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mycophenolate mofetil
Overview
What is mycophenolate mofetil?
Mycophenolate mofetil 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 an empirical formula of CHNO, a molecular weight of 433.50, and the following structural formula:
Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). 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 238. The pKa values for mycophenolate mofetil 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 is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, and tablets containing 500 mg of mycophenolate mofetil.
Inactive ingredients in mycophenolate mofetil 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-30), microcrystalline cellulose. The capsule shells contain yellow iron oxide, FD&C red # 3, gelatin, sodium lauryl sulfate, and titanium dioxide.
Inactive ingredients in mycophenolate mofetil 500 mg tablets include microcrystalline cellulose, croscarmellose sodium, povidone [K-30], magnesium stearate (Vegetable) and opadry brown.
The opadry brown contains FD & C blue #1 aluminum lake, FD & C red #40 aluminum lake, hypromellose, iron oxide red, polyethylene glycol and titanium dioxide.
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How should I use mycophenolate mofetil?
What interacts with mycophenolate mofetil?
Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Mycophenolate mofetil Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
What are the warnings of mycophenolate mofetil?
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Lymphoma and Malignancy
Patients receiving immunosuppressive regimens involving combinations of drugs, including mycophenolate mofetil, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see ). The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Lymphoproliferative disease or lymphoma 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 renal, cardiac, and hepatic transplant patients (see ).
In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148) patients have been observed (see )
Combination with Other Immunosuppressive Agents
Mycophenolate mofetil has been administered in combination with the following agents in clinical trials: antithymocyte globulin (ATGAM), OKT3 (Orthoclone OKT3), cyclosporine (Sandimmune, Neoral) and corticosteroids. The efficacy and safety of the use of mycophenolate mofetil in combination with other immunosuppressive agents have not been determined.
Infections
Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis. In patients receiving mycophenolate mofetil (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 (see ).
Latent Viral Infections
Immunosuppressed patients are at increased risk for opportunistic infections, including activation oflatent viral infections. These include cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) which have been observed in patients receiving immunosuppressants, including mycophenolate mofetil.
Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil. Hemiparesis, apathy, confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated. Consideration should be given to reducing the amount of immunosuppression in patients who develop PML. In transplant patients, physicians should also consider the risk that reduced immunosuppression represents to the graft.
BKVAN is associated with serious outcomes, including deteriorating renal function and renal graft loss (see ). Patient monitoring may help detect patients at risk for BK virus-associated nephropathy. Reduction in immunosuppression should be considered for patients who develop evidence of BK virus-associated nephropathy.
Pregnancy: Teratogenic Effects: Pregnancy Category D
Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant woman. 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, and kidney. In the National Transplantation Pregnancy Registry (NTPR), there were data on 33 MMF-exposed pregnancies in 24 transplant patients; there were 15 spontaneous abortions (45%) and 18 live-born infants. Four of these 18 infants had structural malformations (22%). In postmarketing data (collected from 1995 to 2007) on 77 women exposed to systemic MMF during pregnancy, 25 had spontaneous abortions and 14 had a malformed infant or fetus. Six of 14 malformed offspring had ear abnormalities. Because these postmarketing data are reported voluntarily, it is not always possible to reliably estimate the frequency of particular adverse outcomes. These malformations seen in offspring were similar to findings in animal reproductive toxicology studies. For comparison, the background rate for congenital anomalies in the United States is about 3%, and NTPR data show a rate of 4-5% among babies born to organ transplant patients using other immunosuppressive drugs.
In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Female rats and rabbits received mycophenolate mofetil (MMF) doses equivalent to 0.02 to 0.9 times the recommended human dose for renal and cardiac transplant patients, based on body surface area conversions. In rat offspring, malformations included anophthalmia, agnathia, and hydrocephaly. In rabbit offspring, malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In certain situations, the patient and her healthcare practitioner may decide that the maternal benefits outweigh the risks to the fetus. Women using mycophenolate mofetil at any time during pregnancy should be encouraged to enroll in the National Transplantation Pregnancy Registry.
Pregnancy Exposure Prevention
Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. Mycophenolate mofetil therapy should not be initiated until a negative pregnancy test report is obtained.
Women of childbearing potential (including pubertal girls and peri-menopausal women) taking mycophenolate mofetil must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting mycophenolate mofetil therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping mycophenolate mofetil. Patients should be aware that mycophenolate mofetil reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. (See and ).
