Tamala, treating her RA with ACTEMRA SC injections

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1 escribing A PATIENT S GUIDE TO THE ACTEMRA PREFILLED SYRINGE Tamala, treating her RA with ACTEMRA SC injections INDICATION IMPORTANT SAFETY INFORMATION ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist. ACTEMRA is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well. ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people taking ACTEMRA have died from these infections. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects.

2 Welcome to ACTEMRA Subcutaneous (SC) Injections You and your doctor have made an important decision about your moderate to severe rheumatoid arthritis (RA). ACTEMRA has been FDA approved to help relieve RA signs and symptoms with or without methotrexate. So if you ve taken other disease modifying antirheumatic drugs (DMARDs) like methotrexate that haven t worked well for you, ACTEMRA may be able to help. Getting started on ACTEMRA SC injections We know that starting a new treatment can be confusing. That s why we developed this brochure. Inside, you ll learn more about ACTEMRA SC injections, how ACTEMRA works on RA, and how ACTEMRA has helped other people living with RA. Keep in mind Your rheumatologist and nurse are there to help you through the process of injecting ACTEMRA. If you have any questions about ACTEMRA, don t hesitate to contact them. Important Safety Information Serious infections ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 2

3 Your guide to ACTEMRA Meet people taking ACTEMRA... 4 About ACTEMRA... 6 How ACTEMRA works... 7 Clinical trial results... 8 Taking ACTEMRA...12 What to expect...14 Important Safety Information...16 The ACTEMRA & You patient support program...21 The Genentech Rheumatology Co-pay Card Program...22 Coverage & patient assistance programs...25 You ll Also Get: Steps to Self-Injection portable injection instructions and preparation mat A Patient s Guide to Injecting ACTEMRA a complete instruction handbook 4 Steps to Self-Injection DVD with step-by-step injection instructions 3

4 Meet People Taking ACTEMRA By the age of 24, KAREN was already a successful nurse helping others cope with their difficult conditions. But she had her condition to worry about, and she didn t even know what it was. Without a proper diagnosis, she underwent rounds of treatments, and a knee surgery, but she still couldn t find any help for the pain in her feet and ankles. She decided to stay upbeat and encouraged something she usually does for her patients. Finally, she found a rheumatologist who diagnosed her with moderate to severe RA. After a few years of being on treatments that didn t work well for her, her rheumatologist suggested ACTEMRA SC injections. I have accepted the fact that I have RA, but I will never let it define me. Growing up with 3 brothers and sisters, and later having 3 kids of her own, TAMALA was used to taking care of others. That became more difficult when she started to notice her joints becoming stiff and swollen. After trying to ignore the pain and continuing to do it all, she realized she needed help. She found a rheumatologist who diagnosed her with moderate to severe RA. She started taking a DMARD, but it didn t provide enough relief. So her rheumatologist suggested ACTEMRA SC injections. Today, instead of focusing on my RA, I m focusing on being a good mother and a good wife. 4 Individual results may vary. Genentech sponsors advocates and compensates them for their time and expense in presenting their stories.

5 JODI was attending college when she started experiencing swelling and pain in her finger. Her family doctor diagnosed her with moderate to severe RA. She was stunned. At 18 years old, she pictured working hard at school and meeting new friends, not hours of pain and stiffness. But when the pain became unbearable, she decided to see a rheumatologist. They tried many DMARD treatments over the next 18 years, but the pain, stiffness, and swelling always returned. Then, they decided to try something different. Her rheumatologist suggested ACTEMRA SC injections. Now I can get back to doing the simple things, like preparing dinner for my family. Others may find that silly, but it means the world to me. Important Safety Information Stomach tears If you have diverticulitis (inflammation in parts of the large intestine), talk to your doctor before taking ACTEMRA. Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your doctor right away if you see any of these side effects: - Fever - Stomach-area pain that does not go away - Change in your bowel habits Please keep in mind that ACTEMRA may cause side effects, which will be discussed on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 5

