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1 Avastin is approved to treat metastatic colorectal cancer (mcrc) for: First- or second-line treatment in combination with intravenous 5-fluorouracil based chemotherapy Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body. Discover the facts about tumor-starving * therapy FOR METASTATIC COLORECTAL CANCER (mcrc) PATIENTS STARTING AVASTIN FOR FIRST- OR SECOND-LINE TREATMENT *Anti-angiogenesis. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
2 2 Possible serious side effects Everyone reacts differently to Avastin therapy. So it s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects. Most serious side effects (not common, but sometimes fatal): GI PERFORATION A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever. WOUNDS THAT DON T HEAL A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed. SERIOUS BLEEDING This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor. The information in this brochure is not meant to be medical advice and should not replace the advice of your doctor. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
3 3 What you should know when starting Avastin Avastin is a tumor-starving (anti-angiogenic) therapy. Avastin works differently than chemotherapy Avastin is used with IV 5-FU based chemotherapy for first- or second-line metastatic colorectal cancer (or mcrc) in patients who have not previously received Avastin In clinical studies, people with mcrc were more likely to live longer when Avastin was added to their chemotherapy In clinical studies, Avastin was shown to significantly increase the time people live without their tumors growing or spreading There are serious side effects associated with Avastin therapy. You should discuss any side effects with your doctor Avastin Access Solutions may be able to help you understand how to get the medicine you need. For more information, please call Visit
4 4 About Avastin Avastin is a tumor-starving (or anti-angiogenic) therapy. Avastin works differently than chemotherapy. For metastatic colorectal cancer (mcrc), Avastin is taken with chemotherapy and hits your cancer from another angle. The difference between Avastin and chemotherapy Chemotherapy attacks fast-growing cells, like cancer cells. The purpose of Avastin is to prevent the growth of new blood vessels. This includes normal blood vessels and blood vessels that feed tumors. Tumor Chemotherapy attacks cancer cells Blood Vessels Avastin therapy prevents the growth of blood vessels
5 5 Starving your tumor The purpose of Avastin is to block a protein called vascular endothelial growth factor, or VEGF. Normal cells produce VEGF, but cancer cells overproduce VEGF. Blocking VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors. Tumor before treatment New blood vessels feed the tumor so it can grow and spread. Tumor with Avastin and chemotherapy* Avastin helps prevent blood vessels from reaching the tumor; this could starve the tumor. However, in a study of mcrc patients who continued on Avastin for second-line treatment after a first-line treatment that included Avastin, tumors did not shrink. *Avastin is used with IV 5-FU based chemotherapy for mcrc. Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
6 Avastin has been shown to effectively treat mcrc. Lorraine, oncology nurse Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
7 7 The benefits and risks for patients who started on Avastin for initial treatment In studies, when patients took Avastin and IV 5-FU-based chemotherapy* for first- or second-line treatment instead of chemotherapy alone: More people lived longer The length of time people lived without their tumors growing or spreading increased significantly More people saw their tumors shrink Avastin + chemo 1st line: 20.3 months vs 15.6 months 2nd line: 13.0 months vs 10.8 months TML : 11.2 months vs 9.8 months Individual results may vary. Avastin + chemo 1st line: 10.6 months vs 6.2 months 2nd line: 7.3 months vs 4.7 months TML : 5.7 months vs 4.0 months Avastin + chemo 1st line: 45% vs 35% 2nd line: 23% vs 9% TML : No difference in tumor shrinkage * IV 5-FU-based chemotherapy for first- and second-line treatment; fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after cancer progresses following a first-line treatment that includes Avastin. TML: First- through second-line treatment. To learn about some of the possible serious side effects of Avastin in the treatment of mcrc, see the next page. Please see page 2 for the most serious side effects. Important Safety Information Abnormal passage in the body. This type of passage known as a fistula is an irregular connection from one part of the body to another and can sometimes be fatal.
