TORISEL Side Effects

Read this section, in addition to Safety Considerations, to learn about side effects that have been seen in patients taking TORISEL. Like all medicines, TORISEL can cause side effects. Some can be serious. Be sure to discuss any side effects and anything you may do to manage them with your health care provider (HCP).

The most common side effects (occuring in 30% or more of patients) observed with TORISEL in clinical studies were:

Skin rash:
You may get a skin rash when you take TORISEL. Tell your HCP right away if you have any unusual skin irritation or pain.

Weakness or fatigue
Many cancer treatments, including TORISEL, can cause people to feel weak or fatigued.

Tips for managing fatigue:

• Moderate exercise may help. Talk to your HCP about what types of exercise are right for you and how often you should do them.
• Yoga, tai chi, and other types of mind-body exercises may help. Talk to your HCP about what might be a good option for you.

Mouth sores
People who have taken TORISEL often have had mouth sores. Your HCP may refer to mouth sores by the medical name mucositis. Mucositis can also refer to sores along your digestive tract.

Tips for managing mouth sores:

• Sucking on ice chips can help.
• Good oral hygiene is very important. One thing you can do to keep your mouth clean is brush your teeth with a soft toothbrush twice a day.

Nausea
Like many cancer treatments, TORISEL can cause you to have nausea or feel like you want to vomit.

Tips for managing nausea:

• There are medicines that help you feel less nauseated. Ask you HCP if there's a medicine that might be right for you.
• Hypnosis, relaxation, and other therapies can also help. Talk to your HCP about good options for you.

Swelling or fluid retention
Edema can occur in people who take TORISEL. It's very important to tell your HCP about swelling in any part of your body.

Loss of appetite
While on TORISEL, you may notice that you don't feel hungry or may not feel as motivated to eat as you normally would.

Indication

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

Important Safety Information

• 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 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

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