When you need extra help with your rheumatoid arthritis symptoms Ask about adding Acthar. What is Acthar? Acthar is a prescription medicine to be used as a short-term add-on therapy in the event of symptoms suddenly worsening (flare) for rheumatoid arthritis and juvenile rheumatoid arthritis (in some cases, may require low-dose maintenance therapy). Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
What is rheumatoid arthritis? Rheumatoid arthritis (RA) is a disease that causes inflammation, pain, swelling, and permanent damage in your joints. RA can also cause damage to important organs, such as your heart. RA is a common disease that affects nearly three times as many women as men. Unlike the more common osteoarthritis, RA is an autoimmune disease, where your body s immune system attacks bone and tissues in your joints. This can cause pain, stiffness, and joint damage that can make usual daily activities hard or impossible. The symptoms of RA are chronic, meaning that they continue over time. There can be sudden increases in symptoms called flares. Starting treatment early and keeping your symptoms as low as possible can help prevent damage to your joints and organs. Common RA symptoms Tender, warm, swollen joints Morning stiffness that may last for hours Firm bumps of tissue under the skin on your arms (rheumatoid nodules) Pain and fatigue
What are some common treatments for RA? There is no cure for RA, but there are many medicines available to help relieve symptoms and reduce damage. Most RA patients can manage their symptoms with a combination of medicines to help reduce pain and control inflammation. 3 RA and Treatment Some of the treatments available for RA: NSAIDs (non-steroidal anti-inflammatory drugs) Available over the counter (OTC) or by prescription, NSAIDs can help reduce inflammation. Some common NSAIDs are ibuprofen and naproxen sodium Steroids (or corticosteroids) Can help reduce flares of inflammation DMARDs (disease-modifying antirheumatic drugs) Prescription drugs that can help slow the effects of RA. Some common DMARDs are methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine Biologic DMARDs A type of DMARD that works on the immune system to help control inflammation. Biologic DMARDs are only available with a doctor s prescription Melanocortin proteins A type of medicine that potentially works with your immune system to help reduce inflammation and helps the body produce natural steroid hormones that can reduce RA symptoms Different types of RA treatments work by targeting different stages of the disease process to help relieve symptoms and prevent damage Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
When your RA symptoms get worse, adding Acthar may help. RA symptoms can be hard to manage. Even if you ve tried different medicines, adding Acthar to your current RA medicines may help manage your symptoms. Acthar is a prescription medicine that can be added to the medicine that you re already taking for RA to help manage your symptoms temporarily when they get worse or flare up. Acthar ( ak thär) What is Acthar? Acthar is a melanocortin protein that is an FDA-approved treatment for people with RA who are on other RA medicines and are still feeling symptoms or having flares of their disease. Acthar is not a steroid. Acthar contains the hormone ACTH, which stands for adrenocorticotropic (a-dre-no-cor-ti-co-tro-pic) hormone. ACTH occurs naturally in the body. Acthar is given as an injection under the skin (subcutaneously) or in the muscle (intramuscularly) every 1 to 3 days as directed by your healthcare provider on a short-term basis to help manage RA symptoms. In some cases, your healthcare provider may decide that you should take Acthar for a longer period of time. See Taking Acthar on pages 6 7 to learn more about how to administer and store Acthar. Only your doctor can determine if Acthar is right for you.