8 8 Other possible serious side effects of Avastin Across different cancers SEVERE STROKE OR HEART PROBLEMS These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure, 1%). These can sometimes be fatal. % = Percentage of patients who had this side effect in clinical studies across different cancers UP TO 18 % UP TO 11 % SEVERE HIGH BLOOD PRESSURE Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment.
9 9 KIDNEY PROBLEMS These may be caused by too much protein in the urine and can sometimes be fatal. ABNORMAL PASSAGE IN THE BODY NOT INVOLVING YOUR STOMACH OR INTESTINE This type of passage known as a fistula is an irregular connection from one part of the body to another and can sometimes be fatal. UP TO 7 % UP TO UP TO 2 % 3 % UP TO 0.5 % INFUSION REACTIONS These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions. NERVOUS SYSTEM AND VISION PROBLEMS Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
10 10 Possible side effects of Avastin in mcrc: First-line Side effects of Avastin and IV 5-FU based chemotherapy: First-line % = Percentage of patients who had this side effect in this clinical study SEVERE TO LIFE-THREATENING SIDE EFFECTS CHEMO+AVASTIN (n=392) CHEMO ALONE (n=396) WEAKNESS 10% 7% ABDOMINAL PAIN 8% 5% PAIN 8% 5% HIGH BLOOD PRESSURE 12% 2% BLOOD CLOTS IN THE VEINS OF THE BODY 9% 5% BLOOD CLOTS INSIDE THE ABDOMEN 3% 1% A BRIEF LOSS OF CONSCIOUSNESS 3% 1% DIARRHEA 34% 25% CONSTIPATION 4% 2% REDUCED WHITE BLOOD CELL COUNT 37% 31% REDUCED WHITE BLOOD CELL COUNT THAT MAY INCREASE THE CHANCE OF INFECTION 21% 14%
11 11 Possible side effects of Avastin in mcrc: Second-line Side effects of Avastin and IV 5-FU based chemotherapy: Second-line % = Percentage of patients who had this side effect in this clinical study SEVERE TO FATAL SIDE EFFECTS CHEMO+AVASTIN (n=287) CHEMO ALONE (n=285) TIREDNESS 19% 13% DIARRHEA 18% 13% NUMBNESS AND TINGLING IN FINGERS AND TOES 17% 9% NAUSEA 12% 5% VOMITING 11% 4% DEHYDRATION 10% 5% HIGH BLOOD PRESSURE 9% 2% ABDOMINAL PAIN 8% 5% SEVERE BLEEDING 5% 1% NERVOUS SYSTEM DISTURBANCES 5% 3% BLOCKAGE OF THE BOWEL 4% 1% HEADACHE 3% 0% Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
12 12 Side effects seen most often In clinical studies across different types of cancer, some patients experienced the following side effects: HIGH BLOOD PRESSURE TOO MUCH PROTEIN IN THE URINE NOSEBLEEDS RECTAL BLEEDING BACK PAIN HEADACHE TASTE CHANGE DRY SKIN INFLAMMATION OF THE SKIN INFLAMMATION OF THE NOSE WATERY EYES If you have any questions about your condition or treatment, talk to your doctor. You may report side effects to the FDA at FDA-1088 or You may also report side effects to Genentech at
13 13 Avastin is not for everyone Talk to your doctor if you are: UNDERGOING SURGERY Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed. PREGNANT OR THINK YOU ARE PREGNANT Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant. PLANNING TO BECOME PREGNANT Taking Avastin could cause a woman s ovaries to stop working and may impair her ability to have children. BREASTFEEDING Breastfeeding while on Avastin may harm your baby and is therefore not recommended during and for 6 months after taking Avastin. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
14 14 Taking Avastin When do I take Avastin? For patients starting on Avastin for first- or second-line treatment, Avastin is taken every 2 weeks to treat your metastatic colorectal cancer (mcrc). Because Avastin can be scheduled on the same day you get your chemotherapy, it may not require extra trips to an infusion center. Avastin is taken every 2 weeks For mcrc patients continuing on Avastin for second-line treatment after a first-line treatment that included Avastin, Avastin is taken every 3 weeks. If you have questions about how often you ll receive Avastin infusions, speak with your health care team.
