PATIENT GUIDE. Highlights of Important Safety Information Warnings and Precautions. Your guide to treatment with Signifor LAR for acromegaly

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PATIENT GUIDE Your guide to treatment with Signifor LAR for acromegaly Signifor LAR is indicated for the treatment of patients with acromegaly for whom surgery has not worked well enough or who

Your health care provider should check your blood sugar level before you start receiving Signifor LAR and while you receive it.

1 PATIENT GUIDE Your guide to treatment with Signifor LAR for acromegaly Signifor LAR is indicated for the treatment of patients with acromegaly for whom surgery has not worked well enough or who cannot have surgery. Treatment with Signifor LAR may cause high blood sugar levels (hyperglycemia) and diabetes. Your health care provider should check your blood sugar level before you start receiving Signifor LAR and while you receive it. Tell your health care provider if you have any of these symptoms: excessive thirst urinate more than usual increased appetite with weight loss tiredness If you get hyperglycemia, your health care provider may give you medicine to lower your blood sugar. Your health care provider may also change your dose of Signifor LAR or ask you to stop receiving it.

Table of contents Before starting treatment Before starting treatment 3 How was Signifor LAR (pasireotide) for injectable suspension studied? 4 How will I receive treatment?

2 Table of contents Before starting treatment Before starting treatment 3 How was Signifor LAR (pasireotide) for injectable suspension studied? 4 How will I receive treatment? 6 Resources and support 7 Possible serious side effects: high blood sugar 8 Other possible serious side effects 9 My treatment plan 10 Indication and Important Safety Information 11 Important things to remember 12 Treatment with Signifor LAR may cause your heart to beat slower (bradycardia) or cause changes in the electrical system of your heart (QT interval prolongation). Your health care provider should check your heart s electrical system with an ECG test prior to starting Signifor LAR and after 3 weeks in patients who may be at risk for electrical system problems. Call your health care provider right away if you experience any signs and symptoms such as: weakness dizziness fainting Beginning treatment with Signifor LAR (pasireotide) for injectable suspension is one step in what can be a long journey with this condition. The information in this brochure is intended to help you become familiar with Signifor LAR and how it works. What is Signifor LAR? Signifor LAR is a prescription medicine used to treat adults with acromegaly for whom surgery has not worked well enough or who cannot have surgery. What does my doctor need to know? 1 It s important to tell your doctor about your medical history before starting treatment with Signifor LAR. Please tell your health care provider if you: have high blood sugar (hyperglycemia) have diabetes have or have had heart problems, including an abnormal heart rate or rhythm or problems with the electrical system of your heart (QT prolongation) have a low level of potassium or magnesium in your blood have liver problems have gallstones (cholelithiasis) have any other medical conditions are pregnant or planning to become pregnant. Signifor LAR may harm your unborn baby. are breastfeeding or planning to breastfeed. It is not known if Signifor LAR passes into your breast milk. You and your health care provider should decide if you will receive Signifor LAR or breastfeed. You should not do both. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Signifor LAR for injectable suspension is a type of medication called a somatostatin analog. 1 Somatostatin analogs work by suppressing secretion of growth hormone (GH), which can lead to decreases in insulin-like growth factor 1 (IGF-1). 1 Signifor LAR and other medicines may affect each other, causing side effects. Signifor LAR may affect the way other medicines work, and other medicines may affect how Signifor LAR works. Your health care provider may need to change your dose of Signifor LAR. Especially tell your health care provider if you take: medicines to control your heart beat (anti-arrhythmics) medicines to control your blood pressure (such as beta-blockers or calcium channel blockers) medicines to control the potassium and magnesium (electrolytes) levels in your body medicines that may affect the way the electrical system of your heart works (QT prolongation) cyclosporine bromocriptine Ask your health care provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show to your health care provider and pharmacist when you get a new medicine. 2 3

