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How Treatment May Help

AFINITOR® (everolimus) Tablets

IMPORTANT SAFETY INFORMATION AND APPROVED USE:

Patients should not take AFINITOR 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:

 

  • Rash, dry skin, and itching
  • Diarrhea
  • Infections
  • Feeling weak or tired
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Stomach pain
  • Nausea
  • Fever
  • Loss of appetite, weight loss
  • Headache
  • Vomiting
  • Cough, shortness of breath
  • Nose bleed
  • 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 accompanying 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.

Approved Use:

AFINITOR is a prescription medicine used to treat adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively produce hormones

Important Safety Information:

Patients should not take AFINITOR 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 sirolimu

... See More
Approved Use:

AFINITOR is a prescription medicine used to treat adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery. AFINITOR is not for use in people with carcinoid tumors that actively produce hormones

... See More

Treatment With AFINITOR

  • AFINITOR® (everolimus) Tablets may slow the growth and spread of advanced PNET. The benefits and risks of AFINITOR have been examined in a large clinical trial studying advanced PNET that has progressed and cannot be treated with surgery, including more than 400 patients with these tumors.
  • For patients taking AFINITOR, tumor growth was delayed for twice as long compared with patients taking a placebo sugar pill (11.0 months for AFINITOR patients compared with 4.6 months for patients on placebo). Approximately 4.8% of patients taking AFINITOR experienced a reduction in tumor size. No patients became tumor-free. It’s important to note that an increase in overall survival has not been shown. It is not known if AFINITOR is safe and effective for people with carcinoid tumors.

Before Starting Treatment With AFINITOR

Before you start treatment with AFINITOR, it is important to tell your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking. This is important because some of these may affect how AFINITOR works, or AFINITOR may affect how they work. Using AFINITOR with 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 doctor 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

Ask your health care provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. 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. You should also tell your health care provider before you start taking any new medicine.

Other Things to Tell Your Doctor Before Taking AFINITOR

Talk to your health care provider before taking this medicine if you are allergic to:

  • sirolimus (Rapamune®)
  • temsirolimus (Torisel®)

Ask your health care provider if you do not know.

Before taking AFINITOR, tell your health care provider about all of 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
  • 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. If you become pregnant or think you are pregnant, tell your health care provider right away
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

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

Important Safety Information

Patients should not take AFINITOR 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:

  • Rash, dry skin, and itching
  • Diarrhea
  • Infections
  • Feeling weak or tired
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Stomach pain
  • Nausea
  • Fever
  • Loss of appetite, weight loss
  • Headache
  • Vomiting
  • Cough, shortness of breath
  • Nose bleed
  • 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 accompanying 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.

Approved Use

AFINITOR is a prescription medicine used to treat adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively produce hormones.