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Certican

Certican

everolimus

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
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 adult patients receiving hepatic transplant in combination w/ tacrolimus & corticosteroids.
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Dosage/Direction for Use
Adult Kidney & heart transplantation 750 mcg bid. Liver transplantation 1 mg bid w/ initial dose approx 4 wk after transplantation. Closely monitor whole blood trough levels in patients w/ impaired hepatic function. Reduce dose to approx ⅔ in mild hepatic impairment and to approx ½ in moderate or severe hepatic impairment.
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Overdosage
View Certican overdosage for action to be taken in the event of an overdose.
Administration
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.
Contraindications
Hypersensitivity to everolimus or sirolimus.
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Special Precautions
Increased risk of acute rejection. Use of thymoglobulin (rabbit anti-thymocyte globulin) induction & the everolimus/ciclosporin/steroid regimen. Increased risk of developing lymphomas & other malignancies, particularly of the skin. Oversuppression of the immune system w/ increased susceptibility to infections. Monitor for hyperlipidemia. Angioedema. Increased proteinuria & may increase in severity when substituted for a calcineurin inhibitor (CNI) in a maintenance therapy renal transplant patient w/ preexisting mild proteinuria. Concomitant use w/ ciclosporine; strong CYP3A4 inhibitors; CNI. Regular monitoring of blood drug levels, proteinuria & renal function. Can impair healing. Cases of ILD, some fatal. May increase risk of new-onset DM. Reversible azoospermia & oligospermia in patients treated w/ mTOR inhibitors. Potential risk for male infertility w/ prolonged therapy. Childn <18 yr.
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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.
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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.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Certican detailed prescribing information
Storage
View Certican storage conditions for details to ensure optimal shelf-life.
Description
View Certican description for details of the chemical structure and excipients (inactive components).
Action
View Certican mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Immunosuppressants
ATC Classification
L04AH02 - everolimus ; Belongs to the class of mammalian target of rapamycin (mTOR) kinase inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Certican tab 250 mcg
Packing/Price
60's (P91.75/pack)
Form
Certican tab 500 mcg
Packing/Price
60's (P183.25/pack)
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