Mycophenolate Mofetil

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Mycophenolate 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
[see
5.1 Embryofetal Toxicity
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)].
, Use in Special Populations (8.1, 8.3)]
.
Increased risk of development of lymphoma and other malignancies, particularly of the skin
[see
5.2 Lymphoma and Other Malignancies
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
5.3 Serious Infections
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.
]
.

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

[see

14.1 Kidney Transplantation

Adults

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 in

Table 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 in

Table 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=499 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)
USA Study (N=499 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)
Europe/Canada/ Australia Study (N=503 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)
Europe Study (N=491 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 (AZA 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.

heart

[see

14.2 Heart Transplantation

A 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

	All Patients (ITT)		Treated Patients
	AZA N = 323	Mycophenolate Mofetil N = 327	AZA N = 289	Mycophenolate Mofetil N = 289
Biopsy-proven rejection with hemodynamic compromise at 6 months^a	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.

]

or liver transplants

[see

14.3 Liver Transplantation

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%)

]

, in combination with other immunosuppressants.

Allergic reactions to mycophenolate mofetil for injection have been observed; therefore, mycophenolate mofetil for injection is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate mofetil for injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).

The following adverse reactions are discussed in greater detail in other sections of the label:

Embryofetal Toxicity
[see
5.1 Embryofetal Toxicity
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)].
]
Lymphomas and Other Malignancies
[see
5.2 Lymphoma and Other Malignancies
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)].
]
Serious Infections
[see
5.3 Serious Infections
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.
]
Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia
[see
5.4 Blood Dyscrasias:
Neutropenia and Pure Red Cell Aplasia (PRCA)
Severe neutropenia [absolute neutrophil count (ANC) < 0.5 x 10³/μL] developed in transplant patients receiving mycophenolate mofetil 3 g daily
[see Adverse Reactions (6.1)].
Patients receiving mycophenolate mofetil should be monitored for neutropenia
.
Neutropenia has been observed most frequently in the period from 31 to 180 days post-transplant in patients treated for prevention of kidney, heart and liver rejection. The development of neutropenia may be related to mycophenolate mofetil itself, concomitant medications, viral infections, or a combination of these causes. If neutropenia develops (ANC < 1.3 x 10³/μL), dosing with mycophenolate mofetil should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately
[see Dosage and Administration (2.5)].
Patients receiving mycophenolate mofetil should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Consider monitoring with complete blood counts weekly for the first month, twice monthly for the second and third months, and monthly for the remainder of the first year.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. In some cases, PRCA was found to be reversible with dose reduction or cessation of mycophenolate mofetil therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
]
Gastrointestinal Complications
[see
5.5 Gastrointestinal Complications
Gastrointestinal bleeding requiring hospitalization, ulceration and perforations were observed in clinical trials. Physicians should be aware of these serious adverse effects particularly when administering mycophenolate mofetil to patients with a gastrointestinal disease.
]
Acute Inflammatory Syndrome Associated with Mycophenolate Products
[see
5.7 Acute
Inflammatory Syndrome Associated with Mycophenolate Products
Acute inflammatory syndrome (AIS) has been reported with the use of MMF and mycophenolate products, and some cases have resulted in hospitalization. AIS is a paradoxical pro-inflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain and elevated inflammatory markers including, C-reactive protein and erythrocyte sedimentation rate, without evidence of infection or underlying disease recurrence. Symptoms occur within weeks to months of initiation of treatment or a dose increase. After discontinuation, improvement of symptoms and inflammatory markers are usually observed within 24 to 48 hours.
Monitor patients for symptoms and laboratory parameters of AIS when starting treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider other treatment alternatives based on the risk and benefit for the patient.
]

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.

The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has molecular formula of C₂₃H₃₁NO₇, a molecular weight of 433.49 g/mol, and the following structural formula:

Mycophenolate mofetil, USP is a white to off-white crystalline powder. It is practically insoluble in water; the solubility increases in acidic medium (2.87 mg/mL at pH 1.2). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 2.42. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group.

Mycophenolate mofetil hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.

Mycophenolate mofetil for injection, USP is the hydrochloride salt of mycophenolate mofetil, USP. The chemical name for the hydrochloride salt of mycophenolate mofetil is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has molecular formula of C₂₃H₃₁NO₇ HCl and a molecular weight of 469.96 g/mol.

Mycophenolate mofetil for injection, USP is available as a sterile, white to off-white lyophilized powder in single-dose vials containing mycophenolate mofetil hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil, USP equivalent to 542.1 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg; and citric acid anhydrous, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection, USP to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of mycophenolate mofetil, 6 mg/mL

[see

2.6 Preparation
Instructions of Intravenous for Pharmacists

General Preparation Instructions Before Handling the Formulations

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures¹

[see Warnings and Precautions (5.1), Adverse Reactions (6.2), Use in Specific Populations (8.1, 8.3), How Supplied/Storage and Handling (16.1)].

Care should be taken to avoid direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil for injection because mycophenolate mofetil has demonstrated teratogenic effects in humans

Wearing disposable gloves is recommended during reconstitution of mycophenolate mofetil for injection and when wiping the outer surface of the vial and the table surface after reconstitution. If such contact occurs, wash hands thoroughly with soap and water; rinse eyes with water.

Mycophenolate Mofetil for Injection

Before proceeding with the preparation steps for mycophenolate mofetil for injection read the general preparation instructions

[see General Preparation Instructions Before Handling the Formulation]

and note the following:

Mycophenolate mofetil for injection does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
This product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding the diluent, the vial should not be used.

Mycophenolate mofetil for injection must be reconstituted and further diluted. A detailed description of the preparation is given below.

Table 4: Preparation Instructions of Mycophenolate Mofetil for Injection for Pharmacists

Preparation of the

1 g dose

Reconstitute
two (2) vials of mycophenolate mofetil for injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.
Gently shake the vial to dissolve the drug.
Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.
Dilute
the contents of the two reconstituted vials (approximately 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP.
Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed.

Preparation of the

1.5 g dose

Reconstitute
three (3) vials of mycophenolate mofetil for injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.
Gently shake the vial to dissolve the drug.
Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.
Dilute
the contents of the three reconstituted vials (approximately 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP.
Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed.

The administration of the infusion should be initiated within 4 hours of reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Discard unused portion of the reconstituted solutions.

Mycophenolate mofetil for injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

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