Version July 2025
Note: For infusion reaction prophylaxis, premedicate with an H1 antagonist (eg, diphenhydramine 25 to 50 mg IV) ~30 minutes prior to infusion; use with caution in patients unable to receive antihistamine premedication. Consider Pneumocystis jirovecii pneumonia (PJP) prophylaxis in patients receiving concomitant immunosuppressive or corticosteroid therapy.
Endometrial cancer, locally advanced, recurrent, and/or metastatic (off-label use): IV: 25 mg once weekly; continue until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Hemodialysis: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Mild hepatic impairment (bilirubin >1 to 1.5 x ULN or AST >ULN with bilirubin ≤ULN): Reduce dose to 15 mg once weekly and use with caution.
Moderate-to-severe hepatic impairment (bilirubin >1.5 x ULN): Use is contraindicated.
Hematologic toxicity: ANC <1,000/mm3 or platelets <75,000/mm3: Withhold treatment until resolved; once resolved to ≤ grade 2, may reinitiate treatment with the dose reduced by 5 mg weekly; minimum dose: 15 mg weekly if adjustment for toxicity is needed.
Nonhematologic toxicity: Any toxicity ≥ grade 3: Withhold treatment until resolves to ≤ grade 2; reinitiate treatment with the dose reduced by 5 mg weekly; minimum dose: 15 mg weekly if adjustment for toxicity is needed.
Hyperglycemia: Initiation or alteration of insulin and/or oral hypoglycemic therapy may be required.
Hyperlipidemia: Initiation or alteration of antihyperlipidemic agents may be required.
Infusion/hypersensitivity reaction: Interrupt infusion and observe for 30 to 60 minutes (depending on the severity); treatment may be resumed with discretion at a slower infusion rate (up to 60 minutes); administer an H1 antagonist (if not given as premedication) and/or an IV H2 antagonist (eg, famotidine) ~30 minutes prior to resuming infusion.
Interstitial lung disease: Consider withholding treatment for clinically significant respiratory symptoms until after recovery of symptoms or radiographic improvement. May require empiric treatment with corticosteroids and/or antibiotic therapy. Depending on the severity, may require temsirolimus discontinuation (Duran 2006).
Nephrotic syndrome: Discontinue treatment.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Chest pain (16%), edema (35%)
Dermatologic: Nail disease (14%), pruritus (19%), skin rash (47%), xeroderma (11%)
Endocrine & metabolic: Decreased serum potassium (21%), hypercholesterolemia (87%), hyperglycemia (26%), hypophosphatemia (49%), increased serum triglycerides (83%), weight loss (19%)
Gastrointestinal: Abdominal pain (21%), anorexia (32%), constipation (20%), diarrhea (27%; grades 3/4: 1%), dysgeusia (20%), nausea (37%; grades 3/4: 2%), stomatitis (41%; grades 3/4: 3%), vomiting (19%; grades 3/4: 2%)
Genitourinary: Urinary tract infection (15%)
Hematologic & oncologic: Decreased hemoglobin (94%; grades 3/4: 20%), decreased neutrophils (19%; grades 3/4: 5%), decreased platelet count (40%; grades 3/4: 1%), decreased white blood cell count (32%; grades 3/4: 1%), lymphocytopenia (53%; grades 3/4: 16%)
Hepatic: Increased serum alkaline phosphatase (68%), increased serum aspartate aminotransferase (38%)
Infection: Infection (20%; including abscess, bronchitis, cellulitis, herpes simplex infection, herpes zoster infection)
Nervous system: Asthenia (51%), headache (15%), insomnia (12%), pain (28%)
Neuromuscular & skeletal: Arthralgia (18%), back pain (20%)
Renal: Increased serum creatinine (57%)
Respiratory: Cough (26%), dyspnea (28%), epistaxis (12%), pharyngitis (12%)
Miscellaneous: Fever (24%)
1% to 10%:
Cardiovascular: Hypertension (7%), pericardial effusion (1%), thrombophlebitis (1%), venous thromboembolism (2%; including deep vein thrombosis, pulmonary embolism)
