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A PATIENT’S GUIDE to understanding, living with, and treating the severe diarrhea and flushing associated with carcinoid syndrome. Live in the Moment, when you’re living with the severe diarrhea and f lushing associated with carcinoid syndrome. Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors (carcinoid syndrome) and long-term treatment of with metastatic carcinoid tumors and long-term treatment of the profuse watery the profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP)diarrhea associated with VIP-secreting tumors in patients in whom initial treatment secreting tumors in patients in whom initial treatment with immediate release with immediate release Sandostatin® (octreotide acetate) Injection has been shown Sandostatin® (octreotide acetate) Injection has been shown to be effective to be effective and tolerated. In patients with carcinoid syndrome and VIPomas, the and tolerated. In patients with carcinoid syndrome and VIPomas, the effect of effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and growth and development of metastases has not been determined. development of metastases has not been determined. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Warnings and Precautions Warnings and Precautions Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. require monitoring by your doctor. Please see additional Sandostatin® Immediate-release Injection Important Safety Please see additional LAR LAR Depot Important Safety Information Information on page 14Sandostatin® and Sandostatin® Depot Important Safety Information on page 15. 15 and Sandostatin® Immediate-release Injection Important Safety on page Information on page full 16. Prescribing Information. Please see enclosed Please see enclosed full Prescribing Information. Real people. Real stories. Real life. We’ve created this guide to help you live with the severe diarrhea and flushing associated with carcinoid syndrome. As you read through, you’ll be introduced to people just like you who are managing these symptoms with Sandostatin® LAR Depot (octreotide acetate for injectable suspension)—and living in the moment. What’s inside. On the first few pages, you’ll find the basic science and medical information you need to know. But don’t worry, we’ve made it as straightforward as we can. Then we’ll move on to the section dealing with food choices. How you eat will play an important role in how you feel day to day. That’s why we’ve included tips and advice about how to stock your fridge and pantry to best manage your symptoms. Isaac S. If you’re newly diagnosed, or if you’re starting treatment for the first time, you probably have a million questions. We’ve tried to answer a lot of them for you. We’ve even added in some extras for you to ask your health care provider, as well as some places you can go to learn more. So if you’re ready, let’s get started. IMPORTANT SAFETY INFORMATION Brian H. Warnings and Precautions: Treatment with Sandostatin® LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. Mary E. Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. Please see enclosed full Prescribing Information. 1 Doug B. carcinoid syndrome: Paula Carcinoid syndrome refers to the group of symptoms that result from active carcinoid tumors. When carcinoid tumors start to spread, or metastasize, they can cause sudden and severe symptoms. These symptoms are the result of an increased release of hormones by the carcinoid tumors. Throughout this guide, you’ll see words like carcinoid tumor and carcinoid syndrome— things you’ll hear your health care provider talk about, too. Our goal is to make the information as easy to understand as possible. What causes the symptoms of carcinoid syndrome? 67% of carcinoid tumors occur in the gastrointestinal tract. There are 2 types of carcinoid tumors. Your doctor may refer to them as “functional” or “non-functional.” Functional metastatic carcinoid tumors can release excess hormones, such as serotonin, into the body. It’s these excess hormones that can cause a variety of symptoms, including the severe diarrhea and flushing associated with carcinoid syndrome. Common side effects: Most patient experience side effects at some time. Some common side effects you may experience include: back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Other information: Patients with carcinoid tumors and VIPomas should adhere closely to Flushing (red or purplish skin) • Can be mild to severe • Appears suddenly • Occurs during the night • Temporary (lasting minutes) or prolonged (lasting hours) • Can occur several times a day • Primarily on the face or neck • May be accompanied by warmth and/or a rapid heartbeat LUNG LIVER* Different people experience symptoms differently. Some people have mild diarrhea and constant flushing. And for others, it’s the other way around. You may experience both at the same time or you may have one without the other. STOMACH LARGE INTESTINE SMALL INTESTINE Places where carcinoid tumors can occur in your body The most important thing is to talk to your health care provider if you have any new symptoms or an increase in the symptoms you already have—no matter how mild or severe you think they are. Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. You may want to ask your health care provider: Will my symptoms get worse over time? FAQs IMPORTANT SAFETY INFORMATION Diarrhea (loose, watery stools) MANAGING YOUR SYMPTOMS Neuroendocrine tumors form in the cells of the neuroendocrine system. Neuroendocrine tumors that form in the digestive system are called carcinoids. What are the most common symptoms of carcinoid syndrome? STARTING SANDOSTATIN® “I used to avoid visiting my sister-in-law for the holidays. Now I’m there, enjoying the laughs, the arguments, the embraces.” noun TESTING & TREATMENT The symptoms associated with carcinoid tumors can be subtle and common to other disorders. They may also come and go, and be more severe at certain times than others. That’s why it may have taken some time for you to get a diagnosis of carcinoid syndrome. If this happened to you, you’re not alone. CARCINOID CARCINOID SYNDROME SYNDROM Now we’re going to talk about what you’re experiencing. CARCINOID SYNDROME Please see enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. *Liver is a common site of metastases. their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. 3 SUPPORT 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. TESTING & TREATMENT Once your health care provider has determined that you may have carcinoid syndrome, he or she will perform tests that will help confirm your diagnosis. Joe Before you take this test, there are some foods you shouldn’t eat because they can affect the results. Your health care provider will tell you about them, but here’s a reminder: Treating patients for over 25 years. #1-prescribed somatostatin analogue in the world. Symptom control you can count on.* Here are results from a clinical study of 92 patients with carcinoid syndrome who were treated with Sandostatin LAR Depot or Sandostatin Immediate-release Injection. Sandostatin LAR Depot REDUCES DAILY STOOLS Sandostatin LAR Depot REDUCES FLUSHING 4.5 4.3 STOOLS PER DAY 2.5 EPISODES PER DAY 0.7 STOOLS PER DAY† EPISODES PER DAY† 42% MEAN REDUCTION (30%-48%; n=92) Avocados Bananas Pineapples 84% MEAN REDUCTION (70%-90%; n=92) in flushing frequency. *Patients with carcinoid tumors may experience symptom flare-ups while on therapy. They may be given supplemental Sandostatin® (octreotide acetate) Immediate-release Injection (at the dosage they were receiving prior to switching to Sandostatin LAR Depot) until symptoms are again controlled. † Patients received 10-mg, 20-mg, or 30-mg doses of Sandostatin LAR Depot, or Sandostatin Immediate-release Injection. A 6-month clinical trial of malignant carcinoid syndrome was performed in patients who had previously been shown to be responsive to Sandostatin Immediate-release Injection. MANAGING YOUR SYMPTOMS in frequency of severe diarrhea. STARTING SANDOSTATIN® “My daughter’s graduation from nursing school was no small affair. And I didn’t miss a moment. It was my proudest day.” One of the hormones overproduced by carcinoid tumors is serotonin, which is broken down into a substance called 5-hydroxyindoeacetic acid (5-HIAA for short). To find out if you have carcinoid syndrome, your health care provider will take a sample of your blood and urine to measure your levels of 5-HIAA. When you get a diagnosis of severe diarrhea and flushing associated with carcinoid syndrome, your first thought may be, “What now?” Luckily, there’s a treatment option like Sandostatin LAR Depot (octreotide acetate for injectible suspension). Sandostatin (octreotide acetate) Injection is a medicine approved in 1988 to treat the severe diarrhea and flushing associated with carcinoid syndrome. Along with some small lifestyle changes, it may help you control your symptoms and Live in the Moment. TESTING & TREATMENT How can a test prove I have the severe diarrhea and f lushing associated with carcinoid syndrome? Sandostatin® LAR Depot. Control You Can Trust. IMPORTANT SAFETY INFORMATION Pecans There are also some medicines you shouldn’t take before your 5-HIAA test. Again, your health care provider will tell you, but here’s a reminder: Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include: back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Other information: Patients with carcinoid tumors and VIPomas should adhere closely to their scheduled return visits for reinjection • Acetaminophen (such as Tylenol®*) in order to minimize exacerbation of symptoms. • Salicylates (such as aspirin) Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. • Guaifenesin (found in some cough medicines) Please see enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. 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. SUPPORT • L-dopa (used to treat Parkinson’s disease) *Tylenol is a registered trademark of McNeil Consumer Healthcare. 