Frequently Asked Questions

AFINITOR works by blocking the mammalian target of rapamycin (mTOR) protein. In doing so, AFINITOR helps to slow blood vessels from feeding oxygen and nutrients to the tumor. AFINITOR may also affect healthy, nontumor cells. Although AFINITOR has been studied in patients with advanced PNET, how AFINITOR works has been demonstrated only in laboratory studies.

Click here to get the full Prescribing Information for AFINITOR.

Take AFINITOR once a day at the same time each day. AFINITOR is a prescription medicine that is a once-daily oral tablet. Take AFINITOR exactly as prescribed by your doctor. When you start treatment with AFINITOR, your health care provider may also prescribe a mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. Your doctor may change your dose of AFINITOR or tell you to temporarily interrupt dosing if needed.

Remember:

• Use scissors to open the blister pack
• Take it whole—not crushed, chewed, or broken
• At the same time each day with a glass of water
• Always take with food or always take without food

Share lists of all your prescription medicines, over-the-counter medicines, and herbal supplements and vitamins with your health care provider and your pharmacist. Talk with your health care provider before starting any new medicine.

You should have regular blood tests before you start AFINITOR and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.

You should NOT drink grapefruit juice or eat grapefruit during your treatment with AFINITOR. It may make the amount of AFINITOR in your blood increase to a harmful level.

Before you start treatment with AFINITOR, it is important to tell your doctor about all the 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), and 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
• Medicines that weaken your immune system (your body's ability to fight infections and other problems)

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.

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

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

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
• Have other medical conditions

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• AFINITOR can cause harm to your unborn baby. If you are a woman who is 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
• It is not known if AFINITOR passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of AFINITOR
• If you are a man with a woman partner, you should use effective birth control during treatment and for 4 weeks after your last dose of AFINITOR.

Your doctors and nurses are here to help you with your advanced PNET. It is best to speak openly with them about how you feel and your treatment. Here are a few suggestions to help you:

• Track your symptoms. Keep a record of how you are feeling and share it with your health care team at each visit
• Stick to your treatment. Take your medications as prescribed, and follow all the instructions from your doctor, nurse, or pharmacist
• Communicate openly. Get comfortable letting your team know about all of your symptoms
• Record your side effects.

Keeping an open dialogue with your doctor is very important when you are taking AFINITOR, or any other medication. By telling your doctor about any progress you are making, how you are feeling, or medications you are taking or side effects you are experiencing, you will help your doctor choose the treatment that is best for you.

Download the AFINITOR Patient Brochure which includes a list of questions to ask your doctor and other helpful information to help you track symptoms and side effects.

As you continue along on your advanced PNET treatment journey, keep in mind that having cancer does not change the person you are. Talk to your health care team and learn as much as you can. Do not be afraid to ask for help from your doctors, friends, and support team whenever you feel you need it. Most importantly, always remember that you are not alone.

Your health care provider will prescribe the dose of AFINITOR that is right for you. AFINITOR is available in 2.5-mg, 5-mg, 7.5-mg, and 10-mg strength tablets that are white to slightly yellow in color.

If you miss a dose of AFINITOR, you may still take it up to 6 hours after you normally take it. If it is more than 6 hours after you normally take your AFINITOR, skip the dose for that day. The next day, take your usual dose of AFINITOR at your usual time. Do not take 2 doses to make up for the one that you missed. Contact your doctor if you have any questions or concerns.

If you take too much AFINITOR, contact your doctor or go to the nearest hospital emergency department right away. Take the pack of AFINITOR with you.

AFINITOR tablets come in blister packaging. This protects them from moisture and light. To store your tablets:

• Store AFINITOR at room temperature, between 68°F to 77°F (20°C to 25°C)
• Keep AFINITOR in the pack it comes in
• Open the blister pack with scissors just before taking AFINITOR
• Keep AFINITOR dry and away from light
• Do not use AFINITOR that is out of date or no longer needed

Always be sure to call your doctor if you have any questions about taking your medicine. Also, remember to keep AFINITOR and all medicines out of the reach of children.

AFINITOR may cause side effects in some individuals and every patient's experience with AFINITOR will be different. Some people will experience more side effects than other people. Remember to talk to your doctor about any side effects that may appear, so that together you can work to find a way to manage them.

Serious side effects have been reported with AFINITOR:

You may develop lung or breathing problems. In some patients, lung or breathing problems may be severe and can even lead to death. Tell your health care provider right away if you have any of these symptoms:

• New or worsening cough
• Shortness of breath
• Chest pain
• Difficulty breathing, or wheezing

You may be 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.

Tell your health care provider right away if you have a temperature of 100.5°F or above, have chills, or do not feel well.

Symptoms of hepatitis B or infection may include:

• Fever
• Chills
• Skin rash
• Joint pain and inflammation
• Tiredness
• Loss of appetite
• Nausea
• Pale stools or dark urine
• Yellowing of the skin
• Pain in the upper right side of the stomach

Possible increased risk for a type of allergic reaction called angioedema, in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with AFINITOR. 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.

You 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.

If you have any of the serious side effects listed above, you may need to stop taking AFINITOR for a while or use a lower dose. Follow your health care provider's instructions.

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.

Common side effects of AFINITOR in people with advanced pancreatic neuroendocrine tumors include:

• Mouth ulcers. AFINITOR can cause mouth ulcers and sores. When you start treatment with AFINITOR, your health care provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your health care provider. Your health care provider may tell you to re-start this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.
• 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 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.

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.

Novartis Oncology is committed to helping you get the medicines you need. Getting access to medications can sometimes be difficult or confusing. Patient Assistance Now Oncology (PANO) offers tools and support designed specifically to help make that process easier.

Support for patients includes:

• Help you understand your insurance coverage and financial responsibilities through the insurance verification process
• Help you identify/determine pharmacies covered by your plan
• Provide insurance and Medicare education
• Provide information about financial assistance that may be available
• Patient Support Counselors who are able to provide information in over 160 languages
• One single point of contact to help guide you through getting access to the medicine prescribed by your doctor

Your journey with advanced PNET is not one you are managing alone. Your family and friends can be there to help you with daily tasks, as well as with talking to your doctor and helping you with your medication. Allowing your caregivers, family, and friends to play an important role in your health and well-being can help them be closer to you. You can also turn to support groups in order to connect with other people who have been affected by PNET.

Here are some ways your family and friends may be able to help. They can:

• Go with you to the doctor and take notes and ask questions for you
• Be there to listen when you need to talk
• Help out with everyday tasks

Finding out you have advanced PNET is very difficult. However, you are not alone in your journey.

Finding out as much as you can about advanced PNET will help you play a part in the important decisions you and your doctor will be making.

Get PNET resources and support group information.