Note: For infusion reaction prophylaxis, premedicate with an H1 antagonist (eg, diphenhydramine 25 to 50 mg IV) ~30 minutes prior to infusion.
Endometrial cancer (locally advanced, recurrent, and/or metastatic) (off-label use): IV: 25 mg once weekly; continue until disease progression or unacceptable toxicity (Oza 2011).
Renal cell carcinoma, advanced:
Note: Temsirolimus may be a treatment option for advanced renal cell carcinoma; however, other therapies are generally preferred (Atkins 2022).
IV: 25 mg once weekly; continue until disease progression or unacceptable toxicity (Hudes 2007).
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.
Refer to adult dosing.
Hematologic toxicity: ANC <1,000/mm3 or platelets <75,000/mm3: Withhold treatment until resolves and 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.
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 ~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.
Nephrotic syndrome: Discontinue treatment.
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
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 filter ≤5 micron; if set does not contain an inline filter, a polyethersulfone 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 2016 [group 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 2016; 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
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
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).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Edema (35%), chest pain (16%)
Central nervous system: Pain (28%), headache (15%), insomnia (12%)
Dermatologic: Skin rash (47%), pruritus (19%), nail disease (14%), xeroderma (11%)
Endocrine & metabolic: Increased serum glucose (89%; grades 3/4: 16%), increased serum cholesterol (87%; grades 3/4: 2%), hypertriglyceridemia (83%; grades 3/4: 44%), hypophosphatemia (49%; grades 3/4: 18%), hyperglycemia (26%), hyperlipidemia (≥30%), hypokalemia (21%; grades 3/4: 5%), weight loss (19%)
Gastrointestinal: Mucositis (41%), nausea (37%), anorexia (32%), diarrhea (27%), abdominal pain (21%; grades 3/4: 4%), constipation (20%), dysgeusia (20%), stomatitis (20%), vomiting (19%)
Genitourinary: Urinary tract infection (15%)
Hematologic & oncologic: Decreased hemoglobin (94%; grades 3/4: 20%), lymphocytopenia (53%; grades 3/4: 16%), thrombocytopenia (40%; grades 3/4: 1%; dose-limiting toxicity), decreased white blood cell count (32%; grades 3/4: 1%), anemia (≥30%), decreased neutrophils (19%; grades 3/4: 5%)
Hepatic: Increased serum alkaline phosphatase (68%; grades 3/4: 3%), increased serum AST (38%; grades 3/4: 2%)
Infection: Infection (20%; grades 3/4: 3%; includes abscess, bronchitis, cellulitis, herpes simplex, herpes zoster)
Neuromuscular & skeletal: Weakness (51%), back pain (20%), arthralgia (18%)
Renal: Increased serum creatinine (57%; grades 3/4: 3%)
Respiratory: Dyspnea (28%), cough (26%), epistaxis (12%), pharyngitis (12%)
Miscellaneous: Fever (24%; grades 3/4: 1%)
1% to 10%:
Cardiovascular: Hypertension (7%), venous thromboembolism (2%; includes deep vein thrombosis and pulmonary embolism), pericardial effusion (1%), thrombophlebitis (1%)
Central nervous system: Chills (8%), depression (4%), convulsions (1%)
Dermatologic: Acne vulgaris (10%)
Endocrine & metabolic: Diabetes mellitus (5%)
Gastrointestinal: Gastrointestinal hemorrhage (1%)
Hematologic & oncologic: Rectal hemorrhage (1%)
Hepatic: Hyperbilirubinemia (8%)
Infection: Sepsis (1%), wound infection (1%)
Neuromuscular & skeletal: Myalgia (8%)
Ophthalmic: Conjunctivitis (8%; including lacrimation disorder)
Respiratory: Rhinitis (10%), pneumonia (8%), upper respiratory tract infection (7%), pleural effusion (4%)
Miscellaneous: Wound healing impairment (1%)
<1%, postmarketing, and/or case reports: Acute renal failure, angioedema, causalgia, cholecystitis, cholelithiasis, decreased glucose tolerance, extravasation reactions (with pain, swelling, warmth, erythema), hypersensitivity reaction, interstitial pulmonary disease, intestinal perforation, pancreatitis, pneumonitis, rhabdomyolysis, seizure, Stevens-Johnson syndrome
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; monitor for signs/symptoms of angioedema in patients receiving temsirolimus concurrently with ACE inhibitors or calcium channel blockers.
• 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; promptly evaluate any new or worsening abdominal pain or bloody stools.
• Hyperglycemia: Increases in serum glucose commonly occur during treatment. Initiation or alteration of insulin and/or oral hypoglycemic therapy may be required. Monitor serum glucose before and during treatment. Use with caution in patients with diabetes.
• Hyperlipidemia: Use with caution in patients with hyperlipidemia; may increase serum lipids (cholesterol and triglycerides). Initiation or dosage adjustment of antihyperlipidemic agents may be required. Monitor cholesterol/triglyceride panel at baseline and periodically during treatment.
