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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 17.05.2022
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Renal, Cardiac and Hepatic Transplant
Mycophenolate Mofetil Suspension for injection is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate Mofetil Suspension for injection should be used concomitantly with cyclosporine and corticosteroids.
Mycophenolate Mofetil Suspension for injection is an alternative dosage form to Mycophenolate Mofetil Suspension capsules, tablets and oral suspension. Mycophenolate Mofetil Suspension for injection should be administered within 24 hours following transplantation. Mycophenolate Mofetil Suspension for injection can be administered up to 14 days; patients should be switched to oral Mycophenolate Mofetil Suspension as soon as they can tolerate oral medication.
Mycophenolate Mofetil Suspension (Mycophenolate Mofetil Suspension) is an immunosuppressant, a medicine that lowers your body's immune system. The immune system helps your body fight infections. Your body may "reject" an organ transplant when the immune system treats the new organ as an invader. An immunosuppressant helps to prevent this rejection.
Mycophenolate Mofetil Suspension is used to prevent your body from rejecting a kidney, liver, or heart transplant. Mycophenolate Mofetil Suspension is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.
Renal Transplantation
Adults
A dose of 1 g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g/day of Mycophenolate Mofetil Suspension demonstrated an overall better safety profile than did patients receiving 3 g/day of Mycophenolate Mofetil Suspension.
Pediatrics (3 months to 18 years of age)
The recommended dose of Mycophenolate Mofetil Suspension oral suspension is 600 mg/m² administered twice daily (up to a maximum daily dose of 2 g/10 mL oral suspension). Patients with a body surface area of 1.25 m² to 1.5 m² may be dosed with Mycophenolate Mofetil Suspension capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area > 1.5 m² may be dosed with Mycophenolate Mofetil Suspension capsules or tablets at a dose of 1 g twice daily (2 g daily dose).
Cardiac Transplantation
Adults
A dose of 1.5 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult cardiac transplant patients.
Hepatic Transplantation
Adults
A dose of 1 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult hepatic transplant patients.
Mycophenolate Mofetil Suspension Capsules, Tablets, And
Oral Suspension
The initial oral dose of Mycophenolate Mofetil Suspension should be given as soon as possible following renal, cardiac or hepatic transplantation. Food had no effect on MPA AUC, but has been shown to decrease MPA Cmax by 40%. Therefore, it is recommended that Mycophenolate Mofetil Suspension be administered on an empty stomach. However, in stable renal transplant patients, Mycophenolate Mofetil Suspension may be administered with food if necessary.
Patients should be instructed to take a missed dose as soon as they remember, except if it is near the next scheduled dose, and then continue to take Mycophenolate Mofetil Suspension at the usual times.
Note:
If required, Mycophenolate Mofetil Suspension
Oral Suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Patients With Hepatic Impairment
No dose adjustments are recommended for renal patients with severe hepatic parenchymal disease. However, it is not known whether dose adjustments are needed for hepatic disease with other etiologies.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Geriatrics
The recommended oral dose of 1 g bid for renal transplant patients, 1.5 g bid for cardiac transplant patients, and 1 g bid administered intravenously or 1.5 g bid administered orally in hepatic transplant patients is appropriate for elderly patients.
Preparation Of
Oral Suspension
It is recommended that Mycophenolate Mofetil Suspension
Oral Suspension be constituted by the pharmacist prior to dispensing to the patient.
Mycophenolate Mofetil Suspension
Oral Suspension should not be mixed with any other medication.
Mycophenolate Mofetil Suspension has demonstrated teratogenic effects in humans. There are no adequate and well-controlled studies in pregnant women. Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water.
- Tap the closed bottle several times to loosen the powder.
- Measure 94 mL of water in a graduated cylinder.
- Add approximately half the total amount of water for constitution to the bottle and shake the closed bottle well for about 1 minute.
- Add the remainder of water and shake the closed bottle well for about 1 minute.
- Remove the child-resistant cap and push bottle adapter into neck of bottle.
- Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Dispense with patient instruction sheet and oral dispensers. It is recommended to write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)
After constitution the oral suspension contains 200 mg/mL Mycophenolate Mofetil Suspension. Store constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Storage in a refrigerator at 2° to 8°C (36° to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.