Neutropenia
Severe neutropenia [absolute neutrophil count (ANC) <0.5 x 10/mcL] developed in up to 2.0% of renal, up to 2.8% of cardiac, and up to 3.6% of hepatic transplant patients receiving mycophenolate mofetil 3 g daily (see Patients receiving mycophenolate mofetil should be monitored for neutropenia (see ). The development of neutropenia may be related to mycophenolate mofetil itself, concomitant medications, viral infections, or some combination of these causes. If neutropenia develops (ANC <1.3 x 10/mcL), dosing with mycophenolate mofetil should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see ). Neutropenia has been observed most frequently in the period from 31 to 180 days posttransplant in patients treated for prevention of renal, cardiac, and hepatic rejection.
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.
Pure Red Cell Aplasia (PRCA)
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. 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.
CAUTION: MYCOPHENOLATE MOFETIL INTRAVENOUS SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
What are the precautions of mycophenolate mofetil?
General
Gastrointestinal bleeding (requiring hospitalization) has been observed in approximately 3% of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with mycophenolate mofetil 3 g daily. In pediatric renal transplant patients, 5/148 cases of gastrointestinal bleeding (requiring hospitalization) were observed.
Gastrointestinal perforations have rarely been observed. Most patients receiving mycophenolate mofetil were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with mycophenolate mofetil. Because mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, mycophenolate mofetil should be administered with caution in patients with active serious digestive system disease.
Subjects with severe chronic renal impairment (GFR <25 mL/min/1.73 m) who have received single doses of mycophenolate mofetil showed higher plasma MPA and MPAG AUCs relative to subjects with lesser degrees of renal impairment or normal healthy volunteers. No data are available on the safety of long-term exposure to these levels of MPAG. Doses of mycophenolate mofetil greater than 1 g administered twice a day to renal transplant patients should be avoided and they should be carefully observed (see and ).
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Mycophenolate mofetil may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
In patients with delayed renal graft function posttransplant, mean MPA AUC(0-12h) was comparable, but MPAG AUC(0-12h) was 2-fold to 3-fold higher, compared to that seen in posttransplant patients without delayed renal graft function. In the three controlled studies of prevention of renal rejection, there were 298 of 1483 patients (20%) with delayed graft function. Although patients with delayed graft function have a higher incidence of certain adverse events (anemia, thrombocytopenia, hyperkalemia) than patients without delayed graft function, these events were not more frequent in patients receiving mycophenolate mofetil than azathioprine or placebo. No dose adjustment is recommended for these patients; however, they should be carefully observed (see and ). In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with mycophenolate mofetil than in those receiving azathioprine therapy, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with mycophenolate mofetil (see ).
There were more herpes virus (H. simplex, H. zoster, and cytomegalovirus) infections in cardiac transplant patients treated with mycophenolate mofetil compared to those treated with azathioprine (see ).
It is recommended that mycophenolate mofetil not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied clinically.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in the concomitant administration of mycophenolate mofetil with drugs that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of mycophenolate mofetil (see ).
On theoretical grounds, because mycophenolate mofetil is an IMPDH (inosine monophosphate dehydrogenase) inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
During treatment with mycophenolate mofetil, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see ).
Phenylketonurics
Mycophenolate mofetil Oral Suspension contains aspartame, a source of phenylalanine (0.56 mg phenylalanine/mL suspension). Therefore, care should be taken if mycophenolate mofetil Oral Suspension is administered to patients with phenylketonuria.
Information for Patients
Laboratory Tests
Complete blood counts should be performed weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year (see and ).
Drug Interactions
Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.
Acyclovir
Coadministration of mycophenolate mofetil (1 g) and acyclovir (800 mg) to 12 healthy volunteers resulted in no significant change in MPA AUC and C. However, MPAG and acyclovir plasma AUCs were increased 10.6% and 21.9%, respectively. 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 prodrug (e.g., valacyclovir) to compete for tubular secretion, further increasing the concentrations of both drugs.
Antacids With Magnesium and Aluminum Hydroxides
Absorption of a single dose of mycophenolate mofetil (2 g) was decreased when administered to ten rheumatoid arthritis patients also taking MaaloxTC (10 mL qid). The C and AUC (0-24h) for MPA were 33% and 17% lower, respectively, than when mycophenolate mofetil was administered alone under fasting conditions. Mycophenolate mofetil may be administered to patients who are also taking antacids containing magnesium and aluminum hydroxides; however, it is recommended that mycophenolate mofetil and the antacid not be administered simultaneously.
