Clinical Pharmacology Details


Everolimus


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Indications & Dose:

AFINITOR Treatment of advanced renal cell carcinoma when the disease has progressed despite treatment with vascular endothelial growth factor-targeted therapy | Treatment of unresectable or metastatic, well- or moderatelydifferentiated neuroendocrine tumours of pancreatic origin | Treatment of hormone-receptor-positive, human epidermal growth factor-2 (HER-2) negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a nonsteroidal aromatase inhibitor



Adult: 10 mg once daily


CERTICAN


Liver transplantation l



Adult: Initially 1 mg twice daily, to be started approximately 4 weeks after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4–5 days


Renal transplantation Heart transplantation 



Adult: Initially 750 micrograms twice daily, to be started as soon as possible after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4–5 days

Contraindications:

Hypersensitivity to everolimus, sirolimus or to any of the excipients.

Side Effects:

Cautions:

Precautions:

Increased risk of developing lymphomas and other malignancies, particularly of the skin. Oversuppression of the immune system with increased susceptibility to infection. Patients should be monitored for hyperlipidemia. Regular monitoring of renal function is recommended. Coadministration of everolimus with known strong CYP3A4 inhibitor and inducers is not recommended unless the benefit outweighs the risk. Patients with rare hereditary problems of galactose intolerance, severe lactose deficiency or glucose-lactose malabsorption should not take his medicine. Effective contraception must be use. Should not be used during pregnancy unless clearly necessary. Should not be used by breast-feeding women. 

Interaction:

Caution with concomitant use of Rifampicin, rifabutin or ketoconazole, itraconazole, voriconzaole, clarithronycin, telithromcin or ritonovir 

Warnings:

Adverse Effects:

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Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: