WE RE IN A CONSTANT STRUGGLE. BUT WITH AFINITOR, WE VE FOUND ANOTHER OPTION.

SEGA TSC Novartis Pharmaceuticals Corporation is committed to supporting individuals affected by SEGA with TSC through therapeutic innovation, patient assistance, and support of advocacy organizations. More resources The following resources can provide additional information, support, and encouragement for patients and families affected by SEGA with TSC: The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown. Tuberous Sclerosis Alliance www.tsalliance.org 1-800-225-6872 Important Safety Information The National Organization for Rare Disorders www.rarediseases.org 1-800-999-6673 19 WE RE IN A CONSTANT STRUGGLE. INSPIRE Tuberous Sclerosis Alliance Support Community www.inspire.com/groups/tuberous-sclerosis-alliance 1-800-945-0381 These organizations and websites are independently operated by third parties over whom Novartis Pharmaceuticals Corporation has no control. Novartis assumes no responsibility for any information they may provide. BUT WITH AFINITOR, WE VE FOUND ANOTHER OPTION. Rapamune and Torisel are registered trademarks of Pfizer Inc. or its affiliates. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 AFT1108318_SEGA_PatientBrochure_Cover_v2.indd 2 AFINITOR (everolimus) Tablets and AFINITOR DISPERZ (everolimus tablets for oral suspension) are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. 2015 Novartis Printed in USA 3/15 AFT-1108318 AFINITOR or AFINITOR DISPERZ 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 78% 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, blood sugar and cholesterol levels, and how much AFINITOR is in the blood. Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket. 4/14/15 2:26 PM

Your Guide to AFINITOR and SEGA 2 If you or a loved one has been diagnosed with subependymal giant cell astrocytoma (SEGA) with tuberous sclerosis complex (TSC), you know it s a frustrating struggle. For 30 years, surgery was the only way to treat SEGA brain tumors. If surgery wasn t the answer, there wasn t much else to do except wait to see how the tumors developed. However, now there s another way to go. AFINITOR (everolimus) Tablets and AFINITOR DISPERZ (everolimus tablets for oral suspension) offer important options to treat SEGA brain tumors related to TSC. AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown. Important Safety Information Patients should not take AFINITOR or AFINITOR DISPERZ if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune ) or temsirolimus (Torisel ). AFINITOR or AFINITOR DISPERZ can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider s instructions.

Table of Contents.... What is SEGA with TSC?. 4 What happens after you or a loved one is diagnosed with SEGA?. 5 How does AFINITOR work?. 6 What are the possible side effects of AFINITOR?. 8 How should I take AFINITOR? 12 How is AFINITOR dosed?. 13 Build strong relationships with your health care team 13 Support for patients 14 Commonly asked questions 15 Glossary. 17 3 Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket.

4 What is SEGA with TSC? TSC is a genetic disease that causes noncancerous tumors to form in many organs, including the brain. SEGA is a type of brain tumor that can develop in people with TSC. SEGA tumors are not cancerous but they may be dangerous. Most often, they form in a part of the brain called the foramen of Monro, where they may block the flow of cerebrospinal fluid. This blockage can increase the pressure in the brain, leading to a condition called hydrocephalus. If hydrocephalus is not treated, it may cause problems such as headaches and visual problems. SEGAs usually develop during childhood or adolescence but can also occur in adults. Sometimes, SEGAs are not diagnosed until the tumor has caused symptoms. AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) do not treat hydrocephalus or the symptoms of SEGA. SEGAs are different from subependymal nodules (SENs). A SEN is a small noncancerous tumor. It is found in about 95% of people with TSC. In some of these people, a SEN may become a SEGA. This depends on how large the tumor grows, as well as other specific conditions being present.

What happens after you or a loved one is diagnosed with SEGA? Many medical tests are performed to diagnose SEGAs. These include imaging studies such as a brain magnetic resonance imaging or sometimes computed tomography scans. These help your doctor detect the SEGA. Once diagnosed, a SEGA may need intervention, such as surgery, especially if it is causing symptoms or growing larger. Some patients have SEGAs that cannot be removed completely by surgery. It could be that their tumor is in a location where surgery is not advisable. Until the approval of AFINITOR, there was no other approved treatment option for these people. Now there s another important choice: AFINITOR AFINITOR (everolimus) Tablets and AFINITOR DISPERZ (everolimus tablets for oral suspension) are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown. Important Safety Information 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. 5 Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket.

6 How does AFINITOR work? Now that you know more about SEGA and TSC, it s also important to understand how AFINITOR (everolimus) Tablets and AFINITOR DISPERZ (everolimus tablets for oral suspension) work. AFINITOR and AFINITOR DISPERZ work by calming the overactive signals caused by defects in 1 of 2 TSC genes TSC1 or TSC2. In normal cells, TSC1 and TSC2 form proteins that help control mammalian target of rapamycin (mtor), an important regulator of cell growth, blood supply, and nutrition In people with defects on TSC1 or TSC2, these proteins are not made, and so mtor is not regulated correctly When mtor is not regulated, cells grow too much and tumors can form throughout the body, including the brain AFINITOR and AFINITOR DISPERZ work by blocking mtor Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket. Important Safety Information Infections: AFINITOR or AFINITOR DISPERZ 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, 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 Pain in the upper right side of the stomach Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ.

How effective is AFINITOR? A study of AFINITOR was conducted in 117 patients with SEGA and TSC, between the ages of 0.8 and 26 years. Seventy-eight participants received AFINITOR and 39 received a placebo (sugar pill). This study, conducted over an average of 8 months, showed a significant response in 35% of patients taking AFINITOR. Response is defined as: At least a 50% decrease in SEGA tumor size No new SEGA tumors 1 cm or larger No new or worsening hydrocephalus (excess fluid in the brain; see glossary on page 17) No clear worsening of non-targeted SEGA tumors The responses lasted an average of 5.3 months. In comparison, none of the patients who took a placebo experienced a response. Another study of 28 patients was conducted to evaluate the safety and efficacy of AFINITOR. Patients were treated with AFINITOR for an average of 34 months. At 6 months, AFINITOR shrank the largest SEGA tumor by 50% or more in one-third of patients (9 of 28). The response of these 9 patients lasted an average of 360 days (range 97-1191 days). Seven of these 9 patients continued to see at least a 50% reduction in their SEGA tumor size when the study data were collected. In addition, 3 of 4 patients who previously had SEGA surgery saw their largest tumor shrink to at least half of its original size. No patient developed new SEGA tumors in the study. Important Safety Information AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider s instructions. 7

8 What are the possible side effects of AFINITOR? If you or a loved one begins taking AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension), it is important to have frequent conversations with your health care team, as you may experience side effects. Your doctor will monitor you or your loved one throughout treatment and can help you determine how to address any side effects you may experience. AFINITOR and AFINITOR DISPERZ can cause serious side effects. These serious side effects include: You may develop lung or breathing problems. In some people 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 active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people these infections may be severe, and can even lead to death. You 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, 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 Pain in the upper right side of the stomach

You may have an allergic reaction called angioedema. Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. You should get medical help right away if you have trouble breathing or develop swelling of the tongue, mouth, or throat during treatment with AFINITOR or AFINITOR DISPERZ. You may develop kidney failure. In some people this may be severe and can even lead to death. Your health care provider should do tests to check your kidney function before and during your treatment with AFINITOR (everolimus) Tablets and AFINITOR DISPERZ (everolimus tablets for oral suspension). If you have any of the serious side effects previously listed, you may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Follow your health care provider s instructions. Common side effects of AFINITOR or AFINITOR DISPERZ in people who have SEGA with TSC 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 mouth gel that does not contain alcohol, peroxide, iodine, or thyme Infections Nausea and vomiting Diarrhea and constipation Swelling of your hands, arms, legs, and feet Joint pain Cough Skin problems (such as rash, acne, or dry skin) 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 and AFINITOR DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket. Fever Feeling tired Anxiety, aggression, and other abnormal behaviors Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your health care provider if this happens Low red blood cells, white blood cells, or platelets Increased blood cholesterol level and certain other blood tests Increased blood sugar levels Decreased blood phosphate level 9