Cholestyramine
Following single-dose administration of 1.5 g mycophenolate mofetil to 12 healthy volunteers pretreated with 4 g tid of cholestyramine for 4 days, MPA AUC decreased approximately 40%. This decrease is consistent with interruption of enterohepatic recirculation which may be due to binding of recirculating MPAG with cholestyramine in the intestine. Some degree of enterohepatic recirculation is also anticipated following intravenous administration of mycophenolate mofetil. Therefore, mycophenolate mofetil is not recommended to be given with cholestyramine or other agents that may interfere with enterohepatic recirculation.
Cyclosporine
Cyclosporine (Sandimmune) pharmacokinetics (at doses of 275 to 415 mg/day) were unaffected by single and multiple doses of 1.5 g bid of mycophenolate mofetil in 10 stable renal transplant patients. The mean (±SD) AUC (0-12h) and C of cyclosporine after 14 days of multiple doses of mycophenolate mofetil were 3290 (±822) ng•h/mL and 753 (±161) ng/mL, respectively, compared to 3245 (±1088) ng•h/mL and 700 (±246) ng/mL, respectively, 1 week before administration of mycophenolate mofetil.
In renal transplant patients, mean MPA exposure (AUC) was approximately 30-50% greater when mycophenolate mofetil is administered without cyclosporine compared with when mycophenolate mofetil is coadministered with cyclosporine. This interaction is due to cyclosporine inhibition of multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract, thereby preventing the excretion of MPAG into the bile that would lead to enterohepatic recirculation of MPA. This information should be taken into consideration when MMF is used without cyclosporine.
Ganciclovir
Following single-dose administration to 12 stable renal transplant patients, no pharmacokinetic interaction was observed between mycophenolate mofetil (1.5 g) and intravenous ganciclovir (5 mg/kg). Mean (±SD) ganciclovir AUC and C (n=10) were 54.3 (±19.0) mcg•h/mL and 11.5 (±1.8) mcg/mL, respectively, after coadministration of the two drugs, compared to 51.0 (±17.0) mcg•h/mL and 10.6 (±2.0) mcg/mL, respectively, after administration of intravenous ganciclovir alone. The mean (±SD) AUC and C of MPA (n=12) after coadministration were 80.9 (±21.6) mcg•h/mL and 27.8 (±13.9) mcg/mL, respectively, compared to values of 80.3 (±16.4) mcg•h/mL and 30.9 (±11.2) mcg/mL, respectively, after administration of mycophenolate mofetil alone. Because MPAG plasma concentrations are increased in the presence of renal impairment, as are ganciclovir concentrations, the two drugs will compete for tubular secretion and thus further increases in concentrations of both drugs may occur. In patients with renal impairment in which MMF and ganciclovir or its prodrug (eg, valganciclovir) are coadministered, patients should be monitored carefully.
Oral Contraceptives
A study of coadministration of mycophenolate mofetil (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.20 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) was conducted in 18 women with psoriasis over 3 consecutive menstrual cycles. Mean AUC (0-24h) was similar for ethinylestradiol and 3-keto desogestrel; however, mean levonorgestrel AUC (0-24h) significantly decreased by about 15%. There was large inter-patient variability (%CV in the range of 60% to 70%) in the data, especially for ethinylestradiol. Mean serum levels of LH, FSH and progesterone were not significantly affected. Mycophenolate mofetil may not have any influence on the ovulation-suppressing action of the studied oral contraceptives. However, it is recommended that oral contraceptives are coadministered with mycophenolate mofetil with caution and additional birth control methods be considered (see ).
Sevelamer
Concomitant administration of sevelamer and mycophenolate mofetil in adult and pediatric patients decreased the mean MPA C and AUCby 36% and 26% respectively. This data suggest that sevelamer and other calcium free phosphate binders should not be administered simultaneously with mycophenolate mofetil. Alternatively, it is recommended that sevelamer and other calcium free phosphate binders preferentially could be given 2 hours after mycophenolate mofetil intake to minimize the impact on the absorption of MPA.
