Envarsus XR(tacrolimus)
Envarsus XR 0.75 MG 24HR Extended Release Oral Tablet
Dosage & Administration
| Recommended ENVARSUS XR Initial Dosage | ||
| Initial Oral Dosage | Whole Blood Trough Concentration Range | |
| De novo kidney transplantation with antibody induction | 0.14 mg/kg/day | Month 1: 6-11 ng/mL >Month 1: 4-11 ng/mL |
| Conversion from tacrolimus immediate-release formulations | 80% of the pre-conversion dose of tacrolimus immediate-release | Titrate to 4-11 ng/mL |
Get Your Patient on Envarsus XR
See your patient's specific prior authorization requirements including coverage restrictions and step therapies
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Envarsus XR Prescribing Information
Envarsus XR Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form
Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form
Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form
Benefits investigation
Reimbursement help (FRM)
Envarsus XR Financial Assistance Options
Copay savings program
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Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bridge program
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Overview
- Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
- Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
Patient benefit
- 100% free (outside of insurance)
Patient eligibility
- HCP must enroll patient
- May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
- Typically HCP assisted enrollment (via form)
Foundation programs
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Overview
- Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
- These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
- Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted
Patient eligibility
- Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
- Patients submit proof of out-of-pocket drug costs to charities for reimbursement
Envarsus XR PubMed™ News
Envarsus XR Patient Education
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Patient toolkit
Envarsus XR FAQs
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 with the Transplantation Pregnancy Registry International by contacting them at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.
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.
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.
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.
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.
No, the safety and effectiveness of ENVARSUS XR in pediatric patients have not been established.
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.
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.
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.
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.
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available