Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

remedyrepack inc. - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration ( 2.2)]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level > 80%]), it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration ( 2.3), clinical studies ( 14.3)]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies ( 14.2)]. in patients at high-immunologic risk , the safety and efficacy of sirolimus tablets used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies ( 14.3)]. in pediatric patients , the safety and efficacy of sirolimus tablets have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions ( 6.5), clinical studies ( 14.6)]. the safety and efficacy of de novo use of sirolimus tablets without cyclosporine have not been established in renal transplant patients [see warnings and precautions ( 5.12)]. the safety and efficacy of conversion from calcineurin inhibitors to sirolimus tablets in maintenance renal transplant patients have not been established [see clinical studies ( 14.4)]. sirolimus is indicated for the treatment of patients with lymphangioleiomyomatosis (lam). sirolimus tablets are contraindicated in patients with a hypersensitivity to sirolimus tablets [see warnings and precautions ( 5.4)]. risk summary based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology ( 12.1)]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [see data]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6-15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6-18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre-and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology ( 12.1)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sirolimus and any potential adverse effects on the breastfed child from sirolimus. contraception females should not be pregnant or become pregnant while receiving sirolimus. advise females of reproductive potential that animal studies have been shown sirolimus to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has been stopped [see warnings and precautions ( 5.15), use in specific populations ( 8.1)] . infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with sirolimus [see adverse reactions ( 6.7), nonclinical toxicology ( 13.1)] . ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of sirolimus. azoospermia has been reported in males with the use of sirolimus tablets and has been reversible upon discontinuation of sirolimus in most cases. renal transplant the safety and efficacy of sirolimus in pediatric patients <13 years have not been established. the safety and efficacy of sirolimus oral solution and sirolimus tablets have been established for prophylaxis of organ rejection in renal transplantation in children ≥13 years judged to be at low-to moderate-immunologic risk. use of sirolimus oral solution and sirolimus tablets in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology ( 12.3)]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of sirolimus oral solution or tablets in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies ( 14.6)].   lymphangioleiomyomatosis   the safety and efficacy of sirolimus in pediatric patients less than 18 years have not been established.   clinical studies of sirolimus oral solution or tablets did not include sufficient numbers of patients ≥65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of sirolimus should be reduced in patients with hepatic impairment [see dosage and administration ( 2.7), clinical pharmacology ( 12.3)]. dosage adjustment is not required in patients with renal impairment [see dosage and administration ( 2.8), clinical pharmacology ( 12.3)].

