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Additional Safety Considerations

Read this section and Side Effects, to learn about important information for patients taking TORISEL.

Additional safety considerations

Before starting TORISEL, you should be aware of potentially serious side effects and other safety considerations. Some of these side effects may be easy to notice. Others may be impossible to recognize without special tests that your HCP may require. Patients should always ask their doctors for medical advice about side effects.

Allergic reactions
Some patients in clinical studies had allergic reactions to TORISEL. For this reason, it is recommended that patients receive a medicine (antihistamine) before treatment with TORISEL to lower the chances of an allergic reaction.

  • Even after you receive an antihistamine, it is possible to have an allergic reaction or even a severe reaction called anaphylaxis, which may result in death. Common symptoms of anaphylaxis include abdominal cramps/pain, chest discomfort, diarrhea, and difficulty breathing
  • Tell your HCP if you are allergic to TORISEL or antihistamine or if you cannot take antihistamines for any other reason
  • During treatment, tell your HCP if you have any swelling around your face, difficulty breathing, chest pain, flushing, hives, itching, wheezing, crampy abdominal pain, diarrhea, vomiting, irregular heartbeat, light-headedness, anxiety, or weakness in your muscles

Problems with the immune system
Your immune system may not work normally while you are taking TORISEL. This means you may be at greater risk of getting an infection while receiving TORISEL. Your doctor will monitor you for signs of infection.

Liver function
You should not receive TORISEL if blood tests show that your liver function is moderately or severely impaired. TORISEL should be used with caution in patients whose liver function is mildly impaired and should be given at a reduced dose.

Increased blood sugar levels
You are likely to have raised blood sugar levels when getting TORISEL. This may require treatment with, or an increase in the dose of, a medicine that lowers blood sugar levels.

  • Tell your HCP if you are thirstier than normal, urinating more than normal, feeling hungrier, gaining or losing weight, or feeling tired or irritated

Lung infection
Some people may develop Pneumocystis jiroveci pneumonia (PJP). This is a type of fungal lung infection. And it can cause death. This fungal lung infection may be related to the use of TORISEL and corticosteroids or other medicines that suppress the immune system.

Lung damage
In some people, treatment with TORISEL has been associated with a lung disease that can lead to inflammation and scarring, including rare fatalities.

  • Tell your HCP right away if you have any trouble with breathing, coughing, or wheezing. Also tell your HCP if you feel pain in your chest or develop a fever
  • Your doctor may perform tests before and during TORISEL therapy to make sure you don't have or develop serious lung issues

Increased cholesterol, triglycerides, or both
You are likely to have an increase in cholesterol, triglycerides, or both when getting TORISEL.

  • This may require treatment with, or an increase in the dose of, a medicine that lowers cholesterol, triglycerides, or both

Bowel perforation
Some people who received TORISEL developed tears in the walls of their intestines.

  • Fatal cases have been reported (one fatal case was reported in the main TORISEL trial)
  • Tell your HCP right away if you have any new or worsening stomach pain, blood in your stool, chills, nausea, or vomiting

Kidney failure
Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.

Abnormal wound healing
During treatment with TORISEL, wounds may not heal properly.

  • Tell your HCP if you are recovering from surgery or have an unhealed wound
  • Tell your HCP if you plan to have surgery during treatment with TORISEL

Increased risk of bleeding in the brain
TORISEL may increase the risk of bleeding in the brain, which has, in some cases, been fatal. You may be at an increased risk if you have a central nervous system tumor (such as a brain tumor) or are taking medicine to keep your blood from clotting.

Protein in your urine
Patients taking TORISEL may require monitoring for protein in their urine and kidney problems and should contact their healthcare provider for signs and symptoms of kidney problems. If there is too much protein in your urine, your healthcare provider may tell you to stop taking TORISEL

Medications that can interefere with TORISEL
Some medicines can interfere with the breakdown of TORISEL in your body. Tell your healthcare provider about ALL MEDICINES you are taking, including:

  • antibiotics (specifically rifampicin and rifabutin)
  • anti-seizure medicines (specifically carbamazeapine, phenytoin, and barbituates)
  • antidepressants (specifically nefazodone and selective serotonin re-uptake inhibitors)
  • antifungals
  • antivirals
  • blood thinners
  • steroids such as dexamethasone
  • vaccines
  • blood pressure medicine
  • St. John's Wort

Vaccine issues
Some vaccines may be harmful or less effective when given during the course of treatment with TORISEL.

  • You should avoid the use of live vaccines and close contact with those who have recently received live vaccines
  • Ask your HCP if you can receive a flu shot

Pregnancy concerns
TORISEL can harm an unborn baby.

