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AFINITOR
Bladder, kidney, and other urologic cancers
Breast cancer
CNS cancers
Pancreatic, thyroid, and other endocrine cancers
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Drug Name:

AFINITOR Rx

Generic Name and Formulations:
Everolimus 2.5mg, 5mg, 7.5mg, 10mg; tabs.

Company:
Novartis Pharmaceuticals Corp



Therapeutic Use:

Indications for AFINITOR:

Advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Adult Dose for AFINITOR:

Swallow whole with water or disperse tablet in 30mL of water and drink immediately. Take at the same time each day either consistently with or without food. RCC or renal angiomyolipoma with TSC: 10mg once daily. Mild hepatic impairment (Child-Pugh class A): 7.5mg daily, may reduce to 5mg if not tolerated. Moderate hepatic impairment (Child-Pugh class B), or adverse reactions: reduce to 5mg daily, may be reduce to 2.5mg if not tolerated. Severe hepatic impairment (Child-Pugh class C): max 2.5mg daily if benefits outweigh risk. Concomitant moderate CYP3A4 or P-glycoprotein inhibitors: reduce to 2.5mg once daily; may consider increasing to 5mg if tolerated. If moderate inhibitor is discontinued, allow 2–3 days washout period before increasing everolimus dose; return to dose used prior to initiating the moderate inhibitor. Concomitant strong CYP3A4 inducers: may increase from 10–20mg once daily by increments of 5mg. If strong inducer is discontinued, should return to dose used prior to initiating the strong inducer. Continue as long as benefit observed or until unacceptable toxicity occurs.

Children's Dose for AFINITOR:

Not recommended.

Pharmacological Class:

mTOR kinase inhibitor.

Contraindications:

Sirolimus, temsirolimus, rapamycin allergy.

Warnings/Precautions:

Hepatic impairment (see Adult dose). Increased risk of infections; some may be severe or fatal. Pre-existing invasive fungal infections: treat before starting. Monitor CBCs, renal function, lipids, blood glucose, and for pneumonitis and infections: treat promptly if occur. Women of childbearing potential should use effective method of contraception during and up to 8 weeks after treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

Avoid live vaccines. Potentiated by strong CYP3A4 inhibitors, or P-glycoprotein inhibitors; avoid (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, grapefruit juice). Caution with moderate CYP3A4 inhibitors (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem) or P-glycoprotein inhibitors; reduce everolimus dose if used. Antagonized by strong CYP3A4 inducers; avoid (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort); increase everolimus dose if used.

Adverse Reactions:

Pneumonitis (reduce dose and/or manage with corticosteroids; if severe, discontinue. May restart daily dose at approx. 50% lower than previously administered), infections (discontinue if invasive systemic fungal infection develops), stomatitis (treat with non-alcoholic, non-peroxide mouthwash), GI upset, rash, fatigue, edema, fever, headache, asthenia, cough, decreased appetite; increased serum creatinine, blood glucose, lipids; decreased hemoglobin, platelets, neutrophils, serum phosphate; proteinuria, renal failure, others (see literature).

Metabolism:

Hepatic (CYP3A4, 2D6), PgP.

Elimination:

Fecal, renal (minor).

Generic Availability:

NO

How Supplied:

Tabs—28 (4 blister cards x 7 tabs)

AFINITOR

  • 10mg tablets (Qty:28)
  • appx. price $10139.00
GoodRx

Indications for AFINITOR:

Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

Adult Dose for AFINITOR:

Swallow whole with water or disperse tablet in 30mL of water and drink immediately. Take at the same time each day either consistently with or without food. 10mg once daily. Mild hepatic impairment (Child-Pugh class A): 7.5mg daily, may reduce to 5mg if not tolerated. Moderate hepatic impairment (Child-Pugh class B), or adverse reactions: reduce to 5mg daily, may be reduce to 2.5mg if not tolerated. Severe hepatic impairment (Child-Pugh class C): max 2.5mg daily if benefits outweigh risk. Concomitant moderate CYP3A4 or P-glycoprotein inhibitors: reduce to 2.5mg once daily; may consider increasing to 5mg if tolerated. If moderate inhibitor is discontinued, allow 2–3 days washout period before increasing everolimus dose; return to dose used prior to initiating the moderate inhibitor. Concomitant strong CYP3A4 inducers: may increase from 10–20mg once daily by increments of 5mg. If strong inducer is discontinued, should return to dose used prior to initiating the strong inducer. Continue as long as benefit observed or until unacceptable toxicity occurs.