10 Important Safety Information Patients should not take AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune ) or temsirolimus (Torisel ). AFINITOR or AFINITOR DISPERZ can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ 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, chills, or do not feel well. Other symptoms of hepatitis B or infection may include the following: fever, 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 or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ. Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ. Before taking AFINITOR or AFINITOR DISPERZ, 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 or AFINITOR DISPERZ. 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 or AFINITOR DISPERZ can cause harm to your unborn baby. You should use effective birth control while using AFINITOR or AFINITOR DISPERZ and for 8 weeks after stopping treatment Are breastfeeding or plan to breastfeed. You and your health care provider should decide if you will take AFINITOR or AFINITOR DISPERZ or breastfeed. You should not do both

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) 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 or AFINITOR DISPERZ 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 or AFINITOR DISPERZ 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, peroxide, iodine, or thyme. Infection Nausea and vomiting Diarrhea and constipation Swelling of your hands, arms, legs, and feet Joint pain Cough Skin problems (such as rash, acne, or dry skin) Fever Feeling tired Anxiety, aggression, and other abnormal behaviors Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your health care provider if this happens Low red blood cells, white blood cells, or platelets Increased blood cholesterol level and certain other blood tests Increased blood sugar levels Decreased blood phosphate level Other common side effects include: 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 or AFINITOR DISPERZ. 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, in pocket. The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis. 11

12 How should I take AFINITOR? Your health care provider will prescribe the dose of AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) that is right for you. Take AFINITOR or AFINITOR DISPERZ exactly as your health care provider tells you to. Your health care provider may change your dose of AFINITOR or AFINITOR DISPERZ if needed. Take AFINITOR or AFINITOR DISPERZ one time each day at about the same time. Take AFINITOR or AFINITOR DISPERZ the same way each time, either with food or without food. Use scissors to open the blister pack. AFINITOR Swallow AFINITOR tablets whole with a glass of water. Do not crush AFINITOR tablets. Do not take any tablet that is broken or crushed. AFINITOR DISPERZ If your health care provider prescribes AFINITOR DISPERZ for you, see the Instructions for Use that come with your medicine for instructions on how to prepare and take your dose Each dose of AFINITOR DISPERZ must be prepared as a suspension before it is given AFINITOR DISPERZ can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant Anyone who prepares suspensions of AFINITOR DISPERZ for another person should wear gloves to avoid possible contact with the medicine If you miss a dose of AFINITOR or AFINITOR DISPERZ, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR or AFINITOR DISPERZ, skip the dose for that day. The next day, take AFINITOR or AFINITOR DISPERZ at your usual time. Do not take 2 doses to make up for the one that you missed. If you are not sure about what to do, call your health care provider. If you take too much AFINITOR or AFINITOR DISPERZ contact your health care provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR or AFINITOR DISPERZ with you. You should have regular blood tests before you start AFINITOR or AFINITOR DISPERZ 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 will also need to have additional blood tests regularly to measure how much medicine is in your blood. This will help your health care provider decide how much AFINITOR or AFINITOR DISPERZ you need to take. TM