6 About ACTEMRA How ACTEMRA (tocilizumab) is taken ACTEMRA may be taken as an SC self-injection The medicine is injected under the skin, into fatty tissue, but not any deeper into the muscle. Before injecting yourself on your own, or with the help of a caregiver, your doctor or nurse will train you on how to properly inject ACTEMRA. You or your caregiver should inject for the first time during this training session. ACTEMRA, taken with or without methotrexate, has been proven to help relieve a range of RA symptoms, including swollen and tender joints, and to ease activities like walking. Important Safety Information Changes in blood test results Before starting ACTEMRA, 4 to 8 weeks after starting treatment, and then every 3 months, your doctor will regularly do blood tests to check for the following side effects: Low neutrophil count: Low platelet count: neutrophils are white blood cells that help the body fight infection platelets are blood cells that help with clotting, which stops bleeding Increase in liver function test levels Increase in blood cholesterol levels 6 Neutrophil and platelet counts should not be too low or liver function test levels too high. These may cause your doctor to stop your ACTEMRA treatment for a time or change your dose. Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that.

7 How ACTEMRA works ACTEMRA works differently. That s because it s the first and only RA treatment to directly block the action of interleukin-6, or IL-6, a protein in your body believed to play an important role in RA. WITHOUT ACTEMRA IL-6 connects to the cell and tells the cell to activate. When the cell activates, it may contribute to the signs and symptoms of RA. WITH ACTEMRA ACTEMRA blocks IL-6 from connecting to the cell. IL-6 IL-6 IL-6 IL-6 IL-6 IL-6 IL-6 IL-6 ACTEMRA Receptor Receptor Signal may contribute to signs and symptoms of RA CELL CELL Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 7

8 ACTEMRA SC Injections Clinical Trial Results Proven experience ACTEMRA has been studied in 2 key clinical trials, in over 1,800 people living with moderate to severe RA who had previously taken a DMARD therapy. 2 Key Clinical Trials 1,800 People Studied These studies were done to test how well ACTEMRA would work, and to understand the risks of the drug. Important Safety Information Hepatitis B infection If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your doctor should test you for hepatitis B before starting treatment. Tell your doctor right away if you see any signs of these symptoms: 8 Feeling very tired Skin or eyes look yellow Little or no appetite Vomiting Clay-colored bowel movements Fevers Chills Stomach discomfort Muscle aches Dark urine Skin rash

9 Together, our clinical trial program showed that ACTEMRA, taken with or without DMARDs: Reduced the signs and symptoms of RA Helped relieve swollen and tender joints Decreased the progression of joint damage when taken with DMARDs Eased daily living activities Learn more about injecting ACTEMRA with these useful tools: Steps to Self-Injection portable injection instructions and preparation mat A Patient s Guide to Injecting ACTEMRA a complete instruction handbook 4 Steps to Self-Injection DVD with step-by-step injection instructions And remember to review the Instructions for Use, provided in the ACTEMRA Prescribing Information. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 9

10 ACTEMRA SC Injections Clinical Trial Results (cont d) The BREVACTA study Patients (%) % VS 32% ACTEMRA +DMARDs DMARDs ONLY The dose for study patients taking ACTEMRA as an SC injection was 1 prefilled syringe every 2 weeks. A study, called the BREVACTA study, compared patients taking ACTEMRA SC injections in combination with DMARDs against patients taking only DMARDs. Almost 61% of people taking ACTEMRA SC injections achieved a 20% improvement, also called an ACR20 response, at 24 weeks. By comparison, only 32% of people not taking ACTEMRA achieved the same response. Important Safety Information Serious allergic reactions Strong allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your doctor or nurse before your next injection. Contact 911 immediately, as well as your doctor or nurse, if you experience any of these reactions: Shortness of breath or trouble breathing Swelling of lips, tongue, or face Chest pain 10 Feeling dizzy or faint Moderate or severe abdominal pain or vomiting

11 The SUMMACTA study A different study, called the SUMMACTA study, compared patients taking ACTEMRA SC injections in combination with DMARDs, and patients taking ACTEMRA IV infusions with DMARDs, at 24 weeks of treatment. ACTEMRA SC injections were shown to work as well as ACTEMRA IV infusions. ACTEMRA SC injections + DMARDs: ACTEMRA IV infusions + DMARDs: Almost 70% Almost 73% Almost 70% of people saw a 20% improvement with ACTEMRA 73% of people saw a 20% improvement with ACTEMRA 47% Almost 49% 47% of people saw a 50% improvement with ACTEMRA Almost 49% of people saw a 50% improvement with ACTEMRA The dose for patients taking ACTEMRA as an SC injection was 1 prefilled syringe once a week. Patients taking ACTEMRA as an IV infusion received 1 infusion once every 4 weeks. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 11

