there s a new option for migraine prevention

Transcription

1 there s a new option for migraine prevention Approved Use Aimovig (erenumab-aooe) is a prescription medicine used for the preventive treatment of migraine in adults. Important Safety Information The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages 10-11

2 Aimovig is here For adults with migraine, there s a new preventive treatment that can help. Aimovig is designed for the prevention of migraine. Aimovig is a type of treatment that works by blocking Calcitonin Gene-Related Peptide (CGRP) receptors. Important Safety Information The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages

3 In clinical studies, Aimovig patients reduced their monthly migraine days Aimovig cut the number of monthly migraine days by 50% or more for some patients See Aimovig.com for more information. Important Safety Information The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages 10-11

4 taking Aimovig once a month Aimovig is a self-injection that s taken as 1 dose, once a month. Injections are administered using the Aimovig SureClick autoinjector. To see a demonstration and learn more about Aimovig, go to aimovig.com/demo If your healthcare provider prescribes you the 70 mg dose, take 1 injection. If your healthcare provider prescribes you the 140 mg dose, take 2 separate injections, one after another, using a different prefilled autoinjector for each injection. Important Safety Information Before injecting yourself for the first time, it is important that your healthcare provider show you how, and that you read and understand the Instructions for Use included with your Aimovig medication packaging. The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages

5 how Aimovig works It has been shown that Calcitonin Gene-Related Peptide (CGRP) receptors may play a role in migraine. Aimovig is a preventive treatment designed to target and block CGRP receptors to help prevent migraine. CGRP CGRP receptor Aimovig In your body, you have CGRP and CGRP receptors CGRP attaches to and activates the receptor, and may play a key role in migraine Aimovig blocks the CGRP receptor so CGRP cannot attach to it Aimovig is the first and only preventive migraine treatment designed to block the CGRP receptor. Important Safety Information The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages

6 important safety information Before starting Aimovig, tell your healthcare provider about all your medical conditions, including if you are allergic to rubber or latex, pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. Tell your healthcare provider or pharmacist about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. What are possible side effects of Aimovig? The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Aimovig. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit or call FDA Please see accompanying Aimovig full Prescribing Information, including the Patient Product Information in the back cover pocket

7 12 We re here for you get started with personalized product support from Aimovig Ally. If you have product support questions, we have answers Simply call our Aimovig Ally support team at 833-AIMOVIG ( ), Monday - Friday, 8 am - 8 pm ET Important Safety Information The most common side effects of Aimovig are pain, redness, or swelling at the injection site and constipation. Please see additional Important Safety Information on pages Start now Once you ve been prescribed Aimovig, we ve made it simple to get started quickly. Just one form gives you access to all Aimovig Ally has to offer. You ll also receive a helpful welcome packet with resources to get you started. You have options Our Copay Program can help with out-ofpocket costs if you have commercial insurance and meet the eligibility criteria. We can also help answer your questions about insurance coverage and help identify other resources if you have a financial need. Personalized for you Our support team is your ally. We re here to answer your questions about Aimovig and help you with resources. We offer one-on-one injection demonstrations, such as live video chats. Stay on track Count on us to be a friendly voice during your Aimovig experience. From educational materials to helpful resources and reminders, our support team is here for you. 13

8 Try Aimovig for 2 months at no cost * Talk to your healthcare provider to see if Aimovig is right for you. * Free trial is optional and available at no cost to patients new to Aimovig. Patients are eligible to receive two doses of Aimovig dispensed directly from the Aimovig Ally pharmacy. Doses are delivered on a monthly basis and will be coordinated with the patient. If the dose changes, please contact the Program. No purchase required. Patient may only redeem this offer once. This free trial is not health insurance and is not contingent on or a guarantee of insurance coverage. Trial product cannot be submitted for reimbursement under any healthcare program. Limitations may apply. Not available to residents of Massachusetts. Novartis Pharmaceuticals Corporation and Amgen reserve the right to rescind, revoke, or amend this offer without notice. Enrollment must occur by 12/31/

