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The following serious adverse reactions have been associated with TORISEL (temsirolimus injection) in clinical trials and are discussed in greater detail in other sections of the label [see WARNINGS AND PRECAUTIONS].

Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

Hyperglycemia/Glucose Intolerance [see WARNINGS AND PRECAUTIONS]

Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]

Hyperlipemia [see WARNINGS AND PRECAUTIONS]

Bowel Perforation [see WARNINGS AND PRECAUTIONS]

Renal Failure [see WARNINGS AND PRECAUTIONS]

The most common ( ≥ 30%) adverse reactions observed with TORISEL (temsirolimus injection) are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common ( ≥ 30%) laboratory abnormalities observed with TORISEL (temsirolimus injection) are anemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

In the Phase 3 randomized, open-label study of interferon alfa (IFN-α) alone, TORISEL (temsirolimus injection) alone, and TORISEL (temsirolimus injection) and IFN-α, a total of 616 patients were treated. Two hundred patients received IFN-α weekly, 208 received TORISEL (temsirolimus injection) 25 mg weekly, and 208 patients received a combination of TORISEL and IFN-α weekly [see Clinical Studies].

Treatment with the combination of TORISEL (temsirolimus injection) 15 mg and IFN-α was associated with an increased incidence of multiple adverse reactions and did not result in a significant increase in overall survival when compared with IFN-α alone.

Table 1 shows the percentage of patients experiencing treatment emergent adverse reactions. Reactions reported in at least 10% of patients who received TORISEL (temsirolimus injection) 25 mg alone or IFN-α alone are listed. Table 2 shows the percentage of patients experiencing selected laboratory abnormalities. Data for the same adverse reactions and laboratory abnormalities in the IFN-α alone arm are shown for comparison.

Table 1 : Adverse Reactions Reported in at Least 10% of Patients Who Received 25 mg IV TORISEL (temsirolimus injection) or IFN-α in the Randomized Trial

The following selected adverse reactions were reported less frequently ( < 10%).

Gastrointestinal Disorders - Fatal bowel perforation occurred in 1 patient (1%).

Eye Disorders - Conjunctivitis (including lacrimation disorder) occurred in 15 patients (7%).

Immune System - Allergic/Hypersensitivity reactions occurred in 18 patients (9%).

Angioneurotic edema-type reactions have been observed in some patients who received TORISEL (temsirolimus injection) and ACE inhibitors concomitantly.

Infections - Pneumonia occurred in 17 patients (8%); upper respiratory tract infection occurred in 14 patients (7%).

General Disorders and Administration Site Conditions - Impaired wound healing occurred in 3 patients (1%).

Respiratory, Thoracic and Mediastinal Disorders – Interstitial lung disease occurred in 5 patients (2%), including rare fatalities.

Vascular - Hypertension occurred in 14 patients (7%); venous thromboembolism (including deep vein thrombosis and pulmonary embolus) occurred in 5 patients (2%); thrombophlebitis occurred in 2 patients (1%).

Table 2 : Incidence of Selected Laboratory Abnormalities in Patients Who Received 25 mg IV TORISEL (temsirolimus injection) or IFN-α in the Randomized Trial

Post-marketing and Other Clinical Experience

The following adverse reactions have been identified during postapproval use of TORISEL (temsirolimus injection) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to readily estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of rhabdomyolysis in patients who received TORISEL (temsirolimus injection) .

Agents Inducing CYP3A Metabolism

Co-administration of TORISEL (temsirolimus injection) with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus Cmax (maximum concentration) and AUC (area under the concentration versus the time curve) after intravenous administration, but decreased sirolimus Cmax by 65% and AUC by 56% compared to TORISEL (temsirolimus injection) treatment alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see DOSAGE AND ADMINISTRATION].

Agents Inhibiting CYP3A Metabolism

Co-administration of TORISEL (temsirolimus injection) with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus Cmax or AUC; however, sirolimus AUC increased 3.1-fold, and Cmax increased 2.2-fold compared to TORISEL (temsirolimus injection) alone. If alternative treatment cannot be administered, a dose adjustment should be considered. [see DOSAGE AND ADMINISTRATION].

Interactions with Drugs Metabolized by CYP2D6

The concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of TORISEL (temsirolimus injection) was co-administered. No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolized by CYP2D6 or CYP3A4.

Last reviewed on RxList: 8/5/2010
This monograph has been modified to include the generic and brand name in many instances.