ABOUT AFINITOR FOR ADVANCED PNET

PATIENTS TALK ABOUT THEIR AFINITOR THERAPY

PATIENTS TALK ABOUT THEIR AFINITOR THERAPY
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About AFINITOR for Advanced Pancreatic Neuroendocrine Tumors (PNET)

What is AFINITOR?

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.

You may take AFINITOR at home or any other place that works for you. This may eliminate the need to receive treatment in your doctor's office. AFINITOR should be taken at the same time every day.

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®).

Please see additional Important Safety Information at the bottom of this page.

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

Treatment with AFINITOR

  • 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.
  • AFINITOR may slow the growth and spread of advanced PNET. The benefits and risks of AFINITOR have been examined in the largest 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 increase in survival has not yet been shown. It is not known if AFINITOR is safe and effective for people with carcinoid tumors

Important Safety Information

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.

Please see additional Important Safety Information at the bottom of this page.

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

Understanding how AFINITOR works

The way AFINITOR works, also called its mechanism of action (MOA), is different from many other medications. AFINITOR affects the cancer in two places*:

  • The cancer cells
  • The blood vessels that help feed the cancer cells

As a result, AFINITOR helps the following three important effects to happen:

  • May slow the growth and spread of cancer
  • It can restrict cancer cells from getting the nutrition they need to grow
  • It may slow the blood vessels from growing and supplying the tumor with blood

AFINITOR may also affect healthy, non-tumor cells.

Learn more about the MOA of AFINITOR

*Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in preclinical and clinical studies.

Keep your doctor informed

Having the freedom to take your medicine at home gives you the responsibility for taking it correctly every day. It is important to tell your doctor as soon as possible about any side effects you have while taking AFINITOR. If you report side effects as soon as they start, your health care provider can suggest ways to help relieve them and help manage your therapy. Don’t delay reporting symptoms, as they may worsen. Your doctor may have to reduce the dose of AFINITOR or stop AFINITOR until symptoms get better.

Important Safety Information

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.

Please see additional Important Safety Information at the bottom of this page.

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

 

Important Safety Information

AFINITOR® (everolimus) Tablets can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. 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. AFINITOR can cause incisions to heal slowly or not heal well. Mouth ulcers and mouth sores are common side effects, occurring in up to 86% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, and blood sugar and cholesterol levels.

Please see additional

Important Safety Information.

 
 

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:

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:

 

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

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.