Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
everolimus, Quantity: 2 mg
Novartis Pharmaceuticals Australia Pty Ltd
Everolimus
Tablet, dispersible
Excipient Ingredients: butylated hydroxytoluene; crospovidone; hypromellose; lactose monohydrate; mannitol; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica
Oral
120, 60, 100, 50, 30
(S4) Prescription Only Medicine
Afinitor is indicated for the: ? Treatment of postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? Treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? Treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. ? Treatment of patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. ? Adjunctive treatment of patients aged 2 years and older with TSC and associated refractory seizures.
Visual Identification: White to slightly yellow round flat tablet with bevelled edge engraved D2 on one side and NVR on the other; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-08-28
AFINITOR ® A f i n i t o r ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING AFINITOR? Afinitor contains the active ingredient everolimus. Afinitor is used to treat various types of cancer by slowing the growth of cancer- causing cells. For more information, see Section 1. Why am I using Afinitor? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AFINITOR? Do not use if you have ever had an allergic reaction to Afinitor or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Afinitor? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Afinitor and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE AFINITOR? • Your doctor will tell you the dose of Afinitor that you should take. More instructions can be found in Section 4. How do I use Afinitor? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AFINITOR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Afinitor. • Avoid becoming pregnant while using Afinitor and for up to 8 weeks after you stop using it. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take Afinitor to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • It is not known if Afinitor will influence your ability to drive and use machines. DRINKING ALCOHOL • There are no known interactions bet Lestu allt skjalið
Page 1 of 52 AFINITOR ® (EVEROLIMUS) NAME OF THE MEDICINE The active ingredient of Afinitor is everolimus. The chemical name is 40-O-(2-hydroxyethyl)-rapamycin or 40-O-(2-hydroxyethyl)-sirolimus. Its molecular formula is C 53 H 83 NO 14 and its molecular weight is 958.2. The structural formula of everolimus is: N O O O O O O O OH O O O OH OH O DESCRIPTION Everolimus is a white to faintly yellow powder practically insoluble in water but soluble in organic solvents such as ethanol and methanol. CAS number: 159351-69-6 Excipients: (Tablets) Butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose anhydrous. Page 2 of 52 Excipients: (dispersible tablets) Butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, mannitol, cellulose microcrystalline, and silica colloidal anhydrous. PHARMACOLOGY PHARMACODYNAMICS MECHANISM OF ACTION Everolimus is a signal transduction inhibitor targeting mTOR (mammalian target of rapamycin), or more specifically, mTORC1 (mammalian 'target of rapamycin' complex 1). mTOR is a key serine-threonine kinase playing a central role in the regulation of cell growth, proliferation and survival. The regulation of mTORC1 signalling is complex, being modulated by mitogens, growth factors, energy and nutrient availability. mTORC1 is an essential regulator of global protein synthesis downstream on the PI3K/AKT pathway, which is dysregulated in the majority of human cancers. Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to endocrine resistance in breast cancer. _In vitro_ studies show that oestrogen-dependent and HER2+ breast cancer cells are sensitive to the inhibitory effects of everolimus, and that combination of everolimus with Akt, HER2, or aromatase inhibitors synergistically enhances the anti-tumour effect of everolimus. Two primary regulators of mTORC1 signaling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2). Loss or inactivation of either TSC1 or TSC2 leads to e Lestu allt skjalið