5 Walnuts/ Hickory nuts FAQs You may want to ask your health care provider: How long will it take to get my test results? Tomatoes STARTING SANDOSTATIN® You’re about to start therapy with Sandostatin® LAR Depot (octreotide acetate for injectible suspension). What that means is, you may be on your way to controlling your symptoms rather than having them control you. Below you’ll find a step-by-step guide to what you should expect, and when you should expect it. Jan Your health care provider will monitor your progress on Immediate-release Sandostatin injection and may then prescribe Sandostatin LAR Depot, which will be given as an injection by your health care provider once every 4 weeks. The beginning For the first 2 weeks During the first month: After 3 months: If your health care provider has prescribed Sandostatin to you for the first time, you will start by getting daily injections. You will give yourself daily injections of immediate-release Sandostatin® (octreotide acetate) Injection 2 or 3 times a day. Your health care provider will ask you to continue taking daily injections for 2 more weeks—just to make sure you have good symptom control while the Sandostatin LAR Depot starts working. Your health care provider will check on your progress to see if the dose should be adjusted. Remember to talk about any symptoms you’re having. Try to be as accurate as possible so you can get the right dose. You should also be visiting your health care provider every 4 weeks to check in. Get Sandostatin on your schedule. If you’re eligible, you can get your injections even when you are away from home. See page 14 for more details. Some restrictions apply. • So your health care provider can see how well immediate-release Sandostatin Injection is working from the start • So your health care provider can see if you’re experiencing any common side effects such as back pain, fatigue, headache, abdominal pain, nausea, and dizziness IMPORTANT SAFETY INFORMATION Warnings and Precautions: Treatment with Sandostatin® LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. FAQs 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. You may want to ask your health care provider: What are the side effects of treatment? MANAGING YOUR SYMPTOMS Two reasons why it is important to begin your therapy with daily injections: STARTING SANDOSTATIN® “I never thought I could zip line either. But when you’ve come that far, why not take the shortcut down?” Switching to Sandostatin LAR Depot. Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. Please see enclosed full Prescribing Information. 7 To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. SUPPORT Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. MANAGING YOUR SYMPTOMS Isaac “When the Falcons game heads into overtime, I’m not missing a single play. 40 yard line, 40 rows up. I’m there.” Stay hydrated: Make digestion easier: Avoid high-fat foods and foods rich in amines: Reduce stress: Keep a journal: Record any side effects with Sandostatin LAR treatment: Not that: Cooked vegetables Raw vegetables White potatoes & rice Cabbage Jelly Cream cheese Here’s what you can do to help you manage the severe diarrhea and flushing associated with carcinoid syndrome so that you can continue to enjoy daily activities. Whole-grain bread White bread Clear broth Creamy soup Drink plenty of water each day Pretzels Doughnuts Crackers Butter cookies Ripe bananas Dried fruit Pureed vegetables Relishes Jam Butter Gatorade Soft drinks When you have excessive diarrhea, you can lose a lot of water. That means you could become dehydrated and lose electrolytes. It can also affect your digestion and cause changes in your body weight and nutrition absorption, which can leave you feeling weak and tired. Eat high-protein foods like lean meats, fish, and eggs Cook or finely chop hard-to-digest fruits and vegetables Aged cheeses, pickled foods, cured meats Try to keep a positive attitude every day Avoid large, spicy meals You may want to ask your health care provider: How much protein should I be eating each day? Identifying foods and situations that trigger symptoms can help you avoid them Most patients experience some common side effects such as back pain, fatigue, headache, abdominal pain, nausea, and dizziness Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. 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 enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. SUPPORT 9 Choose this: FAQs Eat simply: When you’re managing the severe diarrhea and flushing associated with carcinoid syndrome, watching what you eat can help you avoid some symptoms or symptom flare-ups. But that doesn’t mean you have to give up your favorite foods altogether. Check out the chart to see what easy substitutions you might make to get the most from every meal. MANAGING YOUR SYMPTOMS Keep your energy up: What can I do to manage the severe diarrhea and f lushing associated with carcinoid syndrome? Choose this. Not that. FAQs You have questions. We have answers. And if you don’t see what you need, visit www.sandostatin.com for more. Q: I’ve heard that Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is changing its administration kit. How will this affect my treatment? A: The Sandostatin LAR Depot dose prescribed by your doctor will stay the same. We’ve just made the mixing and preparation more convenient and the solution easier to prepare—so it may take less time for your health care provider to get ready for your visit. Q: How does Sandostatin LAR Depot work? A: Sandostatin LAR Depot is similar to somatostatin, a hormone that occurs naturally in the body. Both work in the same way to reduce excess hormones and other metabolic activities involved in carcinoid syndrome and VIPomas. Sandostatin LAR Depot remains in the body much longer than somatostatin. Q: What should I do if I miss an appointment? A: If you miss your appointment for your injection, you should call your health care provider’s office immediately to reschedule your visit. If keeping office appointments is difficult for you, talk with your health care provider to see if you qualify for the Mobile Administration Program (MAP). If your health care provider determines you are eligible for MAP, he or she will fill out and submit an enrollment form for you. Then a representative will contact you to schedule your first appointment with a nurse who will administer your injection at a location and time convenient for you. Q: Can I stop taking Sandostatin LAR Depot if I feel better? A: Only after consulting with your health care provider. You may feel better because of the action of Sandostatin LAR Depot, but the underlying problem still exists. Q: How much does Sandostatin LAR Depot cost? A: How much the drug will cost depends on where it is dispensed and what your individual insurance plan may cover. This amount can vary. Q: Does Sandostatin LAR Depot contain latex, gelatin, or gluten? A: There is no latex, gelatin, or gluten present in Sandostatin LAR Depot. Q: How can I get help paying for my Sandostatin LAR Depot? A: Novartis is committed to making sure you have access to the treatments you need. With the Sandostatin LAR Depot Co-pay card, eligible patients may pay no more than $25 per Sandostatin LAR Depot prescription. To find out if you’re eligible, ask your health care provider or call Patient Assistance Now Oncology (PANO) at 1-800-282-7630 to find out about the Co-pay card and insurance reimbursement. Limitations apply. Visit www.sandostatin-copay.com for program Terms and Conditions. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. Q: What are the possible side effects of Sandostatin LAR Depot taken to treat the severe diarrhea and flushing associated with carcinoid syndrome? A: Most patients experience side effects at some time. Some common side effects you may experience include: back pain, fatigue, headache, abdominal pain, nausea, and dizziness. FAQs Q: What dose of Sandostatin LAR Depot is right for me? A: Sandostatin LAR Depot comes in 3 doses. Talk to your doctor to find out which dose is right for you. Q: Can I administer Sandostatin LAR Depot to myself? A: No, Sandostatin LAR Depot should be administered only by a trained health care provider. 11 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 enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. SUPPORT Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. SUPPORT Mobile Administration Program (MAP) PR O GRA M MO IO MINISTRAT AD LE P IO BI “When Mena was born, I was there. Not only in the hospital. I was in the delivery room. I saw my granddaughter take her very first breath.” BI MINISTRAT Mary OGRA M MO AD No one should have to go through anything as tough as the severe diarrhea and flushing associated with carcinoid syndrome, alone. That’s why Novartis has developed many programs and resources for patients and their caregivers. PR LE - providing the resources, support, and information you need. N N We’re here for you If you’re an eligible patient, once your health care provider finds the right dose of Sandostatin® LAR Depot for you, you may be able to get your injections on the go. Talk to your health care provider to find out if MAP is right for you.† • Of course, this shouldn’t replace regularly scheduled appointments with your health care provider. The first dose of Sandostatin LAR Depot must be administered by your treating physician. But with MAP, subsequent doses can be administered in a place that’s convenient for you, even outside of normal office hours. • All MAP Nurses are registered nurses affiliated with United BioSource Corporation® (UBC)—specially trained in the mixing and administration of Sandostatin LAR Depot How RealSupport TM supports you. RealSupport™ can be real helpful. We created this program as a resource to help our patients live in the moment. With educational videos, tips, and recipes, this important tool may provide the information you need to cope with the severe diarrhea and flushing associated with carcinoid syndrome. At your home, office, or destination—our nurses are there for you,* at no charge to you • Talk to your health care provider to find out if MAP is right for you For more information about MAP, please visit www.MobileCarcinoidPatient.com. ™ R E A L I N F O R M AT I O N F R O M R E A L PAT I E N T S Patient Assistance Now Oncology (PANO) Enroll in RealSupport™ at www.joinrealsupport.com and get a personalized Doctor Discussion guide. Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about the broad array of support and reimbursement programs available. Support for patients includes: What’s in the guide? • Insurance verification • Tips for talking with your doctor about the symptoms of severe diarrhea and flushing • Medicare education • Suggestions on getting the most from your treatment plan • Assistance with denials/appeals • Advice on how you can partner with your health care provider to help manage • Therapy-specific support programs for out-of-pocket costs your condition • Assistance with searching for other sources of coverage/funding that could alleviate or reduce costs for patients Get a Patient Injection Guide too As another benefit of your RealSupport™ membership, you will receive a detailed instruction guide on how to self-administer Sandostatin® (octreotide acetate) Immediate-release Injection. IMPORTANT SAFETY INFORMATION Warnings and Precautions: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. ® 13 Foundations for assistance with co-pay costs • Assistance for low-income and uninsured patients • Patients pre-qualified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application *Some restrictions may apply. †Patients with government-provided insurance (such as Medicare Parts B and D or Medicaid) are not eligible at this time. Patients who reside in Massachusetts, Michigan, Minnesota, or Rhode Island are not eligible for this program. Visit www.sandostatin.com for complete terms and conditions. Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. Please see enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. SUPPORT Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. • Referrals to Independent Charitable Doug “I’m waist-deep in the Holston River, hip waders on, reel in hand, and I cast that fly out over the water. It’s a beautiful thing.” RESOURCES Important Safety Information There’s also a host of support groups and organizations that have your back, too. Sandostatin® (octreotide acetate) Immediate-release Injection NET advocacy groups* General advocacy groups* Carcinoid Cancer Foundation (CCF) www.carcinoid.org 1-888-722-3132 (toll-free) American Cancer Society (ACS) www.cancer.org 1-800-227-2345 (toll-free) Caring for Carcinoid Foundation (CFCF) www.caringforcarcinoid.org 1-617-948-2514 CancerCare www.cancercare.org 1-800-813-HOPE (toll-free) Healing NET Foundation www.thehealingnet.org 1-615-369-6463 Novartis resources Neuroendocrine Cancer Awareness Network (NCAN) www.netcancerawareness.org 1-866-850-9555 (toll free) New Jersey Carcinoid Cancer NETwork www.carcinoidnetwork.org 1-609-812-9294 NorCal CarciNET Community www.norcalcarcinet.org CarcinoidLink www.carcinoid.com The NET AllianceTM www.NeuroendocrineTumor.com *These websites are maintained by third parties. Novartis Pharmaceuticals Corporation does not guarantee the accuracy, completeness, or any other aspect of the information on these sites. Important Safety Information Sandostatin® LAR Depot (octreotide acetate for injectable suspension) INDICATIONS AND USAGE Sandostatin LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated. In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases has not been determined. 15 IMPORTANT SAFETY INFORMATION Warnings and Precautions: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, betablockers, and bromocriptine. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Warnings and Precautions: Treatment with Sandostatin (octreotide acetate) Injection may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor. Sandostatin Injection is a prescription medicine indicated for treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Before taking Sandostatin Injection: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, betablockers, calcium channel blockers, agents to control fluid and electrolyte balance, and bromocriptine. The effect of Sandostatin Injection on tumor size, rate of growth and development of metastases has not been determined. Please see enclosed full Prescribing Information. Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include gallstones, heart function changes, diarrhea, loose stools, nausea, abdominal discomfort, blood sugar changes, and underactive thyroid gland including enlargement of thyroid gland. Fewer than 10% of patients experienced vomiting, abnormal stools, constipation, flatulence, pain on injection, headache, dizziness, and inflammation of the pancreas. Intestinal obstruction and low platelet counts have also been observed. Other information: Women of child bearing potential should use adequate contraception during treatment. Talk to your doctor if you are a nursing mother. Diabetic patients should monitor their blood sugar levels frequently. Patients should make sure they are carefully instructed in the correct sterile injection technique before using Sandostatin Injection. Patients with carcinoid tumors and VIPomas should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels. Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include: back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Other information: Patients with carcinoid tumors and VIPomas should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. 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 enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. You’re sitting in your health care provider’s office and your mind is spinning with questions and information. So we wanted to give you a place to jot it all down to make sure you keep it straight. Notes Please see Sandostatin® LAR Depot Important Safety Information on page 15 and Sandostatin® Immediate-release Injection Important Safety Information on page 16. Please see enclosed full Prescribing Information. To learn more call 1-888-NOW-NOVA (669-6682), or visit www.sandostatin.com. Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2015 Novartis 8/15 SDS-1117393 Printed on recycled paper