TORPENZ 5 mg/1
Everolimus · TABLET · Upsher-Smith Laboratories, LLC
TORPENZ is a tablet containing everolimus at 5 mg/1, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.
Key Facts
- Brand Name
- TORPENZ
- Generic Name
- Everolimus
- NDC Code (Product)
0245-0823- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214182
- Drug Class
- Kinase Inhibitor [EPC]; mTOR Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 10/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer TORPENZ tablets are 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. TORPENZ (everolimus) tablets are a kinase inhibitor 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. ( 1.1 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma TORPENZ tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) TORPENZ tablets…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not combine TORPENZ tablets and AFINITOR DISPERZ to achieve the total daily dose. ( 2.1 ) Modify the dose for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4. ( 2.1 ) Breast Cancer: 10 mg orally once daily. ( 2.2 ) TSC-Associated Renal Angiomyolipoma: 10 mg orally once daily. ( 2.5 ) TSC-Associated SEGA: 4.5 mg/m 2 orally once daily; adjust dose to attain trough concentrations of 5 to 15 ng/mL. ( 2.6 , 2.8 ) 2.1 Important Dosage Information TORPENZ tablets and AFINITOR DISPERZ are two different dosage forms. Select the recommended dosage form based on the indication [see Indications and Usage (1) ] . Do not combine TORPENZ tablets and AFINITOR DISPERZ to achieve the total dose. Modify the dosage for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4 [see Dosage and Administration (2.10 , 2.11 , 2.12) ] . 2.2 Recommended Dosage for Hormone Receptor-Positive, HER2-Negative Breast Cancer The recommended dosage of TORPENZ tablets is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.5 Recommend…
Contraindications
4 CONTRAINDICATIONS TORPENZ tablets are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3) ] . Clinically significant hypersensitivity to everolimus or to other rapamycin derivatives. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS P-gp and strong CYP3A4 inhibitors: Avoid concomitant use. ( 2.11 , 7.1 ) P-gp and moderate CYP3A4 inhibitors: Reduce the dose as recommended. ( 2.11 , 7.1 ) P-gp and strong CYP3A4 inducers: Increase the dose as recommended. ( 2.12 , 7.1 ) 7.1 Effect of Other Drugs on TORPENZ Inhibitors Avoid the concomitant use of P-gp and strong CYP3A4 inhibitors [see Dosage and Administration (2.11) , Clinical Pharmacology (12.3) ] . Reduce the dose for patients taking TORPENZ with a P-gp and moderate CYP3A4 inhibitor as recommended [see Dosage and Administration (2.11) , Clinical Pharmacology (12.3) ] . Inducers Increase the dose for patients taking TORPENZ with a P-gp and strong CYP3A4 inducer as recommended [see Dosage and Administration (2.12) , Clinical Pharmacology (12.3) ] . 7.2 Effects of Combination Use of Angiotensin-Converting Enzyme (ACE) Inhibitors Patients taking concomitant ACE inhibitors with TORPENZ may be at increased risk for angioedema. Avoid the concomitant use of ACE inhibitors with TORPENZ [see Warnings and Precautions (5.4) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Non-Infectious Pneumonitis [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Severe Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Angioedema with Concomitant Use of ACE inhibitors [see Warnings and Precautions (5.4) ] Stomatitis [see Warnings and Precautions (5.5) ] Renal Failure [see Warnings and Precautions (5.6) ] Impaired Wound Healing [see Warnings and Precautions (5.7) ] Metabolic Disorders [see Warnings and Precautions (5.9) ] Myelosuppression [see Warnings and Precautions (5.10) ] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.12) ] Breast cancer: Most common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite. ( 6.1 ) TSC-Associated Renal Angiomyolipoma: Most common adverse reaction (incidence ≥ 30%) is stomatitis. ( 6.1 ) TSC-Associated SEGA: Most common adverse reactions (incidence ≥ 30%) are stomatitis and respiratory tract infection. ( 6.1 ) To report SUSPEC…
Frequently Asked Questions
What is TORPENZ used for?
TORPENZ contains Everolimus. It is a tablet taken oral. Consult your doctor for specific uses.
Is TORPENZ a controlled substance?
TORPENZ is not classified as a controlled substance by the DEA.
What is the generic name for TORPENZ?
The generic name for TORPENZ is Everolimus. There are 11 other brand versions of Everolimus.
What is the NDC code for TORPENZ 5 mg/1?
The NDC (National Drug Code) for TORPENZ 5 mg/1 is 0245-0823, listed by Upsher-Smith Laboratories, LLC.