Parenteral Manual

Temsirolimus (INVESTIGATIONAL)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Torisel, CCI-779
Classification: 
Antineoplastic Agent, mTOR Kinase Inhibitor - CYTOTOXIC
Original Date: 
September 2007
Revised Date: 
December 2019
Indications: 
  • Treatment of advanced renal cell carcinoma (RCC)
  • Investigational for other neoplasms

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 

Commercial and Investigational Supply:

  • Refrigerate vials and protect from light.
  • Available as a 25 mg/mL (1.2 mL) concentrate that requires further dilution with the supplied diluent (1.8 mL) for a final concentration of 10 mg/mL.
  • Agitate diluent gently prior to use to ensure complete uniformity. Mix well by inverting vial. DO NOT SHAKE. Allow air bubbles to subside before withdrawing dose.
  • For doses < 10 mg, filter the reconstituted mixture using a syringe filter before measuring the required volume
  • Diluted vials stable 24 hr at room temperature
  • For final product: further dilute with NS to final concentration of 0.04 - 1 mg/mL. Stable for 6 hrs at room temperature. Mix by inversion. DO NOT SHAKE.
  • Protect from excessive light; protective covering not needed if prepared and administered under fluorescent room light.
Compatibility: 
  • Compatible with NS ONLY.
  • Temsirolimus should not be mixed with other solutions or medications.
Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Direct NO
IV Intermittent Infusion

Yes, Use Non-PVC bag & tubing and use a < 5 micron filter for all doses > 10 mg
RN must remain with patient for first 15 minutes

 

Usual dilution: in 250 mL of NS. Final concentration of 0.04 to 1 mg/mL

Infusion time: 30-60 minutes

IV Continuous Infusion NO
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Pediatric

  • 15 mg/m2 dose or 0.5 mg/kg/dose if patient < 10 kg*

*Dose dependent on study protocol

Adult RCC

  • 25 mg IV weekly
  • Dose may be decreased if toxicities occur (refer to protocol)

 

 

 

 

 

Potential hazards of parenteral administration: 

Immediate (within a few minutes to hours):

  • Hypersensitivity reactions (anaphylaxis, dyspnea, flushing and/or chest pain).
  • Common side effects: edema, fever, headache, rash, pruritus, mucositis, nausea, anorexia, diarrhea, abdominal pain, constipation, anemia, weakness, back pain, arthralgia, dyspnea, and cough.

 Delayed (within a few days to months):

  • Myelosuppression, notably anemia and lymphopenia.
  • Hyperglycemia and hyperlipemia are likely.
  • May increase alkaline phosphatase, AST, creatinine and BUN.
  • Abnormal wound healing: caution in perioperative period.
  • May increase risk of bleeding in patients receiving anticoagulants.
  • Interstitial lung disease: dyspnea, cough, hypoxia and/or fever.
  • Rare: angioedema, bowel perforation, pneumonitis.
Notes: 
  • Non-vesicant
  • Premedicate with Benadryl. Have anaphylactic kit available at bedside
  • Monitor vital signs (pulse, respiratory rate, BP, temp) q15 min x 4 after starting infusion, then q30 min x 2
  • High potential for drug interactions. Please contact pharmacy before initiating new medication
  • Monitor: CBC, diff, electrolytes, calcium, phosphate, creatinine, BUN, LDH, AST, Bilirubin T/D, alkaline phosphatase, Total cholesterol, Triglycerides, glucose
  • In patients receiving anticoagulants, monitor INR and PTT before each treatment
  • Contraindicated in patients with bilirubin > 1.5 X ULN

 

References: 

Pfizer. Investigator's Brochure PF-05208748 (Temsirolimus). July 2018 version, Accessed 17Apr2019

Pfizer. Product monograph, Torisel. December 2016 version. Accessed 17Apr2019

Cancer Care Ontario. Temsirolimus Drug Monograph. Accessed 17Apr2019

Children's Oncology Group Protocol ARST1431. 19Nov2018 version (amd#3). Accessed 17Apr2019

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