Dermatologic: Acne vulgaris (10%)
Endocrine & metabolic: Diabetes mellitus (5%)
Gastrointestinal: Gastrointestinal hemorrhage (1%), rectal hemorrhage (1%)
Hepatic: Increased serum bilirubin (8%)
Infection: Sepsis (1%), wound infection (≤1%; including postoperative wound infection)
Nervous system: Chills (8%), depression (4%), seizure (1%)
Neuromuscular & skeletal: Myalgia (8%)
Ophthalmic: Conjunctivitis (8%; including disease of the lacrimal apparatus)
Respiratory: Pleural effusion (4%), pneumonia (8%), rhinitis (10%), upper respiratory tract infection (7%)
Frequency not defined:
Genitourinary: Proteinuria
Hypersensitivity: Anaphylaxis, infusion-related reaction
Renal: Nephrotic syndrome
Postmarketing:
Dermatologic: Stevens-Johnson syndrome
Gastrointestinal: Cholecystitis, cholelithiasis, intestinal perforation (Sugiyama 2020), pancreatitis
Hypersensitivity: Angioedema, hypersensitivity reaction (Sugiyama 2020)
Nervous system: Complex regional pain syndrome
Neuromuscular & skeletal: Rhabdomyolysis
Renal: Acute kidney injury (Sugiyama 2020)
Respiratory: Interstitial lung disease (Sugiyama 2020), pneumonia due to Pneumocystis jirovecii (Sugiyama 2020)
Miscellaneous: Wound healing impairment (Sugiyama 2020)
Bilirubin >1.5 times the upper limit of normal (ULN).
Canadian labeling: Additional contraindications (not in the US labeling): History of anaphylaxis after exposure to temsirolimus, sirolimus, or any component of the formulation.
Concerns related to adverse effects:
• Angioedema: Angioedema has been reported in patients taking mTOR inhibitors in combination with ramipril and/or amlodipine.
• Bone marrow suppression: Anemia, neutropenia, thrombocytopenia, and lymphocytopenia may commonly occur; grades 3 and 4 hematologic toxicity have been observed.
• Bowel perforation: Cases of bowel perforation (fatal) have occurred, usually presenting with abdominal pain, bloody stools, diarrhea, fever, or metabolic acidosis.
• Hyperglycemia: Increases in serum glucose commonly occur during treatment. Use with caution in patients with diabetes.
• Hyperlipidemia: Use with caution in patients with hyperlipidemia; may increase serum lipids (cholesterol and triglycerides).
• Hypersensitivity/infusion reactions: Hypersensitivity/infusion reactions (eg, anaphylaxis, apnea, dyspnea, flushing, loss of consciousness, hypotension, and/or chest pain) have been reported. Infusion reactions may occur during the initial infusion (early in the infusion) or with subsequent infusions. Ensure appropriate supportive care is available. For severe infusion reactions, assess risk versus benefit of continued treatment. Use with caution in patients with hypersensitivity to temsirolimus, sirolimus (a metabolite), or polysorbate 80.
• Infection: Treatment may result in immunosuppression, may increase risk of opportunistic infections and/or sepsis. Pneumocystis jirovecii pneumonia (PJP) has been reported; some cases were fatal. Development of PJP may be associated with the use of concomitant corticosteroids or other immunosuppressive agents.
• Kidney failure: Acute kidney failure with rapid progression (unrelated to disease progression) has been reported, including cases unresponsive to dialysis.
• Proteinuria: Proteinuria, including nephrotic syndrome, is associated with temsirolimus.
• Pulmonary toxicity: Interstitial lung disease (ILD), sometimes fatal, has been reported; symptoms include dyspnea, cough, hypoxia and/or fever, although asymptomatic or mild cases may present; promptly evaluate worsening respiratory symptoms.
• Wound healing: May be associated with impaired wound healing; use caution in the perioperative period.
Disease-related concerns:
• CNS metastases/tumors: May be at increased risk for developing intracerebral bleeding (may be fatal).