How can Acthar help? Your doctor may consider Acthar for you if he or she decides that you could possibly benefit from adding another medicine to your RA treatments. Acthar may be able to help when your symptoms are bothering you more or seem to be getting worse (flares). Patients with RA may see improvements in their symptoms when Acthar is added to other RA medicines. Keep in mind that everyone is different, so responses to treatment will vary. Learn more about treatment with Acthar at www.actharra.com. 5 About Acthar How does Acthar work?* Acthar is believed to work differently from other RA medicines. It is believed to work directly with your immune system and have anti-inflammatory properties. Acthar may also help your body produce its own natural steroid hormones to help reduce inflammation.* *While the exact way Acthar works in the body is unknown, further studies are being conducted. This information is based on laboratory data and how it relates to patient benefits is unknown. Selected Important Safety Information You should not take Acthar if you have: Been recently given a vaccine or are about to take one Suspected congenital infections (in children under 2 years of age) A condition where your adrenal glands produce either too much of certain hormones (as with Cushing s syndrome), or not enough (adrenal insufficiency) Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
How is Acthar taken? Acthar is an injection that is given under the skin (subcutaneously) or in the muscle (intramuscularly) every 1 to 3 days as directed by your healthcare provider Acthar should never be given intravenously (into a vein) or by mouth Acthar can be given when and where it is best for you. You can give it to yourself or it can be given by a friend, family member, caregiver, or your doctor Your doctor will advise you on how to inject Acthar and what the appropriate dose is for you You can also have a registered nurse visit you at your home to provide Home Injection Training Services at no cost to you. If you are interested in Home Injection Training Services, ask your healthcare provider or contact the Acthar Support & Access Program (A.S.A.P.) at 1-888-435-2284 for more information For immediate or ongoing support in administering injections, a registered nurse is available 24/7 through the Patient & Acthar Coaching Team (ActharPACT) program. See page 13 for more information Ask your doctor about enrolling in Home Injection Training Services How is Acthar stored? Acthar should be kept refrigerated (36 46 F or 2 8 C) between uses Store Acthar in the refrigerator Acthar is a gel when refrigerated and changes to liquid form at room temperature. Acthar must be removed from the refrigerator and set out at room temperature for 15 30 minutes before the injection is given
What if I miss a dose of Acthar? Talk with your doctor as soon as you realize that you missed a dose Your doctor will let you know when to take the next dose If you have questions about your Acthar dose, talk to your doctor Can I take other medications while taking Acthar? Continue taking your other treatments as prescribed by your doctor Tell your doctor about any other health conditions you may have or medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements 7 Taking Acthar For answers to questions about how to take or store Acthar, contact Mallinckrodt Product Monitoring and Global Medical Information at 1-800-778-7898 Selected Important Safety Information Never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor Never stop treatment suddenly unless your doctor tells you to Try not to miss any scheduled doctor s appointments, as it is important for the doctor to monitor you while taking Acthar Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
How do I find out if Acthar is right for me? Ask your doctor or healthcare provider these questions to help determine if Acthar is right for you: Can Acthar help when my symptoms get worse? What kind of support will I get on Acthar? How often would I take Acthar? How might Acthar work for me? What are the most common side effects of Acthar? I ve never given myself an injection. Who will teach me? In your opinion, am I a candidate for Acthar? Acthar Support & Access Program (A.S.A.P.) offers financial assistance for eligible patients. See pages 10 11 for more information
What are the most common side effects? Common side effects of Acthar may include: Fluid retention Changes in blood sugar Behavior and mood changes Changes in appetite and weight Increased blood pressure These are not all of the possible side effects of Acthar. Remember, everyone responds differently to treatment. Watch for any changes in how you feel and be sure to let your doctor know. He or she may be able to adjust your treatment or find ways to manage any side effects. For more information, ask your doctor, nurse, or pharmacist, or visit www.actharra.com. You may report side effects by calling one of the following: The FDA at 1-800-FDA-1088 Mallinckrodt Product Monitoring and Global Medical Information at 1-800-778-7898 Talk to your healthcare provider about any questions you have about possible side effects with Acthar 9 Talking to Your Doctor Selected Important Safety Information You should not take Acthar if you have: A skin condition called scleroderma Bone density loss or osteoporosis Any infections, including fungal, bacterial, or viral Eye problems, such as ocular herpes simplex Had recent surgery Stomach ulcers or a history of ulcers Heart problems High blood pressure Allergies to pig-derived proteins Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
Is there financial assistance for Acthar? The Acthar Support & Access Program (A.S.A.P.) is a no-cost program that helps you get all the important information you need about cost, insurance coverage, and home delivery. A.S.A.P. works directly with your insurance company to help you get the best coverage at the lowest possible co-pay. A.S.A.P. helps make Acthar affordable for patients by identifying sources of financial assistance including: $0 co-pay for eligible patients with commercial or private insurance* For financial assistance or patient support, contact A.S.A.P. at 1-888-435-2284 or visit www.acthar.com Acthar offered at no cost for eligible uninsured and underinsured patients Other sources of financial assistance for qualified patients in need To learn more about A.S.A.P., visit www.actharra.com or call 1-888-435-2284. Representatives are available Monday through Friday, 8 am 8 pm and Saturday, 9 am 2 pm EST. Find out how you can receive Home Injection Training Services and additional support through ActharPACT on page 13 * The Acthar Commercial Co-pay Assistance Program provides drug co-pay assistance of up to $25,000 per calendar year for eligible patients. This program is not for patients receiving prescription reimbursement under any federal-, state-, or government-funded insurance programs or where prohibited by law. Programs are administered via third-party organization. Programs are administered via independent charitable organization.