12 Taking ACTEMRA Now that you and your rheumatologist have decided to treat your RA with ACTEMRA SC injections, it s important to learn how ACTEMRA is taken. Your ACTEMRA dose is based on your weight. If your weight changes, your rheumatologist may decide that a change of dose is necessary. Recommended Starting Dose Amounts PATIENTS LESS THAN 220 LB (100 KG) 1 prefilled syringe every 2 weeks PATIENTS 220 LB (100 KG) OR MORE 1 prefilled syringe once a week Important Safety Information Increased risk of cancer ACTEMRA may increase your risk of certain cancers by changing the way your immune system works. 12

13 For patients starting on 1 prefilled syringe every 2 weeks, you and your rheumatologist may decide to change your dose to 1 prefilled syringe every week if you aren t getting the results you need. Your doctor may choose to increase, lower, or hold your dose based on other factors, including changes in your blood tests. Before injecting yourself on your own or with the help of a caregiver, your doctor or nurse will train you on how to properly inject ACTEMRA. You or a caregiver should inject for the first time during this training session. Need help with your injection? If this is the first time you re injecting yourself, it s natural to feel a little nervous. That s why we ve created these tools to help you successfully complete the injection process. Steps to Self-Injection portable injection instructions and preparation mat A Patient s Guide to Injecting ACTEMRA a complete instruction handbook 4 Steps to Self-Injection DVD with step-by-step injection instructions Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 13

14 Taking ACTEMRA (cont d) What to expect before, during, and after treatment Now that you and your doctor have decided to start on ACTEMRA SC injections, it s important to know what will happen during your treatment. Keep in mind that everyone reacts differently to ACTEMRA, and it may not be right for all patients. 1 Blood tests When you start taking ACTEMRA, your rheumatologist will do blood tests 4 to 8 weeks after your first injection. He or she will repeat the tests every 3 months to check for changes in your liver function tests, neutrophil count, and platelet counts. Your rheumatologist should also do blood tests to check for changes in other laboratory tests, such as your cholesterol levels. These additional tests will be done 4 to 8 weeks after your first ACTEMRA SC injection, and then every 6 months thereafter. 2 Getting to know your treatment Before you start taking ACTEMRA SC injections, it s important to know all the side effects of ACTEMRA. So make sure to review the ACTEMRA Medication Guide. Especially take note of the What is the most important information I should know about ACTEMRA?, and What should I tell my healthcare provider before receiving ACTEMRA? sections. 3 Your first injection Your rheumatologist or nurse should train you or your caregiver in his or her office on how to properly inject ACTEMRA. During this training session, you or your caregiver should perform the first injection. You should not attempt to inject yourself before receiving this in-office training. Only patients or caregivers who have been properly trained should use the ACTEMRA prefilled syringe. 14

15 4 Weighing in Your initial ACTEMRA dose is based on your weight. Your rheumatologist should weigh you before starting treatment, and at each office visit. If your weight changes, you and your rheumatologist will decide if a change in dose is necessary. 5 Monitoring for side effects at home ACTEMRA may lead to serious allergic reactions, including death. So it s important to pay close attention to how you re feeling during and after an injection. Allergic reactions may happen during and after any injection, even if they have not happened before. Contact 911 immediately, as well as your doctor or nurse, if you experience any of these reactions: Shortness of breath or trouble breathing Swelling of the lips, tongue, or face Chest pain Feeling dizzy or faint Moderate or severe abdominal pain or vomiting Keep in mind Your rheumatologist and nurse are there to help you through the process of injecting at home. If you have any questions about ACTEMRA, don t hesitate to contact them. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 15

