Dosing and Administration of TORISEL

• The recommended dose of TORISEL is 25 mg IV infused over a 30-60 minute period once a week¹
• Treatment should continue until disease progression or unacceptable toxicity occurs¹
• Patients should receive prophylactic intravenous diphenhydramine 25 to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of TORISEL¹

How TORISEL is supplied¹

Each carton contains 1 vial of each of the following:

• TORISEL (temsirolimus) injection, 25 mg/mL (NDC 0008-1179-01)
• DILUENT for TORISEL (temsirolimus), 1.8 mL (deliverable volume) per vial (NDC 0008-1125-01)

Storage and handling¹

• Keep vials together
• USE ONLY PROVIDED DILUENT
• Store under refrigeration (2°C-8°C; 36°F-46°F)
• Protect from light

TORISEL premedication¹

• Prophylactic premedication
  • Diphenhydramine 25-50 mg IV approximately 30 minutes before each dose of TORISEL is recommended
• Hypersensitivity reactions have been observed
  • Symptoms include, but are not limited to, anaphylaxis, dyspnea, flushing, and chest pain
  • Allergic/hypersensitivity reactions occurred in 9% of patients receiving TORISEL

TORISEL preparation and administration¹

• Recommended dose: 25 mg fixed weekly 30-60 minute infusion, diluted in an aseptic manner
• Step 1: Inject 1.8 mL provided diluent into TORISEL vial
  • Mix by inverting vial – allow time for air bubbles to subside
  • Reconstituted vial: 30 mg in 3 mL (10 mg/mL)
    • Intentional overfill of 0.2 mL
  • 25 mg fixed dose = 2.5 mL reconstituted drug
  • Concentrate-diluent mixture is stable for 24 hours at controlled room temperature
• Step 2: Inject 2.5 mL of concentrate-diluent mixture rapidly into 250 mL 0.9% normal saline
  • Mix by inversion of the bag or bottle; avoid shaking to minimize foaming
  • Complete infusion within 6 hours of reconstitution

TORISEL administration considerations¹

• During preparation and handling, TORISEL should be protected from excessive room light and sunlight
• The sodium chloride injection container should be of non-DEHP-containing materials
  • Glass, polyolefin, polyethylene, or polypropylene
  • TORISEL concentrate contains polysorbate 80
• In-line polyethersulfone filter with pore size ≤ 5 microns
• Infusion pump is preferred method
• Inspect visually for particulate matter and discoloration prior to administration

Dosage interruption/adjustment¹

• Hold for the following:
• Absolute neutrophil count (ANC) < 1,000/mm³
• Platelet count < 75,000/mm³
• NCI CTCAE* grade 3 or greater adverse reactions
• Once toxicities resolve to grade 2 or less
  • Restart with dose reduced by 5 mg/week to dose no lower than 15 mg/week

* Common Terminology Criteria for Adverse Events

Hypersensitivity reaction management¹

• Stop infusion
• Observe patient for 30 to 60 minutes
• At the discretion of the physician, treatment may be resumed
• Consider administration of
• H₁-receptor antagonist (such as diphenhydramine), if not previously administered and/or H₂-receptor antagonist (such as IV famotidine or IV ranitidine) approximately 30 minutes prior to restarting TORISEL infusion
• Resume infusion at slower rate
• Up to 60-minute infusion

Laboratory monitoring

• In the randomized, phase 3 clinical trial, complete blood counts (CBCs) were checked weekly, and chemistry panels were checked every 2 weeks. Laboratory monitoring for patients receiving TORISEL may need to be performed more or less frequently at the physician’s discretion.

For additional dosage and administration information:

• Get the TORISEL Dosing, Administration, and Treatment Management Guide
• View the Preparation and Administration Video

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