Trimethoprim/sulfamethoxazole
Following single-dose administration of mycophenolate mofetil (1.5 g) to 12 healthy male volunteers on day 8 of a 10 day course of trimethoprim 160 mg/sulfamethoxazole 800 mg administered bid, no effect on the bioavailability of MPA was observed. The mean (±SD) AUC and C of MPA after concomitant administration were 75.2 (±19.8) mcg•h/mL and 34.0 (±6.6) mcg/mL, respectively, compared to 79.2 (±27.9) mcg•h/mL and 34.2 (±10.7) mcg/mL, respectively, after administration of mycophenolate mofetil alone.
Norfloxacin and Metronidazole
Following single-dose administration of mycophenolate mofetil (1 g) to 11 healthy volunteers on day 4 of a 5 day course of a combination of norfloxacin and metronidazole, the mean MPA AUC was significantly reduced by 33% compared to the administration of mycophenolate mofetil alone (p<0.05). Therefore, mycophenolate mofetil is not recommended to be given with the combination of norfloxacin and metronidazole. There was no significant effect on mean MPA AUC when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately. The mean (±SD) MPA AUC after coadministration of mycophenolate mofetil with norfloxcin or metronidazole separately was 48.3 (±24) mcg·h/mL and 42.7 (±23) mcg·h/mL, respectively, compared with 56.2 (±24) mcg·h/mL after administration of mycophenolate mofetil alone.
Ciprofloxacin and Amoxicillin plus Clavulanic Acid
A total of 64 mycophenolate mofetil-treated renal transplant recipients received either oral ciprofloxacin 500 mg bid or amoxicillin plus clavulanic acid 375 mg tid for 7 or at least 14 days. Approximately 50% reductions in median trough MPA concentrations (predose) from baseline (mycophenolate alone) were observed in 3 days following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid. These reductions in trough MPA concentrations tended to diminish within 14 days of antibiotic therapy and ceased within 3 days after discontinuation of antibiotics. The postulated mechanism for this interaction is an antibiotic-induced reduction in glucuronidase-possessing enteric organisms leading to a decrease in enterohepatic recirculation of MPA. The change in trough level may not accurately represent changes in overall MPA exposure; therefore, clinical relevance of these observations is unclear.
Rifampin
In a single heart-lung transplant patient, after correction for dose, a 67% decrease in MPA exposure (AUC) has been observed with concomitant administration of mycophenolate mofetil and rifampin. Therefore, mycophenolate mofetil is not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk.
Other Interactions
The measured value for renal clearance of MPAG indicates removal occurs by renal tubular secretion as well as glomerular filtration. Consistent with this, coadministration of probenecid, a known inhibitor of tubular secretion, with mycophenolate mofetil in monkeys results in a 3-fold increase in plasma MPAG AUC and a 2-fold increase in plasma MPA AUC. 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.
Drugs that alter the gastrointestinal flora may interact with mycophenolate mofetil by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption.
Live Vaccines
During treatment with mycophenolate mofetil, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see ). Influenza vaccination may be of value. Prescribers should refer to national guidelines for influenza vaccination.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 104-week oral carcinogenicity study in mice, mycophenolate mofetil in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.5 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, mycophenolate mofetil in daily doses up to 15 mg/kg was not tumorigenic. The highest dose was 0.08 times the recommended clinical dose in renal transplant patients and 0.05 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk (see ).
The genotoxic potential of mycophenolate mofetil was determined in five assays. Mycophenolate mofetil was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. Mycophenolate mofetil was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.07 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Pregnancy
Teratogenic Effects: Pregnancy Category D. See section.
Studies in rats treated with mycophenolate mofetil have shown mycophenolic acid to be excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from mycophenolate mofetil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Based on pharmacokinetic and safety data in pediatric patients after renal transplantation, the recommended dose of mycophenolate mofetil oral suspension is 600 mg/mbid (up to maximum of 1 g bid). Also see
Safety and effectiveness in pediatric patients receiving allogenic cardiac or hepatic transplants have not been established.
Geriatric Use
Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant or other drug therapy. Elderly patients may be at an increased risk of adverse reactions compared with younger individuals (see ).
What are the side effects of mycophenolate mofetil?
The principal adverse reactions associated with the administration of mycophenolate mofetil include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see and ). The adverse event profile associated with the administration of mycophenolate mofetil Intravenous has been shown to be similar to that observed after administration of oral dosage forms of mycophenolate mofetil.
