Novartis Healthcare


Concise Prescribing Info
Prophylaxis of organ rejection in adults at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant in combination w/ ciclosporin for microemulsion & corticosteroids. Prophylaxis of organ rejection in adults receiving hepatic transplant in combination w/ tacrolimus & corticosteroids.
Dosage/Direction for Use
Kidney & heart transplantation 750 mcg bid. Liver transplantation 1 mg bid w/ initial dose approx 4 wk after transplantation.
May be taken with or without food: Take consistently either always w/ or always w/o meals. Swallow whole, do not crush. Avoid grapefruit juice.
Hypersensitivity to everolimus or sirolimus.
Special Precautions
Increased risk of acute rejection; developing lymphomas & other malignancies (particularly of the skin); kidney arterial & venous thrombosis (w/in 2st 30 days post-transplantation); new-onset of DM. Use of thymoglobulin (rabbit anti-thymocyte globulin) induction & the everolimus/ciclosporin/steroid regimen. Oversuppression of the immune system w/ increased susceptibility to infections, especially infections w/ opportunistic pathogens (bacterial, fungal, viral, protozoal) which can include BK virus-associated nephropathy which can lead to kidney graft loss & the potentially fatal JC virus-associated progressive multiple leukoencephalopathy. Monitor for hyperlipidemia. Angioedema. Patient w/ preexisting mild proteinuria. Concomitant use w/ ciclosporin; strong CYP3A4 inhibitors & inducers; calcineurin inhibitor. Regular monitoring of blood drug levels, proteinuria & renal function. May impair healing. Increased frequency of pericardial & pleural effusion in cardiac transplant recipients & incisional hernias in liver transplant recipients. Interstitial lung disease. Galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Potential risk for male infertility (prolonged therapy). Women of childbearing potential should use effective contraception for up to 8 wk after treatment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infections (bacterial, fungal, viral), lower resp tract & lung infections (including pneumonia), upper resp tract infections, UTI; anemia/erythropenia, leukopenia, thrombocytopenia; hyperlipidemia (cholesterol & triglycerides), new onset DM, hypokalemia; insomnia, anxiety, headache; pericardial effusion; HTN, venous thromboembolic events; pleural effusion, cough, dyspnea; diarrhea, nausea, vomiting, abdominal pain; pain, pyrexia, peripheral edema, healing impairment.
Drug Interactions
Not recommended w/ rifampicin, ketoconazole; itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, rifabutin. Increased bioavailability w/ ciclosporin. Increased Cmax w/ erythromycin, verapamil. Increased Cmin w/ octreotide. Atorvastatin, pravastatin. Increased Cmax & AUC w/ midazolam. May increase metabolism & decrease blood levels w/ St. John's wort, anticonvulsants (eg, carbamazepine, phenobarb, phenytoin), anti HIV drugs (eg, efavirenz, nevirapine). May increase blood levels w/ fluconazole; verapamil, nicardipine, diltiazem; nelfinavir, indinavir, amprenavir. Increase blood conc w/ Pgp inhibitors. CYP3A4 & CYP2D6 substrates. Live vaccines. Grapefruit & grapefruit juice.
MIMS Class
ATC Classification
L04AA18 - everolimus ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Certican tab 250 mcg
Certican tab 500 mcg
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