁶⁰⁰ Do not freeze.⁶⁰⁰

Tablets

Mycophenolate mofetil: 25°C (may be exposed to 15–30°C).¹ Dispense in light-resistant container (e.g., original container).¹

Tablets, enteric-coated, film-coated

Mycophenolate sodium: 20—25°C (may be exposed to 15–30°C).²⁷ Dispense in tight containers.²⁷

Parenteral

Powder for Injection

Store dry powder and reconstituted solution at 25°C (may be exposed to 15–30°C); initiate IV infusion within 4 hours of reconstitution and discard unused portion of solutions.¹

Actions

• Mycophenolate mofetil, the 2-morpholinoethyl ester of mycophenolic acid, is an antimetabolite immunosuppressive agent; hydrolyzed in vivo to mycophenolic acid (pharmacologically active metabolite).^{1 600}

• Mycophenolate sodium is an immunosuppressive agent; mycophenolic acid (the active moiety) is released following administration.²⁷

• Selective, noncompetitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), an essential enzyme in de novo guanosine synthesis.^{1 27 600} Because T- and B-cells are dependent on de novo synthesis of purines (e.g., guanosine), mycophenolic acid has potent cytostatic effects on lymphocytes.^{1 27 600}

• Mechanism of action of mycophenolic acid multifaceted.^{1 600} Shifts transcriptional activities in lymphocytes from proliferative state to catabolic processes.^{1 600} Modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways, causing T-cells to become less responsive to antigenic stimulation.^{1 600} Enhances expression of certain negative co-stimulators and decreases expression of positive co-stimulators CD27 and CD28.^{1 600}

• Inhibits proliferative responses of T- and B-cells to both mitogenic and allospecific stimulation, antibody responses, and production of cytokines from lymphocytes and monocytes.^{1 600} By preventing glycosylation of lymphocyte and monocyte glycoproteins involved in intercellular adhesion to endothelial cells, mycophenolic acid may inhibit recruitment of leukocytes to sites of inflammation and graft rejection.^{1 600}

Advice to Patients

• Advise patients to read the FDA-approved patient labeling (Medication Guide and/or Instructions for Use).^{1 27 600}

• Apprise females of reproductive potential and pregnant women of the increased risk of first trimester pregnancy loss and congenital malformations.^{1 27 600} Encourage pregnant women to enroll in the mycophenolate pregnancy exposure registry.^{1 27 600} For patients considering pregnancy, discuss the risks and benefits of mycophenolate, and appropriate alternative immunosuppressants with less potential for embryofetal toxicity.^{1 27 600}

• Counsel females of reproductive potential on the requirements for pregnancy testing, pregnancy planning and prevention.^{1 27 600} Counsel patients on the use of acceptable forms of contraception.^{1 27 600}

• Instruct females of reproductive potential to use an acceptable form of birth control during the entire therapy with mycophenolate and for 6 weeks after discontinuing the drug, unless the patient chooses abstinence.^{1 27 600} Inform patients that mycophenolate may reduce effectiveness of oral contraceptives, and that use of additional barrier contraceptive methods is recommended.^{1 27 600}

• Advise sexually active male patients and/or their partners to use effective contraception during mycophenolate treatment of the male patient and for ≥90 days after cessation of treatment.^{1 27 600}

• Instruct patients to follow instructions for administration, handling, and storage of mycophenolate.^{1 27 600} Advise patients to take mycophenolate as directed. ^{1 27 600}

• Advise patients not to crush mycophenolate mofetil film-coated tablets and not to open mycophenolate mofetil capsules.¹ Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and with the oral suspension.^{1 600} If such contact occurs, instruct patients to wash the area thoroughly with soap and water.^{1 600} In case of ocular contact, instruct patients to rinse eyes with plain water.^{1 600}

• Advise patients to swallow mycophenolate sodium delayed-release tablets whole, and not to crush, chew, or cut the tablets.²⁷ Inform patients to take mycophenolate sodium tablets on an empty stomach, 1 hour before or 2 hours after food.²⁷

• Instruct patients on steps to take if they miss a dose.^{1 27 600}

• Inform patients about the increased risk of developing a variety of infections, and advise patients to contact their clinician if they develop any signs and symptoms of infection.^{1 27 600}

• Inform patients about the risk of lymphoma and other malignancies (particularly skin cancer).^{1 27 600} Advise patients to limit sunlight or other ultraviolet light exposure by wearing protective clothing and using broad-spectrum sunscreens with a high protection factor.^{1 27 600}

• Advise patients of the increased risk for developing blood adverse effects such as anemia or neutropenia.^{1 27 600} Advise patients to immediately contact their clinician if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression.^{1 27 600} Advise patients receiving mycophenolate of the necessity of routine laboratory testing (e.g., complete blood cell count).^{1 27 600}

• Advise patients that mycophenolate can cause GI tract complications, including bleeding, intestinal perforations, and gastric or duodenal ulcers.^{1 27 600} Advise patients to contact their clinician if they have symptoms of GI bleeding or sudden onset or persistent abdominal pain.^{1 27 600}

• Advise patients of the risk of acute inflammatory reactions.^{1 27 600} Advise patients to contact their clinician if they develop fever, joint stiffness, joint pain, or muscle pains.^{1 27 600}

• Advise patients not to donate blood during mycophenolate therapy and for ≥6 weeks following discontinuation of the drug.^{1 27 600}

• Advise males of childbearing potential not to donate semen during mycophenolate therapy and for 90 days following discontinuation of the drug.^{1 27 600}

• Advise patients to avoid driving or operating machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with mycophenolate mofetil.^{1 600}

• Advise patients to discuss first with a clinician if they plan on receiving any vaccines while taking mycophenolate; instruct patients to avoid live virus vaccines. ^{1 27 600}

• Advise patients to inform clinicians of concomitant conditions (e.g., ulcers, Lesch-Nyhan or Kelley-Seegmiller syndrome, phenylketonuria) and existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 27 600} Inform patients that mycophenolate may interact with many drugs.^{1 27 600}

• Advise women to inform clinicians if they are breast-feeding or plan to breast-feed.^{1 27 600}

• Advise patients of other important precautionary information.^{1 27 600}

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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