Afinitor

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Overview

What is Afinitor?

AFINITOR (everolimus) and AFINITOR DISPERZ (everolimus tablets for oral suspension) are kinase inhibitors.

The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2. The structural formula is:

AFINITOR for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.

AFINITOR DISPERZ for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.

What does Afinitor look like?

What are the available doses of Afinitor?

AFINITOR

Tablets, white to slightly yellow and elongated with a bevelled edge:

AFINITOR DISPERZ

Tablets for oral suspension, white to slightly yellowish, round, and flat with a bevelled edge:

What should I talk to my health care provider before I take Afinitor?

How should I use Afinitor?

AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.

10 mg orally once daily. ()

What interacts with Afinitor?

Sorry No Records found

What are the warnings of Afinitor?

Sorry No Records found

What are the precautions of Afinitor?

Sorry No Records found

What are the side effects of Afinitor?

Sorry No records found

What should I look out for while using Afinitor?

AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives .

What might happen if I take too much Afinitor?

Sorry No Records found

How should I store and handle Afinitor?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals. AFINITOR2.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “LCL” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0594-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0566-51Each carton contains 4 blister cards of 7 tablets each7.5 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “7P5” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0620-51Each carton contains 4 blister cards of 7 tablets each10 mg tablets: White to slightly yellow, elongated tablets with a bevelled edge and engraved with “UHE” on one side and “NVR” on the other; available in:Blisters of 28 tablets………………………………………………………………………………NDC 0078-0567-51Each carton contains 4 blister cards of 7 tablets eachAFINITOR DISPERZ2 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D2” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0626-51Each carton contains 4 blister cards of 7 tablets each3 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D3” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0627-51Each carton contains 4 blister cards of 7 tablets each5 mg tablets for oral suspension: White to slightly yellowish, round, flat tablets with a bevelled edge and engraved with “D5” on one side and “NVR” on the other; available in: Blisters of 28 tablets………………………………………………………………………………NDC 0078-0628-51Each carton contains 4 blister cards of 7 tablets eachStore at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anticancer pharmaceuticals.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers and in tuberous sclerosis complex (TSC). Everolimus binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity. Everolimus reduced the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic initiation factor 4E-binding protein (4E-BP1), downstream effectors of mTOR, involved in protein synthesis. S6K1 is a substrate of mTORC1 and phosphorylates the activation domain 1 of the estrogen receptor which results in ligand-independent activation of the receptor. In addition, everolimus inhibited the expression of hypoxia-inducible factor (e.g., HIF-1) and reduced the expression of vascular endothelial growth factor (VEGF). Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in and/or studies.

Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to endocrine resistance in breast cancer. studies show that estrogen-dependent and HER2+ breast cancer cells are sensitive to the inhibitory effects of everolimus, and that combination treatment with everolimus and Akt, HER2, or aromatase inhibitors enhances the anti-tumor activity of everolimus in a synergistic manner.

Two regulators of mTORC1 signaling are the oncogene suppressors tuberin-sclerosis complexes 1 and 2 (). Loss or inactivation of either or leads to activation of downstream signaling. In TSC, a genetic disorder, inactivating mutations in either the or the gene lead to hamartoma formation throughout the body as well as seizures and epileptogenesis. Overactivation of mTOR results in neuronal dysplasia, aberrant axonogenesis and dendrite formation, increased excitatory synaptic currents, reduced myelination, and disruption of the cortical laminar structure causing abnormalities in neuronal development and function. Treatment with an mTOR inhibitor in animal models of mTOR dysregulation in the brain resulted in seizure suppression, prevention of the development of new-onset seizures, and prevention of premature death.

Non-Clinical Toxicology

AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives .

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Non-infectious pneumonitis was reported in up to 19% of patients treated with AFINITOR/AFINITOR DISPERZ in clinical trials, some cases were reported with pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event. The incidence of Grade 3 and 4 non-infectious pneumonitis was up to 4% and up to 0.2%, respectively . Fatal outcomes have been observed.

Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms. Consider opportunistic infections such as pneumocystis jiroveci pneumonia (PJP) in the differential diagnosis. Advise patients to report promptly any new or worsening respiratory symptoms.

Continue AFINITOR/AFINITOR DISPERZ without dose alteration in patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms. Imaging appears to overestimate the incidence of clinical pneumonitis.

For Grade 2 to 4 non-infectious pneumonitis, withhold or permanently discontinue AFINITOR/AFINITOR DISPERZ based on severity . Corticosteroids may be indicated until clinical symptoms resolve. Administer prophylaxis for PJP when concomitant use of corticosteroids or other immunosuppressive agents are required. The development of pneumonitis has been reported even at a reduced dose.

The following serious adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Afinitor

Overview

What is Afinitor?

What does Afinitor look like?

What are the available doses of Afinitor?

What should I talk to my health care provider before I take Afinitor?

How should I use Afinitor?

What interacts with Afinitor?

What are the warnings of Afinitor?

What are the precautions of Afinitor?

What are the side effects of Afinitor?

What should I look out for while using Afinitor?

What might happen if I take too much Afinitor?

How should I store and handle Afinitor?

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