For US residents only.

Understanding the Disease

Advanced Renal Cell Carcinoma (aRCC)

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

... See More
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.

Renal cell carcinoma (RCC) is the most common type of kidney cancer. Advanced renal cell carcinoma, or aRCC, is when the cancer has spread to other places in the body. In order to understand the causes of advanced kidney cancer, it may be helpful to understand the role of your kidneys.

Understanding the role of your kidneys

The kidneys are a filtering system in your body. The kidneys filter waste and extra water from your blood. The filtered, clean blood leaves the kidney and circulates in your body. The waste products and extra water are removed in urine.

Understanding how a tumor starts to grow

Like the rest of your body, your kidneys are made from cells. Cells divide to make new cells when needed. They stop dividing when there are enough cells. But sometimes cells do not stop dividing.

 

If cells continue to divide after there are enough cells, the extra mass formed by these cells may become cancer cells.
These cells can build up into a tumor (a growth or mass of cells) that is either benign (a growth that is not cancer) or
malignant (a cancerous tumor that grows and spreads through the body).

 

What are the causes of kidney cancer?

All of the cells in your body contain genes. Genes contain the instructions that tell cells what to do. Cells become cancerous when something changes, or mutates, those instructions. This mutation causes the cells to keep dividing, making more and more cancer cells.

 

If you have advanced kidney cancer, cancer cells from your kidneys have spread through your body and formed tumors in other places.

 

Unlike some other diseases, there is no one cause of advanced kidney cancer. Researchers think that genetic factors increase your risk of getting kidney cancer. They also think that nongenetic factors, such as smoking and obesity, may be involved. Scientists have studied advanced kidney cancer for years, but do not completely understand how it develops. Continuing research may eventually provide answers.

What are the risk factors for kidney disease?

Knowing some of the risks of kidney cancer is an important way to be proactive about your health.

The most common kidney cancers are renal cell carcinomas. While there is no single known cause of kidney cancer, the risk factors include:

  • Age: As a person gets older, the risk of renal cell carcinoma increases. This disease occurs mostly in people older than 55 years of age
  • Gender: Men are more likely than women to develop renal cell carcinoma
  • Smoking: People who smoke have a higher risk. The good news is that quitting smoking can reduce your risk
  • Obesity: People who are overweight have an increased risk of renal cell carcinoma
  • High blood pressure: Although the reason is unclear, high blood pressure seems to increase the risk of renal cell carcinoma
  • Chemical exposure in the workplace: People who work with certain chemicals (such as asbestos, cadmium, and trichloroethylene) may have an increased risk of renal cell carcinoma
  • Treatment for kidney failure: People with chronic kidney failure who have been treated with long-term dialysis, and people who have had a kidney transplant and take immunosuppressant medication, have a higher risk of developing renal cell carcinoma
  • Genetic factors: Certain inherited disorders make a person more likely to develop one or more types of renal cell carcinomas

It is estimated that over 62,000 people in the United States will be diagnosed with cancer of the kidney in 2016. Currently, there are more than 200,000 kidney cancer survivors living in the United States.

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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.