| Renal Cell Carcinoma

Afinitor vs Temsirolimus - Temsirolimus

Side-by-side clinical, coverage, and cost comparison for renal cell carcinoma.

Deep comparison between: Afinitor vs Temsirolimus with Prescriber.AI

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Safety signalsTemsirolimus has a higher rate of injection site reactions vs Afinitor based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Temsirolimus but not Afinitor, including UnitedHealthcare

Category

Afinitor

Temsirolimus

At A Glance

RouteOral

FrequencyDaily

ClassmTOR inhibitor

RouteIV infusion

FrequencyOnce weekly

ClassmTOR inhibitor

Indications

Hormone receptor positive breast cancer
Neuroendocrine tumor of pancreas
Gastro-enteropancreatic neuroendocrine tumor
Renal Cell Carcinoma
Angiomyolipoma of kidney
Subependymal Giant Cell Astrocytoma
Seizures, Focal

Renal Cell Carcinoma

Dosing

Hormone receptor positive breast cancer 10 mg orally once daily in combination with exemestane until disease progression or unacceptable toxicity.

Neuroendocrine tumor of pancreas, Gastro-enteropancreatic neuroendocrine tumor 10 mg orally once daily until disease progression or unacceptable toxicity.

Renal Cell Carcinoma 10 mg orally once daily until disease progression or unacceptable toxicity.

Angiomyolipoma of kidney 10 mg orally once daily until disease progression or unacceptable toxicity.

Subependymal Giant Cell Astrocytoma Starting dose 4.5 mg/m2 orally once daily (AFINITOR or AFINITOR DISPERZ); titrate to trough concentration 5-15 ng/mL.

Seizures, Focal Starting dose 5 mg/m2 orally once daily (AFINITOR DISPERZ); titrate to trough concentration 5-15 ng/mL.

Advanced Renal Cell Carcinoma 25 mg administered as an intravenous infusion over a 30-60 minute period once weekly; continue until disease progression or unacceptable toxicity. Premedicate with IV diphenhydramine 25-50 mg approximately 30 minutes before each dose.

Dose Modification - Hepatic Impairment Reduce dose to 15 mg/week in patients with mild hepatic impairment (bilirubin >1-1.5x ULN or AST >ULN but bilirubin <=ULN); contraindicated if bilirubin >1.5x ULN.

Dose Modification - Strong CYP3A4 Inhibitors Avoid concomitant use; if unavoidable, reduce dose to 12.5 mg/week and allow approximately 1-week washout after inhibitor discontinuation before returning to prior dose.

Dose Modification - Strong CYP3A4 Inducers Avoid concomitant use; if unavoidable, increase dose from 25 mg/week up to 50 mg/week, then return to prior dose once inducer is discontinued.

Dose Modification - Toxicity Hold for ANC or platelet nadirs meeting threshold criteria or NCI CTCAE grade >=3 adverse reactions; once resolved to grade <=2, restart at dose reduced by 5 mg/week to no lower than 15 mg/week.

Contraindications

Clinically significant hypersensitivity to everolimus or other rapamycin derivatives

Bilirubin >1.5x ULN

Drug Interactions

1236View drug interactions

719View drug interactions

Adverse Reactions

Most common (>=30%) Stomatitis, infections, rash, fatigue, diarrhea, decreased appetite.

Serious Non-infectious pneumonitis, infections, severe hypersensitivity reactions, angioedema, stomatitis, renal failure, impaired wound healing, metabolic disorders (hyperglycemia, dyslipidemia), myelosuppression, radiation sensitization and recall.

Postmarketing Thrombotic microangiopathy, cardiac failure (including with pulmonary hypertension), acute pancreatitis, cholecystitis, cholelithiasis, sepsis, reflex sympathetic dystrophy, arterial thrombotic events, lymphedema, radiation sensitization and recall.

Most common (>=30%) clinical adverse reactions Rash, asthenia, mucositis, nausea, edema, anorexia

Most common (>=30%) laboratory abnormalities Anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, leukopenia

Serious Hypersensitivity/infusion reactions, hepatic impairment, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, intracerebral hemorrhage

Postmarketing Angioedema, rhabdomyolysis, Stevens-Johnson Syndrome, complex regional pain syndrome (reflex sympathetic dystrophy), pancreatitis, cholecystitis, cholelithiasis, extravasation reactions (swelling, pain, warmth, erythema)

Pharmacology

Everolimus is an mTOR inhibitor that binds the intracellular protein FKBP-12 to form an inhibitory complex with mTORC1, suppressing downstream effectors (S6K1, 4E-BP1) involved in protein synthesis, cell proliferation, and angiogenesis, and reducing HIF-1 and VEGF expression; mTOR pathway dysregulation occurs in several human cancers and in tuberous sclerosis complex.

Temsirolimus binds to the intracellular protein FKBP-12, and the resulting protein-drug complex inhibits mTOR (mammalian target of rapamycin), blocking its ability to phosphorylate downstream effectors p70S6k and S6 ribosomal protein, leading to G1 growth arrest in tumor cells and reduced levels of HIF-1, HIF-2 alpha, and vascular endothelial growth factor.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Afinitor