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

remedyrepack inc. - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration ( 2.2)]. in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level > 80%]), it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration ( 2.3), clinical studies ( 14.3)]. cyclosporine withdrawal has not been studied in patients with banff grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dl, black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies [see clinical studies ( 14.2)]. in patients at high-immunologic risk , the safety and efficacy of sirolimus tablets used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient [see clinical studies ( 14.3)]. in pediatric patients , the safety and efficacy of sirolimus tablets have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk [see adverse reactions ( 6.5), clinical studies ( 14.6)]. the safety and efficacy of de novo use of sirolimus tablets without cyclosporine have not been established in renal transplant patients [see warnings and precautions ( 5.12)]. the safety and efficacy of conversion from calcineurin inhibitors to sirolimus tablets in maintenance renal transplant patients have not been established [see clinical studies ( 14.4)]. sirolimus is indicated for the treatment of patients with lymphangioleiomyomatosis (lam). sirolimus tablets are contraindicated in patients with a hypersensitivity to sirolimus tablets [see warnings and precautions ( 5.4)]. risk summary based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [see data, clinical pharmacology ( 12.1)]. there are limited data on the use of sirolimus during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal studies, sirolimus was embryo/fetotoxic in rats at sub-therapeutic doses [see data]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data sirolimus crossed the placenta and was toxic to the conceptus. in rat embryo-fetal development studies, pregnant rats were administered sirolimus orally during the period of organogenesis (gestational day 6-15). sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) and reduced fetal weight at 1 mg/kg (5-fold the clinical dose of 2 mg). the no observed adverse effect level (noael) for fetal toxicity in rats was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg). maternal toxicity (weight loss) was observed at 2 mg/kg (10-fold the clinical dose of 2 mg). the noael for maternal toxicity was 1 mg/kg. in combination with cyclosporine, rats had increased embryo-fetal mortality compared with sirolimus alone. in rabbit embryo-fetal development studies, pregnant rabbits were administered sirolimus orally during the period of organogenesis (gestational day 6-18). there were no effects on embryo-fetal development at doses up to 0.05 mg/kg (0.5-fold the clinical dose of 2 mg, on a body surface area basis); however, at doses of 0.05 mg/kg and above, the ability to sustain a successful pregnancy was impaired (i.e., embryo-fetal abortion or early resorption). maternal toxicity (decreased body weight) was observed at 0.05 mg/kg. the noael for maternal toxicity was 0.025 mg/kg (0.25-fold the clinical dose of 2 mg). in a pre-and post-natal development study in rats, pregnant females were dosed during gestation and lactation (gestational day 6 through lactation day 20). an increased incidence of dead pups, resulting in reduced live litter size, occurred at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg/kg on a body surface area basis). at 0.1 mg/kg (0.5-fold the clinical dose of 2 mg), there were no adverse effects on offspring. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg, the highest dose tested. risk summary it is not known whether sirolimus is present in human milk. there are no data on its effects on the breastfed infant or milk production. the pharmacokinetic and safety profiles of sirolimus in infants are not known. sirolimus is present in the milk of lactating rats. there is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action [see clinical pharmacology ( 12.1)]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sirolimus and any potential adverse effects on the breastfed child from sirolimus. contraception females should not be pregnant or become pregnant while receiving sirolimus. advise females of reproductive potential that animal studies have been shown sirolimus to be harmful to the developing fetus. females of reproductive potential are recommended to use highly effective contraceptive method. effective contraception must be initiated before sirolimus therapy, during sirolimus therapy, and for 12 weeks after sirolimus therapy has been stopped [see warnings and precautions ( 5.15), use in specific populations ( 8.1)] . infertility based on clinical findings and findings in animals, male and female fertility may be compromised by the treatment with sirolimus [see adverse reactions ( 6.7), nonclinical toxicology ( 13.1)] . ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of sirolimus. azoospermia has been reported in males with the use of sirolimus tablets and has been reversible upon discontinuation of sirolimus in most cases. renal transplant the safety and efficacy of sirolimus in pediatric patients <13 years have not been established. the safety and efficacy of sirolimus oral solution and sirolimus tablets have been established for prophylaxis of organ rejection in renal transplantation in children ≥13 years judged to be at low-to moderate-immunologic risk. use of sirolimus oral solution and sirolimus tablets in this subpopulation of children ≥ 13 years is supported by evidence from adequate and well-controlled trials of sirolimus oral solution in adults with additional pharmacokinetic data in pediatric renal transplantation patients [see clinical pharmacology ( 12.3)]. safety and efficacy information from a controlled clinical trial in pediatric and adolescent (< 18 years of age) renal transplant patients judged to be at high-immunologic risk, defined as a history of one or more acute rejection episodes and/or the presence of chronic allograft nephropathy, do not support the chronic use of sirolimus oral solution or tablets in combination with calcineurin inhibitors and corticosteroids, due to the higher incidence of lipid abnormalities and deterioration of renal function associated with these immunosuppressive regimens compared to calcineurin inhibitors, without increased benefit with respect to acute rejection, graft survival, or patient survival [see clinical studies ( 14.6)].   lymphangioleiomyomatosis   the safety and efficacy of sirolimus in pediatric patients less than 18 years have not been established.   clinical studies of sirolimus oral solution or tablets did not include sufficient numbers of patients ≥65 years to determine whether they respond differently from younger patients. data pertaining to sirolimus trough concentrations suggest that dose adjustments based upon age in geriatric renal patients are not necessary. differences in responses between the elderly and younger patients have not been identified. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, or cardiac function, and of concomitant disease or other drug therapy. the maintenance dose of sirolimus should be reduced in patients with hepatic impairment [see dosage and administration ( 2.7), clinical pharmacology ( 12.3)]. dosage adjustment is not required in patients with renal impairment [see dosage and administration ( 2.8), clinical pharmacology ( 12.3)].

Malaisia - inglise - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbvie sdn bhd - cyclosporine -

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

american health packaging - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil capsule, usp is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil capsules, usp should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. 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).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

a-s medication solutions - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil tablets, capsules and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for upto 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. 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).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