• Hepatic impairment: Temsirolimus is predominantly cleared by the liver. Toxicities and deaths (including deaths due to progressive disease) were increased in patients with baseline bilirubin >1.5 x ULN.
• Kidney impairment: An increased incidence of rash, infection, and dose interruptions have been reported in patients with renal insufficiency (CrCl ≤60 mL/minute) who received mTOR inhibitors for the treatment of renal cell cancer (Gupta 2011).
Concurrent drug therapy issues:
• Anticoagulants: Patients who are receiving anticoagulant therapy may be at increased risk for developing intracerebral bleeding (may be fatal).
• Sunitinib: Combination therapy with temsirolimus and sunitinib has resulted in dose-limiting toxicities, including grade 3 or 4 rash, gout, and/or cellulitis.
Special populations:
• Older adult: Older adult patients may be more likely to experience adverse reactions, including diarrhea, edema, and pneumonia.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Patients should not be immunized with live viral vaccines during or shortly after treatment and should avoid close contact with recently vaccinated (live vaccine) individuals.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Torisel: 25 mg/mL (1 mL) [contains alcohol, usp, polyethylene glycol (macrogol), polysorbate 80, propylene glycol]
Generic: 25 mg/mL (1 mL)
Yes
Solution (Temsirolimus Intravenous)
25 mg/mL (per mL): $1,416.00 - $1,910.95
Solution (Torisel Intravenous)
25 mg/mL (per mL): $2,400.38
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Torisel: 25 mg/mL (1.2 mL) [contains alcohol, usp, polyethylene glycol (macrogol), polysorbate 80, propylene glycol]
IV: Infuse over 30 to 60 minutes via an infusion pump (preferred). Use polyethylene-lined non-DEHP, non-PVC administration tubing (if PVC-containing administration set must be used, it should not contain DEHP). Administer through an inline polyethersulfone (PES) filter ≤5 micron; if set does not contain an inline filter, a PES end filter (0.2 to 5 micron) should be added (do not use both an inline and an end filter).
Premedicate with an H1 antagonist (eg, diphenhydramine 25 to 50 mg IV) ~30 minutes prior to infusion. Monitor during infusion; interrupt infusion for hypersensitivity/infusion reaction; monitor for 30 to 60 minutes; may reinitiate at a reduced infusion rate (over 60 minutes) with discretion, 30 minutes after administration of a histamine H1 antagonist and/or a histamine H2 antagonist (eg, famotidine). Administration should be completed within 6 hours of admixture.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Renal cell carcinoma, advanced: Treatment of advanced renal cell carcinoma (RCC).
Endometrial cancer, locally advanced, recurrent, and/or metastatic
Temsirolimus may be confused with everolimus, sirolimus (conventional), sirolimus (protein bound), tacrolimus, temozolomide, tesamorelin
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Temsirolimus requires a two-step dilution process prior to administration. The medication is supplied in a vial containing a total amount of 30 mg in a total volume of 1.2 mL (25 mg/mL). The vial must initially be diluted to 10 mg/mL (with provided 1.8 mL of diluent), then the intended dose should be withdrawn from the 10 mg/mL diluted vial (ie, 2.5 mL for a 25 mg dose) and further diluted for infusion in 250 mL sodium chloride 0.9%. Errors have occurred due to improper preparation.
Temsirolimus, for the treatment of advanced renal cell cancer, is a flat dose (25 mg if no dosage reductions) and is not based on body surface area (BSA).
