Afinitor

Afinitor

everolimus

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
Postmenopausal women w/ hormone receptor-positive & HER-2 negative advanced breast cancer in combination w/ exemestane after failure of treatment w/ letrozole or anastrozole. Advanced neuroendocrine tumors of pancreatic origin. Advanced renal cell carcinoma after failure of therapy w/ sunitinib or sorafenib or after treatment w/ VEGF targeted therapy.
Dosage/Direction for Use
Advanced breast cancer, neuroendocrine tumors, renal cell carcinoma 10 mg once daily.
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.
Contraindications
Hypersensitivity to other rapamycin derivatives.
Special Precautions
Noninfectious pneumonitis, infections, hypersensitivity reactions. Avoid alcohol- or peroxide-containing mouthwashes in case of oral ulceration. Monitor renal function, blood glucose & CBC. Severe hepatic impairment (Child-Pugh class C). Avoid use of live vaccines. Childn <18 yr. Pregnancy & lactation. Male fertility may be compromised.
Adverse Reactions
Infections, decreased appetite, dysgeusia, headache, cough, pneumonitis, epistaxis, dyspnoea, stomatitis, diarrhoea, nausea, vomiting, rash, dry skin, pruritus, nail disorder, fatigue, asthenia, mucosal inflammation, peripheral oedema, pyrexia, decreased wt. Hypertriglyceridemia, dermatitis acreiform, acne, decreased WBC count.
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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EG02 - everolimus ; Belongs to the class of mammalian target of rapamycin (mTOR) kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Afinitor tab 10 mg
Packing/Price
1 × 10's;3 × 10's
Form
Afinitor tab 5 mg
Packing/Price
1 × 10's;3 × 10's
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