Mycophenolate

Mycophenolate mofetil (CellCept , Myhibbin ) used in conjunction with other immunosuppressants for the prevention of rejection of kidney, heart, or liver allografts in adult and pediatric patients ≥3 months of age. Mycophenolate sodium (Myfortic ) used in conjunction with cyclosporine and corticosteroid therapy for the prevention of rejection of kidney allografts in adults and in pediatric patients ≥5 years of age who are ≥6 months post kidney transplant.

Mycophenolate mofetil (CellCept , Myhibbin ) used in conjunction with other immunosuppressants for the prevention of rejection of kidney, heart, or liver allografts in adult and pediatric patients ≥3 months of age. Mycophenolate sodium (Myfortic ) used in conjunction with cyclosporine and corticosteroid therapy for the prevention of rejection of kidney allografts in adults and in pediatric patients ≥5 years of age who are ≥6 months post kidney transplant.

Mycophenolate

The severe or irreversible adverse effects of Mycophenolate, which give rise to further complications include Anemia, Thrombocytopenia, Leucopenia, Bone marrow depression, Hyperglycemia, Hypertension, Hematuria, Tremors, Disturbances of electrolyte, Disturbances of blood lipids. The symptomatic adverse reactions produced by Mycophenolate are more or less tolerable and if they become severe, they can be treated symptomatically, these include Dizziness, Headache, Nausea, Alopecia, Diarrhea, Dyspnea, Insomnia, Pain, Cough, GI hemorrhage, GI disturbance.

May cause fetal harm (see Boxed Warning). Congenital malformations and increased risk of first-trimester pregnancy loss reported. Congenital malformations and pregnancy loss demonstrated in animals. Avoid use during pregnancy if safer treatment options available. Advise females of reproductive potential of potential risk; counsel them regarding pregnancy prevention and planning. Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for human chorionic gonadotropin [HCG]) immediately prior to starting mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits. If pregnancy test positive, consider alternative immunosuppressants with less potential for embryofetal toxicity. Counsel patients of reproductive potential regarding acceptable contraception methods. Advise patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after discontinuance, unless committed to continuous abstinence. Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation. Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after cessation of treatment. Because of risk of fetal/neonatal morbidity and mortality, mycophenolate products available only through a REMS program. Only clinicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolate sodium (see Boxed Warning). Patients should be managed in facilities equipped and staffed with appropriate laboratory and supportive resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up. Risk of lymphoma and other malignancies in patients receiving immunosuppressive regimens (see Boxed Warning). Risk appears to be related to intensity and duration of immunosuppression rather than to any specific immunosuppressive agent. Posttransplant lymphoproliferative disorder reported in patients receiving mycophenolate mofetil in conjunction with other immunosuppressive agents. Most cases appear to be related to Epstein Barr Virus (EBV) infection. Risk appears greatest in individuals who are EBV seronegative, a population which includes many small children. Advise patients with increased risk of skin cancer to limit exposure to sunlight or other ultraviolet light by wearing protective clothing and using broad-spectrum sunscreen with a high protection factor. Increased susceptibility to infections (bacterial, fungal, and protozoal infections; new or reactivated viral infections), including opportunistic infections. May lead to hospitalizations and death (see Boxed Warning). Risk increases with the total immunosuppressive load; use combination immunosuppressant therapy with caution. Serious viral infections reported include polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection; JC virus-associated progressive multifocal leukoencephalopathy (PML); cytomegalovirus (CMV) infections; reactivation of HBV or HCV; and COVID-19. PVAN is associated with serious outcomes (e.g., deteriorating kidney function, renal graft loss). PML (sometimes fatal) commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia. Risk of CMV viremia and CMV disease highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor. Consider dosage reduction or discontinuation of mycophenolate therapy in patients with new infections or reactivated viral infections, considering the risk that reduced immunosuppression represents to the functioning allograft. Monitoring may help identify patients at risk for PVAN. Consider PML in the differential diagnosis in immunosuppressed patients reporting neurologic symptoms; consider consultation with a neurologist as clinically indicated. Routinely provide therapeutic approaches to limiting CMV disease; monitoring may help identify patients at risk. Monitor infected patients for clinical and laboratory signs of active HBV or HCV infection. Severe neutropenia (ANC <500/mm 3 ) reported; observed most frequently between 31–180 days posttransplant. Neutropenia may be related to mycophenolate, concomitant therapies, viral infection, or a combination of these causes. Monitor for blood dyscrasias including neutropenia during therapy. Perform CBCs