9 pay as little as $5 per month The Aimovig TM Copay Program can help lower your out-of-pocket costs if you have commercial insurance and meet the eligibility criteria. With this program, you can pay as little as $5 per month up to a $2,700 annual maximum. Program details: With the Aimovig Copay Program, eligible patients may pay as little as $5 out-of-pocket up to a $2700 annual maximum. This applies to deductible, co-insurance, and copayments for Aimovig The offer is valid for unlimited uses provided the patient re-enrolls. A valid Prescriber ID # is required on the prescription The program provides out-of-pocket assistance for a patient in a 1-year period dating from initial activation. Patient is responsible for costs above the annual maximum Patient may use the card each time the patient fills an Aimovig prescription In order to remain eligible, the patient must renew participation in the program every 12 months by visiting or calling 833-AIMOVIG ( ) Eligibility criteria: Patient must be prescribed Aimovig The Aimovig Copay Program is available to patients with commercial insurance and 18 years or older The program is not open to patients receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE or where prohibited by law. If at any time patients begin receiving coverage under any such federal-, state-, or government-funded healthcare program, patients will no longer be able to use this card and patient must call 833-AIMOVIG to stop participation Patients may not seek reimbursement for value received from the Aimovig Co-Pay Program from any third-party payers, including flexible spending accounts or healthcare savings accounts The program is only valid in the United States, Puerto Rico and the US territories. Other Restrictions may apply. The offer is subject to change or discontinuation without notice This is not health insurance 16 17

10 our mission taking on migraine together Living with migraine means living with devastating physical attacks. But it also means living with misconceptions, stereotypes, and judgment. So we made it our mission to be there with you, through outreach, education, and support that will challenge public perceptions and make the world a more migraine-friendly place. It ll take time and effort. Real change always does. But by standing with you, we can do this, together

11 is Aimovig right for you? It s time to talk to your doctor about Aimovig Amgen Inc. All rights reserved. USA-334C-80002

12 Patient Information AIMOVIG TM (AIM-oh-vig) (erenumab-aooe) injection, for subcutaneous use What is AIMOVIG? AIMOVIG is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if AIMOVIG is safe and effective in children under 18 years of age. Before you start using AIMOVIG, tell your healthcare provider about all your medical conditions, including if you are: Allergic to rubber or latex. The needle shield within the white cap of the single-dose prefilled SureClick autoinjectors and the gray needle cap of the single-dose prefilled syringes contain dry natural rubber. Pregnant or plan to become pregnant. It is not known if AIMOVIG will harm your unborn baby. Breastfeeding or plan to breastfeed. It is not known if AIMOVIG passes into your breast milk. You and your healthcare provider should decide if you will take AIMOVIG or breastfeed. Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. How should I take AIMOVIG? See the detailed Instructions for Use on complete information on how to take AIMOVIG. Take AIMOVIG exactly as your healthcare provider tells you to take it. Before you inject, always check the label of your single-dose prefilled autoinjector or single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AIMOVIG. AIMOVIG is injected under your skin (subcutaneously) 1 time each month. AIMOVIG comes in 2 different types of devices: a single-dose (1 time) prefilled autoinjector or a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you. o If your healthcare provider prescribes the 70 mg dose for you, take 1 injection. o If your healthcare provider prescribes the 140 mg dose for you, take 2 separate injections one after another, using a different prefilled autoinjector or prefilled syringe for each injection. If you want to use the same body site for the two separate injections, make sure the second injection it is not at the same spot you used for the first injection. If you forget to take AIMOVIG or are not able to take the dose at the regular time, take your missed dose as soon as you remember. After that, you can continue to take AIMOVIG 1 time each month from the date of your last dose. What are possible side effects of AIMOVIG? The most common side effects of AIMOVIG include: pain, redness, or swelling at the injection site and constipation. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of AIMOVIG. Ask your pharmacist or healthcare provider for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at FDA You may also report side effects to Amgen at AMGEN ( ). How should I store AIMOVIG? Store AIMOVIG in the refrigerator between 36 F to 46 F (2 C to 8 C). Keep AIMOVIG in the original carton. This will protect the medicine from light. After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68 F to 77 F (20 C to 25 C) for up to 7 days. Throw away AIMOVIG that has been left at room temperature for more than 7 days. Do not freeze. Do not shake. Keep AIMOVIG and all medicines out of the reach of children. General information about the safe and effective use of AIMOVIG. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AIMOVIG for a condition for which it is not prescribed. Do not give AIMOVIG to other people, even if they have the same symptoms that you have. It can harm them. You can ask your pharmacist or healthcare provider for information about AIMOVIG that is written for healthcare professionals. What are the ingredients in AIMOVIG? Active Ingredient: erenumab-aooe Inactive Ingredients: acetate, polysorbate 80, and sucrose. 1