3 How was Signifor LAR (pasireotide) for injectable suspension studied? Study 1: Results of a study of people who either had at least 1 pituitary surgery or did not have pituitary surgery and who had never taken medication for acromegaly 1 How was Signifor LAR (pasireotide) for injectable suspension studied? (cont d) Study 2: Results of a study of people with acromegaly whose acromegaly was not controlled on another somatostatin analog 1 The people in this study showed a history of not responding to treatment with their current somatostatin analog. 31.3% had GH <2.5 µg/l and normalized IGF-1 after 12 months on Signifor LAR 98% vs of people with acromegaly on Signifor LAR had either a reduction in the volume of their pituitary tumor or no change during the study The median change in tumor volume was a reduction of 39.8% The change in tumor volume for these people ranged from a reduction of 97.6% to an increase of 16.9% 19.2% on another somatostatin analog. (The people in this group did not take the maximum dose of the somatostatin analog during the study.) All people in the same study taking either Signifor LAR or another somatostatin analog had smaller ring sizes, and other symptoms such as headache, fatigue, and perspiration were reduced 15.4% who took 40 mg of Signifor LAR every 4 weeks experienced a reduction in both GH and IGF-1 after 6 months 20% who took 60 mg of Signifor LAR every 4 weeks experienced a reduction in both GH and IGF-1 after 6 months vs vs 0% 0% 81% 70% of people with acromegaly who took 40 mg of Signifor LAR every 4 weeks had either a reduction in the volume of their pituitary tumor or no change during the study The median change in tumor volume was a reduction of 10.4% The change in tumor volume for these people ranged from a reduction of 74.5% to an increase of 19.4% who continued taking another somatostatin analog they had taken for at least 6 months before starting the study. (Approximately 75% of the people in this group did not take the maximum dose of the somatostatin analog they took during the study.) who continued taking another somatostatin analog they had taken for at least 6 months before starting the study. (Approximately 75% of the people in this group did not take the maximum dose of the somatostatin analog they took during the study.) of people with acromegaly who took 60 mg of Signifor LAR every 4 weeks had either a reduction in the volume of their pituitary tumor or no change during the study The median change in tumor volume was a reduction of 6.3% The change in tumor volume for these people ranged from a reduction of 66.7% to an increase of 14.5% Treatment with Signifor LAR may cause elevations in liver function tests; therefore, your health care provider may do blood tests to monitor your liver. Common Side Effects: Most patients experience side effects at some time. Some common side effects you may experience include: diarrhea, gallstones, high blood sugar, and diabetes mellitus. These are not all the possible side effects of Signifor LAR. Treatment with Signifor LAR may affect your gallbladder (gallstones, cholelithiasis). Tell your health care provider right away if you experience any of the following signs and symptoms: sudden pain in the upper right stomach area (abdomen) sudden pain in the right shoulder or between your shoulder blades yellowing of the skin and whites of your eyes fever and chills nausea 4 5

4 How will I receive treatment? Signifor LAR (pasireotide) for injectable suspension must be given by a trained health care provider as an injection into the muscle of your buttocks (intramuscularly). 1 Your health care provider will tell you how much Signifor LAR you will receive and when you will receive it. 1 Your health care provider may change your dose of Signifor LAR or the length of time between your injections. Your health care provider will tell you how long you need to receive Signifor LAR. 1 Before you receive Signifor LAR for the first time, your health care provider should do a blood test to check your fasting blood sugar level, electrolyte levels, and your liver function. 1 Before you receive Signifor LAR for the first time and during your treatment, your health care provider should do a test to check your heart (electrocardiogram). 1 How should I store Signifor LAR? 1 46 F 36 F Signifor LAR is administered once a month. Signifor LAR comes as an injection in 3 dosages (20 mg, 40 mg, and 60 mg), and can only be given to you by a trained health care provider. 1 Store Signifor LAR in the refrigerator between 36 F to 46 F (2 C to 8 C). Take Signifor LAR out of the refrigerator at least 30 minutes before you will receive it to allow it to come to room temperature. Do not use Signifor LAR if it has been out of the refrigerator and at room temperature for more than 24 hours. Your health care provider should give you Signifor LAR right away after it is mixed. Keep Signifor LAR and all medicines out of the reach of children. Treatment with Signifor LAR may affect your pituitary hormone levels (pituitary insufficiency). Signifor LAR may reduce the pituitary hormones in your body. Your health care provider should do a blood test to check your pituitary hormone levels before starting Signifor LAR and during treatment. Tell your health care provider if you experience any of these symptoms: nausea and vomiting tiredness dizziness diarrhea low blood glucose levels loss of appetite weight loss Resources and support A SHARED COMMITMENT TO ENHANCED PITUITARY CARE PEAK is an education and access program for patients with certain pituitary disorders. The PEAK program can help you: Access your medication Navigate the insurance process Connect with patient organizations and support groups PEAK aims to make it easier for you to find the support you need. TO LEARN MORE ABOUT PEAK The PEAK team can be reached Monday Friday (8 am 8 pm ET) to answer any questions or concerns you may have. How to contact PEAK: Online: By phone: Common Side Effects: Most patients experience side effects at some time. Some common side effects you may experience include: diarrhea, gallstones, high blood sugar, and diabetes mellitus. 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 Signifor LAR. For more information and to get advice about side effects, ask your health care provider or pharmacist. 6 7