weekly during the first month of therapy, twice monthly during the second and third months, and then monthly thereafter during the first year. If neutropenia (ANC <1300/mm 3 ) develops (or anemia with mycophenolate sodium therapy), discontinue or adjust dosage, perform suitable diagnostic tests, and initiate appropriate patient management. Instruct patients to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow depression. Pure red cell aplasia (PRCA) reported in patients receiving immunosuppressive regimens containing mycophenolate. Mechanism for mycophenolate-induced PRCA not been determined. Consider possibility of graft rejection if immunosuppression is reduced in transplant patients; implement any changes to immunosuppressive therapy under appropriate medical supervision. GI bleeding (requiring hospitalization), ulceration, and perforation reported. Clinicians should be aware of serious adverse GI effects when administering mycophenolate mofetil to patients with GI disease. Use caution in patients with serious active GI disease. Mycophenolic acid inhibits inosine monophosphate dehydrogenase; avoid in patients with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome. In such patients, the drug may cause an exacerbation of disease symptoms characterized by overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease, including renal failure. Cases of acute inflammatory syndrome (AIS), some resulting in hospitalization, reported. AIS characterized by fever, arthralgias, arthritis, muscle pain, and elevated inflammatory markers (e.g., C-reactive protein, erythrocyte sedimentation rate) without evidence of infection or underlying disease recurrence. Symptoms occur within weeks to months of drug initiation or a dosage increase; improvement of symptoms and inflammatory markers usually observed within 24—48 hours following treatment discontinuation. Monitor patients for symptoms and laboratory parameters of AIS when initiating treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider treatment alternatives based on risks and benefits for the patient. Avoid use of live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines) during treatment with mycophenolate mofetil. Advise patients that vaccinations may be less effective. Advise patients to discuss with the clinician before seeking any immunizations. Do not administer mycophenolate mofetil IV solution by rapid or bolus IV injection; rapid infusion increases risk of local adverse reactions (e.g., phlebitis, thrombosis). Mycophenolate mofetil oral suspension (CellCept , not Myhibbin ) contains aspartame, a source of phenylalanine (0.56 mg of phenylalanine/mL of the suspension). Phenylalanine can be harmful to patients with phenylketonuria. Before prescribing mycophenolate mofetil oral suspension to a patient with phenylketonuria, consider combined daily amount of phenylalanine from all sources, including mycophenolate mofetil. Do not donate blood during therapy and for ≥6 weeks following treatment discontinuation. Men should not donate semen during therapy and for at least 90 days following treatment discontinuation. Several drugs, when used concomitantly with mycophenolate mofetil, have potential to alter systemic mycophenolic acid exposure. May be appropriate to measure plasma mycophenolic acid concentrations before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant drugs. Mycophenolate mofetil may impact the ability to drive or operate machinery. Advise patients to avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with mycophenolate mofetil. Pregnancy exposure registry available that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing the drug. Visit [Web] or call 1-800-617-8191 for more information. May cause fetal toxicity when administered to pregnant women. Increased risk of first-trimester pregnancy loss and serious congenital malformations in multiple organ systems reported. Documented malformations include external ear and other facial abnormalities (e.g., cleft lip and palate) and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Congenital malformations and pregnancy loss also observed in animals. Apprise females of reproductive potential and pregnant women of the potential hazard. Consider alternative immunosuppressants with less potential for embryofetal toxicity. Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later. Perform repeat pregnancy tests during routine follow-up visits. No data on presence of mycophenolate in human milk or effects of the drug on milk production. Distributed into milk in rats. Consider developmental and health benefits of breast-feeding along with mother's clinical need for mycophenolate and any potential adverse effects on breast-fed infant from the drug or underlying maternal condition. Advise females of reproductive potential of the potential risks of fetal toxicity; counsel them regarding pregnancy prevention and planning. If pregnancy being considered, discuss risks and benefits of mycophenolate therapy and consider alternative immunosuppressants with less potential for embryofetal toxicity. In females of reproductive potential, perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits. If pregnancy test is positive, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Counsel patients of reproductive potential regarding use of acceptable contraception; refer to the prescribing information for specific, acceptable contraceptive methods. Advise female patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after treatment discontinuance, unless committed to complete abstinence from heterosexual contact. Advise patients that concomitant use of mycophenolate and certain oral hormonal contraceptives may result in decreased concentrations of the oral hormonal contraceptive. Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation. Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after discontinuation of treatment. Mycophenolate mofetil: Safety and effectiveness established in pediatric patients ≥3 months of age for the prophylaxis of organ rejection of allogenic renal, cardiac, or hepatic transplants. Combination of inactive ingredients (e.g., simethicone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, glycerin) in oral suspension (Myhibbin ) may impact GI tolerability; monitor pediatric patients receiving the drug for signs and symptoms of GI intolerance. Mycophenolate sodium: Safety and efficacy established in stable renal transplant recipients 5–16 years of age who were initiated on the drug ≥6 months posttransplant. Safety and efficacy not established in children <5 years of age; a mycophenolate sodium dosage form appropriate for pediatric patients with body surface area <1.19 m 2 currently not available. Safety and efficacy not established in de novo renal transplant patients. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant diseases and drug therapy. Possible increased risk of developing GI hemorrhage, pulmonary edema, or certain infections (e.g., invasive CMV infection). Mycophenolate mofetil: No dosage adjustment necessary for renal transplant recipients with severe hepatic parenchymal disease; not known whether dosage adjustment is needed for other hepatic diseases. No data available for cardiac transplant recipients with severe hepatic parenchymal disease. Mycophenolate sodium: Specific studies evaluating pharmacokinetics of mycophenolate sodium have not been conducted in patients with hepatic impairment. Mycophenolate mofetil: Dosage adjustment not necessary in renal transplant recipients experiencing postoperative delayed graft function; however, closely monitor these patients. Do not use mycophenolate mofetil dosages exceeding 1 g twice daily in renal transplant recipients with severe chronic impairment of the graft (GFR <25 mL/minute per 1.73 m 2 ). No data available in cardiac or hepatic transplant recipients with severe chronic renal impairment; may use if potential benefits outweigh potential risks. Mycophenolate sodium: Specific studies evaluating pharmacokinetics not conducted in patients with renal impairment. Mycophenolic acid AUC in patients with renal impairment receiving mycophenolate sodium not expected to increase appreciably relative to values in patients with normal renal function; however, AUC values for the phenolic glucuronide metabolite of mycophenolic acid are expected to increase substantially.

May cause fetal harm (see Boxed Warning). Congenital malformations and increased risk of first-trimester pregnancy loss reported. Congenital malformations and pregnancy loss demonstrated in animals. Avoid use during pregnancy if safer treatment options available. Advise females of reproductive potential of potential risk; counsel them regarding pregnancy prevention and planning. Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for human chorionic gonadotropin [HCG]) immediately prior to starting mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits. If pregnancy test positive, consider alternative immunosuppressants with less potential for embryofetal toxicity. Counsel patients of reproductive potential regarding acceptable contraception methods. Advise patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after discontinuance, unless committed to continuous abstinence. Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation. Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after cessation of treatment. Because of risk of fetal/neonatal morbidity and mortality, mycophenolate products available only through a REMS program. Only clinicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolate sodium (see Boxed Warning). Patients should be managed in facilities equipped and staffed with appropriate laboratory and supportive resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up. Risk of lymphoma and other malignancies in patients receiving immunosuppressive regimens (see Boxed Warning). Risk appears to be related to intensity and duration of immunosuppression rather than to any specific immunosuppressive agent. Posttransplant lymphoproliferative disorder reported in patients receiving mycophenolate mofetil in conjunction with other immunosuppressive agents. Most cases appear to be related to Epstein Barr Virus (EBV) infection. Risk appears greatest in individuals who are EBV seronegative, a population which includes many small children. Advise patients with increased risk of skin cancer to limit exposure to sunlight or other ultraviolet light by wearing protective clothing and using broad-spectrum sunscreen with a high protection factor. Increased susceptibility to infections (bacterial, fungal, and protozoal infections; new or reactivated viral infections), including opportunistic infections. May lead to hospitalizations and death (see Boxed Warning). Risk increases with the total immunosuppressive load; use combination immunosuppressant therapy with caution. Serious viral infections reported include polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection; JC