Substrate of CYP3A4 (Major), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Angiotensin-Converting Enzyme Inhibitors: Temsirolimus may increase adverse/toxic effects of Angiotensin-Converting Enzyme Inhibitors. Specifically, the risk of angioedema may be increased. Risk C: Monitor
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloSPORINE (Systemic): Temsirolimus may increase adverse/toxic effects of CycloSPORINE (Systemic). An increased risk of calcineurin inhibitor-induced hemolytic uremic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy (HUS/TTP/TMA) has been described with concomitant sirolimus use. Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Temsirolimus. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Temsirolimus. Specifically, sirolimus concentrations may be decreased. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Temsirolimus. CYP3A4 Inducers (Strong) may decrease active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be decreased. Management: Avoid concomitant use of temsirolimus and strong CYP3A4 inducers. If coadministration is unavoidable, increase temsirolimus dose to 50 mg per week. Resume previous temsirolimus dose after discontinuation of the strong CYP3A4 inducer. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Moderate): May increase active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be increased. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be increased. Management: Avoid concomitant use of temsirolimus and strong CYP3A4 inhibitors. If coadministration is unavoidable, decrease temsirolimus dose to 12.5 mg per week. Resume previous temsirolimus dose 1 week after discontinuation of the strong CYP3A4 inhibitor. Risk D: Consider Therapy Modification
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
DexAMETHasone (Systemic): May decrease active metabolite exposure of Temsirolimus. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Rifabutin: May decrease active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be decreased. Rifabutin may decrease serum concentration of Temsirolimus. Risk C: Monitor
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
SUNItinib: Temsirolimus may increase adverse/toxic effects of SUNItinib. Risk C: Monitor
Tacrolimus (Systemic): May increase adverse/toxic effects of Temsirolimus. Temsirolimus may increase adverse/toxic effects of Tacrolimus (Systemic). Temsirolimus may decrease serum concentration of Tacrolimus (Systemic). Temsirolimus may increase serum concentration of Tacrolimus (Systemic). Risk X: Avoid
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Grapefruit and grapefruit juice may increase the levels/effects of sirolimus. Management: Avoid grapefruit and grapefruit juice.
Patients who could become pregnant should be advised to avoid pregnancy and use effective contraception during treatment and for 3 months after the last temsirolimus dose. Patients with partners who could become pregnant should also use effective birth control during treatment and for 3 months after the last temsirolimus dose.
Based on findings in animal reproduction studies and on the mechanism of action, in utero exposure to temsirolimus may cause fetal harm.
It is not known if temsirolimus is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 3 weeks following the last temsirolimus dose.
Avoid grapefruit juice (may increase the levels of the major metabolite, sirolimus).
CBC with differential and platelets, serum glucose (baseline and periodic), serum cholesterol and triglycerides (baseline and periodic), liver function (baseline and periodic), renal function tests (baseline and periodic), urine protein (baseline and periodic); radiographic assessment by lung computed tomography scan or chest radiograph (baseline and periodic) even in absence of clinical respiratory symptoms.
Monitor for signs/symptoms of hypersensitivity and infusion reactions; monitor for signs/symptoms of infection, interstitial lung disease (or radiographic changes), hyperglycemia (excessive thirst, polyuria), bowel perforation (promptly evaluate any new or worsening abdominal pain or bloody stools), nephrotic syndrome, angioedema (if receiving concurrent ACE inhibitors or calcium channel blockers).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Temsirolimus and its active metabolite, sirolimus, are targeted inhibitors of mTOR (mechanistic target of rapamycin) kinase activity. Temsirolimus (and sirolimus) bind to FKBP-12, an intracellular protein, to form a complex which inhibits mTOR signaling, halting the cell cycle at the G1 phase in tumor cells. Inhibition of mTOR blocks downstream phosphorylation of p70S6k and S6 ribosomal proteins. In renal cell carcinoma, mTOR inhibition also exhibits anti-angiogenesis activity by reducing levels of HIF-1 and HIF-2 alpha (hypoxia inducible factors) and vascular endothelial growth factor (VEGF).
Distribution: Vdss: 172 L.
Metabolism: Hepatic; via CYP3A4 to sirolimus (primary active metabolite) and 4 minor metabolites.
Half-life elimination: Temsirolimus: 17.3 hours; Sirolimus: 54.6 hours.
Time to peak, plasma: Temsirolimus: At end of infusion; Sirolimus: 0.5 to 2 hours after temsirolimus infusion.
Excretion: Feces (78%); urine (4.6%).
