TORISEL® (temsirolimus)

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Hepatic impairment: TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1‐1.5 x ULN or AST >ULN but bilirubin ≤ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of ≥grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin >1.5 x ULN

Hypersensitivity/Infusion reactions: Hypersensitivity/infusion reactions, including flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity, and anaphylaxis, may occur very early in the first infusion or with subsequent infusions. Pretreat with an H1 antihistamine. TORISEL infusion should be interrupted in patients with infusion reactions and appropriate therapy given

Hyperglycemia/Hyperlipemia: Serum glucose, serum cholesterol, and triglycerides should be tested before and during TORISEL treatment. TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid‐lowering agents, respectively

Infections: TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections. Pneumocystis jiroveci pneumonia (PJP), including fatalities, has been reported with TORISEL. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis of PJP should be considered in patients taking concomitant corticosteroids or other immunosuppressive agents

Interstitial lung disease (ILD): Cases of ILD, some resulting in death, have occurred. Some patients were asymptomatic or had minimal symptoms. Patients should undergo baseline radiography prior to TORISEL therapy and periodically thereafter, even in the absence of clinical respiratory symptoms. Follow patients closely and, if clinically significant respiratory symptoms develop, consider withholding TORISEL until recovery of symptoms and radiographic improvement of pneumonitis findings. Some patients required TORISEL discontinuation and/or treatment with corticosteroids and/or antibiotics. Opportunistic infections such as PJP should be considered in the differential diagnosis

Bowel perforation: Cases of fatal bowel perforation occurred with TORISEL. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen

Renal failure: Cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression occurred in patients who received TORISEL

Wound healing complications: Due to abnormal wound healing, use TORISEL with caution in the perioperative period

Intracerebral hemorrhage: Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving TORISEL

Vaccinations: Live vaccinations and close contact with those who received live vaccines should be avoided

Use in pregnancy: TORISEL may cause fetal harm. Patients and their partners should be advised to avoid pregnancy throughout treatment and for 3 months after TORISEL therapy has stopped

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

Most common ARs & laboratory abnormalities: The most common (incidence ≥30%) adverse reactions observed with TORISEL are rash (47%), asthenia (51%), mucositis (41%), nausea (37%), edema (35%), and anorexia (32%). The most common laboratory abnormalities (incidence ≥30%) are anemia (94%), hyperglycemia (89%), hyperlipemia (87%), hypertriglyceridemia (83%), elevated alkaline phosphatase (68%), elevated serum creatinine (57%), lymphopenia (53%), hypophosphatemia (49%), thrombocytopenia (40%), elevated AST (38%), and leukopenia (32%)

Most common grade 3/4 ARs & laboratory abnormalities: Most common grade 3/4 adverse reactions and laboratory abnormalities included asthenia (11%), dyspnea (9%), hemoglobin decreased (20%), lymphocytes decreased (16%), glucose increased (16%), phosphorus decreased (18%), and triglycerides increased (44%)

Postmarketing use: Pleural effusion, hemodynamically significant pericardial effusions requiring intervention, convulsions, rhabdomyolysis, Stevens‐Johnson Syndrome, complex regional pain syndrome, pancreatitis, cholecystitis, cholelithiasis, and extravasations have been reported during postmarketing use

CYP3A coadministration: Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended

Avoid St. John’s Wort which may decrease TORISEL plasma concentrations, and grapefruit juice which may increase plasma concentrations of the major metabolite of TORISEL

Concomitant use of TORISEL with sunitinib: The combination of TORISEL and sunitinib resulted in dose‐limiting toxicity (grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization)

TORISEL® (temsirolimus) is indicated for the treatment of advanced renal cell carcinoma.

Please see full Prescribing Information for TORISEL® (temsirolimus).