15 15 How do I take Avastin? You take Avastin as an infusion. That means you receive Avastin through a small needle in your vein or through a port, which is a device placed under the skin. If your Avastin infusions are tolerated: 90 minutes 60 minutes minutes minutes 1st infusion 2nd infusion 3rd infusion Future infusions You always get the same dose of Avastin. If your Avastin infusions are tolerated, they can take as little as 30 minutes. What can I expect from my infusion? Your doctor or nurse will monitor you for signs of infusion reactions, and may stop Avastin treatment if severe reactions occur. Reactions can include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
16 16 How long do I take Avastin? You start taking Avastin with IV 5-FU based chemotherapy to treat your metastatic colorectal cancer (mcrc). And you keep taking Avastin as long as your disease is controlled and your side effects are manageable. Chemotherapy Avastin If your doctor changes your IV 5-FU based chemotherapy, you may still take Avastin as long as your disease is controlled and your side effects are manageable If your cancer progresses during this initial treatment, talk to your doctor about whether continuing Avastin with a different chemo may be an option. Important Safety Information Avastin may cause severe stroke or heart problems, which can sometimes be fatal. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal.
17 17 What to remember about Avastin There are some side effects that may require you to stop Avastin. But as long as your side effects stay manageable and your cancer is under control, you may keep taking Avastin. Continue taking Avastin even if: You change your chemotherapy treatment because of side effects You want a break from your treatment and your side effects are manageable You are seeing good results. Continuing to take Avastin may help to control your cancer If you are having issues paying for Avastin, call Avastin Access Solutions ( ) for resources that can connect you to the medicine you need. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
18 Life is a gift. So I m doing what I can to fight cancer. Juanita, mother, grandmother, scrapbooker This patient story is representative of the patient at the time of interview. The current status of the patient is not represented here.
19 19 Help From Avastin Access Solutions Your health insurance plan and the cost of your medicine might keep you from getting prescribed treatment. Avastin Access Solutions may be able to help. Avastin Access Solutions can find out: If your health insurance plan covers your Avastin How much your co-pay will be There are options to help you get the medicine your doctor has prescribed. Avastin Access Solutions can refer you to patient assistance options. Avastin Access Solutions For more information, please visit or call Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
20 20 Avastin.com The Avastin website can be a helpful resource for you during treatment. You can visit at any time for information about Avastin, patient stories, and more. Avastin in Action This simple animated video walks you through the steps of how Avastin is designed to work. Downloadable Resources Access informational brochures, treatment tools, and more. Visit TODAY Patient Support Programs Explore additional care networks that can help support you throughout your treatment. Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
21 21 Questions about Avastin to ask your doctor 1. Is Avastin right for me? 2. How is Avastin different from chemotherapy? 3. What should I know about the side effects of Avastin? 4. If my chemotherapy treatment changes because of side effects, can I still take Avastin? 5. How often do I take Avastin?
22 22 Notes Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.
23 Additional resources If you d like to join a support group, ask your health care team if there s one in your area. Here are some national organizations that provide services to people with cancer and their families: American Gastroenterological Association Medical information website about digestive system diseases, including colorectal cancer Visit Colon Cancer Alliance Telephone helpline, online support community, and survivor buddy program. A network of caregiver support groups is also available. Visit or call Cancer.net Online resource providing timely, oncologist-approved information from the American Society of Clinical Oncology to help patients and families make informed health care decisions. Visit or call National Comprehensive Cancer Network NCCN creates clinical practice guidelines for use by patients, clinicians, and other health care decision makers with the goal of improving the quality of oncology practice. Visit or call Information is provided for informational purposes and convenience only. Genentech is not responsible for the accuracy of the information contained on a third-party site and does not recommend or endorse the content provided on the site. The information provided by Genentech USA, Inc. or these organizations is meant for informational purposes only and is not meant to replace a physician s medical advice.
24 Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information Genentech USA, Inc., South San Francisco, CA. All rights reserved. May 2018 AVC/111914/0026(3)a
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