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Generic Name for ZORTRESS
Everolimus 0.25mg, 0.5mg, 0.75mg; tabs.
Legal Classification:
Rx
Pharmacological Class for ZORTRESS
Immunosuppressant (macrolide).
Manufacturer of ZORTRESS
Novartis Pharmaceuticals Corp
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Indications for ZORTRESS
Organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk, in combination with basiliximab induction and reduced doses of cyclosporine and corticosteroids.
Adult dose for ZORTRESS
Give as soon as possible after transplantation. Swallow whole. ≥18yrs: initially 0.75mg every 12 hours (1.5mg/day) in combination with reduced dose cyclosporine. May adjust dose at 4–5 day intervals to achieve everolimus trough concentration target range 3–8ng/mL. Moderate hepatic dysfunction: reduce daily dose by ½ the initial daily dose. Initiate oral prednisone as soon as oral medication is tolerated.
Children's dosing for ZORTRESS
<18yrs: not recommended.
Contraindications for ZORTRESS
Sirolimus allergy.
Warnings/Precautions for ZORTRESS
Precaution(s): Increased risk of infections, lymphomas and other malignancies (eg, skin). Avoid sun, UV light. High immunologic risk or prophylaxis in other organs: not established. Severe hepatic impairment or hereditary disorders (eg, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption): not recommended. Diabetes. Obtain everolimus and cyclosporine whole blood concentrations periodically (see literature); and trough concentrations during dose adjustments. Monitor CBCs, renal function, urine protein, lipids, blood glucose, and for pneumonitis and infections. Pregnancy (Cat.C); use effective method of contraception during and up to 8 weeks after therapy. Nursing mothers: not recommended.
Interactions for ZORTRESS
Avoid live vaccines, standard doses of cyclosporine. Increased risk of angioedema with ACE-inhibitors. Potentiated by CYP3A4 and/or P-glycoprotein inhibitors; avoid strong inhibitors (eg, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, grapefruit juice, digoxin); monitor and adjust dose with moderate inhibitors (eg, erythromycin, fluconazole, nicardipine, diltiazem, nelfinavir, indinavir, amprenavir), or CYP3A4 and P-glycoprotein substrate (eg, verapamil). Antagonized by CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine, St. Johns Wort); avoid strong inducers (eg, rifampin, rifabutin). Avoid simvastatin, lovastatin; monitor if used with atorvastatin or pravastatin. Caution with other nephrotoxic drugs, CYP3A4 or CYP2D6 substrates with a narrow therapeutic index.
Adverse Reactions for ZORTRESS
Peripheral edema, GI upset, constipation, hypertension, anemia, infections (eg, UTI), hyperlipidemia, angioedema, malignancies (eg, lymphomas, skin), proteinuria, nephrotoxicity, graft thrombosis, delayed wound healing/dehiscence, polyoma virus infections (eg, BK virus-associated nephropathy), non-infectious pneumonitis (reduce or interrupt dose and/or manage with corticosteroids), thrombotic microangiopathy, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, new-onset diabetes post-transplant, male infertility.
How is ZORTRESS supplied?
Tabs—60 (10 x 6 blister strips)