What should I avoid while taking AFINITOR or AFINITOR DISPERZ? You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension). It may make the amount of AFINITOR or AFINITOR DISPERZ in your blood increase to a harmful level. How are AFINITOR and AFINITOR DISPERZ dosed? Not all patients taking AFINITOR or AFINITOR DISPERZ will take the same dose. Your doctor will determine the correct dose of AFINITOR or AFINITOR DISPERZ for you or your loved one based on height and weight. Your doctor may adjust this dose depending on response to the medication, side effects, changes in other medications you are taking, or the amount of drug in the blood. Tests that measure the level of AFINITOR in the blood allow the doctor to determine the dose for each person. You or your loved one will need to have blood tests regularly to measure how much medicine is in the blood. You can help ensure that you or your loved one is getting the appropriate dose of AFINITOR or AFINITOR DISPERZ. Let your doctor or nurse know right away if you or your loved one experience any side effect that s bothersome or does not go away. Your health care provider may change your dose of AFINITOR or AFINITOR DISPERZ, or stop prescribing it. Build strong relationships with your health care team Living with SEGA with TSC may feel like a constant struggle, but there is help. Your doctors and nurses are here to support you as you manage this challenging disease. It s best to speak openly with them about disease symptoms and treatment. Here are a few suggestions to help you get the most out of treatment with AFINITOR or AFINITOR DISPERZ: Follow the treatment plan. Stick to your doctor s instructions Communicate openly. Get comfortable letting your team know about all the disease symptoms Take an active role Keep your health care team up to date on prescription and nonprescription medications, vitamins or herbal supplements, allergies, and any changes in diet Write down symptoms as accurately as possible If you or your loved one have any other health conditions, continue to monitor those as well Don t hesitate to speak up and ask questions AFINITOR tablets are available in 2.5-mg, 5-mg, 7.5-mg, and 10-mg strength tablets AFINITOR DISPERZ tablets for oral suspension are available in 2-mg, 3-mg, and 5-mg strength tablets 13 Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket. TM

14 Support for patients Novartis Pharmaceuticals Corporation has made a commitment to help those in need access our medicines. The following programs offer support to patients living with SEGA with TSC who have been prescribed AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension). AfiniTRAC (Treatment, Reimbursement, Access, Commitment) is a comprehensive treatment and reimbursement support program for patients from Novartis, the maker of AFINITOR. The program includes dedicated Care Facilitators who offer personalized support for AFINITOR and AFINITOR DISPERZ patients and their caregivers, as well as guidance throughout the insurance process. AfiniTRAC provides: Treatment education and support for both patients and caregivers Reimbursement support for eligible patients Help with access to a range of available resources To find out more about AfiniTRAC, call 1-888-9AfiniTRAC (1-888-923-4648) or visit www.afinitor.com. AFINITOR Co-Pay Card: For most eligible patients, the co-pay for your AFINITOR (everolimus) Tablets prescription will be no more than $25 for each 28-day prescription. Novartis will pay the remainder of your co-pay for AFINITOR, up to a maximum of $6350 per month, every month that you remain on treatment with AFINITOR. To take advantage of these savings, simply print out the AFINITOR Co-Pay Card and take it with you to your pharmacy along with your AFINITOR prescription. Limitations apply. For more information about the AFINITOR Co-Pay Card, ask your doctor. Print your card online at www. AFINITOR.com. Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket.

Commonly asked questions about AFINITOR Q. What is the difference between AFINITOR (everolimus) and sirolimus? A. Everolimus and sirolimus are different medicines. The brand name of everolimus is AFINITOR. Sirolimus is known by the brand name Rapamune and is often referred to as rapamycin. Sirolimus is not approved by the Food and Drug Administration (FDA) for the treatment of SEGA with TSC. AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension) are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown. Direct comparisons between Rapamune (sirolimus) and AFINITOR cannot be made since there have not been any clinical studies comparing the 2 directly. Q. What should I avoid while taking AFINITOR? A. You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR or AFINITOR DISPERZ. It may make the amount of AFINITOR or AFINITOR DISPERZ in your blood increase to a harmful level. Q. Are there any other medications approved by the FDA for SEGA with TSC? A. No. AFINITOR and AFINITOR DISPERZ are the first and only medications approved by the FDA for adults and children with SEGA associated with TSC when the tumor cannot be removed completely by surgery. The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown. Q. Are there any resources that can provide treatment or reimbursement support for me or my loved one? A. Yes. You can learn all about these resources in our patient support section on page 14. Q. Can I receive a vaccine while taking AFINITOR or AFINITOR DISPERZ? A. You should tell your health care provider if you 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 or AFINITOR DISPERZ. If you are not sure about the type of vaccine, ask your health care provider. See more questions on the next page. TM 15