5 Possible serious side effects: high blood sugar 1 Other possible serious side effects 1 High blood sugar (or hyperglycemia) and diabetes are possible serious side effects of treatment with Signifor LAR (pasireotide) for injectable suspension. One important part of managing side effects is making sure your blood sugar levels are regularly checked. When should my doctor check my blood sugar levels? Before you start treatment with Signifor LAR»»»»»»»»»»While you re receiving treatment with Signifor LAR If I do get hyperglycemia, how might my doctor help? Signs and symptoms of high blood sugar Tell your health care provider if you are: feeling very thirsty urinating more than usual hungrier than usual, with weight loss more tired than usual If you get hyperglycemia while receiving Signifor LAR, your health care provider may give you another medicine to lower your blood sugar. Your health care provider may also change your dose of Signifor LAR or advise you to stop receiving it. When it comes to side effects, each person may have a different experience. In addition to hyperglycemia, Signifor LAR (pasireotide) for injectable suspension may cause serious side effects, such as: slow heart rate (bradycardia). Signifor LAR can cause your heart to beat slower. People who have, or have had heart problems, or take certain medicines used to treat slow heart rate or that may cause a slow heart rate, are at higher risk for bradycardia. Tell your health care provider if you get any of these symptoms: weakness fainting or near fainting spells changes in the electrical system of your heart (QT interval prolongation). Tell your health care provider if you get any of these symptoms: weakness fainting or near fainting spells higher than normal liver function tests. Your health care provider should do blood tests to check your liver while you receive Signifor LAR. gallstones (cholelithiasis). Tell your health care provider if you get any of these symptoms: sudden pain in your upper right stomach area (abdomen) sudden pain in your right shoulder or between your shoulder blades yellowing of your skin and whites of your eyes fever with chills nausea low levels of pituitary hormones (pituitary insufficiency). Signifor LAR may reduce the pituitary hormones in your body. Your health care provider should do a blood test to check your pituitary hormone levels before you start receiving Signifor LAR and while you receive it. Tell your health care provider if you get any of these symptoms: nausea and vomiting tiredness diarrhea low blood glucose levels loss of appetite weight loss 8 9

