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Pharmacologic classification: mTOR (kinase) inhibitor
Therapeutic classification: antineoplastic
Pregnancy risk category: D
AVAILABLE FORMS
Injection: 25 mg/ml
INDICATIONS AND DOSAGES
Advanced renal cell carcinoma--
Adults: 25 mg I.V. over 30 to 60 minutes once per week until disease progresses or unacceptable toxicity occurs. Give an antihistamine before start of the infusion to decrease risk of hypersensitivity reactions.
CONTRAINDICATIONS AND CAUTIONS
No known contraindications.
Use cautiously in patients with known hypersensitivity to temsirolimus or sirolimus, polysorbate 800, or any component of the drug. Also use cautiously with renal impairment, CNS tumors, during postoperative period, and in patients who are pregnant or breast-feeding.
INTERACTIONS
Drug-drug.
Ace inhibitors: Risk of angioneurotic edema-type reaction when used together. Use together cautiously.
Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole: Increased risk of elevated serum levels and toxicity when combined with these drugs. Avoid use together. If combination must be used, reduce dosage of temsirolimus to 12.5 mg/week and monitor patient closely. If concomitant drug is discontinued, allow one week before returning temsirolimus to normal dose.
Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampicin, rifampin: Risk of decreased serum levels and loss of therapeutic effect if combined with these drugs. If combination must be used, increase temsirolimus dose to 50 mg/week and return dose to normal before discontinuing.
Live vaccines: Risk of infection if combined. Don't administer live vaccines while patient is taking this drug.
Drug-herb.
St. John's wort: Risk of unpredictable altered serum levels. Avoid use together.
Drug-food.
Grapefruit juice: Risk of increased serum levels if combined. Avoid use together.
ADVERSE REACTIONS
CNS: headache, insomnia, taste loss, taste perversion, depression, intracerebral hemorrhage, weakness.
CV: chest pain, edema, hypertension, thrombophlebitis, venous thromboembolism.
GI: mucositis, anorexia, nausea, diarrhea, abdominal pain, constipation, vomiting, bowel perforation.
GU: renal failure, UTI.
Metabolic: hyperglycemia, glucose intolerance, hyperlipemia.
Respiratory: interstitial lung disease, pharyngitis, pneumonia, rhinitis, cough, dyspnea, epistaxis, upper respiratory tract infection.
Skin: rash, pruritus, nail disorder, dry skin, acne.
Other: chills, conjunctivitis, impaired wound healing, infections, back pain, arthralgia, myalgia, weight loss, fever, hypersensitivity reactions.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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temsirolimus