16 Important Safety Information After reading about ACTEMRA, please talk to your doctor if you have any questions. ACTEMRA is: Available by medical prescription only For adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief ACTEMRA can cause serious side effects Serious infections 16 ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Before taking ACTEMRA, tell your doctor if you have: An infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Infection signs, with or without a fever, include: - Sweating or chills - Muscle aches - Cough - Shortness of breath - Blood in phlegm (mucus) - Weight loss - Warm, red, or painful skin or sores on your body Any of the following conditions that may give you a higher chance of getting infections. These include: - Diabetes - HIV - A weak immune system Tuberculosis (TB) or have been in close contact with someone who has TB. Your doctor should test you for TB before starting ACTEMRA and during treatment with ACTEMRA Lived in or currently live in parts of the United States known for fungal infections. These parts include the Ohio and Mississippi River Valleys and the Southwest Hepatitis B or have had hepatitis B Be sure to contact your doctor or nurse if you see any signs of these side effects. - Diarrhea or stomach pain - Painful or more frequent urination - Feeling very tired

17 Stomach tears If you have diverticulitis (inflammation in parts of the large intestine), talk to your doctor before taking ACTEMRA. Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your doctor right away if you see any of these side effects: - Fever - Stomach-area pain that does not go away - Change in your bowel habits Changes in blood test results Before starting ACTEMRA, 4 to 8 weeks after starting treatment, and then every 3 months, your doctor will regularly do blood tests to check for the following side effects: Low neutrophil count: Low platelet count: neutrophils are white blood cells that help the body fight infection platelets are blood cells that help with clotting, which stops bleeding Increase in liver function test levels Increase in blood cholesterol levels Neutrophil and platelet counts should not be too low or liver function test levels too high. These may cause your doctor to stop your ACTEMRA treatment for a time or change your dose. Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that. Please see full Prescribing Information and Medication Guide, including Serious Side Effects, for more Important Safety Information. 17

18 Important Safety Information (cont d) Increased risk of cancer ACTEMRA may increase your risk of certain cancers by changing the way your immune system works. Hepatitis B infection If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your doctor should test you for hepatitis B before starting treatment. Tell your doctor right away if you see any signs of these symptoms: Feeling very tired Skin or eyes look yellow Little or no appetite Vomiting Clay-colored bowel movements Fevers Chills Stomach discomfort Muscle aches Dark urine Skin rash Serious allergic reactions Strong allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your doctor or nurse before your next injection. Contact 911 immediately, as well as your doctor or nurse, if you experience any of these reactions: Shortness of breath or trouble breathing Swelling of lips, tongue, or face Chest pain Feeling dizzy or faint Moderate or severe abdominal pain or vomiting Nervous system problems While rare, multiple sclerosis has been diagnosed in some people taking ACTEMRA. 18

19 Common side effects Tell your doctor if you have these or any other side effect that bothers you or does not go away: Upper respiratory tract infections (like common cold and sinus infections) Increased blood pressure (also called hypertension) Headache! Injection site reactions ACTEMRA & pregnancy Tell your doctor if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your doctor should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. To learn more, call or talk to your doctor to register. Reporting side effects Tell your doctor right away if you are experiencing any side effects. You may report side effects to the FDA at FDA-1088 or You may also call Genentech at Please see full Prescribing Information and Medication Guide, including Serious Side Effects, for more Important Safety Information. 19

20 Before I started on ACTEMRA, I felt like my RA was out of control. I feel as though I m finally managing my condition. Important Safety Information Nervous system problems While rare, multiple sclerosis has been diagnosed in some people taking ACTEMRA. Karen, treating her RA with ACTEMRA SC injections

21 Welcome to the ACTEMRA & You patient support program As a patient, you know living with the pain of RA isn t easy. That s why there s the ACTEMRA & You patient support program. If you choose to join, you ll receive our one-of-a-kind treatment tracking journal, and even more features that can help you better manage the challenges of your RA, like: ACTEMRA Travel Pack Sharps container & disposal service Informative newsletters RA-friendly exercise videos RA-friendly recipes Get your free ACTEMRA Travel Kit & free sharps container when you join. Join now by: 1 Filling out the enclosed business reply card OR 2 Calling ACTEMRA ( ) You do not need to be on ACTEMRA to join the ACTEMRA & You patient support program. You can request tools by calling ACTEMRA ( ) from 6 am to 12 am ET. Please keep in mind that no purchase is necessary to join the program. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 21