13 AIMOVIG (erenumab-aooe) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA USA U.S. License No Marketed by: Amgen Inc. (Thousand Oaks, CA 91320), and Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936) Patent: Amgen Inc. All rights reserved. For more information, go to or call AMGEN ( ). This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: 05/2018 v1 2

14 Instructions for Use AIMOVIG TM (AIM-oh-vig) (erenumab-aooe) Injection, For Subcutaneous Use Single-Dose Prefilled SureClick Autoinjector Guide to parts Before use After use Purple start button Expiration Date Expiration Date Window Yellow window (injection complete) Medicine White cap on Green safety guard White cap off Important: Needle is inside 1

15 Important Before you use AIMOVIG SureClick autoinjector, read this important information: Storing your AIMOVIG SureClick autoinjector Keep the autoinjector out of the reach of children. Keep the autoinjector in the original carton to protect from light. The autoinjector should be kept in the refrigerator at 36 F to 46 F (2 C to 8 C). After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68 F to 77 F (20 C to 25 C) for up to 7 days. Throw away AIMOVIG that has been left at room temperature for more than 7 days. Do not freeze. Using your AIMOVIG SureClick autoinjector The needle shield within the white cap of the AIMOVIG autoinjector contains dry natural rubber, which is made from latex. Tell your healthcare provider if you are allergic to latex. It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. Do not use the autoinjector after the expiration date on the label. Do not shake the autoinjector. Do not remove the white cap from the autoinjector until you are ready to inject. Do not freeze or use the autoinjector if it has been frozen. Do not use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call AMGEN ( ). 2

16 Step 1: Prepare Read this before you inject. Check your prescription. AIMOVIG comes as a single-dose (1 time) prefilled autoinjector. Your healthcare provider will prescribe the dose that is best for you. If your healthcare provider prescribes the 70 mg dose for you, take 1 injection, using a prefilled autoinjector. If your healthcare provider prescribes the 140 mg dose for you, take 2 separate injections one after another, using a different prefilled autoinjector for each injection. Before you inject, always check the label of your single-dose prefilled autoinjector to make sure you have the correct medicine and the correct dose of AIMOVIG. A Remove autoinjector from the carton. You may need to use more than 1 autoinjector based on your prescribed dose. Carefully lift the autoinjector straight up out of the carton. Leave the autoinjector at room temperature for at least 30 minutes before injecting. Do not put the autoinjector back in the refrigerator after it has reached room temperature. Do not try to warm the autoinjector by using a heat source such as hot water or microwave. Do not leave the autoinjector in direct sunlight. Do not shake the autoinjector. Do not remove the white cap from the autoinjector yet. 3

17 B Inspect the autoinjector. White cap on Window Medicine Make sure the medicine in the window is clear and colorless to slightly yellow. Do not use the autoinjector if the medicine is cloudy or discolored or contains flakes or particles. Do not use the autoinjector if any part appears cracked or broken. Do not use the autoinjector if the autoinjector has been dropped. Do not use the autoinjector if the white cap is missing or not securely attached. Do not use the autoinjector if the expiration date printed on the label has passed. In all cases, use a new autoinjector, and call AMGEN ( ). C Gather all materials needed for your injection. Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the: New autoinjector Alcohol wipes Cotton balls or gauze pads Adhesive bandages Sharps disposal container 4