Mycophenolate mofetil Oral
The incidence of adverse events for mycophenolate mofetil 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 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 (see ).
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 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 had an overall better safety profile than did patients receiving 3 g/day of mycophenolate mofetil.
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 compared to patients treated with azathioprine. The incidence of sepsis was comparable in mycophenolate mofetil 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 compared to patients receiving azathioprine, but was comparable in hepatic transplant patients treated with mycophenolate mofetil or azathioprine.
Patients receiving mycophenolate mofetil alone or as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see ). 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 (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 (see ).
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 x 10/mcL) 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 3 g daily (see and ).
All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load (see and 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 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 (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 (see ).
In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with mycophenolate mofetil than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with mycophenolate mofetil.
The following adverse events were reported with 3% to <20% incidence in renal, cardiac, and hepatic transplant patients treated with mycophenolate mofetil, in combination with cyclosporine and corticosteroids.
| (n=336) % | (n=330) % | (n=326) % | (n=289) % | (n=289) % | (n=277) % | (n=287) % | |
| Pain | 33.0 | 31.2 | 32.2 | 75.8 | 74.7 | 74.0 | 77.7 |
| Abdominal pain | 24.7 | 27.6 | 23.0 | 33.9 | 33.2 | 62.5 | 51.2 |
| Fever | 21.4 | 23.3 | 23.3 | 47.4 | 46.4 | 52.3 | 56.1 |
| Headache | 21.1 | 16.1 | 21.2 | 54.3 | 51.9 | 53.8 | 49.1 |
| Infection | 18.2 | 20.9 | 19.9 | 25.6 | 19.4 | 27.1 | 25.1 |
| Sepsis | – | – | – | – | – | 27.4 | 26.5 |
| Asthenia | – | – | – | 43.3 | 36.3 | 35.4 | 33.8 |
| Chest pain | – | – | – | 26.3 | 26.0 | – | – |
| Back pain | – | – | – | 34.6 | 28.4 | 46.6 | 47.4 |
| Ascites | – | – | – | – | – | 24.2 | 22.6 |
| Anemia | 25.6 | 25.8 | 23.6 | 42.9 | 43.9 | 43.0 | 53.0 |
| Leukopenia | 23.2 | 34.5 | 24.8 | 30.4 | 39.1 | 45.8 | 39.0 |
| Thrombocytopenia | – | – | – | 23.5 | 27.0 | 38.3 | 42.2 |
| Hypochromicanemia | – | – | – | 24.6 | 23.5 | – | – |
| Leukocytosis | – | – | – | 40.5 | 35.6 | 22.4 | 21.3 |
| Urogenital | |||||||
| Urinary tractinfection | 37.2 | 37.0 | 33.7 | – | – | – | – |
| Kidney functionabnormal | – | – | – | 21.8 | 26.3 | 25.6 | 28.9 |
| Cardiovascular | |||||||
| Hypertension | 32.4 | 28.2 | 32.2 | 77.5 | 72.3 | 62.1 | 59.6 |
| Hypotension | – | – | – | 32.5 | 36.0 | – | – |
| Cardiovasculardisorder | – | – | – | 25.6 | 24.2 | – | – |
| Tachycardia | – | – | – | 20.1 | 18.0 | 22.0 | 15.7 |
| Peripheral edema | 28.6 | 27.0 | 28.2 | 64.0 | 53.3 | 48.4 | 47.7 |
| Hypercholesteremia | – | – | – | 41.2 | 38.4 | – | – |
| Edema | – | – | – | 26.6 | 25.6 | 28.2 | 28.2 |
| Hypokalemia | – | – | – | 31.8 | 25.6 | 37.2 | 41.1 |
| Hyperkalemia | – | – | – | – | – | 22.0 | 23.7 |
| Hyperglycemia | – | – | – | 46.7 | 52.6 | 43.7 | 48.8 |
| Creatinine increased | – | – | – | 39.4 | 36.0 | – | – |
| BUN increased | – | – | – | 34.6 | 32.5 | – | – |
| Lacticdehydrogenaseincreased | – | – | – | 23.2 | 17.0 | – | – |
| Hypomagnesemia | – | – | – | – | – | 39.0 | 37.6 |
| Hypocalcemia | – | – | – | – | – | 30.0 | 30.0 |
| Digestive | |||||||
| Diarrhea | 31.0 | 36.1 | 20.9 | 45.3 | 34.3 | 51.3 | 49.8 |
| Constipation | 22.9 | 18.5 | 22.4 | 41.2 | 37.7 | 37.9 | 38.3 |
| Nausea | 19.9 | 23.6 | 24.5 | 54.0 | 54.3 | 54.5 | 51.2 |
| Dyspepsia | – | – | – | – | – | 22.4 | 20.9 |
| Vomiting | – | – | – | 33.9 | 28.4 | 32.9 | 33.4 |
| Anorexia | – | – | – | – | – | 25.3 | 17.1 |
| Liver function testsabnormal | – | – | – | – | – | 24.9 | 19.2 |