16 Commonly asked questions about AFINITOR (cont d) Q. What other medications should a patient avoid when taking AFINITOR (everolimus) Tablets or AFINITOR DISPERZ (everolimus tablets for oral suspension)? A. Know the medicines you take. Keep a list of them and show it to your health care provider and pharmacist when you get a new medicine. Be sure to tell your health care provider if you take: St. John s Wort (Hypericum perforatum) Medicine 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 or AFINITOR DISPERZ may need to be changed. You should also tell your health care provider before you start taking any new medicine. TM Medicines that weaken your immune system (your body s ability to fight infections and other problems) Q. What is the difference between AFINITOR and AFINITOR DISPERZ? A. AFINITOR tablets are taken whole with a glass of water. AFINITOR DISPERZ tablets for oral suspension are taken as a suspension only, mixed with water, and taken by mouth. These 2 formulations should not be combined. Use one or the other. Q. What should I tell my health care provider before taking AFINITOR or AFINITOR DISPERZ? A. Before taking AFINITOR or AFINITOR DISPERZ, 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 or AFINITOR DISPERZ. If you are not sure about the type of immunization or vaccine, ask your health care provider Have any other medical conditions Are pregnant, or could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. You should use effective birth control while using AFINITOR or AFINITOR DISPERZ and for 8 weeks after stopping treatment Are breastfeeding or plan to breastfeed. It is not known if AFINITOR or AFINITOR DISPERZ passes into your breast milk. You and your health care provider should decide if you will take AFINITOR or AFINITOR DISPERZ or breastfeed. You should not do both

Glossary Here are some helpful definitions of medical terms you may come across in this guide. Cerebrospinal fluid: A fluid that normally flows through the cavities of the brain. Foramen of Monro: The small opening on both the right and left sides of the brain that connects the third ventricle with the lateral ventricles (the spaces in the brain through which cerebrospinal fluid flows). The foramen of Monro is often the site of growth for SEGAs. Hydrocephalus: The buildup of fluid in the cavities (ventricles) deep within the brain. The excess fluid increases the size of the ventricles and puts pressure on the brain. Live vaccine: A vaccine that is prepared from live organisms (such as bacteria and viruses) that have been weakened. Live vaccines include measles, mumps, rubella, chickenpox, and the nasal flu vaccine, etc. Mouth ulcers: Sores or open lesions in the mouth. mtor: Mammalian target of rapamycin; an important protein that is present in both normal cells and tumor cells. It controls tumor cell growth as well as the supply of blood and nutrients to the tumor. SEGA: Subependymal giant cell astrocytoma; noncancerous brain tumor that can occur in up to 20% of patients with TSC. SEN: Subependymal nodule; small noncancerous brain tumor that occurs in 95% of patients with TSC. TSC1 and TSC2: Genes that form proteins that help control an important regulator of cell growth called mtor. In SEGA patients, either TSC1 or TSC2 does not work properly, which may cause tumors to grow. TSC: Tuberous sclerosis complex; a genetic disorder that may cause benign tumors to form in vital organs and can affect many different parts of the body, including the brain. 17 Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket.

Use the following pages to record any notes or questions you may have for your health care team. 18 Please see additional Important Safety Information on pages 10-11. Please see accompanying full Prescribing Information for AFINITOR and AFINITOR DISPERZ, including Patient Information, in pocket.