virus-associated progressive multifocal leukoencephalopathy (PML); cytomegalovirus (CMV) infections; reactivation of HBV or HCV; and COVID-19. PVAN is associated with serious outcomes (e.g., deteriorating kidney function, renal graft loss). PML (sometimes fatal) commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia. Risk of CMV viremia and CMV disease highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor. Consider dosage reduction or discontinuation of mycophenolate therapy in patients with new infections or reactivated viral infections, considering the risk that reduced immunosuppression represents to the functioning allograft. Monitoring may help identify patients at risk for PVAN. Consider PML in the differential diagnosis in immunosuppressed patients reporting neurologic symptoms; consider consultation with a neurologist as clinically indicated. Routinely provide therapeutic approaches to limiting CMV disease; monitoring may help identify patients at risk. Monitor infected patients for clinical and laboratory signs of active HBV or HCV infection. Severe neutropenia (ANC <500/mm 3 ) reported; observed most frequently between 31–180 days posttransplant. Neutropenia may be related to mycophenolate, concomitant therapies, viral infection, or a combination of these causes. Monitor for blood dyscrasias including neutropenia during therapy. Perform CBCs weekly during the first month of therapy, twice monthly during the second and third months, and then monthly thereafter during the first year. If neutropenia (ANC <1300/mm 3 ) develops (or anemia with mycophenolate sodium therapy), discontinue or adjust dosage, perform suitable diagnostic tests, and initiate appropriate patient management. Instruct patients to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow depression. Pure red cell aplasia (PRCA) reported in patients receiving immunosuppressive regimens containing mycophenolate. Mechanism for mycophenolate-induced PRCA not been determined. Consider possibility of graft rejection if immunosuppression is reduced in transplant patients; implement any changes to immunosuppressive therapy under appropriate medical supervision. GI bleeding (requiring hospitalization), ulceration, and perforation reported. Clinicians should be aware of serious adverse GI effects when administering mycophenolate mofetil to patients with GI disease. Use caution in patients with serious active GI disease. Mycophenolic acid inhibits inosine monophosphate dehydrogenase; avoid in patients with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome. In such patients, the drug may cause an exacerbation of disease symptoms characterized by overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease, including renal failure. Cases of acute inflammatory syndrome (AIS), some resulting in hospitalization, reported. AIS characterized by fever, arthralgias, arthritis, muscle pain, and elevated inflammatory markers (e.g., C-reactive protein, erythrocyte sedimentation rate) without evidence of infection or underlying disease recurrence. Symptoms occur within weeks to months of drug initiation or a dosage increase; improvement of symptoms and inflammatory markers usually observed within 24—48 hours following treatment discontinuation. Monitor patients for symptoms and laboratory parameters of AIS when initiating treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider treatment alternatives based on risks and benefits for the patient. Avoid use of live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines) during treatment with mycophenolate mofetil. Advise patients that vaccinations may be less effective. Advise patients to discuss with the clinician before seeking any immunizations. Do not administer mycophenolate mofetil IV solution by rapid or bolus IV injection; rapid infusion increases risk of local adverse reactions (e.g., phlebitis, thrombosis). Mycophenolate mofetil oral suspension (CellCept , not Myhibbin ) contains aspartame, a source of phenylalanine (0.56 mg of phenylalanine/mL of the suspension). Phenylalanine can be harmful to patients with phenylketonuria. Before prescribing mycophenolate mofetil oral suspension to a patient with phenylketonuria, consider combined daily amount of phenylalanine from all sources, including mycophenolate mofetil. Do not donate blood during therapy and for ≥6 weeks following treatment discontinuation. Men should not donate semen during therapy and for at least 90 days following treatment discontinuation. Several drugs, when used concomitantly with mycophenolate mofetil, have potential to alter systemic mycophenolic acid exposure. May be appropriate to measure plasma mycophenolic acid concentrations before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant drugs. Mycophenolate mofetil may impact the ability to drive or operate machinery. Advise patients to avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with mycophenolate mofetil. Pregnancy exposure registry available that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing the drug. Visit [Web] or call 1-800-617-8191 for more information. May cause fetal toxicity when administered to pregnant women. Increased risk of first-trimester pregnancy loss and serious congenital malformations in multiple organ systems reported. Documented malformations include external ear and other facial abnormalities (e.g., cleft lip and palate) and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Congenital malformations and pregnancy loss also observed