Envarsus XR 1 mg/1
Tacrolimus · TABLET, EXTENDED RELEASE · Veloxis Pharmaceuticals, Inc
Envarsus XR is a tablet, extended release containing tacrolimus at 1 mg/1, taken oral. Manufactured by Veloxis Pharmaceuticals, Inc.
Key Facts
- Brand Name
- Envarsus XR
- Generic Name
- Tacrolimus
- NDC Code (Product)
68992-3010- Manufacturer
- Veloxis Pharmaceuticals, Inc
- Strength
- 1 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA206406
- Marketing Start
- 09/01/2015
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants ( 1.1 ) The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in De Novo Kidney Transplant Patients ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see Clinical Studies (14.1) ]. 1.2 Prophylaxis of Organ Rejection in Stable Kidney Transplant Patients Converting from Immediate-Release Formulations 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) ].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take once daily on empty stomach at the same time of the day, preferably in the morning. ( 2.1 ) Avoid eating grapefruit or drinking grapefruit juice or alcohol. ( 2.1 ) African-American patients may need to be titrated to higher dosages to achieve the target tacrolimus concentrations. ( 2.4 ) Patients with severe hepatic impairment may require a lower starting dose. ( 2.4 ) Frequent monitoring of trough concentrations is recommended. ( 2.5 ) 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 2.1 Important Administration Instructions ENVARSUS XR (tacrolimus extended-release tablets) is not interchangeable or substitutable with tacrolimus extended-release capsules, tacrolimus capsules, and tacrolimus for oral suspension. Under or overexposure to tacrolimus may result in graft rejection or other serious adverse reactions [see Warnings and Precautions (5.3) ]. E…
Contraindications
4 CONTRAINDICATIONS ENVARSUS XR is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in ENVARSUS XR. Known hypersensitivity to tacrolimus or any of the ingredients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Risk of rejection with strong CYP3A inducers and risk of serious adverse reactions with strong CYP3A inhibitors: Adjust dose and monitor tacrolimus concentrations. ( 2.4 , 5.9 , 7.2 ) Therapeutic drug monitoring and dose reduction for ENVARSUS XR should be considered when ENVARSUS XR is co-administered with cannabidiol ( 2.5 , 5.13 , 7.3 ). See Full Prescribing Information for clinically significant drug interactions. ( 7.1 , 7.2 ) 7.1 Mycophenolic Acid When ENVARSUS XR is prescribed with a given dose of mycophenolic acid (MPA) product, exposure to MPA is higher with ENVARSUS XR co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA associated adverse reactions and reduce the dose of concomitantly administered MPA products as needed. 7.2 Effects of Other Drugs/Substances on ENVARSUS XR Table 7. Effects of Other Drugs/Substances on ENVARSUS XR a, d a ENVARSUS XR dosage adjustment recommendation based on observed effect of co-administered drug on tacrolimus exposures [see Clinical Pharmacology (12.3) ] , literature reports of altered tacr…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are discussed in greater detail in other sections of the labeling: Lymphoma and Other Malignancies [see Boxed Warning, Warnings and Precautions (5.1) ] Serious Infections [see Boxed Warning, Warnings and Precautions (5.2) ] New Onset Diabetes after Transplant [see Warnings and Precautions (5.4) ] Nephrotoxicity due to ENVARSUS XR and Drug Interactions [see Warnings and Precautions (5.5) ] Neurotoxicity [see Warnings and Precautions (5.6) ] Hyperkalemia [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] QT Prolongation [see Warnings and Precautions (5.10) ] Pure Red Cell Aplasia [see Warnings and Precautions (5.12) ] Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions (5.13) ] De novo kidney transplant patients: Most common adverse reactions (incidence ≥15%) include: diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia and headache. ( 6.1 ) Conversion of kidney transplant patients from immediate-release to exten…
Frequently Asked Questions
What is Envarsus XR used for?
Envarsus XR contains Tacrolimus. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Envarsus XR a controlled substance?
Envarsus XR is not classified as a controlled substance by the DEA.
What is the generic name for Envarsus XR?
The generic name for Envarsus XR is Tacrolimus. There are 12 other brand versions of Tacrolimus.
What is the NDC code for Envarsus XR 1 mg/1?
The NDC (National Drug Code) for Envarsus XR 1 mg/1 is 68992-3010, listed by Veloxis Pharmaceuticals, Inc.