american health packaging - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil tablet, usp is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil tablets, usp should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. 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).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus 0.25 mg - zortress is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant [ see clinical studies   (14.1)] . zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus and cyclosporine is recommended for all patients receiving these products [ see dosage and administration (2.2 , 2.3)] . zortress is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. zortress is to be administered no earlier than 30 days posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [ s ee warnings and precautions (5. 5 ) , clinical studies (14.2) ] . tdm of everolimus and tacrolimus is recommended for all patients receiving these products [ s ee dosage and administration (2.3 , 2.5)] . the safety and efficacy of zortress has not been established in the following populations: - kidney transplant patients at high immunologic risk. - recipients of transplanted organs other than kidney and liver [see warnings and precautions (5.7)] . - pediatric patients (less than 18 years). zortress is contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product.  risk summary based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , zortress can cause fetal harm when administered to a pregnant woman. there are limited case reports of zortress use in pregnant women; however, these reports are insufficient to inform a drug-associated risk of adverse developmental outcomes. reproductive studies in animals have demonstrated that everolimus was maternally toxic in rabbits and caused embryo-fetal toxicities in rats and rabbits, at exposures near or below those achieved in human transplant patients. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data everolimus crossed the placenta and was toxic to the conceptus. everolimus administered daily to pregnant rats by oral gavage at 0.1 mg/kg (approximately one tenth the exposure in humans administered the lowest starting dose of 0.75 mg twice daily), from before mating through organogenesis, resulted in increased preimplantation loss and embryonic resorptions. these effects occurred in the absence of maternal toxicities. everolimus administered daily by oral gavage to pregnant rabbits during organogenesis resulted in abortions, maternal toxicity and lethality, and increased fetal resorptions. at these doses, exposure to everolimus (auc) was approximately one-tenth-, one-half-, and one- and one-half-fold the exposures in humans administered the starting clinical dose, respectively. in a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. at a dose of 0.1 mg/kg (0.6 mg/m2 ), there were no adverse effects on delivery and lactation or signs of maternal toxicity; however, there were reductions in body weight (up to 9% reduction) and in survival of offspring (~5%). there were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring. risk summary there is no data regarding the presence of zortress in human milk, the effects on breastfed infants, or the effects on milk production. everolimus and/or its metabolites are readily transferred into milk of lactating rats at a concentration 3.5 times higher than in maternal rat serum. in pre-post-natal and juvenile studies in rats, exposure to everolimus during the postnatal period caused developmental toxicity [see use in specific populations (8.1), nonclinical toxicology (13.2)] . advise lactating women not to breastfeed because of the potential for serious adverse reactions in infants exposed to everolimus. contraception females should not be pregnant or become pregnant while receiving zortress. advise females of reproductive potential that animal studies have been performed showing zortress to be harmful to the mother and developing fetus [see use in specific populations (8.1)] . females of reproductive potential are recommended to use highly effective contraception methods while receiving zortress and up to 8 weeks after treatment has been stopped. infertility females amenorrhea occurred in female patients taking zortress [see adverse reactions (6.2)] . zortress may cause pre-implantation loss in females based on animal data [see nonclinical toxicology (13.1)] . female fertility may be compromised by treatment with zortress. males zortress treatment may impair fertility in males based on human [see warnings and precautions (5.18), adverse reactions (6.2, 6.3)] and animal findings [see nonclinical toxicology (13.1)] . the safe and effective use of zortress in kidney or liver transplant patients younger than 18 years of age has not been established. there is limited clinical experience on the use of zortress in patients of age 65 years or older. there is no evidence to suggest that elderly patients will require a different dosage recommendation from younger adult patients [ s ee c linical pharmacology   ( 12. 5 ) ] . everolimus whole blood trough concentrations should be closely monitored in patients with impaired hepatic function. for patients with mild hepatic impairment (child-pugh class a), the dose should be reduced by approximately one-third of the normally recommended daily dose. for patients with moderate or severe hepatic impairment (child-pugh class b or c), the initial daily dose should be reduced to approximately half of the normally recommended daily dose. further dose adjustment and/or dose titration should be made if a patient’s whole blood trough concentration of everolimus, as measured by an lc/ms/ms assay, is not within the target trough concentration range of 3 to 8 ng/ml [ s ee clinical pharmacology (12. 6 )] . no dose adjustment is needed in patients with renal impairment [ s ee clinical pharmacology (12. 6 ) ] .

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids. 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.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

novitium pharma llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus oral solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.  in patients at low-to moderate-immunologic risk , it is recommended that sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration (2.2)].   in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra; peak pra level > 80%]), it is recommended that sirolimus oral solution be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration (2.3), clinical studies (14.3)]. cyclosporine   withdrawal   has not been studied in patients with banff grade  3 acute rejection or   vascular rejection prior to cyclosporine

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1)] . everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus and cyclosporine is recommended for all patients receiving these products [see dosage and administration (2.2 and 2.3)] . everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus is to be administered no earlier than 30 days posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5) and clinical studies (14.2)] . tdm of everolimus and tacrolimus is recommended for all patients receiving these products [see dosage and administration (2.3, 2.5)] . the safety and efficacy of everolimus has not been