Acthar Commercial Co-pay Assistance Program Terms and Conditions: The Acthar Commercial Co-pay Assistance Program provides drug co-pay assistance of up to $25,000 per calendar year for eligible patients This program is valid for eligible, privately insured patients. For more details about the eligibility criteria, see information to the right This program is not valid with Medicare, Medicaid, or other state or federal health programs This program is not valid for uninsured patients Program offer is limited to one per person and is not transferable Patients should consult their insurance provider concerning any limitations that may apply to this program under their insurance policy The program does not represent prescription drug coverage or insurance and is not intended to substitute for such coverage Patients are responsible for any co-payment or co-insurance costs above and beyond the program s annual maximum benefit Void where prohibited by law Not valid outside the United States Mallinckrodt reserves the right to terminate or modify this program at any time without notice Eligibility Criteria: Approved indication US permanent resident Patient (or patient s legal representative) must be 18 years of age or older to opt in to program Commercially or privately insured Not insured by a federal or state healthcare plan or where prohibited by law Selected Important Safety Information 11 Financial Assistance Never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor Never stop treatment suddenly unless your doctor tells you to Try not to miss any scheduled doctor s appointments, as it is important for the doctor to monitor you while taking Acthar Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
How do I get started on Acthar? You can only get Acthar through a specialty pharmacy that will arrange delivery directly to you. The specialty pharmacy will contact you to get information and schedule delivery At the time of your first Acthar prescription and each refill, you may receive calls from the specialty pharmacy to make sure your needs are met It s important to answer these calls and speak to the specialist to make sure that you receive your Acthar prescription accurately and on time Even if caller ID lists the number as unknown or blocked, it may be a call about Acthar support You must be available at the time of delivery to receive your prescription and provide a signature. You can arrange to have your Acthar delivered to your healthcare provider s office or an alternate address if necessary Acthar will need to be refrigerated promptly after delivery If you need immediate answers to questions about the storage of Acthar, contact Mallinckrodt Product Monitoring and Global Medical Information at 1-800-778-7898. Getting your medication through A.S.A.P. Your healthcare provider sends your Acthar prescription to A.S.A.P. A.S.A.P. works with your insurance company and a specialty pharmacy You receive a call A.S.A.P. may call for information Acthar is delivered The specialty pharmacy to your door will call to schedule delivery Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information.
How do I learn how to take Acthar? You can have a licensed nurse visit you at your home to provide Home Injection Training Services to you or a caregiver. This service is provided at no cost to you and is made available by the maker of Acthar. If you are interested in Home Injection Training Services, be sure to let your healthcare provider know. Call A.S.A.P. at 1-888-435-2284 to learn more. Ask your doctor about enrolling in Home Injection Training Services What if I have questions or need support along the way? The Patient & Acthar Coaching Team (ActharPACT) is a no-cost service that provides personalized support from a registered nurse to help you with your Acthar treatment. When you sign up with ActharPACT, you will receive a personal PACT nurse who s available 24/7 Talk to your PACT nurse at any time about Acthar treatment and any challenges that may come up Schedule regular calls with your PACT nurse at a time and frequency that s best for you throughout the course of your treatment Receive educational materials and ongoing support through text, email, mail, or online, with the ability to cancel service at any time Phone coaching services are available in over 20 languages* To sign up for ActharPACT, visit www.actharpactrheum.com or call 1-877-546-PACT (7228). 13 Getting Started & Patient Support * Phone translation services available for all languages may vary for unscheduled calls. To ensure availability, it is best to request the service when enrolling.
