Classes
DAE Class; Rx
Common Brand Names; Torisel
- Antineoplastics, mTOr Kinase Inhibitors
Description
Inhibitor of mammalian target of rapamycin (mTOR)
Used for advanced renal cell cancer
Premedication with antihistamine is recommended due to risk of hypersensitivity / infusion reaction
Indications
Indicated for the treatment of advanced renal cell cancer.
For the treatment of heavily pretreated, relapsed or refractory mantle cell lymphoma (MCL).
For the treatment of relapsed or refractory high-grade malignant glioma.
For the treatment of relapsed or refractory neuroblastoma in pediatric patients.
For the treatment of relapsed or refractory rhabdomyosarcoma.
For the treatment of recurrent glioblastoma multiforme.
Contraindications
Bilirubin > 1.5 times the upper limit of normal
Adverse Effects
>10%
Decreased hemoglobin (94%)
Hyperglycemia (89%)
Hypercholesterolemia (87%)
Hypertriglyceridemia (83%)
Increased alkaline phosphatase (68%)
Increased serum creatinine (57%)
Decreased lymphocyte count (53%)
Asthenia (51%)
Hypophosphatemia (49%)
Rash (47%)
Mucositis (41%)
Decreased platelet count (40%)
Increased AST/SGOT (38%)
Nausea (37%)
Edema (35%)
Leukopenia (32%)
Anorexia (32%)
Anemia (>30%)
Dyspnea (28%)
Pain (28%)
Hyperlipidemia (28%)
Diarrhea (27%)
Cough (26%)
Pyrexia (24%)
Abdominal pain (21%)
Decreased potassium levels (21%)
Back pain (20%)
Constipation (20%)
Dysguesia (20%)
Infections (20%)
Pruritus (19%)
Urinary tract infection (15%)
Vomiting (19%)
Weight loss (19%)
Decreased neutrophils (19%)
Arthralgia (18%)
Chest pain (16%)
Headache (15%)
Nail disorders (14%)
Epistaxis (12%)
Insomnia (12%))
Pharyngitis (12%)
Dry skin (11%)
1-10%
Rhinitis (10%)
Acne (10%)
Hypersensitivity reaction (9%)
Pneumonia (8%)
Increased total bilirubin (8%)
Interstitial lung disease (2%)
Bowel perforation (1%)
Chills
Depression
Myalgia
Post-marketing Reports
Pancreatitis
Cholecystitis
Cholelithiasis
Warnings
May increase risks of hypersensitivity reactions; hyperglycemia; hyperlipidemia; intracerebral hemorrhage (CNS tumor and/or on anticoagulants)
To treat hypersensitivity reactions, stop therapy and treat with an antihistamine; therapy may be restarted at physician discretion at a slower rate
Monitor for symptoms or radiographic changes of interstitial lung disease (ILD); if ILD suspected, discontinue therapy, and consider use of corticosteroids and/or antibiotics
Infections may result from immunosuppression
Bowel perforation may occur; 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 therapy
Due to abnormal wound healing, use caution in perioperative period
Elderly patients may be more likely to experience certain adverse reactions, including diarrhea, edema and pneumonia
Monitor throughout the infusion and appropriate supportive care should be available; interrupt infusion in all patients with severe infusion reactions and administer medical therapy
Interstitial lung disease reported, some resulting in death; prescribing information recommends baseline radiographic assessment by lung CT or chest radiograph prior to initiation
Avoid pregnancy during and for 3 months post-treatment
Consider dose modification if used concurrently with CYP3A4 inhibitors or inducers
Proteinuria (including cases of nephrotic syndrome) has occurred; monitor urine protein prior to start of therapy and periodically thereafter; discontinue therapy in patients who develop nephrotic syndrome
Avoid grapefruit juice
May decrease effects of live vaccinations
Angioedema reported in patients taking mammalian target of rapamycin (mTOR) inhibitors in combination with ramipril and/or amlodipine; monitor patients for signs and symptoms of angioedema when temsirolimus is given concomitantly with an angiotensin converting enzyme (ACE) inhibitors (eg, ramipril) or calcium channel blockers (CCB; eg, amlodipine)
Pregnancy and Lactation
Pregnancy
Can cause fetal harm when administered to pregnant women based on animal studies and the mechanism of action
Lactation
Data are not available regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production
Maximum Dosage
Adults
25 mg IV once weekly.
Geriatric
25 mg IV once weekly.
Adolescents
Safety and efficacy have not been established.
Children
Safety and efficacy have not been established.
How supplied
Temsirolimus
injectable solution
- 25mg/mL