22 The Genentech Rheumatology Co-pay Card Program Eligible patients receive up to $10,000 per 12-month period. They pay $5 per co-pay until the $10,000 limit is reached. Please visit RACopay.com to learn complete program terms and conditions. Are you eligible? You are eligible if you: Use ACTEMRA (tocilizumab) for the approved RA indication Have commercial (nongovernment-funded) insurance Are over the age of Except, you are not eligible if you: Receive free ACTEMRA from the Genentech Access to Care Foundation (GATCF) or other sources Have a federal or state government-funded health plan. These include Medicare, Medicare Advantage, Medicaid, SCHIP, and TRICARE Live in a state where the program is prohibited by law

23 Important Co-pay Program Information The Genentech Rheumatology Co-pay Card Program is not a benefit plan. This program helps with co-pays for ACTEMRA only. It does not pay for other costs related to the office visit or infusion This program can be used only where the law allows it. It can be used only if you meet the program s rules Genentech reserves the right to refuse to pay. This may be done if you do not qualify for the program. Genentech reserves the right to change or end this program. This may be done in whole or in part, without notice, at any time Using the Genentech Rheumatology Co-pay Card Program does not mean you must keep using ACTEMRA. Also, you do not have to keep seeing the same doctor for treatments. You may stop taking ACTEMRA at any time and for any reason The co-pay card can be used at any doctor s office that takes part in the program. Doctors can enroll at any time If you are a patient who lives in Vermont, visit RACopay.com or call RA-COPAY ( ) to request a card Are you uninsured? The Genentech Access to Care Foundation may be able to help you get your ACTEMRA treatments for free. Please see page 25 for more information. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 23

24 APPLY TODAY You can request a card by doing one of the following: Ask your doctor Call RA-COPAY ( ) Visit RACopay.com Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 24

25 Coverage & Patient Assistance Programs ACT Fast Program If your health plan hasn t decided if it is going to cover ACTEMRA for self-injection, we can help. If you qualify, ACT Fast may provide medicine for free for up to 6 months, or until your health plan provider makes a decision, whichever comes first. To learn more, call ACTEMRA ( ). Genentech Rheumatology Access Solutions Genentech Rheumatology Access Solutions can connect you to the medicine you need if you are concerned about paying for ACTEMRA. We are here to help. Whether you have healthcare coverage or not, we can help by: Finding out if your health plan pays for your medicine Guiding you through the process of getting your medicine Connecting you with our patient assistance programs Enroll now by filling out the PAN (Patient Authorization and Notice of release of information) form in your doctor s office or online at Genentech-Access.com/Rheumatology. 25

26 NOTES: Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 26

27 NOTES: Learning About the Prefilled Syringe 27

28 VISIT ACTEMRA.COM OR CALL ACTEMRA ( ) FOR MORE INFORMATION Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects Genentech USA, Inc. All rights reserved. ACT /14 ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

29 A PATIENT S GUIDE TO INJECTING ACTEMRA USING THE PREFILLED SYRINGE INDICATION ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist. ACTEMRA is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well. IMPORTANT SAFETY INFORMATION ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people taking ACTEMRA have died from these infections. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects, as well as full Instructions for Use.

30 Learning to Self-Inject With the ACTEMRA Prefilled Syringe By choosing ACTEMRA subcutaneous (SC) injections, which are given under the skin, you and your doctor have made an important step in treating your moderate to severe rheumatoid arthritis (RA). We understand that some people may be uncomfortable injecting themselves for the first time. That s why we created this easy-to-follow injection brochure. We hope it will help you or your caregiver feel comfortable and confident using the ACTEMRA prefilled syringe. If you still have questions, our nurses are here to help. Simply call ACTEMRA ( ) today for additional support. Inside You ll Find Information About: Getting to know the ACTEMRA prefilled syringe Preparing for your injection Steps to self-injection Important Safety Information 4 steps to selfinjection 2013 Genentech USA, Inc. All rights reserved. ACT Learn more about the injection process with the 4 Steps to Self-Injection DVD, which is included in this kit. 2

31 Don t be afraid to inject yourself. After training with my nurse and injecting myself a few times, I felt comfortable and confident doing it on my own. Tamala, treating her RA with ACTEMRA SC injections Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects, as well as full Instructions for Use. 3