Mycophenolate Mofetil Suspension
Intravenous
Adults
Mycophenolate Mofetil Suspension
Intravenous is an alternative dosage form to Mycophenolate Mofetil Suspension capsules, tablets and oral suspension recommended for patients unable to take oral Mycophenolate Mofetil Suspension. Mycophenolate Mofetil Suspension
Intravenous should be administered within 24 hours following transplantation. Mycophenolate Mofetil Suspension
Intravenous can be administered for up to 14 days; patients should be switched to oral Mycophenolate Mofetil Suspension as soon as they can tolerate oral medication.
Mycophenolate Mofetil Suspension
Intravenous must be reconstituted and diluted to a concentration of 6 mg/mL using 5% Dextrose Injection USP. Mycophenolate Mofetil Suspension
Intravenous is incompatible with other intravenous infusion solutions. Following reconstitution, Mycophenolate Mofetil Suspension
Intravenous must be administered by slow intravenous infusion over a period of NO LESS THAN 2 HOURS by either peripheral or central vein.
CAUTION: Mycophenolate Mofetil Suspension INTRAVENOUS SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
Preparation Of Infusion Solution (6 mg/mL)
Caution should be exercised in the handling and preparation of solutions of Mycophenolate Mofetil Suspension
Intravenous. Avoid direct contact of the prepared solution of Mycophenolate Mofetil Suspension
Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Mycophenolate Mofetil Suspension
Intravenous does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions. Additionally, 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 diluent, the vial should not be used.
Mycophenolate Mofetil Suspension
Intravenous infusion solution must be prepared in two steps: the first step is a reconstitution step with 5% Dextrose Injection USP, and the second step is a dilution step with 5% Dextrose Injection USP. A detailed description of the preparation is given below:
Step 1
- Two (2) vials of Mycophenolate Mofetil Suspension
Intravenous are used for preparing each 1 g dose, whereas three (3) vials are needed for each 1.5 g dose. Reconstitute the contents of each vial by injecting 14 mL of 5% Dextrose Injection USP.
- 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.
Step 2
- To prepare a 1 g dose, further dilute the contents of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP. To prepare a 1.5 g dose, further dilute the contents of the three reconstituted vials (approx. 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP. The final concentration of both solutions is 6 mg Mycophenolate Mofetil Suspension per mL.
- Inspect the infusion solution for particulate matter or discoloration. Discard the infusion solution if particulate matter or discoloration is observed.
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from 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).
Mycophenolate Mofetil Suspension
Intravenous should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
Dosage Adjustments
In renal transplant patients with severe chronic renal impairment (GFR < 25 mL/min/1.73 m²) outside the immediate posttransplant period, doses of Mycophenolate Mofetil Suspension greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in renal transplant patients experiencing delayed graft function postoperatively.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Mycophenolate Mofetil Suspension may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
If neutropenia develops (ANC < 1.3 x 10/μL), dosing with Mycophenolate Mofetil Suspension should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately.
Handling And Disposal
Mycophenolate Mofetil Suspension has demonstrated teratogenic effects in humans. Mycophenolate Mofetil Suspension tablets should not be crushed and Mycophenolate Mofetil Suspension capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Mycophenolate Mofetil Suspension capsules and Mycophenolate Mofetil Suspension
Oral Suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. Should a spill occur, wipe up using paper towels wetted with water to remove spilled powder or suspension. Caution should be exercised in the handling and preparation of solutions of Mycophenolate Mofetil Suspension
Intravenous. Avoid direct contact of the prepared solution of Mycophenolate Mofetil Suspension
Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
How supplied
Mycophenolate Mofetil Suspension (Mycophenolate Mofetil Suspension capsules) 250 mg
Blue-brown, two-piece hard gelatin capsules, printed in black with “Mycophenolate Mofetil Suspension 250” on the blue cap and “Roche” on the brown body. Supplied in the following presentations:
NDC Number | Size |
NDC 0004-0259-01 | Bottle of 100 |
NDC 0004-0259-05 | Package containing 12 bottles of 120 |
NDC 0004-0259-43 | Bottle of 500 |
Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Mycophenolate Mofetil Suspension (Mycophenolate Mofetil Suspension tablets) 500 mg
Lavender-colored, caplet-shaped, film-coated tablets printed in black with “Mycophenolate Mofetil Suspension 500” on one side and “Roche” on the other. Supplied in the following presentations:
NDC Number | Size |
NDC 0004-0260-01 | Bottle of 100 |
NDC 0004-0260-43 | Bottle of 500 |
Storage And Dispensing Information
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.