in animals. Apprise females of reproductive potential and pregnant women of the potential hazard. Consider alternative immunosuppressants with less potential for embryofetal toxicity. Perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, and repeat the pregnancy test with the same sensitivity 8—10 days later. Perform repeat pregnancy tests during routine follow-up visits. No data on presence of mycophenolate in human milk or effects of the drug on milk production. Distributed into milk in rats. Consider developmental and health benefits of breast-feeding along with mother's clinical need for mycophenolate and any potential adverse effects on breast-fed infant from the drug or underlying maternal condition. Advise females of reproductive potential of the potential risks of fetal toxicity; counsel them regarding pregnancy prevention and planning. If pregnancy being considered, discuss risks and benefits of mycophenolate therapy and consider alternative immunosuppressants with less potential for embryofetal toxicity. In females of reproductive potential, perform a blood or urine pregnancy test (i.e., having a sensitivity of ≥25 mIU/mL for HCG) immediately prior to beginning mycophenolate therapy, repeat pregnancy test with the same sensitivity 8—10 days later, and perform repeat pregnancy tests during routine follow-up visits. If pregnancy test is positive, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Counsel patients of reproductive potential regarding use of acceptable contraception; refer to the prescribing information for specific, acceptable contraceptive methods. Advise female patients to use acceptable forms of contraception throughout the entire therapy and for 6 weeks after treatment discontinuance, unless committed to complete abstinence from heterosexual contact. Advise patients that concomitant use of mycophenolate and certain oral hormonal contraceptives may result in decreased concentrations of the oral hormonal contraceptive. Sexually active male patients and/or their female partners recommended to use effective contraception during treatment of the male patient and for ≥90 days after treatment discontinuation. Male patients should not donate sperm during treatment with mycophenolate and for ≥90 days after discontinuation of treatment. Mycophenolate mofetil: Safety and effectiveness established in pediatric patients ≥3 months of age for the prophylaxis of organ rejection of allogenic renal, cardiac, or hepatic transplants. Combination of inactive ingredients (e.g., simethicone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, glycerin) in oral suspension (Myhibbin ) may impact GI tolerability; monitor pediatric patients receiving the drug for signs and symptoms of GI intolerance. Mycophenolate sodium: Safety and efficacy established in stable renal transplant recipients 5–16 years of age who were initiated on the drug ≥6 months posttransplant. Safety and efficacy not established in children <5 years of age; a mycophenolate sodium dosage form appropriate for pediatric patients with body surface area <1.19 m 2 currently not available. Safety and efficacy not established in de novo renal transplant patients. Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant diseases and drug therapy. Possible increased risk of developing GI hemorrhage, pulmonary edema, or certain infections (e.g., invasive CMV infection). Mycophenolate mofetil: No dosage adjustment necessary for renal transplant recipients with severe hepatic parenchymal disease; not known whether dosage adjustment is needed for other hepatic diseases. No data available for cardiac transplant recipients with severe hepatic parenchymal disease. Mycophenolate sodium: Specific studies evaluating pharmacokinetics of mycophenolate sodium have not been conducted in patients with hepatic impairment. Mycophenolate mofetil: Dosage adjustment not necessary in renal transplant recipients experiencing postoperative delayed graft function; however, closely monitor these patients. Do not use mycophenolate mofetil dosages exceeding 1 g twice daily in renal transplant recipients with severe chronic impairment of the graft (GFR <25 mL/minute per 1.73 m 2 ). No data available in cardiac or hepatic transplant recipients with severe chronic renal impairment; may use if potential benefits outweigh potential risks. Mycophenolate sodium: Specific studies evaluating pharmacokinetics not conducted in patients with renal impairment. Mycophenolic acid AUC in patients with renal impairment receiving mycophenolate sodium not expected to increase appreciably relative to values in patients with normal renal function; however, AUC values for the phenolic glucuronide metabolite of mycophenolic acid are expected to increase substantially.

1 g (1 (1)) 12 hourly PO — Starting within 72 hrs of transplantation.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Mycophenolate is known to interact with other drugs, the details of drug interactions is as follows:DrugDetailsSeverityOnsetManagementCholestyramineConcurrent use decrease the AUC approximately 40%.Magnesium Oxides and HydroxidesConcurrent use decrease the absorption of mycophenolate.RifampicinSevelamer HClReduced level of mycophenolate is observed when co-administered with sevelamer HCl close monitoring of blood concentrations should be considered during the use of combination and after its withdrawal. These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

No storage information is recorded for this medicine yet.