Irlandia - angielski - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - tacrolimus - ointment - other dermatological preparations; tacrolimus

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

veloxis pharmaceuticals, inc - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus anhydrous 0.75 mg - envarsus xr is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see clinical studies (14.1)]. envarsus xr is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants [see clinical studies (14.2)]. envarsus xr is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in envarsus xr. pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to envarsus xr during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. healthcare providers are encouraged to advise their patients to register by contacting the transplantation pregnancy registry international at 1-877-955-6877 or https://www.transplantpregnancyregistry.org. risk summary tacrolimus can cause fetal harm when administered to a pregnant woman. data from postmarketing surveillance and tpri suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress [see human data]. advise pregnant women of the potential risk to the fetus. administration of oral tacrolimus to pregnant rabbits and rats throughout the period of organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation and embryofetal death at clinically relevant doses (0.7 to 3.7 times the recommended clinical dose [0.14 mg/kg/day], on a mg/m² basis). administration of oral tacrolimus to pregnant rats after organogenesis and throughout lactation produced maternal toxicity, effects on parturition, reduced pup viability and reduced pup weight at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, marked effects on parturition, embryofetal loss, malformations, and reduced pup viability at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died [see animal data]. the background risk of major birth defects and miscarriage in 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 to 4 % and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk risks during pregnancy are increased in organ transplant recipients. the risk of premature delivery following transplantation is increased. pre-existing hypertension and diabetes confer additional risk to the pregnancy of an organ transplant recipient. pre-gestational and gestational diabetes are associated with birth defects/congenital anomalies, hypertension, low birth weight and fetal death. cholestasis of pregnancy (cop) was reported in 7% of liver or liver-kidney (lk) transplant recipients, compared with approximately 1% of pregnancies in the general population. however, cop symptoms resolved postpartum and no long-term effects on the offspring were reported. maternal adverse reactions envarsus xr may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). monitor maternal blood glucose levels regularly [see warnings and precautions (5.4)]. envarsus xr may exacerbate hypertension in pregnant women and increase pre-eclampsia. monitor and control blood pressure [see warnings and precautions (5.7, 5.8)]. fetal/neonatal adverse reactions renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking envarsus xr. labor or delivery there is an increased risk for premature delivery (<37 weeks) following transplantation and maternal exposure to envarsus xr. data human data there are no adequate and well controlled studies on the effects of tacrolimus in human pregnancy. safety data from the tpri and postmarketing surveillance suggest infants exposed to tacrolimus in utero have an increased risk for miscarriage, pre-term delivery (<37 weeks), low birth weight (<2500 g), birth defects/congenital anomalies and fetal distress. tpri reported 450 and 241 total pregnancies in kidney and liver transplant recipients exposed to tacrolimus, respectively. the tpri pregnancy outcomes are summarized in table 8. in the table below, the number of recipients exposed to tacrolimus concomitantly with mycophenolic acid (mpa) products during the preconception and first trimester periods is high (27% and 29% for renal and liver transplant recipients, respectively). because mpa products may also cause birth defects, the birth defect rate may be confounded and this should be taken into consideration when reviewing the data, particularly for birth defects. birth defects observed include cardiac malformations, craniofacial malformations, renal/urogenital disorders, skeletal abnormalities, neurological abnormalities and multiple malformations. * includes multiple births and terminations. † birth defect rate confounded by concomitant mpa products exposure in over half of offspring with birth defects. additional information reported by tpri in pregnant transplant patients receiving tacrolimus included diabetes during pregnancy in 9% of kidney recipients and 13% of liver recipients and hypertension during pregnancy in 53% of kidney recipients and 16.2% of liver recipients. animal data administration of oral tacrolimus to pregnant rabbits throughout organogenesis produced maternal toxicity and abortion at 0.32 mg/kg (0.7 times the recommended clinical dose based on body surface area). at 1 mg/kg (2.3 times the recommended clinical dose) embryofetal lethality and fetal malformations (ventricular hypoplasia, interventricular septal defect, bulbous aortic arch, stenosis of ductus arteriosus, omphalocele, gallbladder agenesis, skeletal anomalies) were observed. administration of 3.2 mg/kg oral tacrolimus (3.7 times the recommended clinical dose) to pregnant rats throughout organogenesis produced maternal toxicity/lethality, embryofetal lethality and decreased fetal body weight in the offspring of c-sectioned dams; and decreased pup viability and interventricular septal defect in offspring of dams that delivered. in a peri/postnatal development study, oral administration of tacrolimus to pregnant rats during late gestation (after organogenesis) and throughout lactation produced maternal toxicity, effects of parturition, and reduced pup viability at 3.2 mg/kg (3.7 times the recommended clinical dose); among these pups that died early, an increased incidence of kidney hydronephrosis was observed. reduced pup weight was observed at 1mg/kg (1.2 times the recommended clinical dose). administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, embryofetal loss and reduced pup viability at 3.2 mg/kg (3.7 times the recommended clinical dose). interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died. effects on parturition (incomplete delivery of nonviable pups) were observed at 1 mg/kg (1.2 times the recommended clinical dose) [see nonclinical toxicology (13.1)]. risk summary controlled lactation studies have not been conducted in humans; however tacrolimus has been reported to be present in human milk. the effects of tacrolimus on the breastfed infant, or on milk production have not been assessed. tacrolimus is excreted in rat milk and in peri-/postnatal rat studies, exposure to tacrolimus during the postnatal period was associated with developmental toxicity in the offspring at clinically relevant doses [see pregnancy (8.1), nonclinical toxicology (13.1)]. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for envarsus xr and any potential adverse effects on the breastfed child from envarsus xr or from the underlying maternal condition. contraception envarsus xr can cause fetal harm when administered to pregnant women. advise female and male patients of reproductive potential to speak with their healthcare provider on family planning options including appropriate contraception prior to starting treatment with envarsus xr [see use in specific populations (8.1), nonclinical toxicology (13.1)]. infertility based on findings in animals, male and female fertility may be compromised by treatment with envarsus xr [see nonclinical toxicology (13.1)]. the safety and effectiveness of envarsus xr in pediatric patients have not been established. clinical studies of envarsus xr did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. in studies 1, 2 and 3, there were 37 patients 65 years of age and older, and no patients were over 75 years [see clinical studies (14)] . 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, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. the pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy subjects with normal renal function. however, due to its potential for nephrotoxicity, monitoring of renal function in patients with renal impairment is recommended; tacrolimus dosage should be reduced if indicated [see warnings and precautions (5.5) and clinical pharmacology (12.3)] . the mean clearance of tacrolimus was substantially lower in patients with severe hepatic impairment (mean child-pugh score: >10) compared to healthy subjects with normal hepatic function [see clinical pharmacology (12.3)] . with greater tacrolimus whole blood trough concentrations in patients with severe hepatic impairment, there is a greater risk of adverse reactions and dosage reduction is recommended [see dosage and administration (2.4)] . for patients with moderate hepatic impairment, monitor tacrolimus whole blood trough concentrations. for patients with mild hepatic impairment, no dosage adjustments are needed. african-american patients may need to be titrated to higher envarsus xr dosages to attain comparable trough concentrations compared to caucasian patients. the pharmacokinetics of envarsus xr were evaluated in a study of 46 stable african-american kidney transplant recipients converted from tacrolimus immediate-release to envarsus xr and indicated that an 80% conversion factor is appropriate for african-american patients [see dosage and administration (2.4), clinical pharmacology (12.3)] . african-american and hispanic kidney transplant patients are at an increased risk for new onset diabetes after transplant. monitor blood glucose concentrations and treat appropriately [see warnings and precautions (5.4)].