18 D Prepare and clean your injection site. Upper arm Stomach area (abdomen) Thigh You can use: Your thigh Stomach area (abdomen), except for a 2 inch area right around your navel Outer area of upper arm (only if someone else is giving you the injection) Clean your injection site with an alcohol wipe. Let your skin dry. Do not touch this area again before injecting. If you want to use the same body site for the two separate injections needed for the 140 mg dose, make sure the second injection is not at the same spot you used for the first injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks. Step 2: Get ready E Pull the white cap straight off, only when you are ready to inject. Do not leave the white cap off for more than 5 minutes. This can dry out the medicine. It is normal to see a drop of liquid at the end of the needle or green safety guard. Do not twist or bend the white cap. Do not put the white cap back onto the autoinjector. Do not remove the white cap from the autoinjector until you are ready to inject. 5

19 F Stretch or pinch your injection site to create a firm surface. Stretch method Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide. Pinch method Pinch skin firmly between your thumb and fingers, creating an area about 2 inches wide. Important: Keep skin stretched or pinched while injecting. 6

20 Step 3: Inject G Hold the stretch or pinch. With the white cap off, place the autoinjector on your skin at 90 degrees. Important: Do not touch the purple start button yet. H Firmly push the autoinjector down onto skin until the autoinjector stops moving. Push down Important: You must push all the way down but do not touch the purple start button until you are ready to inject. I When you are ready to inject, press the purple start button. You will hear a click. 7

21 J Keep pushing down on your skin. Your injection could take about 15 seconds. When the injection is complete, you may hear or feel a click and the window will turn yellow. 15 seconds Window turns yellow when injection is done Note: After you remove the autoinjector from your skin, the needle will be automatically covered. Important: When you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Call your healthcare provider immediately. Step 4: Finish K Discard the used autoinjector and the white cap. Put the used AIMOVIG autoinjector and white cap in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the SureClick autoinjector in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: Made of a heavy-duty plastic 8

22 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 throw away 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: Do not reuse the autoinjector. Do not recycle the autoinjector or sharps disposal container or throw them into household trash. Important: Always keep the sharps disposal container out of the reach of children. L Examine the injection site. If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed. M Check your prescription. If your dose is 140 mg, repeat Steps 1 through 4. The second injection will complete your dose. Commonly asked questions What will happen if I press the purple start button before I am ready to do the injection on my skin? Even when you press the purple start button, the injection will only happen when the green safety guard is also pushed into the autoinjector. Can I move the autoinjector around on my skin while I am choosing an injection site? It is okay to move the autoinjector around on the injection site as long as you do not press the purple start button. However, if you press the purple start button and the green safety guard is pushed into the autoinjector, the injection will begin. Can I release the purple start button after I start my injection? You can release the purple start button, but continue to hold the autoinjector firmly against your skin during the injection. Will the purple start button pop up after I release my thumb? The purple start button may not pop up after you release your thumb if you held your thumb down during the injection. This is okay. What do I do if I did not hear a click after pushing the device down on my skin for 15 seconds? If you did not hear a click, you can confirm a complete injection by checking that the window has turned yellow. Whom do I contact if I need help with the autoinjector or my injection? 9

23 If you need more information or help, visit or call AMGEN ( ). For more information, go to or call AMGEN ( ). AIMOVIG (erenumab-aooe) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA USA U.S. License No Marketed by: Amgen Inc. (Thousand Oaks, CA 91320), and Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936) 2018 Amgen Inc. All rights reserved. Symbol table This product contains dry natural rubber Do not reuse CAUTION, consult accompanying documents Lot number This Instructions for Use has been approved by the U.S. Food and Drug Association. Approved: 05/2018 v1 10