Mycophenolate Mofetil Suspension
Oral Suspension (Mycophenolate Mofetil Suspension for oral suspension)
Supplied as a white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension. Supplied in the following presentation:
NDC Number | Size |
NDC 0004-0260-01 | Bottle of 100 |
NDC 0004-0260-43 | Bottle of 500 |
Storage
Store dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Store constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) for up to 60 days. Storage in a refrigerator at 2° to 8°C (36° to 46°F) is acceptable. Do not freeze.
Mycophenolate Mofetil Suspension
Intravenous (Mycophenolate Mofetil Suspension hydrochloride for injection)
Supplied in a 20 mL, sterile vial containing the equivalent of 500 mg Mycophenolate Mofetil Suspension as the hydrochloride salt in cartons of 4 vials:
NDC Number |
NDC 0004-0298-09 |
Storage
Store powder and reconstituted/infusion solutions at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Distributed by: Genentech USA, Inc. A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: September 2013
See also:
What is the most important information I should know about Mycophenolate Mofetil Suspension?
Mycophenolate Mofetil Suspension can harm an unborn baby or cause birth defects, especially if used during the first trimester of pregnancy. Do not use if you are pregnant.
If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy before and during your treatment with Mycophenolate Mofetil Suspension, and for at least 6 weeks after your treatment ends. You will also need to have a negative pregnancy test within 1 week before you start using this medication.
Tell your doctor right away if you become pregnant while using Mycophenolate Mofetil Suspension.
Although Mycophenolate Mofetil Suspension can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Mycophenolate Mofetil Suspension is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.
Using Mycophenolate Mofetil Suspension can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of cancer. Your blood will need to be tested on a weekly or monthly basis while using this medication. Do not miss any scheduled appointments.
Do not open the Mycophenolate Mofetil Suspension capsule or crush or chew a tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin.
Use Mycophenolate Mofetil Suspension capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Mycophenolate Mofetil Suspension capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mycophenolate Mofetil Suspension capsules refilled.
- Take Mycophenolate Mofetil Suspension capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating unless your doctor tells you otherwise.
- Swallow Mycophenolate Mofetil Suspension capsules whole. Do not break, crush, chew, or open the capsule before swallowing. If capsules are opened accidentally, do not inhale or touch the powder contained inside the capsules. If contact occurs, wash the contact area immediately with soap and water; rinse eyes with plain water.
- If you cannot swallow Mycophenolate Mofetil Suspension capsules whole, check with your doctor. You may need a different doseform of Mycophenolate Mofetil Suspension capsules.
- If you take antacids that contain aluminum or magnesium, do not take them at the same time as Mycophenolate Mofetil Suspension capsules. Ask your doctor or pharmacist how to take them with Mycophenolate Mofetil Suspension capsules.
- If you take sevelamer, take it 2 hours after taking Mycophenolate Mofetil Suspension capsules.
- Do not stop taking Mycophenolate Mofetil Suspension capsules or change the dose unless your doctor tells you to.
- If you miss a dose of Mycophenolate Mofetil Suspension capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Check with your doctor if you are not sure what to do.
Ask your health care provider any questions you may have about how to use Mycophenolate Mofetil Suspension capsules.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Organ transplantation: Prophylaxis of organ rejection in patients receiving allogeneic renal (Mycophenolate Mofetil Suspension [Mycophenolate Mofetil Suspension], Mycophenolate Mofetil Suspension [enteric-coated mycophenolate sodium]), cardiac (Mycophenolate Mofetil Suspension), or liver (Mycophenolate Mofetil Suspension) transplants, in combination with other immunosuppressants
Note: While traditionally used in combination with cyclosporine, mycophenolate is now used primarily in combination with tacrolimus and, to a lesser extent, with a mammalian target of rapamycin inhibitor (everolimus or sirolimus) for prophylaxis of rejection in renal, cardiac, and hepatic transplants (AASLD [Lucey 2013]; Aliabadi 2012; Eisen 2013; Groetzner 2009; Guethoff 2013; ISHLT [Costanzo 2010]; KDIGO [Chapman 2010]).
