TORISEL® Medication Guide

(temsirolimus)

17 PATIENT COUNSELING INFORMATION

Allergic (Hypersensitivity/Infusion) Reactions

Patients should be informed of the possibility of serious allergic reactions, including anaphylaxis (including life threatening and fatal reactions), despite premedication with antihistamines, and to immediately report any facial swelling or difficulty breathing [see Warnings and Precautions (5.1)].

Increased Blood Glucose Levels

Patients are likely to experience increased blood glucose levels while taking TORISEL. This may result in the need for initiation of, or increase in the dose of, insulin and/or hypoglycemic agents. Patients should be directed to report any excessive thirst or frequency of urination to their physician [see Warnings and Precautions (5.3)].

Infections

Patients should be informed that they may be more susceptible to infections while being treated with TORISEL [see Warnings and Precautions (5.4)].

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 or immunosuppressive agents, should be directed to report promptly any new or worsening respiratory symptoms to their physician.

Increased Blood Triglycerides and/or Cholesterol

Patients are likely to experience elevated triglycerides and/or cholesterol during TORISEL treatment. This may require initiation of, or increase in the dose of, lipid-lowering agents [see Warnings and Precautions (5.6)].

Bowel Perforation

Patients should be warned of the possibility of bowel perforation. Patients should be directed to report promptly any new or worsening abdominal pain or blood in their stools [see Warnings and Precautions (5.7)].

Renal Failure

Patients should be informed of the risk of renal failure [see Warnings and Precautions (5.8)].

Wound Healing Complications

Patients should be advised of the possibility of abnormal wound healing if they have surgery within a few weeks of initiating therapy or during therapy [see Warnings and Precautions (5.9)].

Intracerebral Bleeding

Patients with CNS tumors and/or receiving anticoagulants should be informed of the increased risk of developing intracerebral bleeding (including fatal outcomes) while on TORISEL [see Warnings and Precautions (5.10)].

Proteinuria and Nephrotic Syndrome

Advise patients that treatment with TORISEL may require monitoring for proteinuria and nephrotic syndrome and to contact their health care provider for signs and symptoms of nephrotic syndrome [see Warnings and Precautions (5.11)].

Medications that can interfere with TORISEL

Some medicines can interfere with the breakdown or metabolism of TORISEL. In particular, patients should be directed to inform their physician if they are taking any of the following: Protease inhibitors, anti-epileptic medicines including carbamazepine, phenytoin, and barbiturates, St. John's Wort, rifampicin, rifabutin, nefazodone or selective serotonin re-uptake inhibitors used to treat depression, antibiotics or antifungal medicines used to treat infections [see Warnings and Precautions (5.12)].

Vaccinations

Patients should be advised that vaccinations may be less effective while being treated with TORISEL. In addition, the use of live vaccines, and close contact with those who have received live vaccines, while on TORISEL should be avoided [see Warnings and Precautions (5.14)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that TORISEL can cause fetal harm. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.15) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with TORISEL and for 3 months after receiving the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with TORISEL and for 3 months after receiving the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise lactating women not to breastfeed during treatment with TORISEL and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise patients that male and female fertility may be compromised by treatment with TORISEL [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].

Elderly Patients

Elderly patients should be advised that they may be more likely to experience certain adverse reactions including diarrhea, edema, and pneumonia [see Warnings and Precautions (5.16)].

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Medication Guide

17 PATIENT COUNSELING INFORMATION

Allergic (Hypersensitivity/Infusion) Reactions

Patients should be informed of the possibility of serious allergic reactions, including anaphylaxis (including life threatening and fatal reactions), despite premedication with antihistamines, and to immediately report any facial swelling or difficulty breathing [see Warnings and Precautions (5.1)].

Increased Blood Glucose Levels

Patients are likely to experience increased blood glucose levels while taking TORISEL. This may result in the need for initiation of, or increase in the dose of, insulin and/or hypoglycemic agents. Patients should be directed to report any excessive thirst or frequency of urination to their physician [see Warnings and Precautions (5.3)].

Infections

Patients should be informed that they may be more susceptible to infections while being treated with TORISEL [see Warnings and Precautions (5.4)].

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 or immunosuppressive agents, should be directed to report promptly any new or worsening respiratory symptoms to their physician.

Increased Blood Triglycerides and/or Cholesterol

Patients are likely to experience elevated triglycerides and/or cholesterol during TORISEL treatment. This may require initiation of, or increase in the dose of, lipid-lowering agents [see Warnings and Precautions (5.6)].

Bowel Perforation

Patients should be warned of the possibility of bowel perforation. Patients should be directed to report promptly any new or worsening abdominal pain or blood in their stools [see Warnings and Precautions (5.7)].

Renal Failure

Patients should be informed of the risk of renal failure [see Warnings and Precautions (5.8)].

Wound Healing Complications

Patients should be advised of the possibility of abnormal wound healing if they have surgery within a few weeks of initiating therapy or during therapy [see Warnings and Precautions (5.9)].

Intracerebral Bleeding

Patients with CNS tumors and/or receiving anticoagulants should be informed of the increased risk of developing intracerebral bleeding (including fatal outcomes) while on TORISEL [see Warnings and Precautions (5.10)].

Proteinuria and Nephrotic Syndrome

Advise patients that treatment with TORISEL may require monitoring for proteinuria and nephrotic syndrome and to contact their health care provider for signs and symptoms of nephrotic syndrome [see Warnings and Precautions (5.11)].

Medications that can interfere with TORISEL

Some medicines can interfere with the breakdown or metabolism of TORISEL. In particular, patients should be directed to inform their physician if they are taking any of the following: Protease inhibitors, anti-epileptic medicines including carbamazepine, phenytoin, and barbiturates, St. John's Wort, rifampicin, rifabutin, nefazodone or selective serotonin re-uptake inhibitors used to treat depression, antibiotics or antifungal medicines used to treat infections [see Warnings and Precautions (5.12)].

Vaccinations

Patients should be advised that vaccinations may be less effective while being treated with TORISEL. In addition, the use of live vaccines, and close contact with those who have received live vaccines, while on TORISEL should be avoided [see Warnings and Precautions (5.14)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that TORISEL can cause fetal harm. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.15) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with TORISEL and for 3 months after receiving the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with TORISEL and for 3 months after receiving the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise lactating women not to breastfeed during treatment with TORISEL and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise patients that male and female fertility may be compromised by treatment with TORISEL [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].

Elderly Patients

Elderly patients should be advised that they may be more likely to experience certain adverse reactions including diarrhea, edema, and pneumonia [see Warnings and Precautions (5.16)].

Medication Guide

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