• Hypersensitivity/infusion reactions: Hypersensitivity/infusion reactions (eg, anaphylaxis, apnea, dyspnea, flushing, loss of consciousness, hypotension, and/or chest pain) have been reported. Infusion reaction may occur during the initial infusion (early in the infusion) or with subsequent infusions. Premedicate with an antihistamine (H1 antagonist) prior to infusion (use with caution in patients unable to receive antihistamine premedication); monitor throughout infusion (appropriate supportive care should be available); interrupt infusion for hypersensitivity reaction and observe patient for 30 to 60 minutes. With discretion, treatment may be resumed at a slower infusion rate; administer an H1 antagonist (if not given as premedication) and/or an IV H2 antagonist (eg, famotidine) ~30 minutes prior to resuming infusion. 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 (PCP) has been reported; some cases were fatal. Development of PCP may be associated with the use of concomitant corticosteroids or other immunosuppressive agents; consider PCP prophylaxis in patients receiving concomitant immunosuppressive or corticosteroid therapy.
• Proteinuria: Proteinuria, including nephrotic syndrome, is associated with temsirolimus. Monitor for proteinuria at baseline and periodically throughout therapy; discontinue use if nephrotic syndrome occurs.
• 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. If symptoms develop, consider withholding temsirolimus until symptom recovery and radiographic improvement occur. Consider empiric treatment with corticosteroids and/or antibiotic therapy. Baseline chest radiographic assessment (CT scan or x-ray) is recommended; follow periodically, even in the absence of clinical pulmonary symptoms.
• Renal failure: Acute renal failure with rapid progression (unrelated to disease progression) has been reported, including cases unresponsive to dialysis. 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).
• 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: Use with caution and reduce the dose in patients with mild hepatic impairment (bilirubin >1 to 1.5 x ULN or AST >ULN with bilirubin ≤ULN). Use is contraindicated in patients with moderate-to-severe hepatic impairment (bilirubin >1.5 x ULN). Temsirolimus is predominantly cleared by the liver. Toxicities were increased in patients with baseline bilirubin >1.5 x ULN.
Concurrent drug therapy issues:
• Anticoagulants: Patients who are receiving anticoagulant therapy may be at increased risk for developing intracerebral bleeding (may be fatal).
• Drug-drug interactions: Avoid concomitant use with strong CYP3A4 inhibitors and strong CYP3A4 inducers; consider alternative agents that avoid or lessen the potential for CYP-mediated interactions.
• 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.
Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Angiotensin-Converting Enzyme Inhibitors: Temsirolimus may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Specifically, the risk of angioedema may be increased. Risk C: Monitor therapy
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CycloSPORINE (Systemic): Temsirolimus may enhance the adverse/toxic effect 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 therapy
CYP3A4 Inducers (Moderate): May decrease serum concentrations of the active metabolite(s) of Temsirolimus. Specifically, sirolimus concentrations may be decreased. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Temsirolimus. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Temsirolimus. Specifically, concentrations of sirolimus may be decreased. CYP3A4 Inducers (Strong) may decrease the serum concentration of Temsirolimus. 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 serum concentrations of the active metabolite(s) of Temsirolimus. Specifically, concentrations of sirolimus may be increased. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) 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 enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
DexAMETHasone (Systemic): May decrease serum concentrations of the active metabolite(s) of Temsirolimus. Risk C: Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 serum concentrations of the active metabolite(s) of Temsirolimus. Specifically, concentrations of sirolimus may be decreased. Rifabutin may decrease the serum concentration of Temsirolimus. Risk C: Monitor therapy
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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
Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
SUNItinib: Temsirolimus may enhance the adverse/toxic effect of SUNItinib. Risk X: Avoid combination
Tacrolimus (Systemic): May enhance the adverse/toxic effect of Temsirolimus. Temsirolimus may enhance the adverse/toxic effect of Tacrolimus (Systemic). Temsirolimus may decrease the serum concentration of Tacrolimus (Systemic). Temsirolimus may increase the serum concentration of Tacrolimus (Systemic). Risk X: Avoid combination
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Grapefruit and grapefruit juice may increase the levels/effects of sirolimus. Management: Avoid grapefruit and grapefruit juice.
Females of reproductive potential should be advised to avoid pregnancy and use effective contraception during treatment and for 3 months after the last temsirolimus dose. Male patients with female partners of reproductive potential 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, temsirolimus may cause fetal harm if administered to a pregnant woman.
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 (weekly), serum chemistries including glucose (baseline and every other week), serum cholesterol and triglycerides (baseline and periodic), liver function (baseline and periodic), renal function tests (baseline and periodic), urine protein (baseline and periodic).
Monitor for infusion reactions; monitor for signs/symptoms of infection, interstitial lung disease (or radiographic changes), hyperglycemia (excessive thirst, polyuria), bowel perforation, nephrotic syndrome, angioedema (if receiving 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 hours; Sirolimus: ~55 hours
Time to peak, plasma: Temsirolimus: At end of infusion; Sirolimus: 0.5 to 2 hours after temsirolimus infusion
Excretion: Feces (78%); urine (<5%)
Solution (Temsirolimus Intravenous)
25 mg/mL (per mL): $1,416.00 - $1,910.95
Solution (Torisel Intravenous)
25 mg/mL (per mL): $2,219.50
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