Mycophenolate Mofetil Suspension may also be used to prevent organ rejection in patients receiving cardiac and hepatic transplantations although not labeled for these transplantations (Lehmkuhl 2008; Wang 2015).
Off Label Uses
Acute graft-versus-host disease, refractory (treatment)
Data from a multicenter, randomized, 4-arm phase II trial in patients with acute graft-versus-host disease (GVHD) who had undergone an allogeneic hematopoietic stem cell transplantation (HSCT) support the use of mycophenolate (in combination with corticosteroids) in the treatment of this condition. Additional trials may be necessary to further define the role of mycophenolate in this condition.
See also:
What other drugs will affect Mycophenolate Mofetil Suspension?
Acyclovir: Higher MPAG (the phenolic glucuronide of MPA) and acyclovir plasma concentrations were observed when Mycophenolate Mofetil Suspension was administered with acyclovir than when the drugs were administered alone. Because MPAG plasma concentrations are increased in the presence of renal impairment, as are acyclovir concentrations, the potential exists for mycophenolate and acyclovir or its prodrugs eg, valacyclovir, to compete for tubular secretion, further increasing the concentrations of both drugs.
Antacids and Proton Pump Inhibitors (PPIs): Decreased mycophenolic acid (MPA) exposure has been observed when antacids eg, magnesium and aluminium hydroxides and PPIs, including lansoprazole and pantoprazole were administered with Mycophenolate Mofetil Suspension. When comparing rates of transplant rejection or rates of graft loss between Mycophenolate Mofetil Suspension patients taking PPIs versus Mycophenolate Mofetil Suspension patients not taking PPIs, no significant differences were seen. These data support extrapolation of this finding to all antacids because the reduction in exposure when Mycophenolate Mofetil Suspension was co-administered with magnesium and aluminium hydroxides is considerably lower than when Mycophenolate Mofetil Suspension was co-administered with PPIs.
Cholestyramine: Following single-dose administration of Mycophenolate Mofetil Suspension 1.5 g to normal healthy subjects pre-treated with 4 g three times daily of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA. Caution should be used during concomitant administration or with drugs that interfere with enterohepatic circulation..
Ciclosporin A: Ciclosporin A (CsA) pharmacokinetics was unaffected by Mycophenolate Mofetil Suspension. However, in renal transplant patients, concomitant administration of Mycophenolate Mofetil Suspension and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of Mycophenolate Mofetil Suspension.
Ganciclovir: Based on the results of a single-dose administration study of recommended doses of mycophenolate oral and ganciclovir IV, and the known effects of renal impairment on the pharmacokinetics of Mycophenolate Mofetil Suspension and ganciclovir, it is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration. No substantial alteration of MPA pharmacokinetics is anticipated and Mycophenolate Mofetil Suspension dose adjustment is not required. In patients with renal impairment in which Mycophenolate Mofetil Suspension and ganciclovir or its prodrugs eg, valganciclovir are co-administered, patients should be monitored carefully.
Oral Contraceptives:
Rifampicin: After correction for dose, a 70% decrease in MPA exposure (AUC0-12) has been observed with concomitant rifampicin administration in a single heart-lung transplant patient. It is therefore recommended to monitor MPA exposure levels and to adjust Mycophenolate Mofetil Suspension doses accordingly to maintain clinical efficacy when the drugs are administered concomitantly.
Tacrolimus: Exposure to tacrolimus concomitantly administered with Mycophenolate Mofetil Suspension had no effect on the AUC or Cmax of MPA in liver transplant recipients. A similar finding was observed in a recent study in kidney transplant recipients.
In renal transplant patients, it was shown that the tacrolimus concentration did not appear to be altered by Mycophenolate Mofetil Suspension.
However, in stable hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of Mycophenolate Mofetil Suspension (1.5 g twice daily) were administered to patients taking tacrolimus.
