Adult Dosing
Advanced renal cell carcinoma
- 25 mg IV infused over 30-60 mins once weekly; treat until disease progression or unacceptable toxicity
- Pre-medicate with H1 antagonist (e.g. diphenhydramine) 30 mins prior to infusion
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment
- Renal impairment: No dose adjustments
Hepatic Dose Adjustment
- Mild hepatic impairment (bilirubin >1-1.5 x ULN or AST > ULN with bilirubin < or = ULN): Reduce dose to 15 mg once weekly
- Moderate to severe hepatic impairment (bilirubin > 1.5 x ULN): Use is contraindicated
Hematologic toxicity (ANC </1000mm
3 or platelets <75,000/mm
3)
- Withhold treatment until resolution and restart treatment with a 5 mg/week dose reduction; minimum dose: 15 mg/week if adjustment for toxicity is needed
- Therapy may cause hypersensitivity reactions. Immediately suspend therapy and treat with an antihistamine if such reactions occur. Therapy may be restarted at physician discretion at a slower rate
- Cautiously administer in patients with mild hepatic impairment. Dosage reduction recommended in patients with mild hepatic impairment. Do not administer to patients with bilirubin >1.5 x ULN
- Periodically monitor glucose and lipid profiles as hyperglycemia and hyperlipemia are likely to occur and may require treatment
- Carefully monitor patients for the occurrence of infections, including opportunistic infections
- Monitor for symptoms or radiographic changes of interstitial lung disease (ILD). If ILD is suspected, discontinue therapy, and consider use of corticosteroids and/or antibiotics
- Bowel perforation may occur with the use of therapy. Prior to initiating drug, carefully evaluate fever, abdominal pain, bloody stools, and/or acute abdomen promptly
- Renal failure, sometimes fatal, has occurred. Monitor renal function at baseline and while on temsirolimus therapy
- In the perioperative period, caution should be exercised with the use of therapy because therapy has been associated with abnormal wound healing
- Avoid use of live vaccinations and close contact with those who received live vaccines during therapy
- Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant
Cautions: Use cautiously in
- Hypersensitivity to polysorbate 80
- Hypersensitivity to antihistamines
- Patients unable to receive antihistamines
- Anticoagulant use
- Recent surgery
- Diabetes mellitus
- Risk of diabetes mellitus
- CNS tumor
Pregnancy Category:D
Breastfeeding: Safety unknown. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