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

physicians total care, inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus - unii:wm0haq4wnm) - tacrolimus 1 mg in 1 g - protopic ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy  for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. protopic ointment is not indicated for children younger than 2 years of age (see boxed warning, warnings and precautions: pediatric use). protopic (tacrolimus) ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

leo pharma inc - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus anhydrous 0.3 mg in 1 g - protopic® ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy  for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. protopic® ointment is not indicated for children younger than 2 years of age (see boxed warning, warnings and precautions: pediatric use). protopic® ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

Australia - angielski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - tacrolimus monohydrate, quantity: 5.112 mg (equivalent: tacrolimus, qty 5 mg) - capsule, hard - excipient ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; gelatin; purified water; sodium lauryl sulfate; brilliant blue fcf; phloxine b; titanium dioxide; quinoline yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute - adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Australia - angielski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - tacrolimus monohydrate, quantity: 1.022 mg (equivalent: tacrolimus, qty 1 mg) - capsule, hard - excipient ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; gelatin; purified water; sodium lauryl sulfate; brilliant blue fcf; iron oxide yellow; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute - adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Australia - angielski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - tacrolimus monohydrate, quantity: 0.511 mg (equivalent: tacrolimus, qty 0.5 mg) - capsule, hard - excipient ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; gelatin; purified water; sodium lauryl sulfate; brilliant blue fcf; allura red ac; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute - adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Izrael - angielski - Ministry of Health

astellas pharma international b.v., israel - tacrolimus - capsules - tacrolimus 1 mg - tacrolimus - tacrolimus - prophylaxis of transplant rejection in liver kidney or heart allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

Izrael - angielski - Ministry of Health

astellas pharma international b.v., israel - tacrolimus - capsules - tacrolimus 1 mg - tacrolimus - tacrolimus - prophylaxis of transplant rejection in liver kidney or heart allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

Izrael - angielski - Ministry of Health

astellas pharma international b.v., israel - tacrolimus - capsules - tacrolimus 5 mg - tacrolimus - tacrolimus - prophylaxis of transplant rejection in liver kidney or heart allograft recipients. treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.