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Temsirolimus for the initial treatment of poor-prognosis metastatic renal cell carcinoma[1]

Temsirolimus for the initial treatment of poor-prognosis metastatic renal cell carcinoma[1]
Cycle length: Weekly.
Drug Dose and route Administration Given on days
Temsirolimus 25 mg IV* Dilute in 250 mL NS and infuse via an infusion pump over 60 minutes for the first dose.Δ Subsequent doses may be given over 30 minutes if tolerated. Once weekly
Pretreatment considerations:
Emesis risk
  • LOW (10 to 30% frequency of emesis).
  • Refer to UpToDate topic on "Prevention and treatment of chemotherapy-induced nausea and vomiting in adults".
Prophylaxis for infusion reactions
  • Temsirolimus has caused hypersensitivity reactions, including anaphylaxis, which can occur with the initial as well as subsequent infusions. Premedication with an H1-antagonist such as diphenhydramine is recommended.
  • Refer to UpToDate topic on "Infusion reactions to systemic chemotherapy".
Dose adjustment for baseline liver dysfunction
  • For patients with liver dysfunction (bilirubin >1 to 1.5 times the ULN or AST >ULN with a normal bilirubin), the dose of temsirolimus should be reduced to 15 mg. Temsirolimus is contraindicated for bilirubin >1.5 times the ULN.[2]
  • Refer to UpToDate topics on "Chemotherapy hepatotoxicity and dose modification in patients with liver disease: Conventional cytotoxic agents" and "Chemotherapy hepatotoxicity and dose modification in patients with liver disease: Molecularly targeted agents" and "Chemotherapy nephrotoxicity and dose modification in patients with kidney impairment: Molecularly targeted agents".
Monitoring parameters:
  • CBC with differential and platelet count weekly during treatment.
  • Serum electrolytes at baseline then every two to four weeks.
  • Serum glucose, cholesterol, and triglycerides at baseline then every four weeks.
Suggested dose modifications for toxicity:
Myelotoxicity
  • Temsirolimus should not be administered if the ANC is <1000/microL and/or platelet count is <75,000/microL. Withhold treatment until ANC is >1000/microL and platelets are >75,000/microL, then restart with a 5-mg per week dose reduction (minimum dose is 15 mg per week).[2]
This table is provided as an example of how to administer this regimen; there may be other acceptable methods. This regimen must be administered by a clinician trained in the use of chemotherapy, who should use independent medical judgment in the context of individual circumstances to make adjustments, as necessary.
IV: intravenous; NS: normal saline; ULN: upper limit of normal; AST: aspartate aminotransferase; CBC: complete blood count; ANC: absolute neutrophil count; DEHP: di (2-ethylhexyl) phthalate; PVC: polyvinyl chloride.
* Total dose, not adjusted for weight or body surface area.
¶ Diluent solutions should not be modified without consulting a detailed reference due to potential incompatibility(ies).
Δ Administer through an inline 5-micron (or smaller), polyethersulfone filter. Do not use DEHP-containing (PVC) containers or administration sets.[2]
References:
  1. Hudes G, et al. N Engl J Med 2007; 356:2271.
  2. Temsirolimus injection. United States Prescribing Information. US National Library of Medicine. (Available online at dailymed.nlm.nih.gov, accessed on October 10, 2019).
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