Temsirolimus
Generic Name: temsirolimus
Brand Names:
Torisel
11 DESCRIPTION Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C 56 H 87 NO 16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH.
Overview
11 DESCRIPTION Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C 56 H 87 NO 16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH.
Uses
1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • The recommended dose of TORISEL is 25 mg administered as an intravenous infusion over a 30–60 minute period once a week. Treat until disease progression or unacceptable toxicity. ( 2.1 ) • Antihistamine pre-treatment is recommended. ( 2.2 ) • Dose reduction is required in patients with mild hepatic impairment. ( 2.4 ) • TORISEL (temsirolimus) injection vial contents must first be diluted with the enclosed diluent before diluting the resultant solution with 250 mL of 0.9% Sodium Chloride Injection. ( 2.5 ) 2.1 Advanced Renal Cell Carcinoma The recommended dose of TORISEL for advanced renal cell carcinoma is 25 mg administered as an intravenous infusion over a 30 – 60 minute period once a week.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label [see Warnings and Precautions (5) ] . • Hypersensitivity/Infusion Reactions [see Warnings and Precautions (5.1) ] • Hepatic Impairment [see Warnings and Precautions (5.2) ] • Hyperglycemia/Glucose Intolerance [see Warnings and Precautions (5.3) ] • Infections [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease [see Warnings and Precautions (5.5) ] • Hyperlipidemia [see Warnings and Precautions (5.6) ] • Bowel Perforation [see Warnings and Precautions (5.7) ] • Renal Failure [see Warnings and Precautions (5.8) ] • Wound Healing Complications [see Warnings and Precautions (5.9) ] • Intracerebral Hemor...
Interactions
7 DRUG INTERACTIONS Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of TORISEL. If alternatives cannot be used, dose modifications of TORISEL are recommended. ( 7.1 , 7.2 , 7.3 ) 7.1 Agents Inducing CYP3A Metabolism Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus C max (maximum concentration) and AUC (area under the concentration versus the time curve) after intravenous administration, but decreased sirolimus C max by 65% and AUC by 56% compared to TORISEL treatment alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see Dosage and Administration (2.4) ] .
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity/Infusion Reactions (including some life-threatening and rare fatal reactions) can occur early in the first infusion of TORISEL. Patients should be monitored throughout the infusion. ( 5.1 ) • To treat hypersensitivity reactions, stop TORISEL and treat with an antihistamine. TORISEL may be restarted at physician discretion at a slower rate. ( 5.1 ) • Hepatic Impairment: Use caution when treating patients with mild hepatic impairment and reduce dose. ( 2.4 , 5.2 ) • Hyperglycemia and hyperlipidemia are likely and may require treatment. Monitor glucose and lipid profiles. ( 5.3 , 5.6 ) • Infections may result from immunosuppression. ( 5.4 ) • Monitor for symptoms or radiographic changes of interstitial lung disease (ILD). 4 CONTRAINDICATIONS TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2) ] . TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Although there are no data on the use of TORISEL in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes.
Storage
Each kit is supplied in a single carton containing one single-use vial of 25 mg/mL of temsirolimus and one DILUENT vial which includes a deliverable volume of 1.8 mL, and must be stored at 2º–8º C (36º–46º F). Protect from light. TORISEL is a cytotoxic drug. Follow applicable special handling and disposal procedures 1 .
Frequently Asked Questions
What is Temsirolimus used for?▼
1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
What are the side effects of Temsirolimus?▼
6 ADVERSE REACTIONS The following serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label [see Warnings and Precautions (5) ] . • Hypersensitivity/Infusion Reactions [see Warnings and Precautions (5.1) ] • Hepatic Impairment [see Warnings and Precautions (5.2) ] • Hyperglycemia/Glucose Intolerance [see Warnings and Precautions (5.3) ] • Infections [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease [see Warnings and Precautions (5.5) ] • Hyperlipidemia [see Warnings and Precautions (5.6) ] • Bowel Perforation [see Warnings and Precautions (5.7) ] • Renal Failure [see Warnings and Precautions (5.8) ] • Wound Healing Complications [see Warnings and Precautions (5.9) ] • Intracerebral Hemor...
Can I take Temsirolimus during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, temsirolimus can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Although there are no data on the use of TORISEL in pregnant women, there are limited data on the use of sirolimus, the active metabolite of temsirolimus, during pregnancy; however, these data are insufficient to inform a drug-associated risk of adverse developmental outcomes.
What are the important warnings for Temsirolimus?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity/Infusion Reactions (including some life-threatening and rare fatal reactions) can occur early in the first infusion of TORISEL. Patients should be monitored throughout the infusion. ( 5.1 ) • To treat hypersensitivity reactions, stop TORISEL and treat with an antihistamine. TORISEL may be restarted at physician discretion at a slower rate. ( 5.1 ) • Hepatic Impairment: Use caution when treating patients with mild hepatic impairment and reduce dose. ( 2.4 , 5.2 ) • Hyperglycemia and hyperlipidemia are likely and may require treatment. Monitor glucose and lipid profiles. ( 5.3 , 5.6 ) • Infections may result from immunosuppression. ( 5.4 ) • Monitor for symptoms or radiographic changes of interstitial lung disease (ILD). 4 CONTRAINDICATIONS TORISEL is contraindicated in patients with bilirubin >1.5×ULN [see Warnings and Precautions (5.2) ] . TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.