Children's Dose for AFINITOR:

Not recommended.

Pharmacological Class:

mTOR kinase inhibitor.

Contraindications:

Sirolimus, temsirolimus, rapamycin allergy.

Warnings/Precautions:

Hepatic impairment (see Adult dose). Increased risk of infections; some may be severe or fatal. Pre-existing invasive fungal infections: treat before starting. Monitor CBCs, renal function, lipids, blood glucose, and for pneumonitis and infections: treat promptly if occur. Women of childbearing potential should use effective method of contraception during and up to 8 weeks after treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

Avoid live vaccines. Potentiated by strong CYP3A4 inhibitors, or P-glycoprotein inhibitors; avoid (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, grapefruit juice). Caution with moderate CYP3A4 inhibitors (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem) or P-glycoprotein inhibitors; reduce everolimus dose if used. Antagonized by strong CYP3A4 inducers; avoid (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort); increase everolimus dose if used.

Adverse Reactions:

Pneumonitis (reduce dose and/or manage with corticosteroids; if severe, discontinue. May restart daily dose at approx. 50% lower than previously administered), infections (discontinue if invasive systemic fungal infection develops), stomatitis (treat with non-alcoholic, non-peroxide mouthwash), GI upset, rash, fatigue, edema, fever, headache, asthenia, cough, decreased appetite; increased serum creatinine, blood glucose, lipids; decreased hemoglobin, platelets, neutrophils, serum phosphate; proteinuria, renal failure, others (see literature).

Metabolism:

Hepatic (CYP3A4, 2D6), PgP.

Elimination:

Fecal, renal (minor).

Generic Availability:

NO

How Supplied:

Tabs—28 (4 blister cards x 7 tabs)

AFINITOR

  • 10mg tablets (Qty:28)
  • appx. price $10139.00
GoodRx

Indications for AFINITOR:

Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) in patients who require therapeutic intervention but are not candidates for curative surgical resection.

Adult Dose for AFINITOR:

Swallow whole with water or disperse tablet in 30mL of water and drink immediately. Take at the same time each day either consistently with or without food. BSA< 0.58m2: not studied. Initially: BSA: 0.5–1.2m2: 2.5mg once daily; 1.3–2.1m2: 5mg once daily; ≥2.2m2: 7.5mg once daily. Evaluate SEGA volume approx. 3 months after starting therapy and periodically thereafter; dose adjustments may be made at 2 week intervals. Trough concentrations should be assessed every 2 weeks, dosing should be titrated to attain a concentration of 5–10ng/mL (see literature). Severe adverse reactions: temporarily reduce dose or interrupt therapy; consider alternate day dosing for patients receiving 2.5mg daily. Severe hepatic impairment: not recommended. Concomitant strong CYP3A4 inhibitors: avoid; moderate CYP3A4 and/or PgP inhibitors: reduce dose by 50%, if CYP3A4 and/or PgP inhibitor discontinued, return to dose used prior to initiating moderate inhibitor. Concomitant strong CYP3A4 inducers: avoid, if required, then double dose of everolimus; if discontinued, then return to dose used prior to initiating strong inducer. Continue as long as benefit observed or until unacceptable toxicity occurs.

Children's Dose for AFINITOR:

<3yrs: not recommended.

Pharmacological Class:

mTOR kinase inhibitor.

Contraindications:

Sirolimus, temsirolimus, rapamycin allergy.

Warnings/Precautions:

Hepatic impairment (see Adult dose). Increased risk of infections; some may be severe or fatal. Pre-existing invasive fungal infections: treat before starting. Monitor CBCs, renal function, lipids, blood glucose, and for pneumonitis and infections: treat promptly if occur. Women of childbearing potential should use effective method of contraception during and up to 8 weeks after treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

Avoid live vaccines. Potentiated by strong CYP3A4 inhibitors, or P-glycoprotein inhibitors; avoid (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, grapefruit juice). Caution with moderate CYP3A4 inhibitors (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem) or P-glycoprotein inhibitors; reduce everolimus dose if used. Antagonized by strong CYP3A4 inducers; avoid (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort); increase everolimus dose if used.

