Envarsus XR(Tacrolimus Extended-release Tablets)
ENVARSUS XR Rx

Generic Name and Formulations:

Tacrolimus 0.75mg, 1mg, 4mg; ext-rel tabs.

Company:

Veloxis Pharmaceuticals
Indications for ENVARSUS XR:

Organ rejection prophylaxis in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants.

Limitations Of use:

Not interchangeable or substitutable with other tacrolimus products.

Adult:

Swallow whole. Take once daily in the morning, preferably on an empty stomach. Converting from tacrolimus immediate-release: give 80% of total daily dose of the immediate-release product. Monitor and titrate dose to achieve target whole blood trough concentration 4–11ng/mL. Black patients may require higher doses. See full labeling.

Children:

Not established.

Warnings/Precautions:

Increased risk of lymphomas and other malignancies (eg, skin). Avoid sun, UV light. Epstein Barr Virus seronegative; monitor. Increased risk of infections (eg, bacterial, viral, fungal, protozoal), opportunistic infections including polyoma virus, JC virus-associated progressive multifocal leukoencephalopathy, cytomegalovirus; monitor. New-onset diabetes: monitor blood glucose levels esp. in Black and Hispanic patients. Monitor for neurotoxicity; consider dose reduction or discontinuation if occurs. Hepatic or renal impairment; monitor and consider dose reduction. Obtain tacrolimus whole blood concentrations (see full labeling), serum creatinine, and serum potassium periodically. Avoid in congenital long QT syndrome. CHF, bradyarrhythmias, concomitant antiarrhythmic drugs, or electrolyte disturbances: consider obtaining ECGs and monitor electrolytes periodically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Concomitant live vaccines: not recommended. Avoid grapefruit/grapefruit juice, alcohol. Concomitant mycophenolic acid (MPA) products; monitor and reduce MPA dose as needed. Concomitant strong CYP3A inhibitors (eg, protease inhibitors, azole antifungals) or inducers (eg, antimycobacterials, anticonvulsants, St. John's wort): adjust dosing regimen, closely monitor tacrolimus blood concentrations and for QT prolongation. Concomitant voriconazole, posaconazole: give ⅓ of original dose. Concomitant mild or moderate CYP3A inhibitors (eg, antibiotics, calcium channel blockers, amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole, omeprazole, azole antifungals) or inducers (eg, methylprednisolone, prednisone), magnesium and aluminum hydroxide antacids, metoclopramide: monitor and adjust dose as needed. Concomitant potassium-sparing diuretics, ACEIs, ARBs may increase risk of hyperkalemia; monitor. Additive nephrotoxicity with CYP3A inhibitors, aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors.

Pharmacological Class:

Immunosuppressant (calcineurin-inhibitor).

Adverse Reactions:

Diarrhea, increased creatinine, nausea, peripheral edema, tremor, anemia, headache, hypertension, infections, hyperkalemia, hypomagnesemia, nephrotoxicity or neurotoxicity (esp. in high doses), post-transplant diabetes mellitus, posterior reversible encephalopathy syndrome (consider reduced dose or discontinue), malignancies (lymphomas, skin), post-transplant lymphoproliferative disorder, pure red cell aplasia (consider discontinuation), Torsade de Pointes.

Generic Availability:

NO

How Supplied:

Ext-rel tabs—30, 100