6 My treatment plan Your doctor may use a treatment plan to help you stay on track with your therapy. The example plan below is for you and your doctor to fill out together. Your doctor may change your plan. Please bring the plan when you visit your doctor. The plan will help you remember some of the important parts of your treatment. My treatment goals My target growth hormone (GH) level is My target insulin-like growth factor 1 (IGF-1) level is Before I start treatment with Signifor LAR (pasireotide) for injectable suspension On / / my current GH level is On / / my current IGF-1 level is While I have treatment with Signifor LAR (After 3 months) On / / my GH level is (After 3 months) On / / my IGF-1 level is (After months) On / / my GH level is (After months) On / / my IGF-1 level is Other important things to talk to my doctor about What dose of Signifor LAR am I currently on? When will my dosage be reviewed? Has there been any change in my condition? Are there any lifestyle changes I should make? Before taking Signifor LAR: Tell your health care provider about all the medicines you take including over-thecounter medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take medicine to control your heart beat (anti-arrhythmics) to control your blood pressure (such as beta-blockers or calcium channel blockers) to control potassium and magnesium (electrolytes) levels in your body that affects the electrical system in your heart (QT prolongation) cyclosporine bromocriptine Indication and Important Safety Information Signifor LAR (pasireotide) for injectable suspension INDICATION Signifor LAR is indicated for the treatment of patients with acromegaly for whom surgery has not worked well enough or who cannot have surgery. IMPORTANT SAFETY INFORMATION This information does not take the place of talking to your health care provider about your medical condition or your treatment. Signifor LAR may cause serious side effects described below. : Treatment with Signifor LAR may cause high blood sugar levels (hyperglycemia) and diabetes. Your health care provider should check your blood sugar level before you start receiving Signifor LAR and while you receive it. Tell your health care provider if you have any of these symptoms: excessive thirst urinate more than usual increased appetite with weight loss tiredness If you get hyperglycemia, your health care provider may give you medicine to lower your blood sugar. Your health care provider may also change your dose of Signifor LAR or ask you to stop receiving it. Treatment with Signifor LAR may cause your heart to beat slower (bradycardia) or cause changes in the electrical system of your heart (QT interval prolongation). Your health care provider should check your heart s electrical system with an ECG test prior to starting Signifor LAR and after 3 weeks in patients who may be at risk for electrical system problems. Call your health care provider right away if you experience any signs and symptoms such as: weakness fainting Treatment with Signifor LAR may cause elevations in liver function tests; therefore, your health care provider may do blood tests to monitor your liver. Treatment with Signifor LAR may affect your gallbladder (gallstones, cholelithiasis). Tell your health care provider right away if you experience any of the following signs and symptoms: sudden pain in the upper right stomach area (abdomen) Please see full Prescribing Information enclosed in pocket in back cover. sudden pain in the right shoulder or between your shoulder blades yellowing of the skin and whites of your eyes fever and chills nausea Treatment with Signifor LAR may affect your pituitary hormone levels (pituitary insufficiency). Signifor LAR may reduce the pituitary hormones in your body. Your health care provider should do a blood test to check your pituitary hormone levels before starting Signifor LAR and during treatment. Tell your health care provider if you experience any of these symptoms: nausea and vomiting tiredness diarrhea low blood glucose levels loss of appetite weight loss Common Side Effects: Most patients experience side effects at some time. Some common side effects you may experience include: diarrhea, gallstones, high blood sugar, and diabetes mellitus. 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 Signifor LAR. For more information and to get advice about side effects, ask your health care provider or pharmacist. Before taking Signifor LAR: Tell your health care provider about all the medicines you take including over-the-counter medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take medicine to control your heart beat (anti-arrhythmics) to control your blood pressure (such as betablockers or calcium channel blockers) to control potassium and magnesium (electrolytes) levels in your body that affects the electrical system in your heart (QT prolongation) cyclosporine bromocriptine You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA

Important things to remember 1 Keep Signifor LAR (pasireotide) for injectable suspension and all medicines out of the reach of children Store Signifor LAR in the refrigerator between 36 F to 46 F (2

7 Important things to remember 1 Keep Signifor LAR (pasireotide) for injectable suspension and all medicines out of the reach of children Store Signifor LAR in the refrigerator between 36 F to 46 F (2 C to 8 C) Signifor LAR can only be given to you by a trained health care professional Tell your doctor if you have any side effect that bothers you or that does not go away You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Reference: 1. Signifor LAR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis Printed in USA 6/15 SIA

TIPS FOR GETTING THE MOST OUT OF YOUR TREATMENT.

Keeping it Real. TIPS FOR GETTING THE MOST OUT OF YOUR TREATMENT. Guiding you through your treatment Taking KISQALI (ribociclib) as prescribed is essential to getting the most out of your treatment. That