| Respiratory | |||||||
| Infection | 22.0 | 23.9 | 19.6 | 37.0 | 35.3 | – | – |
| Dyspnea | – | – | – | 36.7 | 36.3 | 31.0 | 30.3 |
| Cough increased | – | – | – | 31.1 | 25.6 | – | – |
| Lung disorder | – | – | – | 30.1 | 29.1 | 22.0 | 18.8 |
| Sinusitis | – | – | – | 26.0 | 19.0 | – | – |
| Pleural effusion | – | – | – | – | – | 34.3 | 35.9 |
| Rash | – | – | – | 22.1 | 18.0 | – | – |
| Tremor | – | – | – | 24.2 | 23.9 | 33.9 | 35.5 |
| Insomnia | – | – | – | 40.8 | 37.7 | 52.3 | 47.0 |
| Dizziness | – | – | – | 28.7 | 27.7 | – | – |
| Anxiety | – | – | – | 28.4 | 23.9 | – | – |
| Paresthesia | – | – | – | 20.8 | 18.0 | – | – |
| (n=336) | (n=330) | (n=326) | (n=289) | (n=289) | (n=277) | (n=287) | |
| % | % | % | % | % | % | % | |
| Herpes simplex | 16.7 | 20.0 | 19.0 | 20.8 | 14.5 | 10.1 | 5.9 |
| CMV | |||||||
| – Viremia/ syndrome | 13.4 | 12.4 | 13.8 | 12.1 | 10.0 | 14.1 | 12.2 |
| – Tissue invasive disease | 8.3 | 11.5 | 6.1 | 11.4 | 8.7 | 5.8 | 8.0 |
| Herpes zoster | 6.0 | 7.6 | 5.8 | 10.7 | 5.9 | 4.3 | 4.9 |
| – Cuta-neous disease | 6.0 | 7.3 | 5.5 | 10.0 | 5.5 | 4.3 | 4.9 |
| Candida | 17.0 | 17.3 | 18.1 | 18.7 | 17.6 | 22.4 | 24.4 |
| – Muco-cutaneous | 15.5 | 16.4 | 15.3 | 18.0 | 17.3 | 18.4 | 17.4 |
| Body as a Whole | abdomen enlarged, abscess, accidental injury, cellulitis, chills occurring with fever, cyst, face edema, flu syndrome, hemorrhage, hernia, lab test abnormal, malaise, neck pain, pelvic pain, peritonitis | ||||||
| Hematologic and Lymphatic | coagulation disorder, ecchymosis, pancytopenia, petechia, polycythemia, prothrombin time increased, thromboplastin time increased | ||||||
| Urogenital | acute kidney failure, albuminuria, dysuria, hydronephrosis, hematuria, impotence, kidney failure, kidney tubular necrosis,nocturia, oliguria, pain, prostatic disorder, pyelonephritis, scrotal edema, urine abnormality, urinary frequency, urinary incontinence, urinary retention, urinary tract disorder | ||||||
| Cardiovascular | angina pectoris, arrhythmia, arterial thrombosis, atrial fibrillation, atrial flutter, bradycardia, cardiovascular disorder, congestive heart failure, extrasystole, heart arrest, heart failure, hypotension, pallor, palpitation, pericardial effusion, peripheral vascular disorder, postural hypotension, pulmonary hypertension, supraventricular tachycardia, supraventricular extrasystoles, syncope, tachycardia, thrombosis, vasodilatation, vasospasm, ventricular extrasystole, ventricular tachycardia, venous pressure increased | ||||||
| Metabolic andNutritional | abnormal healing, acidosis, alkaline phosphatase increased, alkalosis, bilirubinemia, creatinine increased, dehydration, gamma glutamyl transpeptidase increased, generalized edema, gout, hypercalcemia, hypercholesteremia, hyperlipemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypochloremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, hypovolemia, hypoxia, lactic dehydrogenase increased, respiratory acidosis, SGOT increased, SGPT increased, thirst, weight gain, weight loss | ||||||
| Digestive | anorexia, cholangitis, cholestatic jaundice, dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, gum hyperplasia, hepatitis, ileus, infection, jaundice, liver damage, liver function tests abnormal, melena, mouth ulceration, nausea and vomiting, oral moniliasis, rectal disorder, stomach ulcer, stomatitis | ||||||
| Respiratory | apnea, asthma, atelectasis, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, lung edema, lung disorder, neoplasm, pain, pharyngitis, pleural effusion, pneumonia, pneumothorax, respiratory disorder, respiratory moniliasis, rhinitis, sinusitis, sputum increased, voice alteration | ||||||
| Skin andAppendages | acne, alopecia, fungal dermatitis, hemorrhage, hirsutism, pruritus, rash, skin benign neoplasm, skin carcinoma, skin disorder, skin hypertrophy, skin ulcer, sweating, vesiculobullous rash | ||||||
| Nervous | agitation, anxiety, confusion, convulsion, delirium, epression, dry mouth, emotional lability, hallucinations, hypertonia, hypesthesia,nervousness, neuropathy, paresthesia, psychosis, somnolence,thinking abnormal, vertigo | ||||||
