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TORISEL® (temsirolimus) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TORISEL® safely and effectively. See full prescribing information for TORISEL.

TORISEL Kit (temsirolimus) injection, for intravenous use
Initial U.S. Approval: 2007

RECENT MAJOR CHANGES

Warnings and Precautions, Proteinuria and Nephrotic Syndrome (5.11) 3/2018
Warnings and Precautions, Embryo-Fetal Toxicity (5.15) 3/2018

INDICATIONS AND USAGE

TORISEL® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)

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)

DOSAGE FORMS AND STRENGTHS

TORISEL injection, 25 mg/mL supplied with DILUENT for TORISEL. (3)

CONTRAINDICATIONS

TORISEL is contraindicated in patients with bilirubin > 1.5×ULN. (4)

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). If ILD is suspected, discontinue TORISEL, and consider use of corticosteroids and/or antibiotics. (5.5)
  • Bowel perforation may occur. Evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly. (5.7)
  • Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on TORISEL. (5.8)
  • Due to abnormal wound healing, use TORISEL with caution in the perioperative period. (5.9)
  • Proteinuria and nephrotic syndrome may occur. Monitor urine protein prior to the start of TORISEL therapy and periodically thereafter. Discontinue TORISEL in patients with who develop nephrotic syndrome. (5.11)
  • Live vaccinations and close contact with those who received live vaccines should be avoided. (5.14)
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception. (5.15, 8.1, 8.3)
  • Elderly patients may be more likely to experience certain adverse reactions, including diarrhea, edema and pneumonia. (5.16)

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥30%) are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence ≥30%) are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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)

USE IN SPECIFIC POPULATIONS

Lactation: Do not breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2018

What's New

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