Certican山萊恩

Certican

everolimus

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
Prophylaxis of organ rejection at low to moderate immunological risk receiving renal, hepatic or cardiac transplant. In combination w/ ciclosporin (for microemulsion) & corticosteroids. In combination w/ tacrolimus & corticosteroids in hepatic transplant.
Dosage/Direction for Use
Adult Renal or cardiac transplant Initially 0.75 mg bd administered after transplantation. Hepatic transplant 1 mg bd w/ initial dose approx 4 wk after transplantation. Adjust dose at 4-5 days intervals based on achieved blood levels, tolerability, response, change in co-medications & clinical situation.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o meals. Swallow whole, do not chew/crush. Avoid grapefruit juice.
Contraindications
Hypersensitivity to everolimus & sirolimus.
Special Precautions
Management of immunosuppression. Combination w/ thymoglobulin induction. Serious & opportunistic infections. Liver function impairment.  Lymphomas. Monitor for skin neoplasms & minimise exposure to UV light, sunlight & use sunscreen. Hyperlipidemia. Angioedema. Everolimus & calcineurin inhibitor-induced renal dysfunction. Proteinuria. Renal graft thrombosis. Wound-healing combinations. Thrombotic microangiopathy/thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome. Vaccination. Interstital lung disease/non-infectious pneumonitis. New onset DM. Male infertility may occur in prolonged use. Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Black patients. Childn & adolescents. Pregnancy & lactation.
Adverse Reactions
Viral, bacterial & fungal infections, upper & lower resp tract infection, sepsis, UTI, wound infection, leucopenia, hyperlipidaemia, pericardial & pleural effusion, HTN, abdominal pain, peripheral oedema, incisional hernia.
Drug Interactions
Strong & moderate CYP3A4 inhibitors/inducers. Increased bioavailability w/ ciclosporin. Increased clearance & decreased Cmax & AUC of midazolam. Increased blood levels w/ fluconazole, erythromycin, verapamil, nicardipin, diltiazem, nelfinavir, indinavir, amprenavir. Increased metabolism & decreased blood levels w/ St. John's wort, carbamezapine, phenobarb, phenytoin, efavirenz, nevirapine. Grape fruit juice; live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AA18 - everolimus ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Certican tab 0.25 mg
Packing/Price
60's
Form
Certican tab 0.5 mg
Packing/Price
60's
Form
Certican tab 0.75 mg
Packing/Price
60's
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