32 Important Information About the Prefilled Syringe Read and follow the Instructions for Use that come with your ACTEMRA prefilled syringe before you start using it, and each time you get a prescription refill Before you use the ACTEMRA prefilled syringe for the first time, make sure your healthcare provider shows you the way to use it Do not remove the needle cap until you re ready to inject ACTEMRA Do not try to take apart the syringe at any time Do not reuse the same syringe If you feel your ACTEMRA prefilled syringe is damaged or have any other concerns, please call the ACTEMRA Help Line at ACTEMRA ( ) from 6 am to 12 am ET. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects, as well as full Instructions for Use. 4

33 The ACTEMRA Prefilled Syringe Before use Expiration date Trigger Fingers. Do not touch, as this may release the needle shield early. Needle Cap Plunger Needle After use Needle Shield (extended and locked) 5

34 PREPARING FOR YOUR INJECTION A well-lit, clean, flat surface, such as a table A new ACTEMRA prefilled syringe Alcohol pads (available at your local pharmacy) Cotton ball or gauze (available at your local pharmacy) A puncture-resistant container or sharps container Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects, as well as full Instructions for Use. 6

35 My rheumatology nurse walked me through everything, how you insert the needle, clean the injection site, and how to dispose of the needle properly. Sheri, treating her RA with ACTEMRA SC injections 7

36 Steps to Self-Injection STEP 1 PREPARING FOR AN ACTEMRA SC INJECTION Find a comfortable space with a clean, flat, working surface Take the box containing the syringe out of the refrigerator and open the box. Do not touch the trigger fingers on the syringe as this may damage the syringe Remove one single-use ACTEMRA prefilled syringe from the box and let it warm up for 30 minutes to allow it to reach room temperature. If the syringe does not reach room temperature, this could cause your injection to feel uncomfortable and make it difficult to push the plunger in Expiration date on box 30 minutes Do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water Check the expiration date on the ACTEMRA prefilled syringe (see Figure A). Do not use if the expiration date has passed because it may not be safe to use. If the expiration date has passed, safely dispose of the syringe in a sharps container and get a new one FIGURE A Expiration date on syringe 8 Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects.

37 Do not remove the needle cap while allowing your ACTEMRA prefilled syringe to reach room temperature Keep your unused syringes in the original carton and keep in the refrigerator at 36 F-46 F (2 C-8 C). Do not freeze Hold your ACTEMRA prefilled syringe with the covered needle pointing down (see Figure B) Check the liquid in the ACTEMRA prefilled syringe. It should be clear and colorless to pale yellow. Do not inject ACTEMRA if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use. Safely dispose of the syringe in a sharps container and get a new one Wash your hands well with soap and water FIGURE B 9

38 Steps to Self-Injection (continued) STEP 2 CHOOSE AND PREPARE AN INJECTION SITE Choose an injection site The front of your thigh and your abdomen except for the 2-inch area around your navel are the recommended injection sites (see Figure C) The outer area of the upper arms may also be used only if the injection is being given by a caregiver. Do not attempt to use the upper arm area by yourself (see Figure C) Rotate injection site Choose a different injection site for each new injection at least 1 inch from the last area you injected Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or not intact front = injection sites FIGURE C back Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 10

39 Prepare the injection site Wipe the injection site with an alcohol pad in a circular motion and let it air-dry to reduce the chance of getting an infection (see Figure D). Do not touch the injection site again before giving the injection Do not fan or blow on the clean area FIGURE D 11

40 Steps to Self-Injection (continued) STEP 3 INJECT ACTEMRA Hold the ACTEMRA prefilled syringe with one hand and pull the needle cap straight off with your other hand (see Figure E). Do not hold the plunger while you remove the needle cap. If you cannot remove the needle cap, you should ask a caregiver for help or contact your healthcare provider Dispose of the needle cap in a sharps container (see Figure F) There may be a small air bubble in the ACTEMRA prefilled syringe. You do not need to remove it FIGURE E You may see a drop of liquid at the end of the needle. This is normal and will not affect your dose FIGURE F 12

41 Do not touch the needle or let it touch any surfaces Do not use the prefilled syringe if it is dropped If it is not used within 5 minutes of needle cap removal, the syringe should be disposed of in the puncture-resistant container or sharps container, and a new syringe should be used Never reattach the needle cap after removal Hold the ACTEMRA prefilled syringe in one hand between the thumb and index finger (see Figure G) FIGURE G Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 13

