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    DAE Class; Rx

    Common Brand Names; Torisel

    • Antineoplastics, mTOr Kinase Inhibitors

    Inhibitor of mammalian target of rapamycin (mTOR)
    Used for advanced renal cell cancer
    Premedication with antihistamine is recommended due to risk of hypersensitivity / infusion reaction

    Indicated for the treatment of advanced renal cell cancer.

    For the treatment of heavily pretreated, relapsed or refractory mantle cell lymphoma (MCL). 

    For the treatment of relapsed or refractory high-grade malignant glioma.

    For the treatment of relapsed or refractory neuroblastoma in pediatric patients.

    For the treatment of relapsed or refractory rhabdomyosarcoma.

    For the treatment of recurrent glioblastoma multiforme.

    Bilirubin > 1.5 times the upper limit of normal


    Decreased hemoglobin (94%)

    Hyperglycemia (89%)

    Hypercholesterolemia (87%)

    Hypertriglyceridemia (83%)

    Increased alkaline phosphatase (68%)

    Increased serum creatinine (57%)

    Decreased lymphocyte count (53%)

    Asthenia (51%)

    Hypophosphatemia (49%)

    Rash (47%)

    Mucositis (41%)

    Decreased platelet count (40%)

    Increased AST/SGOT (38%)

    Nausea (37%)

    Edema (35%)

    Leukopenia (32%)

    Anorexia (32%)

    Anemia (>30%)

    Dyspnea (28%)

    Pain (28%)

    Hyperlipidemia (28%)

    Diarrhea (27%)

    Cough (26%)

    Pyrexia (24%)

    Abdominal pain (21%)

    Decreased potassium levels (21%)

    Back pain (20%)

    Constipation (20%)

    Dysguesia (20%)

    Infections (20%)

    Pruritus (19%)

    Urinary tract infection (15%)

    Vomiting (19%)

    Weight loss (19%)

    Decreased neutrophils (19%)

    Arthralgia (18%)

    Chest pain (16%)

    Headache (15%)

    Nail disorders (14%)

    Epistaxis (12%)

    Insomnia (12%))

    Pharyngitis (12%)

    Dry skin (11%)


    Rhinitis (10%)

    Acne (10%)

    Hypersensitivity reaction (9%)

    Pneumonia (8%)

    Increased total bilirubin (8%)

    Interstitial lung disease (2%)

    Bowel perforation (1%)




    Post-marketing Reports




    May increase risks of hypersensitivity reactions; hyperglycemia; hyperlipidemia; intracerebral hemorrhage (CNS tumor and/or on anticoagulants)

    To treat hypersensitivity reactions, stop therapy and treat with an antihistamine; therapy may be restarted at physician discretion at a slower rate

    Monitor for symptoms or radiographic changes of interstitial lung disease (ILD); if ILD suspected, discontinue therapy, and consider use of corticosteroids and/or antibiotics

    Infections may result from immunosuppression

    Bowel perforation may occur; evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly

    Renal failure, sometimes fatal, has occurred; monitor renal function at baseline and while on therapy

    Due to abnormal wound healing, use caution in perioperative period

    Elderly patients may be more likely to experience certain adverse reactions, including diarrhea, edema and pneumonia

    Monitor throughout the infusion and appropriate supportive care should be available; interrupt infusion in all patients with severe infusion reactions and administer medical therapy

    Interstitial lung disease reported, some resulting in death; prescribing information recommends baseline radiographic assessment by lung CT or chest radiograph prior to initiation

    Avoid pregnancy during and for 3 months post-treatment

    Consider dose modification if used concurrently with CYP3A4 inhibitors or inducers

    Proteinuria (including cases of nephrotic syndrome) has occurred; monitor urine protein prior to start of therapy and periodically thereafter; discontinue therapy in patients who develop nephrotic syndrome

    Avoid grapefruit juice

    May decrease effects of live vaccinations

    Angioedema reported in patients taking mammalian target of rapamycin (mTOR) inhibitors in combination with ramipril and/or amlodipine; monitor patients for signs and symptoms of angioedema when temsirolimus is given concomitantly with an angiotensin converting enzyme (ACE) inhibitors (eg, ramipril) or calcium channel blockers (CCB; eg, amlodipine)


    Can cause fetal harm when administered to pregnant women based on animal studies and the mechanism of action


    Data are not available regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production


    25 mg IV once weekly.


    25 mg IV once weekly.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    injectable solution

    • 25mg/mL