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Management of Select TORISEL Adverse Events

Visit Safety Overview for the full adverse event profile, warnings and precautions, and drug interactions.

  • TORISEL administration should be held if the patient experiences at least 1 of the following toxicities1:
    • Absolute neutrophil count (ANC) <1,000/mm3
    • Platelet count <75,000/mm3
    • NCI CTCAE grade 3 or greater adverse reactions
  • Once toxicities have been resolved to grade 2 or less, TORISEL may be restarted with the dose reduced by
    5 mg/week to a dose no lower than 15 mg/week1

Hypersensitivity reactions

Phase 3 trial results

  • Allergic/hypersensitivity reactions occurred in 18 (9%) patients on TORISEL1
  • 4.8% of patients experienced an allergic reaction on the same day they were dosed with TORISEL2
  • Symptoms included (but are not limited to) anaphylaxis, dyspnea, flushing, and chest pain1

Post-marketing surveillance

  • Hypersensitivity reactions include some life-threatening and rare fatal reactions, which can occur very early in the first infusion of TORISEL, but may also occur with subsequent infusions2

Recommendations1

  • Patients should be monitored early during the infusion and appropriate supportive care should be available if patient develops a hypersensitivity reaction
  • Stop infusion of TORISEL
  • Observe for 30 to 60 minutes (depending on reaction severity)
  • Consider administration of H1 receptor antagonist (if not previously administered) and/or H2 receptor antagonist approximately 30 minutes prior to restarting TORISEL infusion
  • Restart infusion at slower rate (up to 60 minutes)

 

Hyperglycemia/glucose intolerance

  • The use of TORISEL is likely to result in increases of serum glucose

Phase 3 trial results1

  • 89% of patients had at least one elevated serum glucose event while on treatment
  • 16% had grade 3/4 hyperglycemia

Recommendations1

  • Advise patients to report
    • Excessive thirst
    • Increase in the volume or frequency of urination
  • Consider initiating or increasing dose of insulin and/or oral hypoglycemic agent if necessary
  • Test serum glucose before and during treatment with TORISEL
  • In the phase 3 clinical trial, chemistry panel was checked every 2 weeks1
  • Laboratory monitoring should be performed at the physician’s discretion

Hyperlipemia1

  • The use of TORISEL is likely to result in increases of serum triglycerides and cholesterol

Phase 3 trial results

  • 87% of patients had at least 1 elevated serum cholesterol value1
    • 2% were grade 3/4
  • 83% had at least 1 elevated serum triglyceride value1
    • 44% were grade 3/4

Recommendations1

  • Test serum cholesterol and triglycerides before and during treatment
  • May require initiation, or increase in dose, of lipid-lowering agents
  • In the phase 3 clinical trial, chemistry panel was checked every 2 weeks1
  • Laboratory monitoring should be performed at the physician’s discretion

Wound-healing complications1

Phase 3 trial results

  • 3 cases of impaired wound healing occurred

Recommendations

  • Advise patients treated with TORISEL of the possibility of abnormal wound healing if they have surgery while on therapy
  • Caution should be exercised with the use of TORISEL in the perioperative period

Interstitial lung disease (ILD)1

Phase 3 trial results

  • 5 cases (2%) of ILD occurred, including rare fatalities
  • Some patients were asymptomatic, with infiltrates detected on CT scan or chest radiograph
  • Others presented with dyspnea, cough, hypoxia, and fever
  • Some required discontinuation of TORISEL and/or treatment with corticosteroids and/or antibiotics
  • Some patients continued treatment without additional intervention

Recommendations

  • Patients should be advised to report promptly any new or worsening respiratory symptoms
  • Monitor for symptoms or radiographic changes of ILD
  • If ILD is suspected, discontinue TORISEL, and consider use of corticosteroids and/or antibiotics

 

Bowel perforation

Phase 3 trial results1

  • Patients with bowel perforation presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen
  • 1 case of fatal bowel perforation occurred

Recommendations

  • Patients should be advised to report promptly any new or worsening abdominal pain or blood in their stools
  • Evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly

TORISEL Dosing, Administration, and Treatment Management Guide

View and download a detailed guide on dosing, administration, and side effects management for TORISEL.

Get the TORISEL Dosing, Administration, and Treatment Management Guide

Please click here for Important Safety Information
Next: Warnings and Precautions »

Patient Education Materials

Give your patients and their caregivers information about renal cell carcinoma and TORISEL.

Contact Wyeth About TORISEL

 

References:

  1. TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.  
  2. Data on file, Wyeth Pharmaceuticals Inc.

 

 

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