Envarsus XR(tacrolimus)
Envarsus XR 0.75 MG 24HR Extended Release Oral Tablet
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Envarsus XR Prescribing Information
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Envarsus XR FAQs
What is the Transplantation Pregnancy Registry International?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.
What should healthcare providers advise their patients regarding the pregnancy registry?Healthcare providers are encouraged to advise their patients to register with the Transplantation Pregnancy Registry International by contacting them at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.
What are the risks associated with tacrolimus use during pregnancy?Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and the TPRI suggest that infants exposed to tacrolimus in utero are at risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress. The background risk of major birth defects and miscarriage in the indicated population is unknown.
What should healthcare providers advise pregnant women who are taking ENVARSUS XR?Healthcare providers should advise pregnant women of the potential risk to the fetus associated with ENVARSUS XR use. They should monitor maternal blood glucose levels regularly, as ENVARSUS XR may increase hyperglycemia in pregnant women with diabetes. ENVARSUS XR may also exacerbate hypertension in pregnant women and increase pre-eclampsia, so healthcare providers should monitor and control blood pressure.
What are the pregnancy outcomes associated with tacrolimus use?TPRI reported that 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. The TPRI pregnancy outcomes in kidney and liver transplant recipients exposed to tacrolimus are summarized in Table 8, and birth defects observed include cardiac malformations, craniofacial malformations, renal/urogenital disorders, skeletal abnormalities, neurological abnormalities, and multiple malformations.
What is the recommended family planning advice for patients of reproductive potential taking ENVARSUS XR?ENVARSUS XR can cause fetal harm when administered to pregnant women, so healthcare providers should advise female and male patients of reproductive potential to speak with them on family planning options, including appropriate contraception, prior to starting treatment with ENVARSUS XR.
Is ENVARSUS XR safe for use in pediatric patients?No, the safety and effectiveness of ENVARSUS XR in pediatric patients have not been established.
Are there any differences in how elderly patients respond to ENVARSUS XR?Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. However, 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.
What is the recommended monitoring for patients with renal impairment taking ENVARSUS XR?While the pharmacokinetics of tacrolimus in patients with renal impairment is similar to that in healthy subjects with normal renal function, monitoring of renal function in patients with renal impairment is recommended due to its potential for nephrotoxicity. Tacrolimus dosage should be reduced if indicated.
What is the recommended dosage for patients with hepatic impairment taking ENVARSUS XR?For patients with severe hepatic impairment (mean Child-Pugh score: >10), dosage reduction is recommended due to the greater risk of adverse reactions with greater tacrolimus whole blood trough concentrations. For patients with moderate hepatic impairment, monitoring of tacrolimus whole blood trough concentrations is recommended. For patients with mild hepatic impairment, no dosage adjustments are needed.
Do African-American patients need different dosages of ENVARSUS XR?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 and indicated that an 80% conversion factor is appropriate for African-American patients.
Are there any specific risks for African-American and Hispanic kidney transplant patients taking ENVARSUS XR?African-American and Hispanic kidney transplant patients are at an increased risk for new onset diabetes after transplant. Blood glucose concentrations should be monitored and treated appropriately.
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