42 Steps to Self-Injection (continued) STEP 3 INJECT ACTEMRA (continued) Do not pull back on the plunger of the syringe Use your other hand and gently pinch the area of skin you cleaned. Hold the pinched skin firmly. Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could cause the injection to feel uncomfortable Do not hold or push the plunger while inserting the needle into the skin 90 OK 45 Use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45 and 90 (see Figure H). It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful and the medicine may not work FIGURE H Keep the syringe in position, and let go of the pinched skin 14 Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects.

43 Slowly inject all of the medicine by gently pushing the plunger all the way down (see Figure I). You must press the plunger all the way down to get the full dose of medicine and to ensure the trigger fingers are completely pushed to the side. If the plunger is not fully depressed, the needle shield will not extend to cover the needle when it is removed. If the needle is not covered, carefully place the syringe into the puncture-resistant container to avoid injury with the needle FIGURE I Keep in mind that the ACTEMRA solution in the syringe is thicker than water. It may take some pressure to push the plunger all the way down. 15

44 Steps to Self-Injection (continued) STEP 3 INJECT ACTEMRA (continued) After the plunger is pushed all the way down, keep pressing down on the plunger to be sure all of the medicine is injected before taking the needle out of the skin Keep pressing down on the plunger while you take the needle out of the skin at the same angle as inserted (see Figure J) After the needle is removed completely from the skin, release the plunger, allowing the needle shield to protect the needle (see Figure K) FIGURE J After the injection There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site Do not rub the injection site If needed, you may cover the injection site with a small bandage FIGURE K 16

45 STEP 4 PROPERLY DISPOSE OF THE SYRINGE The ACTEMRA prefilled syringe should not be reused Put the used syringe in your puncture-resistant container (see Figure L) Do not put the needle cap back on the needle FIGURE L See page 21 of A Patient s Guide to the ACTEMRA Prefilled Syringe for more information on joining the ACTEMRA & You patient support program. As a member, you can get a free sharps container and ACTEMRA Travel Pack. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 17

46 Steps to Self-Injection (continued) STEP 4 PROPERLY DISPOSE OF THE SYRINGE (continued) If your injection is given by another person, this person must also be careful when removing the syringe and disposing of the syringe to prevent accidental needle stick injury and passing infection How do I dispose of used syringes? Put your used needles and syringes, including ACTEMRA, in an FDA-cleared sharps disposal container right away after use. Do not dispose of loose needles and syringes in your household trash If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: Made of a heavy-duty plastic Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out Upright and stable during use Leak-resistant Properly labeled to warn of hazardous waste inside the container - When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA s website at 18

47 - Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container Keep ACTEMRA prefilled syringes and the disposal container out of the reach of children Record your injection: Write down the date, time, and specific part of your body where you injected yourself. It may also be helpful to write down any questions or concerns about the injection so you can ask your healthcare provider Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 19

48 Steps to Self-Injection (continued) Patient advice regarding allergic reactions If you develop symptoms such as, but not limited to, skin rash; itching; chills; swelling of face, lips, tongue, or throat; chest pain, wheezing, difficulty breathing or swallowing; or feeling dizzy or faint at any time while not at your doctor s office during or following an ACTEMRA SC injection, you should seek emergency care immediately. Patient advice regarding early recognition and treatment to limit risk of a serious infection Be alert for the first signs of infection such as: Body aches, fever, chills Cough, chest discomfort/tightness, shortness of breath Redness, heat, unusual swelling of skin or joint Abdominal pain, tenderness, and/or change in bowel function Call your doctor and seek medical attention without delay if you think you might be developing an infection. If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance. Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects. 20

49 Keep track of your injections INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: INJECTION DATE: INJECTION LOCATION: 21

50 Important Safety Information After reading about ACTEMRA, please talk to your doctor if you have any questions. ACTEMRA is: Available by medical prescription only For adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief ACTEMRA can cause serious side effects ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people taking ACTEMRA have died from these infections. ACTEMRA can cause other serious side effects These include: Stomach tears Hepatitis B infection Changes in blood test results, including low neutrophil and platelet counts, and increases in certain liver function test levels and blood cholesterol levels An increased risk of certain cancers by changing the way your immune system works Serious allergic reactions, including death. These may happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your doctor or nurse before your next injection Nervous system problems Tell your doctor if you: Are allergic to ACTEMRA, or had a bad reaction to ACTEMRA previously 22