Adverse Reactions:

Pneumonitis (reduce dose and/or manage with corticosteroids; if severe, discontinue. May restart daily dose at approx. 50% lower than previously administered), infections (discontinue if invasive systemic fungal infection develops), stomatitis (treat with non-alcoholic, non-peroxide mouthwash), GI upset, rash, fatigue, edema, fever, headache, asthenia, cough, decreased appetite; increased serum creatinine, blood glucose, lipids; decreased hemoglobin, platelets, neutrophils, serum phosphate; proteinuria, renal failure, others (see literature).

Metabolism:

Hepatic (CYP3A4, 2D6), PgP.

Elimination:

Fecal, renal (minor).

Generic Availability:

NO

How Supplied:

Tabs—28 (4 blister cards x 7 tabs)

AFINITOR

  • 10mg tablets (Qty:28)
  • appx. price $10139.00
GoodRx

Indications for AFINITOR:

Progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.

Adult Dose for AFINITOR:

Swallow whole with water or disperse tablet in 30mL of water and drink immediately. Take at the same time each day either consistently with or without food. 10mg once daily. Mild hepatic impairment (Child-Pugh class A): 7.5mg daily, may reduce to 5mg if not tolerated. Moderate hepatic impairment (Child-Pugh class B), or adverse reactions: reduce to 5mg daily, may be reduce to 2.5mg if not tolerated. Severe hepatic impairment (Child-Pugh class C): max 2.5mg daily if benefits outweigh risk. Concomitant moderate CYP3A4 or P-glycoprotein inhibitors: reduce to 2.5mg once daily; may consider increasing to 5mg if tolerated. If moderate inhibitor is discontinued, allow 2–3 days washout period before increasing everolimus dose; return to dose used prior to initiating the moderate inhibitor. Concomitant strong CYP3A4 inducers: may increase from 10–20mg once daily by increments of 5mg. If strong inducer is discontinued, should return to dose used prior to initiating the strong inducer. Continue as long as benefit observed or until unacceptable toxicity occurs.

Children's Dose for AFINITOR:

Not recommended.

Pharmacological Class:

mTOR kinase inhibitor.

Contraindications:

Sirolimus, temsirolimus, rapamycin allergy.

Warnings/Precautions:

Hepatic impairment (see Adult dose). Increased risk of infections; some may be severe or fatal. Pre-existing invasive fungal infections: treat before starting. Monitor CBCs, renal function, lipids, blood glucose, and for pneumonitis and infections: treat promptly if occur. Women of childbearing potential should use effective method of contraception during and up to 8 weeks after treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

Avoid live vaccines. Potentiated by strong CYP3A4 inhibitors, or P-glycoprotein inhibitors; avoid (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, grapefruit juice). Caution with moderate CYP3A4 inhibitors (eg, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem) or P-glycoprotein inhibitors; reduce everolimus dose if used. Antagonized by strong CYP3A4 inducers; avoid (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort); increase everolimus dose if used.

Adverse Reactions:

Pneumonitis (reduce dose and/or manage with corticosteroids; if severe, discontinue. May restart daily dose at approx. 50% lower than previously administered), infections (discontinue if invasive systemic fungal infection develops), stomatitis (treat with non-alcoholic, non-peroxide mouthwash), GI upset, rash, fatigue, edema, fever, headache, asthenia, cough, decreased appetite; increased serum creatinine, blood glucose, lipids; decreased hemoglobin, platelets, neutrophils, serum phosphate; proteinuria, renal failure, others (see literature).

Metabolism:

Hepatic (CYP3A4, 2D6), PgP.

Elimination:

Fecal, renal (minor).

Generic Availability:

NO

How Supplied:

Tabs—28 (4 blister cards x 7 tabs)

AFINITOR

  • 10mg tablets (Qty:28)
  • appx. price $10139.00
GoodRx

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