Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Post-marketing and Other Clinical Experience
- pancreatitis, cholecystitis, and cholelithiasis
5 WARNINGS AND PRECAUTIONS
- The use of TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections [see Adverse Reactions (6.1)]
- Pneumocystis jiroveci pneumonia (PJP), including fatalities, has been .....
5.5 Interstitial Lung Disease
- It is recommended that patients be followed closely for occurrence of clinical respiratory symptoms. If clinically significant respiratory symptoms develop, consider withholding ..... For patients who require use of corticosteroids, prophylaxis of PJP may be considered.
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
- see PI for extensive changes in this subsection .....
- The following selected adverse reactions were reported less frequently (<10%) .....
17 PATIENT COUNSELING INFORMATION
Interstitial Lung Disease
- Patients should be warned of the possibility of developing interstitial lung disease, a chronic inflammation of the lungs, which may rarely result in death [see Warnings and Precautions (5.5)]. Patients, including those who are taking or have taken corticosteroids orimmunosuppressive agents, should be directed to report promptly any new or worsening respiratory symptoms to their physician.
WARNINGS AND PRECAUTIONS
- Patients should be monitored throughout the infusion and appropriate supportive care should be available. Temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered. A benefit-risk assessment should be done prior to the continuation of temsirolimus therapy in patients with severe or life-threatening reactions.
Interstitial Lung Disease
- Cases of interstitial lung disease, some resulting in death, occurred in patients who received Torisel.
- It is recommended that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to the initiation of Torisel therapy. Follow such assessments periodically, even in the absence of clinical respiratory symptoms.
- It is recommended that patients be followed closely for occurrence of clinical respiratory symptoms. If clinically significant respiratory symptoms develop, consider withholding Torisel administration until after recovery of symptoms and improvement of radiographic findings related to pneumonitis. Empiric treatment with corticosteroids and/or antibiotics may be considered. Elderly Patients
- Based on the results of a phase 3 study, elderly patients may be more likely to experience certain adverse reactions including diarrhea, edema and pneumonia.