| Endocrine | Cushing’s syndrome, diabetes mellitus, hypothyroidism, parathyroid disorder | ||||||
| Musculoskeletal | arthralgia, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis | ||||||
| Special Senses | abnormal vision, amblyopia, cataract (not specified), conjunctivitis, deafness, ear disorder, ear pain, eye hemorrhage, tinnitus, lacrimation disorder |
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 oral suspension 600 mg/m bid (up to 1 g bid) were generally similar to those observed in adult patients dosed with mycophenolate mofetil 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, leucopenia, and anemia, which were observed in a higher proportion in pediatric patients.
Mycophenolate Mofetil Intravenous
The adverse event profile of mycophenolate mofetil Intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral mycophenolate mofetil in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of mycophenolate mofetil Intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of mycophenolate mofetil 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 Intravenous.
In the active controlled study in hepatic transplant patients, 2 g/day of mycophenolate mofetil Intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous mycophenolate mofetil was similar to that of intravenous azathioprine.
Postmarketing Experience
Congenital Disorders:
Digestive:
Hematologic and Lymphatic:
Infections:
Respiratory:
OVERDOSAGE
The experience with overdose of mycophenolate mofetil in humans is very limited. The events received from reports of overdose fall within the known safety profile of the drug. The highest dose administered to renal transplant patients in clinical trials has been 4 g/day. In limited experience with cardiac and hepatic transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, principally neutropenia, leading to a need to reduce or discontinue dosing.
In acute oral toxicity studies, no deaths occurred in adult mice at doses up to 4000 mg/kg or in adult monkeys at doses up to 1000 mg/kg; these were the highest doses of mycophenolate mofetil tested in these species. These doses represent 11 times the recommended clinical dose in renal transplant patients and approximately 7 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In adult rats, deaths occurred after single-oral doses of 500 mg/kg of mycophenolate mofetil. The dose represents approximately 3 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.
MPA and MPAG are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 mcg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine ).
What should I look out for while using mycophenolate mofetil?
Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Mycophenolate mofetil Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
ID238
(see boxed )
What might happen if I take too much mycophenolate mofetil?
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How should I store and handle mycophenolate mofetil?
Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373Mycophenolate mofetil capsules, 250 mgWhite to off-white colored free flowing powder filled in size ‘1’ hard gelatin capsule with Ivory Cap and Ivory Body, printed ‘SAL’ on cap and ‘726’ on body in black. Supplied in the following presentations: NDC Number Size NDC 59762-0703-1 Bottle of 100NDC 59762-0703-2 Bottle of 120NDC 59762-0703-3 Bottle of 500StorageStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Mycophenolate mofetil tablets, 500 mg Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Supplied in the following presentations: NDC Number Size NDC 59762-0702-1 Bottle of 100NDC 59762-0702-3 Bottle of 500 Storage and Dispensing InformationStore at 20°- 25°C (68°-77°F). {See USP controlled room temperature}. Dispense in light-resistant containers, such as the manufacturer’s original containers.Made in India Distributed by:Greenstone LLCPeapack, NJ 07977Revised: June 20101014373
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mycophenolate mofetil has been demonstrated in experimental animal models to prolong the survival of allogeneic transplants (kidney, heart, liver, intestine, limb, small bowel, pancreatic islets, and bone marrow).
