| Renal transplant rejection

Nulojix vs Envarsus XR

Side-by-side clinical, coverage, and cost comparison for renal transplant rejection.

Deep comparison between: Nulojix vs Envarsus with Prescriber.AI

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Safety signalsEnvarsus has a higher rate of injection site reactions vs Nulojix based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Envarsus but not Nulojix, including UnitedHealthcare

Category

Nulojix

Envarsus

At A Glance

RouteIV infusion

FrequencyEvery 4 weeks

ClassSelective T cell costimulation blocker

RouteOral

FrequencyOnce daily

ClassCalcineurin inhibitor

Indications

Renal transplant rejection

Renal transplant rejection

Dosing

Renal transplant rejection Initial phase: 10 mg/kg IV on Day 1, Day 5, and end of Weeks 2, 4, 8, and 12; maintenance phase starting Week 16: 5 mg/kg IV every 4 weeks (+/- 3 days), administered over 30 minutes.

Renal transplant rejection (de novo, with antibody induction) 0.14 mg/kg/day orally once daily on an empty stomach; target trough 6-11 ng/mL in month 1, 4-11 ng/mL thereafter.

Renal transplant rejection (conversion from tacrolimus immediate-release) 80% of the pre-conversion total daily dose of tacrolimus immediate-release orally once daily; titrate to target trough 4-11 ng/mL.

Contraindications

EBV seronegative or unknown EBV serostatus, due to risk of post-transplant lymphoproliferative disorder (PTLD) predominantly involving the CNS

Known hypersensitivity to tacrolimus or to any ingredient in ENVARSUS XR

Drug Interactions

264View drug interactions

1432View drug interactions

Adverse Reactions

Most common (>=20%) Anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, leukopenia

Serious PTLD predominantly involving the CNS, serious infections including JC virus-associated PML and polyoma virus nephropathy

Postmarketing Anaphylaxis, venous thrombosis of the renal allograft

Most common (>=10%) diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia, headache, hypophosphatemia, leukopenia, nausea, insomnia, increased blood creatinine, hypomagnesemia, hypokalemia, hyperglycemia

Serious lymphoma and other malignancies, serious infections, new onset diabetes after transplant, nephrotoxicity, neurotoxicity, hyperkalemia, hypertension, QT prolongation, pure red cell aplasia, thrombotic microangiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura

Postmarketing agranulocytosis, hemolytic anemia, hemolytic uremic syndrome, pancytopenia, pure red cell aplasia, thrombotic thrombocytopenic purpura, cardiac arrest, Torsades de pointes, hearing loss, blindness, gastrointestinal perforation, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, lymphoma, progressive multifocal leukoencephalopathy, posterior reversible encephalopathy syndrome, acute renal failure, rhabdomyolysis

Pharmacology

Selective T cell costimulation blocker; belatacept is a soluble CTLA4-Ig fusion protein that binds CD80 and CD86 on antigen-presenting cells, blocking CD28-mediated T lymphocyte costimulation and inhibiting T cell proliferation and cytokine production that mediate immunologic rejection.

Tacrolimus is a calcineurin inhibitor that binds the intracellular protein FKBP-12, forming a complex that inhibits calcineurin phosphatase activity, thereby preventing T-lymphocyte activation and proliferation by blocking production of multiple cytokines including IL-2 and TNF-alpha.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Nulojix