  • Both men and women should use an effective form of birth control during and for 3 months after the last dose of TORISEL
  • Tell your HCP before beginning treatment if you or your partner are pregnant or thinking of becoming pregnant

Lactation
Do not breastfeed during treatment with TORISEL and for 3 weeks after the last dose

Infertility
TORISEL may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you

Concerns for people 65 or older
If you are 65 or older, you may be more likely to experience certain issues during TORISEL therapy, including:

  • Diarrhea
  • Edema (swelling)
  • Pneumonia

Steps to take before and during TORISEL treatment

  • Before you start treatment with TORISEL, it's important to tell your health care provider (HCP) about ALL MEDICINES you are taking
  • Tell your HCP if you are pregnant, if you plan to become pregnant, or if you have a partner who may become pregnant
  • Tell your HCP if you are allergic to TORISEL or antihistamines
  • Tell your HCP if you have any swelling around your face or difficulty breathing during or after treatment
  • Avoid eating grapefruit or drinking grapefruit juice. It may change the amount of TORISEL in your body
  • Talk to your HCP about potential blood tests. Your blood may be tested before you start TORISEL treatment and at other times over the course of therapy. Your HCP may tell you not to eat or drink before blood tests

Read about TORISEL Side Effects.

Read this section and Side Effects, to learn about important information for patients taking TORISEL.

   
 
 

Important Safety Information

Scroll for Important Safety Information and Indication.
  • You should not receive TORISEL if certain tests show that your liver function is moderately or severely impaired. TORISEL should be used with caution in patients whose liver function is mildly impaired and should be given at a reduced dose.
  • TORISEL can cause serious side effects. If you experience side effects that are too severe to tolerate, your health care professional may choose to delay your treatment, give you a lower dose of TORISEL, or discontinue treatment.
  • Before you begin treatment with TORISEL, your doctor may give you an antihistamine. It is possible to have a serious (including a life-threatening or fatal) allergic reaction even after you receive an antihistamine. Tell your doctor or nurse if you are allergic to antihistamines or are unable to take antihistamines for any other medical reasons. Tell your doctor or nurse if you have any swelling around your face or trouble breathing during or after treatment with TORISEL.
  • Patients are likely to experience increased blood sugar levels. This may require treatment with or an increase in the dose of a medicine that lowers blood sugar levels. Tell your doctor or nurse if you are thirstier than usual or urinate more often than usual.
  • Patients are likely to experience an increase in cholesterol and/or triglycerides. This may require treatment with or an increase in the dose of a medicine that lowers cholesterol and/or triglycerides.
  • Before you begin treatment with TORISEL, tell your doctor or nurse about ALL MEDICINES you are taking, including
    • Prescription medications, including but not limited to antibiotics, anticonvulsants, antidepressants, antifungals, antivirals, blood pressure medications, blood thinners, dexamethasone, vaccines
    • Nonprescription (over the counter) medications
    • Vitamins
    • Herbal supplements, including but not limited to St. John’s Wort
  • Avoid eating grapefruit or drinking grapefruit juice during the course of your treatment with TORISEL, including the time between treatments, as they may change the amount of TORISEL in your body.
  • Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.
  • Patients may also be at risk for Pneumocystis jiroveci pneumonia (PJP), a fungal infection in the lungs. Fatal cases have been reported. This may be related to the use of TORISEL along with corticosteroids or other medications that suppress the immune system.
  • Patients may get chronic inflammation of the lungs during treatment with TORISEL. Rare fatal cases have been reported. Tell your doctor or nurse right away if you have any trouble breathing, or develop a cough or fever.
  • TORISEL may cause bowel perforation. Fatal cases have been reported. Tell your doctor or nurse right away if you have any new or worsening stomach pain or blood in your stool.
  • Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.
  • During treatment with TORISEL, wounds may not heal properly. Tell your doctor or nurse if you are recovering from surgery or have an unhealed wound. Tell your doctor or nurse if you plan to have surgery during treatment with TORISEL.
  • TORISEL may increase the risk of bleeding in the brain, which has, in some cases, been fatal. You are at increased risk if
    • You have a central nervous system tumor, such as a brain tumor
    • You are taking medicine to keep your blood from clotting
  • Some vaccines may be less effective when given during the course of treatment with TORISEL. You should avoid the use of live vaccines and close contact with people who have recently received live vaccines. Ask your doctor or nurse if you are eligible to receive a flu shot.
  • Both men and women should use a reliable form of birth control during treatment and for 3 months after the last dose of TORISEL. TORISEL can harm an unborn baby. Tell your doctor or nurse before beginning treatment if you are pregnant or thinking of becoming pregnant.
  • Elderly patients may be more likely to experience certain side effects including diarrhea, edema and pneumonia.
  • The most common side effects are
    • Rash
    • Weakness/fatigue
    • Mouth sores
    • Nausea
    • Swelling/fluid retention
    • Loss of appetite



Indication

TORISEL is indicated for the treatment of advanced renal cell carcinoma.


Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.