Mycophenolate mofetil has also been shown to reverse ongoing acute rejection in the canine renal and rat cardiac allograft models. Mycophenolate mofetil also inhibited proliferative arteriopathy in experimental models of aortic and cardiac allografts in rats, as well as in primate cardiac xenografts. Mycophenolate mofetil was used alone or in combination with other immunosuppressive agents in these studies. Mycophenolate mofetil has been demonstrated to inhibit immunologically mediated inflammatory responses in animal models and to inhibit tumor development and prolong survival in murine tumor transplant models.
Mycophenolate mofetil is rapidly absorbed following oral administration and hydrolyzed to form MPA, which is the active metabolite. MPA is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes. MPA inhibits proliferative responses of T- and B-lymphocytes to both mitogenic and allospecific stimulation. Addition of guanosine or deoxyguanosine reverses the cytostatic effects of MPA on lymphocytes. MPA also suppresses antibody formation byB-lymphocytes. MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Mycophenolate mofetil did not inhibit early events in the activation of human peripheral blood mononuclear cells, such as the production of interleukin-1 (IL-1) and interleukin-2 (IL-2), but did block the coupling of these events to DNA synthesis and proliferation.
Non-Clinical Toxicology
Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. Mycophenolate mofetil Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).ID238
(see boxed )
Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.
Gastrointestinal bleeding (requiring hospitalization) has been observed in approximately 3% of renal, in 1.7% of cardiac, and in 5.4% of hepatic transplant patients treated with mycophenolate mofetil 3 g daily. In pediatric renal transplant patients, 5/148 cases of gastrointestinal bleeding (requiring hospitalization) were observed.
Gastrointestinal perforations have rarely been observed. Most patients receiving mycophenolate mofetil were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with mycophenolate mofetil. Because mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, mycophenolate mofetil should be administered with caution in patients with active serious digestive system disease.
Subjects with severe chronic renal impairment (GFR <25 mL/min/1.73 m) who have received single doses of mycophenolate mofetil showed higher plasma MPA and MPAG AUCs relative to subjects with lesser degrees of renal impairment or normal healthy volunteers. No data are available on the safety of long-term exposure to these levels of MPAG. Doses of mycophenolate mofetil greater than 1 g administered twice a day to renal transplant patients should be avoided and they should be carefully observed (see and ).
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. Mycophenolate mofetil may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
In patients with delayed renal graft function posttransplant, mean MPA AUC(0-12h) was comparable, but MPAG AUC(0-12h) was 2-fold to 3-fold higher, compared to that seen in posttransplant patients without delayed renal graft function. In the three controlled studies of prevention of renal rejection, there were 298 of 1483 patients (20%) with delayed graft function. Although patients with delayed graft function have a higher incidence of certain adverse events (anemia, thrombocytopenia, hyperkalemia) than patients without delayed graft function, these events were not more frequent in patients receiving mycophenolate mofetil than azathioprine or placebo. No dose adjustment is recommended for these patients; however, they should be carefully observed (see and ). In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with mycophenolate mofetil than in those receiving azathioprine therapy, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with mycophenolate mofetil (see ).
There were more herpes virus (H. simplex, H. zoster, and cytomegalovirus) infections in cardiac transplant patients treated with mycophenolate mofetil compared to those treated with azathioprine (see ).
It is recommended that mycophenolate mofetil not be administered concomitantly with azathioprine because both have the potential to cause bone marrow suppression and such concomitant administration has not been studied clinically.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in the concomitant administration of mycophenolate mofetil with drugs that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of mycophenolate mofetil (see ).
On theoretical grounds, because mycophenolate mofetil is an IMPDH (inosine monophosphate dehydrogenase) inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
During treatment with mycophenolate mofetil, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective (see ).
The principal adverse reactions associated with the administration of mycophenolate mofetil include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see and ). The adverse event profile associated with the administration of mycophenolate mofetil Intravenous has been shown to be similar to that observed after administration of oral dosage forms of mycophenolate mofetil.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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