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Treatment Options

AFINITOR

Important Safety Information:

Patients should not take AFINITOR® (everolimus) Tablets if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their health care provider's instructions. Serious side effects include:

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.

Kidney Failure: Patients taking AFINITOR may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Delayed Wound Healing: AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:

 

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your health care provider
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John's wort (Hypericum perforatum), medicines that weaken your immune system (your body's ability to fight infections and other problems), or medicines for:

 

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects: Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

 

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite, weight loss
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste
  • Dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs, mouth and throat, back or joints
  • High blood glucose
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders

Other side effects that may occur with AFINITOR:

 

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

Indication

Advanced Renal Cell Carcinoma (RCC)

AFINITOR is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.

The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or register marks of Novartis.

Approved Use:

AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked. AFINITOR may slow the growth and spread of kidney cancer cells and reduce blood supply to the tumor.

Important Safety Information:

Patients should not take AFINITOR® (everolimus) Tablets if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are

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Approved Use:

AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.

Drug Therapy Options for Advanced Kidney Cancer

The next treatment step: cancer medications

After you and your doctor have discussed surgery, you will talk about the next step in your treatment journey. This step may be a cancer medicine.

 

There are several things to think about when choosing medicine on your treatment journey. Different medicines are appropriate for different patients, work in different ways, and have different side effects. As different individuals will react differently to the same medicines, your doctor will not be able to predict exactly what your experience will be. Be sure to ask your doctor about the side effects of the drug(s) he or she recommends so that you know what to expect. Remember, some people are not bothered by certain side effects as much as other people are bothered by certain side effects.

 

Another factor in your decision making will be whether you and your doctor think an oral or an intravenous (IV) medicine is appropriate for you.

  • Oral medications are tablets that you can take by mouth at home
  • Intravenous (IV) medications are given through your vein and must be administered at a doctor's office or health care facility. You have to go to your doctor's office to receive them

Many drugs for advanced kidney cancer are taken orally. This eliminates the need to receive treatment in your doctor's office or health care facility.

 

Understanding your advanced kidney cancer medication options

When surgery alone is not enough to control kidney cancer, doctors may recommend specific kinds of medicine to help fight the disease. Today, there are a number of different treatments available to treat advanced kidney cancer. In fact, over the past decade, there have been a number of options made available in the treatment of advanced kidney cancer.

 

When going over your advanced kidney cancer treatment options, you and your doctor will decide which medicine is right for you. Some medicines can be used at any point in your treatment journey, while others cannot. Some medicines are taken orally, and some of them are given as IV medicines in your doctor's office. Whichever medicine you and your doctor choose for you to take on your treatment journey, be sure to take it exactly as instructed by your doctor.

 

AFINITOR is indicated for the treatment of adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.

Treatment options include:

  • Vascular endothelial growth factor (VEGF) inhibitors
  • Mammalian target of rapamycin (mTOR) inhibitors
  • Immunotherapy

Surgical Options for Advanced Kidney Cancer

Choosing the right surgery for you

The first step in treating kidney cancer is usually surgery. Surgery to remove a kidney is called nephrectomy. There are several types of nephrectomy. You and your surgeon will decide which type is right for you.

 

  • Radical nephrectomy removes the whole kidney and some small organs and tissue near the kidney. This is the most common surgery for advanced kidney cancer
  • Partial nephrectomy removes only the tumor and nearby kidney tissue. The rest of the kidney is left in place. This type of surgery is used when the tumor is small (ie, less than four centimeters). It is also used if the patient only has one kidney or if there is cancer in both kidneys

What to expect after your surgery

After surgery you may feel weak and tired for several weeks, but it is important to remember that people do not really need two kidneys. One healthy kidney will work harder to make up for the kidney that was removed. You can even live with only part of one kidney if some of it is removed by surgery.

An alternative step to surgery

Another procedure you and your doctor may talk about as you create your treatment plan is arterial embolization. This procedure involves blocking the blood supply to a tumor. Blocking the blood supply makes the tumor shrink.

Arterial embolization has many uses:

  • It can take the place of surgery as some people cannot have surgery, for example, because a kidney is already damaged
  • It can be used before surgery to shrink the tumor. This may make surgery easier to perform
  • It may also be used to help relieve the symptoms of advanced kidney cancer, such as pain or blood in the urine

What happens during arterial embolization?

If arterial embolization is a step you and your doctor decide to take, you will need to go to the hospital. Your doctor will insert a narrow tube into your leg. The tube will go up to the main blood vessel of your kidney. Your doctor will inject a substance into the blood vessel that will block blood from flowing into the kidney. Blocking blood keeps the tumor from getting oxygen and other nutrients it needs to grow.

 

Important Safety Information

Patients should not take AFINITOR® (everolimus) Tablets if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their health care provider's instructions. Serious side effects include:

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.

Kidney Failure: Patients taking AFINITOR may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Delayed Wound Healing: AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your health care provider
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John's wort (Hypericum perforatum), medicines that weaken your immune system (your body's ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure
 

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects: Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite, weight loss
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste
  • Dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs, mouth and throat, back or joints
  • High blood glucose
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders
 

Other side effects that may occur with AFINITOR:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

Indication

Advanced Renal Cell Carcinoma (RCC)

AFINITOR is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]) have not worked.

The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or register marks of Novartis.