TEMSIROLIMUS

TEMSIROLIMUS
(tem-si-ro-li'mus)
Torisel
Classifications: antineoplastic agent; protein-tyrosine kinase inhibitor;
Therapeutic: antineoplastic agent

Prototype: Gefitinib
Pregnancy Category: D

Availability

25 mg/mL concentrated solution

Action

Inhibits an intracellular protein that controls cell division in renal carcinoma and other tumor cells.

Therapeutic Effect

Results in arrest of growth in tumor cells.

Uses

Treatment of advanced renal cell carcinoma.

Unlabeled Uses

Astrocytoma, mantle cell lymphoma (MCL).

Contraindications

Live vaccines; pregnancy (category D); lactation. Safe use in children has not been established.

Cautious Use

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

Dosage Adjustment
Regimen with a strong CYP3A4 inhibitor: 12.5 mg/wk
Regimen with a strong CYP3A4 inducer: 50 mg based on tolerability

Administration

Intravenous
  • 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 30–60 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. CV: Hypertension, thrombophlebitis, venous thromboembolism. GI: Abdominal pain, anorexia, constipation, diarrhea, fatal bowel perforation, mucositis, nausea, vomiting. Hematologic: Decrease hemoglobin, leukocytopenia, lymphopenia, neutropenia, thrombocytopenia. Metabolic: Elevated alkaline phosphatase, elevated AST, elevated serum creatinine, hypokalemia, hypophosphatemia, hyperbilirubinemia, hypercholesterolemia, hyperglycemia, hypertriglyceridemia, weight loss. Musculoskeletal: Arthralgia, back pain, myalgia. Respiratory: Cough, dyspnea, epistaxis, interstitial lung disease, pharyngitis, pneumonia, rhinitis, upper respiratory tract infection. Skin: Acne, dry skin, nail disorder, pruritus, rash. Special Senses: Conjunctivitis. Urogenital: Urinary tract infection.

Interactions

Drug: azole antifungal agents (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole), cyclosporine, inhibitors of CYP3A4 (hiv protease inhibitors, clarithromycin, diltiazem), mycophenolate mofetil, and sunitinib 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.

Pharmacokinetics

Peak: 0.5–2 h. Metabolism: In liver. Elimination: Primarily in stool. Half-Life: 17.3 h.

Nursing Implications

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 30–60 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).

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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