51 Common side effects Tell your doctor if you have these or any other side effect that bothers you or does not go away: Upper respiratory tract infections (like common cold and sinus infections) Increased blood pressure (also called hypertension) Headache! Injection site reactions ACTEMRA & pregnancy Tell your doctor if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your doctor should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. To learn more, call or talk to your doctor to register. Reporting side effects Tell your doctor right away if you are experiencing any side effects. You may report side effects to the FDA at FDA-1088 or You may also call Genentech at Please see full Prescribing Information and Medication Guide, including Serious Side Effects, for more Important Safety Information. Injecting ACTEMRA (tocilizumab) 23

52 VISIT ACTEMRA.COM OR CALL ACTEMRA ( ) FOR MORE INFORMATION Please see Important Safety Information on pages For more Important Safety Information, please see full Prescribing Information and Medication Guide, including Serious Side Effects Genentech USA, Inc. All rights reserved. ACT /14 ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

53 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use Initial U.S. Approval: 2010 WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. (5.1) If a serious infection develops, interrupt ACTEMRA until the infection is controlled. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ACTEMRA. (5.1) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) RECENT MAJOR CHANGES Indications and Usage (1.2) 04/2013 Dosage and Administration (2.1, 2.2, 2.3, 2.5, 2.6, 2.7) 10/2013 Warnings and Precautions (5.3, 5.5) 10/ INDICATIONS AND USAGE ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) (1.1) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease- Modifying Anti-Rheumatic Drugs (DMARDs). Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.2) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis DOSAGE AND ADMINISTRATION ACTEMRA may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used. (2) Rheumatoid Arthritis (2.1) Recommended Adult Intravenous (IV) Dosage: When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response. Recommended Adult Subcutaneous (SC) Dosage: Patients less than 100 kg 162 mg administered subcutaneously every weight other week, followed by an increase to Patients at or above 100 kg weight every week based on clinical response 162 mg administered subcutaneously every week Polyarticular Juvenile Idiopathic Arthritis (2.2) Recommended Intravenous PJIA Dosage Every 4 Weeks Patients less than 30 kg weight 10 mg per kg Patients at or above 30 kg weight 8 mg per kg Systemic Juvenile Idiopathic Arthritis (2.3) Recommended Intravenous SJIA Dosage Every 2 Weeks Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg General Dosing Information (2.4) It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm 3, platelet count below 100,000 per mm 3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). (2.1, 5.3) ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA patients. (2.1, 12.3) Administration of Intravenous formulation (2.5) For adults, PJIA and SJIA patients at or above 30 kg, dilute to 100 ml in 0.9% Sodium Chloride for intravenous infusion using aseptic technique. For PJIA and SJIA patients less than 30 kg, dilute to 50 ml in 0.9% Sodium Chloride for intravenous infusion using aseptic technique. Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push. Administration of Subcutaneous formulation (2.6) Follow the Instructions for Use for prefilled syringe Dose Modifications (2.7) Recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia DOSAGE FORMS AND STRENGTHS Single-use vials of ACTEMRA (20 mg per ml) for intravenous administration: 80 mg per 4 ml (3) 200 mg per 10 ml (3) 400 mg per 20 ml (3) Prefilled Syringe (PFS) for subcutaneous administration: A single use PFS providing 162 mg of ACTEMRA in 0.9mL (3) CONTRAINDICATIONS ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA. (4) WARNINGS AND PRECAUTIONS Serious Infections do not administer ACTEMRA during an active infection, including localized infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. (5.1) Gastrointestinal (GI) perforation use with caution in patients who may be at increased risk. (5.2) Laboratory monitoring recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.7, 5.3) Hypersensitivity reactions, including anaphylaxis and death have occurred. (5.5) Live vaccines Avoid use with ACTEMRA. (5.8, 7.3) ADVERSE REACTIONS Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at or FDA at FDA-1088 or USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 11/2014 1

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