Important Safety Information Who should NOT take Acthar? You should not take Acthar if you have: A skin condition called scleroderma Bone density loss or osteoporosis Any infections, including fungal, bacterial, or viral Eye problems, such as ocular herpes simplex Had recent surgery Stomach ulcers or a history of ulcers Heart problems High blood pressure Allergies to pig-derived proteins Been recently given a vaccine or are about to take one Suspected congenital infections (in children under 2 years of age) A condition where your adrenal glands produce either too much of certain hormones (as with Cushing s syndrome), or not enough (adrenal insufficiency) Tell your doctor if you have any of these conditions or any other health problems. Also, share with your doctor what medicines you are taking. Don t forget to mention nonprescription medicines, vitamins, and herbal supplements. What is the most important information I should know about Acthar? Never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor Never stop treatment suddenly unless your doctor tells you to Try not to miss any scheduled doctor s appointments, as it is important for the doctor to monitor you while taking Acthar Acthar can cause side effects similar to those with steroid treatments. While taking Acthar, tell your doctor right away if you have any of the symptoms listed here: Increased risk of infections. You may be more likely to get new infections. Also, old infections may become active. Before and during treatment, tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores Adrenal gland changes. When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol, which may cause symptoms of Cushing s syndrome, such as upper body fat, rounded moon face, bruising easily, or muscle weakness Sometimes when you stop taking Acthar long term, your body may not produce enough cortisol on its own. This is called adrenal insufficiency. Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers Increased blood pressure, body salt, and fluid levels. Your doctor may check your blood pressure while you are being treated with Acthar. He or she may recommend some changes to your diet, such as eating less salt and taking certain supplements Unpredictable response to vaccines. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
Masking other conditions. Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on Stomach or intestinal problems. Acthar may put you at increased risk for bleeding from the stomach or getting stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate Changes in mood or behavior. Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping Worsening of other medical conditions. If you have other conditions, such as diabetes or muscle weakness, you may find they get worse Eye problems. It s possible that you may develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage Allergic reactions. Your body may develop antibodies or become sensitive when Acthar is used long term. Signs of allergic reaction in children are: Skin rash Swelling of the face, tongue, lips, or throat Trouble breathing Problems with growth and physical development. Using Acthar long term can affect growth and physical development in children. This can be reversed when Acthar is no longer needed Bone density loss. Acthar may cause osteoporosis at any age Potential harm to unborn baby. Tell your doctor if you are pregnant or plan on becoming pregnant What are the most common side effects of Acthar? The most common side effects of Acthar are similar to those of steroids. They include: Fluid retention Behavior and mood Changes in blood sugar changes Increased blood pressure Changes in appetite and weight Specific side effects in children under 2 years of age include: Increased risk of infections Increased blood pressure Irritability Symptoms of Cushing s syndrome Cardiac hypertrophy (thickening of the heart muscle) Weight gain The above side effects may also be seen in adults and children over 2 years of age. These are not all of the possible side effects of Acthar. Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898. Please see the accompanying full Prescribing Information. 15 Important Safety Information
Talk to your doctor to see if Acthar could help you manage your rheumatoid arthritis symptoms. To hear about other patients experience with Acthar or to become a patient ambassador, visit www.actharra.com. Selected Important Safety Information The most common side effects of Acthar are similar to those of steroids. They include: Fluid retention Behavior and mood changes Changes in blood sugar Increased blood pressure Changes in appetite and weight Please see the Important Safety Information on pages 14 15. Please see the accompanying full Prescribing Information. Mallinckrodt, the M brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. 2015 Mallinckrodt. PM-01-18-2208 08/15 Printed in USA