Trimethoprim/Sulfamethoxazole, Norfloxacin and Metronidazole: No effect on the systemic exposure of MPA was observed when Mycophenolate Mofetil Suspension was concomitantly administered with any antibiotic separately. In contrast, the combination of norfloxacin and metronidazole reduced the MPA AUC0-48 by 30% following a single dose of Mycophenolate Mofetil Suspension.
Ciprofloxacin and Amoxicillin Plus Clavulanic Acid: Reductions in pre-dose (trough) MPA concentrations of 54% have been reported in renal transplant recipients in the days immediately following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid. Effects tended to diminish with continued antibiotic use and cease after discontinuation. The change in pre-dose level may not accurately represent changes in overall MPA exposure therefore clinical relevance of these observations is unclear.
Others: Co-administration of probenecid with Mycophenolate Mofetil Suspension in monkeys raises plasma AUC of MPAG by 3-fold. Thus, other drugs known to undergo renal tubular secretion may compete with MPAG and thereby, raise plasma concentrations of MPAG or the other drug undergoing tubular secretion.
Concomitant administration of sevelamer and Mycophenolate Mofetil Suspension in adults and pediatric patients decreased the MPA Cmax and AUC0-12 by 30% and 25%, respectively. These data suggest that sevelamer and other calcium-free phosphate binders preferentially should be given 2 hrs after Mycophenolate Mofetil Suspension intake to minimize the impact on the absorption of MPA.
Live Vaccines: Live vaccines should not be given to patients with an impaired immune response. The antibody response to other vaccines may be diminished.
See also:
What are the possible side effects of Mycophenolate Mofetil Suspension?
The principal adverse reactions associated with the administration of Mycophenolate Mofetil Suspension include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection. The adverse event profile associated with the administration of Mycophenolate Mofetil Suspension intravenous has been shown to be similar to that observed after administration of oral dosage forms of Mycophenolate Mofetil Suspension.
Mycophenolate Mofetil Suspension
Oral
The incidence of adverse events for Mycophenolate Mofetil Suspension was determined in randomized, comparative, double-blind trials in prevention of rejection in renal (2 active, 1 placebo-controlled trials), cardiac (1 active-controlled trial), and hepatic (1 active-controlled trial) transplant patients.
Geriatrics
Elderly patients (≥65 years), particularly those who are receiving Mycophenolate Mofetil Suspension as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus [CMV] tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared to younger individuals.
Safety data are summarized below for all active-controlled trials in renal (2 trials), cardiac (1 trial), and hepatic (1 trial) transplant patients. Approximately 53% of the renal patients, 65% of the cardiac patients, and 48% of the hepatic patients have been treated for more than 1 year. Adverse events reported in ≥20% of patients in the Mycophenolate Mofetil Suspension treatment groups are presented below.
The placebo-controlled renal transplant study generally showed fewer adverse events occurring in ≥20% of patients. In addition, those that occurred were not only qualitatively similar to the azathioprine-controlled renal transplant studies, but also occurred at lower rates, particularly for infection, leukopenia, hypertension, diarrhea and respiratory infection.
The above data demonstrate that in three controlled trials for prevention of renal rejection, patients receiving 2 g/day of Mycophenolate Mofetil Suspension had an overall better safety profile than did patients receiving 3 g/day of Mycophenolate Mofetil Suspension.
The above data demonstrate that the types of adverse events observed in multicenter controlled trials in renal, cardiac, and hepatic transplant patients are qualitatively similar except for those that are unique to the specific organ involved.
Sepsis, which was generally CMV viremia, was slightly more common in renal transplant patients treated with Mycophenolate Mofetil Suspension compared to patients treated with azathioprine. The incidence of sepsis was comparable in Mycophenolate Mofetil Suspension and in azathioprine-treated patients in cardiac and hepatic studies.
In the digestive system, diarrhea was increased in renal and cardiac transplant patients receiving Mycophenolate Mofetil Suspension compared to patients receiving azathioprine, but was comparable in hepatic transplant patients treated with Mycophenolate Mofetil Suspension or azathioprine.
Patients receiving Mycophenolate Mofetil Suspension alone or as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The incidence of malignancies among the 1483 patients treated in controlled trials for the prevention of renal allograft rejection who were followed for ≥1 year was similar to the incidence reported in the literature for renal allograft recipients.
Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving Mycophenolate Mofetil Suspension (2 g or 3 g daily) with other immunosuppressive agents in controlled clinical trials of renal, cardiac, and hepatic transplant patients followed for at least 1 year. Non-melanoma skin carcinomas occurred in 1.6% to 4.2% of patients, other types of malignancy in 0.7% to 2.1% of patients. Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.
Severe neutropenia (ANC <0.5 × 10 3/µL) developed in up to 2.0% of renal transplant patients, up to 2.8% of cardiac transplant patients and up to 3.6% of hepatic transplant patients receiving Mycophenolate Mofetil Suspension 3 g daily.
All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load. Table 10 shows the incidence of opportunistic infections that occurred in the renal, cardiac, and hepatic transplant populations in the azathioprine-controlled prevention trials:
The following other opportunistic infections occurred with an incidence of less than 4% in Mycophenolate Mofetil Suspension patients in the above azathioprine-controlled studies: Herpes zoster, visceral disease; Candida, urinary tract infection, fungemia/disseminated disease, tissue invasive disease; Cryptococcosis; Aspergillus/Mucor; Pneumocystis carinii.
In the placebo-controlled renal transplant study, the same pattern of opportunistic infection was observed compared to the azathioprine-controlled renal studies, with a notably lower incidence of the following: Herpes simplex and CMV tissue-invasive disease.
In patients receiving Mycophenolate Mofetil Suspension (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients..
In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with Mycophenolate Mofetil Suspension than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with Mycophenolate Mofetil Suspension.
The following adverse events were reported with 3% to<20% incidence in renal, cardiac, and hepatic transplant patients treated with Mycophenolate Mofetil Suspension, in combination with cyclosporine and corticosteroids.
Pediatrics
The type and frequency of adverse events in a clinical study in 100 pediatric patients 3 months to 18 years of age dosed with Mycophenolate Mofetil Suspension oral suspension 600 mg/m 2 bid (up to 1 g bid) were generally similar to those observed in adult patients dosed with Mycophenolate Mofetil Suspension capsules at a dose of 1 g bid with the exception of abdominal pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis, respiratory tract infection, hypertension, leukopenia, and anemia, which were observed in a higher proportion in pediatric patients.
Mycophenolate Mofetil Suspension
Intravenous
The adverse event profile of Mycophenolate Mofetil Suspension intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral Mycophenolate Mofetil Suspension in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of Mycophenolate Mofetil Suspension intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of Mycophenolate Mofetil Suspension intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.
Adverse events attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with Mycophenolate Mofetil Suspension intravenous.
In the active controlled study in hepatic transplant patients, 2 g/day of Mycophenolate Mofetil Suspension intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous Mycophenolate Mofetil Suspension was similar to that of intravenous azathioprine.
Postmarketing Experience
Congenital Disorders : Embryofetal Toxicity:Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to Mycophenolate Mofetil Suspension during pregnancy.
Digestive
Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy.
Hematologic and Lymphatic:
Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with Mycophenolate Mofetil Suspension in combination with other immunosuppressive agents.
Infections :
- Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally
- There is evidence of a higher frequency of certain types of serious infections such as tuberculosis and atypical mycobacterial infection.
- Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with Mycophenolate Mofetil Suspension. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function.
Polyomavirus associated neuropathy (PVAN), especially due to BK virus infection, has been observed in patients receiving immunosuppressants, including Mycophenolate Mofetil Suspension. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
- Viral reactivation has been reported in patients infected with HBV or HCV.
Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in posttransplant patients receiving Mycophenolate Mofetil Suspension.
Each gastro-resistant tablet contains mycophenolic acid 180 mg or 360 mg equivalent to mycophenolate sodium 192.4 mg or 384.4 mg.
Mycophenolate Mofetil Suspension also contains the following excipients: Maize starch, povidone (K-30), crospovidone, lactose, colloidal silicon dioxide, magnesium stearate. Tablet Coating: Hypromellose phthalate/hydroxypropylmethylcellulose phthalate, titanium dioxide, iron oxide yellow, indigotin (180-mg tab only), iron oxide red (360-mg tab only).
Mycophenolate sodium is the sodium salt of the active moiety, mycophenolic acid.
However, we will provide data for each active ingredient