Classifications: antineoplastic agent; protein-tyrosine kinase inhibitor; Therapeutic: antineoplastic agent
Pregnancy Category: D
25 mg/mL concentrated solution
Inhibits an intracellular protein that controls cell division in renal carcinoma and other tumor cells.
Results in arrest of growth in tumor cells.
Treatment of advanced renal cell carcinoma.
Astrocytoma, mantle cell lymphoma (MCL).
Live vaccines; pregnancy (category D); lactation. Safe use in children has not been established.
Hypersensitivity to temsirolimus, sirolimus, polysorbate 80, or antihistamines; diabetes mellitus; history of hyperlipemia;
respiratory disorders; perioperative period due to potential for abnormal wound healing; CNS tumors (primary or by metastasis)
and concomitant use of anticoagulants; hepatic impairment.
Route & Dosage
|Renal Cell Carcinoma
Adult: IV 25 mg qwk
Regimen with a strong CYP3A4 inhibitor: 12.5 mg/wk
Regimen with a strong CYP3A4 inducer: 50 mg based on tolerability
- Patients should receive prophylactic IV diphenhydramine 25 to 50 mg (or similar antihistamine) 30 min before each dose.
PREPARE: IV Infusion: Inject 1.8 mL of supplied diluent into the 25 mg/mL vial to yield 10 mg/mL. Withdraw the required dose and inject rapidly
into a 250 mL DEHP-free container of NS. Invert to mix.
ADMINISTER: IV Infusion: Use DEHP-free infusion line with a 5 micron or less in-line filter. Infuse over 3060 min. Complete infusion within
6 h of preparation.
INCOMPATIBILITIES Solution/additive: Do not add other drugs or agents to temsirolimus IV solutions.
- Store at 2°8° C (36°46° F). Protect from light. The 10 mg/mL drug solution is stable for
up to 24 h at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole:
Allergic/hypersensitivity reactions, asthenia,
chest pain, chills, edema,
impaired wound healing, infections, pain, pyrexia. CNS: Depression
, dysgeusia, headache, insomnia
Hypertension, thrombophlebitis, venous thromboembolism. GI:
Abdominal pain, anorexia, constipation
, fatal bowel perforation, mucositis, nausea,
, leukocytopenia, lymphopenia, neutropenia
, thrombocytopenia. Metabolic: Elevated alkaline phosphatase, elevated AST, elevated serum creatinine,
hyperbilirubinemia, hypercholesterolemia, hyperglycemia, hypertriglyceridemia,
weight loss. Musculoskeletal: Arthralgia
, back pain, myalgia. Respiratory:
, epistaxis, interstitial
lung disease, pharyngitis, pneumonia
, rhinitis, upper respiratory tract infection
. Skin: Acne
, dry skin, nail disorder, pruritus, rash. Special Senses: Conjunctivitis
Urinary tract infection
InteractionsDrug: azole antifungal agents
(fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole), cyclosporine
, inhibitors of CYP3A4 (hiv protease inhibitors
, clarithromycin, diltiazem
), mycophenolate mofetil,
increase the plasma
levels of temsirolimus.
Inducers of CYP3A4 (dexamethasone, rifampin, rifabutin, phenytoin
) decrease the plasma
level of temsirolimus. Food: Grapefruit
and grapefruit juice
increase the plasma
level of temsirolimus. Herbal: St. John's wort
decreases the plasma
level of temsirolimus.
0.52 h. Metabolism:
In liver. Elimination:
Primarily in stool. Half-Life:
Assessment & Drug Effects
- Withhold drug and notify physician for absolute neutrophil count <1000/mm3 or platelet count <75,000/mm3.
- Monitor for infusion-related reactions during and for at least one hour after completion of infusion.
- Slow or stop infusion for infusion-related reactions. If infusion is restarted after 3060 min of observation, slow
rate to up to 60 min and continue observation.
- Monitor respiratory status and report promptly dyspnea, cough, S&S of hypoxia, fever.
- Lab tests: Baseline and periodic CBC with differential and platelet count, lipid profile, LFTs, alkaline phosphatase, kidney
function tests, serum electrolytes, plasma glucose, ABGs.
- Monitor diabetics for loss of glycemic control.
Patient & Family Education
- Avoid live vaccines and close contact with those who have received live vaccines.
- Use effective contraceptive measures to prevent pregnancy.
- Men with partners of childbearing age should use reliable contraception throughout treatment and for 3 mo after the last
dose of temsirolimus.
- Report promptly any of the following: S&S of infection, difficulty breathing, abdominal pain, blood in stools, abnormal wound
healing, S&S of hypersensitivity (see Appendix F).