Gengraf Capsules and Zortress

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Using everolimus together with cycloSPORINE is not recommended. CycloSPORINE can increase your blood levels of everolimus to dangerous levels, resulting in increased risk of serious side effects such as pneumonitis (inflammation of the lungs), infection, mouth ulcers, anemia, or bleeding. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

GENERALLY AVOID: Coadministration with cyclosporine may significantly increase the plasma concentrations of everolimus. The mechanism is cyclosporine inhibition of the CYP450 3A4 first-pass metabolism and intestinal P-glycoprotein secretion of everolimus. In a single-dose study of 12 healthy subjects, administration of everolimus (2 mg) in combination with cyclosporine (microemulsion 175 mg) increased everolimus peak plasma concentration (Cmax) by 82% (range 25% to 158%) and systemic exposure (AUC) by 168% (range 46% to 365%) compared to administration of everolimus alone. In 59 de novo kidney transplant patients at increased risk for delayed graft function, everolimus trough concentrations (Cmin) were increased on average by 2.9-fold (range 0- to 5.6-fold) when cyclosporine was added to an everolimus-based regimen. Patients who delayed initiation of cyclosporine by 3 to 14 days (n=16) based on recovery of renal function had two- to threefold lower everolimus Cmin values during the first two weeks compared to patients who began cyclosporine treatment within 48 hours of transplant (n=40). In a study of 6 stable cardiac transplant patients, mean everolimus Cmax, Cmin and AUC were increased by 54%, 83% and 90%, respectively, following a switch from tacrolimus to cyclosporine coadministration, despite relatively low cyclosporine exposure. Everolimus has not been reported to significantly affect the pharmacokinetics of cyclosporine in kidney and heart transplant patients. However, everolimus can potentiate the nephrotoxicity of cyclosporine. In renal transplant patients, reduced allograft function with elevated serum creatinine occurred more frequently in patients treated with everolimus and full-dose cyclosporine than in control patients treated with mycophenolate mofetil. Heart transplant patients treated with the combination also had more frequent elevations of serum creatinine. These events were reported less frequently when everolimus was used with lower dosages of cyclosporine.

MANAGEMENT: Everolimus should generally not be used with potent or moderate inhibitors of CYP450 3A4 and/or P-glycoprotein. The possibility of prolonged and/or increased pharmacologic effects of everolimus therapy should be considered in patients who require coadministration with cyclosporine, including adverse effects such as pneumonitis, stomatitis, infection, dyspnea, diarrhea, anemia, leucopenia, thrombocytopenia, hyperglycemia, and hyperlipidemia. Therapeutic drug monitoring is recommended whenever cyclosporine is added to or withdrawn from therapy, and the dosage(s) of one or both drugs adjusted as necessary. Renal function tests including serum creatinine and blood urea nitrogen (BUN) should also be performed regularly during coadministration.

Gengraf Capsules

Generic Name: cyclosporine

Brand name: Gengraf, Neoral, Sandimmune, Sandimmune

Synonyms: Gengraf (Capsules, Modified), Gengraf

What is Gengraf Capsules?

Zortress

Generic Name: everolimus

Brand name: Zortress, Afinitor, Afinitor Disperz

Synonyms: n.a.

What is Zortress?