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See related Afinitor tab information |
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Manufacturer |
Novartis |
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Distributor |
Zuellig |
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Contents |
Everolimus |
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Indications |
Treatment of advanced renal cell carcinoma after failure of sunitinib or sorafenib therapy or after treatment w/ VEGF-targeted therapy.
Click to view Afinitor detailed prescribing infomation |
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Dosage |
Adult 10 mg once daily, may be decreased to 5 mg daily.
Click to view Afinitor detailed prescribing infomation |
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Overdosage |
View Afinitor overdosage for action to be taken in the event of an overdose. |
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Administration |
May be taken with or without food (Take consistently either w/ or w/o food. Swallow whole w/ a glass of water. Do not chew/crush. Avoid grapefruit products.). |
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Contraindications |
Hypersensitivity to other rapamycin derivatives.
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Special Precautions |
Severe hepatic impairment (Child-Pugh class C). Increased risk of infection. Discontinue in case of noninfectious pneumonitis & invasive systemic fungal infection. Avoid alcohol- or peroxide-containing mouthwashes in case of oral ulceration. Monitor renal function (including BUN or serum creatinine), fasting serum glucose & CBC. Childn <18 yr. Pregnancy, lactation. Male fertility may be compromised.
Click to view Afinitor detailed prescribing infomation |
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Adverse Drug Reactions |
Stomatitis, rash, fatigue, asthenia, pyrexia, diarrhoea, anorexia, nausea, mucosal inflammation, vomiting, dry mouth, cough, peripheral oedema, infections, dry skin, epistaxis, pruritus, dyspnoea, pneumonitis, dysgeusia, headache, decreased wt.
View ADR Monitoring Form |
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Drug Interactions |
Live vaccines. May increase everolimus blood conc: Strong or moderate inhibitors of CYP3A4 or P-glycoprotein (PgP) eg ketoconazole, itraconazole, ritonavir, clarithromycin, telithromycin, erythromycin, verapamil, ciclosporin, fluconazole, diltiazem, amprenavir, fosamprenavir, aprepitant. Grapefruit & other foods that affect CYP450 & PgP. May decrease everolimus blood conc: Strong or moderate inducers or CYP3A4 or PgP eg rifampicin, rifabutin. St John's wort, carbamazepine, phenobarb, phenytoin, efavirenz, nevirapine.
View more drug interactions with Afinitor |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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Description |
View Afinitor description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Afinitor mechanism of action for pharmacodynamics and pharmacokinetics details. |
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